[House Hearing, 116 Congress]
[From the U.S. Government Publishing Office]
HEARING ON PROTECTING SCIENTIFIC INTEGRITY
IN THE COVID-19 RESPONSE
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED SIXTEENTH CONGRESS
SECOND SESSION
__________
MAY 14, 2020
__________
Serial No. 116-110
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Energy and Commerce
govinfo.gov/committee/house-energy
energycommerce.house.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
53-689 PDF WASHINGTON : 2024
-----------------------------------------------------------------------------------
COMMITTEE ON ENERGY AND COMMERCE
FRANK PALLONE, Jr., New Jersey
Chairman
BOBBY L. RUSH, Illinois GREG WALDEN, Oregon
ANNA G. ESHOO, California Ranking Member
ELIOT L. ENGEL, New York FRED UPTON, Michigan
DIANA DeGETTE, Colorado JOHN SHIMKUS, Illinois
MIKE DOYLE, Pennsylvania MICHAEL C. BURGESS, Texas
JAN SCHAKOWSKY, Illinois STEVE SCALISE, Louisiana
G. K. BUTTERFIELD, North Carolina ROBERT E. LATTA, Ohio
DORIS O. MATSUI, California CATHY McMORRIS RODGERS, Washington
KATHY CASTOR, Florida BRETT GUTHRIE, Kentucky
JOHN P. SARBANES, Maryland PETE OLSON, Texas
JERRY McNERNEY, California DAVID B. McKINLEY, West Virginia
PETER WELCH, Vermont ADAM KINZINGER, Illinois
BEN RAY LUJAN, New Mexico H. MORGAN GRIFFITH, Virginia
PAUL TONKO, New York GUS M. BILIRAKIS, Florida
YVETTE D. CLARKE, New York, Vice BILL JOHNSON, Ohio
Chair BILLY LONG, Missouri
DAVID LOEBSACK, Iowa LARRY BUCSHON, Indiana
KURT SCHRADER, Oregon BILL FLORES, Texas
JOSEPH P. KENNEDY III, SUSAN W. BROOKS, Indiana
Massachusetts MARKWAYNE MULLIN, Oklahoma
TONY CARDENAS, California RICHARD HUDSON, North Carolina
RAUL RUIZ, California TIM WALBERG, Michigan
SCOTT H. PETERS, California EARL L. ``BUDDY'' CARTER, Georgia
DEBBIE DINGELL, Michigan JEFF DUNCAN, South Carolina
MARC A. VEASEY, Texas GREG GIANFORTE, Montana
ANN M. KUSTER, New Hampshire
ROBIN L. KELLY, Illinois
NANETTE DIAZ BARRAGAN, California
A. DONALD McEACHIN, Virginia
LISA BLUNT ROCHESTER, Delaware
DARREN SOTO, Florida
TOM O'HALLERAN, Arizona
------
Professional Staff
JEFFREY C. CARROLL, Staff Director
TIFFANY GUARASCIO, Deputy Staff Director
MIKE BLOOMQUIST, Minority Staff Director
Subcommittee on Health
ANNA G. ESHOO, California
Chairwoman
ELIOT L. ENGEL, New York MICHAEL C. BURGESS, Texas
G. K. BUTTERFIELD, North Carolina, Ranking Member
Vice Chair FRED UPTON, Michigan
DORIS O. MATSUI, California JOHN SHIMKUS, Illinois
KATHY CASTOR, Florida BRETT GUTHRIE, Kentucky
JOHN P. SARBANES, Maryland H. MORGAN GRIFFITH, Virginia
BEN RAY LUJAN, New Mexico GUS M. BILIRAKIS, Florida
KURT SCHRADER, Oregon BILLY LONG, Missouri
JOSEPH P. KENNEDY III, LARRY BUCSHON, Indiana
Massachusetts SUSAN W. BROOKS, Indiana
TONY CARDENAS, California MARKWAYNE MULLIN, Oklahoma
PETER WELCH, Vermont RICHARD HUDSON, North Carolina
RAUL RUIZ, California EARL L. ``BUDDY'' CARTER, Georgia
DEBBIE DINGELL, Michigan GREG GIANFORTE, Montana
ANN M. KUSTER, New Hampshire GREG WALDEN, Oregon (ex officio)
ROBIN L. KELLY, Illinois
NANETTE DIAZ BARRAGAN, California
LISA BLUNT ROCHESTER, Delaware
BOBBY L. RUSH, Illinois
FRANK PALLONE, Jr., New Jersey (ex
officio)
C O N T E N T S
----------
Page
Hon. Anna G. Eshoo, a Representative in Congress from the State
of California, opening statement............................... 1
Prepared statement........................................... 3
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, opening statement.............................. 4
Prepared statement........................................... 5
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 7
Prepared statement........................................... 8
Hon. Greg Walden, a Representative in Congress from the State of
Oregon, opening statement...................................... 11
Prepared statement........................................... 13
Witnesses
Richard A. Bright, Ph.D., Senior Advisor, National Institutes of
Health......................................................... 15
Prepared statement........................................... 17
Mike L. Bowen, Executive Vice President of Prestige Ameritech of
North Richland Hills........................................... 85
Prepared statement........................................... 87
Answers to submitted questions............................... 301
Submitted Material
Letter of May 11, 2020, to Ms. Eshoo, on SUD, from Mr. Burgess,
submitted by Mr. Burgess....................................... 130
Letter of May 12, 2020, to Ms. Eshoo, on Dr. Bright, from Mr.
Burgess, submitted by Mr. Burgess.............................. 135
Letter of May 12, 2020, to Ms. Eshoo, on Gaps in Overcomes
Demands from Mr. Burgess, submitted by Mr. Burgess............. 140
Letter of May 13, 2020, to Ms. Eshoo, on Strategic National
Stockpile, from Mr. Burgess, submitted by Mr. Burgess.......... 143
Letter of May 13, 2020, to Ms. Eshoo, on Testing and PPE Demand,
from Mr. Burgess, submitted by Mr. Burgess..................... 146
Letter of May 8, 2020, to Ms. Eshoo, on SNS, from Mr. Burgess,
submitted by Mr. Burgess....................................... 150
Letter of May 10, 2020, to Mr. Burgess, from Ms. Eshoo, submitted
by Ms. Eshoo................................................... 153
Letter of May 12, 2020, to Mr. Burgess, from Ms. Eshoo, submitted
by Ms. Eshoo................................................... 154
Letter of May 13, 2020, to Mr. Burgess, from Ms. Eshoo, submitted
by Ms. Eshoo................................................... 157
Article of January 30, 2020, ``House panel plans coronavirus
hearing, citing public anxiety,'' Politico article entitled,
submitted by Mr. Burgess....................................... 158
SES, PMAP of May 2019, submitted by Ms. Eshoo.................... 159
Report of October 2019, ``Global Health Security Index: Building
Collective Action and Accountability,'' from NTI, Johns Hopkins
University, submitted by Mr. Eshoo \1\
Article of May 2020, ``HHS Vaccine Expert to Detail Complaint in
House Testimony,'' Wall Street Journal, submitted by Ms. Eshoo. 170
----------
\1\ The information has been retained in committee files and also
is available at https://docs.house.gov/meetings/IF/IF14/
20200514/110967/HHRG-116-IF14-20200514-SD014.pdf.
Article of March 15, 2020, ``A Complete List of Trump's Attempts
to Play Down Coronavirus,'' New York Times, submitted by Ms.
Eshoo.......................................................... 173
Article of May 2020, ``A nurse without an N95 mask raced in to
treat a `code blue' patient, L. A. Times, submitted by Ms.
Eshoo.......................................................... 181
Tweet of March 19, 2020, from Bayer US, submitted by Ms. Eshoo... 189
Article of April 27, 2020, ``State Department says coronavirus
samples from China `critical' for developing vaccine; Experts
say that's not the case,'' CBS News, submitted by Ms. Eshoo.... 191
Report of April 14, 2020, ``Characteristics of Health Care
Personnel with COVID-19, United States,'' CDC, Morbidity and
Mortality Weekly, submitted by Ms. Eshoo....................... 197
Article of May 14, 2020, ``Colleagues paint a mixed picture of
ousted vaccine chief,'' by Dan Diamond, Politico, submitted by
Ms. Eshoo \2\
Article of April 7, 2020, ``Communities of Color at Higher Risk
for Health and Economic Challenges due to COVID-19,'' Kaiser
Family Foundation, submitted by Ms. Eshoo...................... 202
Update of May 13, 2020, COVID-19 Coronvirus Pandemic, from
Worldmeter, submitted by Ms. Eshoo \3\
Article of May 7, 2020, ``FDA Pulls Approval for Dozens of Mask
Makers in China'' by Austen Hufford and Mark Maremont, Wall
Street Journal, submitted by Ms. Eshoo......................... 213
Article of April 22, 2020, ``Health Chief's Early Missteps Set
Back Coronavirus Response'' by Rebecca Ballhaus and Stephanie
Armour, Wall Street Journal, submitted by Ms. Eshoo............ 216
Report of February 27, 2020, ``Here's the Johns Hopkins study
President Trump referenced in his coronavirus news conference''
Johns Hopkins University HUB, submitted by Ms. Eshoo........... 226
Letter of May 12, 2020, to Mr. Bright, by Jacob B. Land, OSC,
submitted by Ms. Eshoo......................................... 230
Letter of May 14, 2020, to Ms. Eshoo and Mr. Burgess, from Jaime
Pia Cortes, Executive President, Puerto Rico Hospital
Association, submitted by Ms. Eshoo............................ 232
Fact of May 13, 2020, ``President Donald J. Trump is Committed to
Providing Support to Underserved Communities Impacted by the
Coronavirus Pandemic,'' submitted by Ms. Eshoo................. 236
Statement from CARES, submitted by Ms. Eshoo..................... 239
Article of April 14, 2020, ``The Huge Cost of Waiting to Contain
the Pandemic,'' by Britta L. Jewell and Nicholas P. Jewell, New
York Times, submitted by Ms. Eshoo............................. 250
Fact of May 11, 2020, ``The United States has Built the World's
Leading Coronavirus Testing System,'' submitted by Ms. Eshoo... 255
Release of April 11, 2020, ``The White House has invoked the
Defense Production Act to produce over 39 million N95 masks
over the next 90 days'' submitted by Ms. Eshoo................. 257
Remarks of May 13, 2020, ``President Trump, Vice President Pence,
and Members of the Coronavirus Task Force in Press Briefing,''
by James S. Brady, White House Briefing, submitted by Ms. Eshoo
\4\
Article of May 14, 2020, ``Top Trump critic will testify before a
chairwoman who is a close ally,'' by Dan Diamond, Politico,
submitted by Ms. Eshoo......................................... 259
----------
\2\ The information has been retained in committee files and also
is available at https://docs.house.gov/meetings/IF/IF14/
20200514/110967/HHRG-116-IF14-20200514-SD021.pdf.
\3\ The information has been retained in committee files and also
is available at https://docs.house.gov/meetings/IF/IF14/
20200514/110967/HHRG-116-IF14-20200514-SD023.pdf.
\4\ The information has been retained in committee files and also
is available at https://docs.house.gov/meetings/IF/IF14/
20200514/110967/HHRG-116-IF14-20200514-SD031.pdf.
Statement of Alex Azar, submitted by Ms. Eshoo \5\
Article of April 15, 2020, ``True Toll of COVID-19 on U.S. Health
Care Workers Unknown,'' by Christina Jewett and Liz Szabo,
Kaiser Health News, submitted by Ms. Eshoo..................... 267
Article ``Trump administration pushed use of remdesivir, but
unequal rollout angers doctors,'' by Christopher Rowland,
submitted by Ms. Eshoo......................................... 270
Article of May 11, 2020, ``Trump's White House banner claims,
America leads the world in testing,'' That's wrong, by German
Lopez, VOX, submitted by Ms. Eshoo............................. 274
Article of May 14, 2020, ``U.S. medical stockpile wasn't built to
handle current crisis, former director says,'' Politico,
submitted by Ms. Eshoo......................................... 279
Article of May 4, 2020, ``The coronavirus pandemic is pushing
America into a mental health crisis, by William Wan,'' The
Washington Post, submitted by Ms. Eshoo........................ 285
Article of Feb 13, 2020, ``Will the New Coronavirus `Go Away' in
April?,'' submitted by Ms. Eshoo............................... 292
Report of April 7, 2020, ``States Competing in `Global Jungle'
for PPE,'' by Andrew Soergel, Senior Writer, Economics, U.S.
News & World Report submitted by Mr. Lujan..................... 296
Letter of February 15, 2020, to Laura Wolf and Rick Bright, by
Mike Bowen, Prestige Ameritech, submitted by Mr. Walden........ 299
----------
\5\ The information has been retained in committee files and
also is available at https://docs.house.gov/meetings/IF/IF14/
20200514/110967/HHRG-116-IF14-20200514-SD036.pdf.
HEARING ON PROTECTING SCIENTIFIC INTEGRITY IN THE COVID-19 RESPONSE
----------
THURSDAY, MAY 14, 2020
House of Representatives,
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:03 a.m., in
the John D. Dingell, Room 2123, Rayburn House Office Building,
Hon. Anna G. Eshoo (chairwoman of the subcommittee) presiding.
Members present: Representatives Eshoo, Engel, Butterfield,
Matsui, Castor, Sarbanes, Lujan, Schrader, Kennedy, Cardenas,
Welch, Ruiz, Dingell, Kuster, Kelly, Barragan, Blunt Rochester,
Rush, Pallone (ex officio), Burgess (subcommittee ranking
member), Guthrie, Griffith, Bilirakis, Long, Bucshon, Brooks,
Mullin, Hudson, Carter, and Walden (ex officio).
Also present: Representative O'Halleran.
Staff present: Billy Benjamin, Systems Administrator;
Jeffrey C. Carroll, Staff Director; Aisling McDonough, Policy
Coordinator; Joe Orlando, Staff Assistant; Andrew Souvall,
Director of Communications, Outreach and Member Services;
Jennifer Barblan, Minority Chief Counsel, Oversight and
Investigations; Mike Bloomquist, Minority Staff Director; Tyler
Greenberg, Minority Staff Assistant; Peter Kielty, Minority
General Counsel; Ryan Long, Minority Deputy Staff Director;
James Paluskiewicz, Minority Chief Counsel, Health; Tiffany
Haverly Minority Communications Director; and Elizabeth Allen,
Burgess Health Counsel.
Ms. Eshoo. The Subcommittee on Health will now come to
order. Good morning colleagues. The Chair now recognizes
herself for 5 minutes for an opening statement.
Mr. Burgess. Parliamentary inquiry as we start this
hearing?
Ms. Eshoo. I want to do my opening statement. I already
recognized myself. I will recognize you afterward.
OPENING STATEMENT OF HON. ANNA G. ESHOO, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
I never thought I would be holding, or that we would be
holding a hearing under these sad circumstances, but I think it
is a necessary one.
Our country is in pain. Americans are afraid, they are
sick, they are hungry and jobless, and over 80,000 souls have
been lost. And the government that was supposed to protect them
has failed. They are heroes and they have risen, extraordinary
ordinary Americans showing courage, compassion and a sense of
self-sacrifice and duty beyond what could have or should have
been asked of them. Regular Americans have risen when their
leaders have not.
We are the greatest country on Earth. And yet, we have the
most cases and the most deaths from COVID-19 of any Nation in
the world. Why? First is the inept, ineffective and extremely
late effort to respond to what was clear to many scientists and
public health experts in January. That basic delay cost
precious lives, and is continuing to cost lives. We can't have
a system where the price paid is unconscionable, mothers losing
daughters, and daughters losing fathers because of
incompetence, denial, delay, and a disorganized response.
Frankly, I am tired of those who bear the responsibility,
accepting none of it, while deflecting blame on others, the
previous administration, the World Health Organization, the
Wuhan lab, anywhere but where the blame belongs.
Second, the United States has and remains dangerously
dependent on foreign countries for our supply of critical
lifesaving drugs and lifesaving equipment, masks, gloves, PPE,
and ventilators. As a result, we can't treat our own people
without relying on China and others to supply us. We can't
outfit our first responders, our hospital workers, our nurses,
our doctors. We can't care for our own Nation in crisis. This
surely is a national security issue.
I want to thank the gentlewoman from Indiana, Ms. Brooks,
for her bipartisan work with me to address the drug supply
chain issue, as well as other members, on a bipartisan basis,
for their legislation on those issues as well.
Today, we are going to hear about the disastrous Federal
response to an approaching pandemic. Dr. Bright has filed one
of the most specific and troubling whistleblower complaints I
have ever seen. He was the right person, with the right
judgment, at the right time. He was not only ignored, he was
fired for being right. We can't have a system where the
government fires those who get it right and reward those who
get it completely wrong.
Mr. Michael Bowen, the executive vice president of Prestige
Ameritech, will speak to America's crippling dependence on
foreign countries for critical medical supplies. A public
health issue, and a national security issue.
Our country is paying a terrible price today and it rests
on Congress to address these threats where any effort of an
adversary can cut off our supply of lifesaving drugs and
supplies, our lifeline. And this would create a healthcare
disaster on a scale never experienced before. I bear this
responsibility, as does every Member of Congress.
This subcommittee has jurisdiction over our country's most
prestigious healthcare institutions, FDA, NIH, CDC, and BARDA.
We have to listen, we have to learn, and we must work together
for the people of our country who need us so, so much,
regardless of inconvenient truths.
Finally, I regret that Secretary Azar, Dr. Robert Kadlec,
and Dr. Peter Navarro have all refused to testify today.
I now ask for a moment of silence in honor of the over
80,000 Americans who have lost their lives from COVID-19.
[The prepared statement of Ms. Eshoo follow:]
Prepared Statement of Hon. Anna G. Eshoo
I never thought I would be holding a hearing under these
sad circumstances, but it is a necessary one.
Our country is in pain.
Americans are afraid, sick, hungry, and jobless, and over
80,000 souls have been lost. And the government that was
supposed to protect them, has failed.
Heroes have risen . . . extraordinary/ordinary Americans
showing courage, compassion, and a sense of self-sacrifice and
duty beyond what could have, or should have been asked of them.
Regular Americans have risen when their leaders have not.
We are the greatest country on earth, and yet we have the
most cases and the most deaths from COVID-19 of any nation in
the world.
Why?
First is the inept, ineffective, and extremely late effort
to respond to what was clear to many scientists and public
health experts in January. That basic delay has cost precious
lives, and is continuing to cost lives.
We can't have a system where the price paid is
unconscionable--mothers losing daughters, daughters losing
fathers because of incompetence, denial, delay, and a
disorganized zed response.
I'm tired of those who bear the greatest responsibility
accepting none of it, while deflecting blame on others--the
previous Administration, the World Health Organization , the
Wuhan Lab - anywhere but where the blame belongs.
Second, the United States has and remains dangerously
dependent on foreign countries for our supply of critical,
lifesaving drugs, and lifesaving equipment--masks, gloves, PPE,
and ventilators.
As a result, we can't treat our own people without relying
on China and others to supply us.
We can't outfit our first responders, our hospital workers,
our doctors. We can't care for our own nation in crisis.
Today we will hear about the disastrous federal response to
an approaching pandemic. Dr. Bright has filed one of the most
specific and troubling whistleblower complaints I've ever seen.
He was the right person with the right judgment at the right
time. He was not only ignored, he was fired for being right. We
can't have a system where the government fires those who get it
right and reward those who get it completely wrong.
Mr. Michael Bowen, the Executive Vice President of Prestige
Ameritech, will speak to America's crippling dependence on
foreign countries for critical medical supplies--a public
health issue and a national security issue.
Our country is paying a terrible price today, and it rests
on Congress to address this threat where any effort of an
adversary to cut off our supply of lifesaving drugs and
supplies--our lifeline--would create a health care disaster on
a scale never experienced before. I bear this responsibility as
does every Member of Congress.
Finally, I regret that Secretary Azar, Dr. Robert Kadlec,
and Dr. Peter Navarro have all refused to testify today.
I now ask for a moment of silence in honor of the over
80,000 Americans who have lost their lives from COVID-19.
Ms. Eshoo. The Chair now recognizes----
Mr. Burgess. Before I am recognized for an opening
statement. I wonder if I might be recognized for a
parliamentary inquiry.
Ms. Eshoo. The gentleman is recognized to state his
parliamentary inquiry.
Mr. Burgess. The inquiry is I would like clarification on
the witness before us today. Is this witness testifying as a
government witness or as an individual?
Ms. Eshoo. Dr. Bright is testifying as a Federal employee,
correct? And representing--he is a Federal employee
representing himself.
I now recognize the ranking member of the subcommittee.
Mr. Walden. Madam Chair, just a question. Normally we have
nameplates identifying who is at the table. I know Dr. Bright,
but I am not sure who is next to him.
Ms. Eshoo. You are correct. I don't know why we don't have
nameplates. I didn't notice that when I came into the hearing
room. Can the staff provide them? Is there any way the staff
can provide them? I think we can.
I also would like to inform the members that Dr. Bright's
attorney, Debra Katz, is at the table, she has requested a
microphone. She is not here as a witness, so we will not be
asking her questions. She is simply here to--representing her
client.
I now would like to recognize the ranking member of the
subcommittee, Dr. Burgess, for his 5 minutes for an opening
statement.
OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF TEXAS
Mr. Burgess. I thank the Chair. And the Energy and
Commerce, particularly the Subcommittee on Health, is the
premiere health subcommittee in the Congress. We have a broad
jurisdiction, a longstanding tradition of tackling important
healthcare issues in a bipartisan manner. I personally, like
our witness today, have been very, very concerned, in fact,
sounding the alarm about this novel coronavirus since January.
So I ask, why is this the first official hearing that we are
having on this topic? To say this is a disappointment would be
an understatement.
But not only disappointment, but, quite frankly, I am
concerned it took five months to have a hearing on this novel
coronavirus, instead of tackling any of the issues suggested in
the letters that I have sent to you this week, we are examining
a whistleblower complaint that is only one week old before a
proper investigation. In these letters, I will find the
importance of addressing the strategic national stockpile,
COVID-19's impact on mental health, testing. Certainly, we
should have a hearing on testing, racial disparities and
provider relief. Lack of attention to these details is
detrimental to our Nation's overall response to this pandemic,
and it is the responsibility of this House and the
responsibility of this committee. We continue to stand on the
sidelines instead of becoming fully engaged.
Every whistleblower deserves to be heard. Dr. Bright has
raised serious allegations and they deserve investigation.
Whistleblowers must have their rights protected and deserve to
have their allegations investigated with policies and
procedures that have been long-established and upheld as
independent and fair.
Madam Chair, on April 23rd, CNN reported that you planned
to called Dr. Bright to testify. Dr. Bright did not actually
file his whistleblower complaint with the Office of Special
Counsel until Tuesday, May 5. That same day, it was announced
on social media that you planned to hold a hearing, but it was
not officially noticed until two days later. By Friday, May 8,
the Office of Special Counsel recommended that Dr. Bright be
temporarily reinstated as director of BARDA so that he could
early conduct its investigation and move forward with its usual
processes of reviewing whistleblower complaints.
Despite the hearing memo, no final determination of a
violation of a whistleblower statute actually has been made.
Following a robust investigation process, the customary setting
for a whistleblower hearing would be in our Energy and Commerce
Committee under oath in the Oversight and Investigations
Subcommittee. To say this hearing is premature and it is
disservice to the investigations of Dr. Bright's complaint, I
think, goes without saying.
You have trampled on minority rights. You would have never
tolerated that when you were in the minority. You neglected the
tradition of this committee and the manner this hearing was
called. The number of procedural fouls committed in advance of
this hearing would certainly have led the Chair to foul out of
multiple basketball games. Apparently in a world without
sports, this subcommittee has become political sport.
More than 80,000 American lives have been lost to this
pandemic. It continues to wreak havoc on our communities, not
only in terms of physical health, but mental health and
certainly financial health. We should be conducting a hearing
on the real-time implementation of the Pandemic All-Hazards
Preparedness and Advancing Innovation Act, and we should have
done it in February.
As a Democratic counterpart to the primary author, Dr.
Susan Brooks on this legislation, you, Madam Chair, should have
a great interest in holding such a hearing.
In my district, we have seen deaths amongst young African
Americans from COVID-19. We are hearing about a new phenomenon
of very young individuals who are dying from an intense
inflammatory response, apparently sparked by infection with
this virus.
We should hear from some of these families and medical
professionals to analyze why this virus has disproportionately
affected some communities, particularly minority communities.
So, I said it before: not all heroes wear capes hospitals,
doctors, and other healthcare providers are on the front lines
every single day battling this virus; they go to work so we can
stay home, which we have done very successfully. The inability
to conduct nonessential procedures in visits has led to
financial harm to our hospitals and doctors. How our States and
the country preparing to ease back into providing medical care?
Is the distribution of provider relief funds in the CARES Act
working?
These are the questions we should be asking the experts
today. I appreciate Chairman Pallone's willingness to hold
telephone briefings, since we all have our own questions. But
let me just say, this pandemic is about the public health of
our Nation. I want to thank you for your commitment to hold
future hearings on the strategic national stockpile, mental
health, and racial disparities. I am happy to help you set the
agenda for the rest of the year. I hope you will commit to
additional hearings on testing and the provider relief fund.
And I request that my letters and your responses be part of the
record.
I yield back.
[The prepared statement of Mr. Burgess follow:]
Prepared Statement of Hon. Michael C. Burgess
Thank you, Madam Chair. The Energy and Commerce
Subcommittee on Health is the premier health subcommittee in
Congress. We have a broad jurisdiction and a long-standing
tradition of tackling important health care issues in a
bipartisan manner. I have been sounding the alarm about COVID-
19 since January. So why is this the first official hearing we
are having on the topic? To say this is a disappointment is an
understatement.
Not only am I disappointed but, quite frankly, I am
concerned it took five months to have a hearing on COVID-19.
Instead of tackling any of the issues suggested in the letters
I wrote to you this week, we are examining a week-old
whistleblower complaint before a proper investigation. In these
letters, I outlined the importance of addressing the Strategic
National Stockpile, COVID-19's impact on mental health,
testing, racial disparities, and provider relief. The lack of
attention to these issues is detrimental to our nation's
overall response to this pandemic. Yet, we continue to stand on
the sidelines instead of becoming fully engaged.
Every whistleblower deserves to be heard. Dr. Bright has
raised serious allegations that should be investigated.
Whistleblowers must have their rights protected and deserve to
have their allegations investigated with policies and
procedures that have been long established and upheld as
independent and fair.
Madam Chair, on April 23, CNN reported that you planned to
call Dr. Bright to testify. Dr. Bright did not actually file
his whistleblower complaint with the Office of Special Counsel
until Tuesday, May 5. That same day, it was announced on
Twitter that you planned to hold a hearing, but it was not
officially noticed until two days later.
By Friday, May 8, the Office of Special Counsel recommended
that Dr. Bright be temporarily reinstated as director of BARDA
so that it could conduct its investigation and move forward
with its usual process of thoroughly reviewing a whistleblower
complaint.
Despite your misleading hearing memo--no final
determination of a violation of whistleblower statute has been
made. Following a robust investigation process, the customary
setting for a whistleblower hearing in the Energy and Commerce
Committee would be under oath in the Oversight and
Investigations Subcommittee. This hearing is premature and a
disservice to the investigation of Dr. Bright's complaint.
You disrespected [trampled] minority rights and neglected
the tradition of this Committee in the manner this hearing was
called. The number of procedural fouls committed in advance of
this hearing would certainly have led the Chair to foul out of
multiple basketball games. Apparently in a world without
sports, this subcommittee has become a political football.
More than 80,000 American lives have been lost to this
pandemic. COVID-19 continues to wreak havoc on our communities
not only in terms of physical health, but mental health and
financial health. We should be conducting a hearing on the
real-time implementation of the Pandemic and All-Hazards
Preparedness and Advancing Innovation Act. As the Democratic
counterpart to the primary author, Rep. Susan Brooks, on this
legislation, you should have great interest in holding such a
hearing.
In my district, we have seen deaths among young African
Americans from COVID-19. We should hear from some of these
families and medical professionals to analyze why this virus
has disproportionally impacted minority communities.
Not all heroes wear capes. Hospitals, doctors, and other
health care providers are on the front lines every day battling
this virus. They go to work so we can stay home. The inability
to conduct non-essential procedures and visits has led to
financial difficulties. How are states and the country
preparing to ease back into providing medical care? Is the
distribution of the Provider Relief Fund in the CARES Act
working? These are the questions we should be asking experts
today.
I appreciate Chairman Pallone's willingness to hold
telephone briefings on testing since we all have our own
questions about it. Because of its importance to re-opening the
economy, it is critical that this subcommittee promptly holds a
public hearing to hear from experts.
In conclusion, this pandemic is about the public health of
our nation. Thank you for your commitment to hold future
hearings on the strategic national stockpile, mental health and
racial disparities. I hope you will commit to additional
hearings on testing and the Provider Relief Fund.
I request that my letters and your responses be inserted
into the record, and I yield back.
Ms. Eshoo. The gentleman yields back. I think the gentleman
will recall that I called for a hearing on January 30th. And on
the heels of that, it was to be with Dr. Kadlec, Dr. Fauci, all
the heads of our health agencies. And it was Secretary Azar
that said, they cannot come. I am the top person and when I
come, they will come with me. So that was January 30th.
Mr. Burgess. Madam Chair, if I may. I used to go to the
Oversight and Government Reform--for two days.
Ms. Eshoo. I am not finished yet, Dr. Burgess. You have
written several letters to me in the last week, and I
communicated to you I am happy to sit down with you to review
and to come up with all the appropriate hearings that this
subcommittee should hold, and we will work together on that. We
have a lot of work to do. You are absolutely right, the
stockpile, testing, the list are as long as Pennsylvania
Avenue. So we will work together on that, rest assured.
Ms. Eshoo.Now, I would like to recognize the chairman of
the full committee, Mr. Pallone for 5 minutes for opening his
opening statement.
OPENING STATEMENT OF HON. FRANK PALLONE, Jr., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. Thank you, Madam Chair. And thank you, Ms.
Eshoo, for initiating this hearing and putting all your energy
into it so that we are here today with Dr. Bright.
We are here as part of the Energy and Commerce Committee's
ongoing work to confront the largest public health and economic
crisis of our lifetimes. It has been mentioned more than 80,000
Americans have lost their lives, while more than over 36
million others have lost their jobs as of today. This is a
national emergency that requires every aspect of government to
work together to reduce the spread of this terrible virus so we
can confidently begin to reopen our economy. While this
Congress and the President have worked together to enact four
laws to combat the pandemic and provide economic assistance to
the American people, new laws are simply not enough.
President Trump and his administration have failed to
provide the consistent and stable leadership that is necessary
to guide our Nation through this public health and economic
crisis. For months, the President has delivered mixed messages
and misinformation to the American people, creating confusion
across the Nation. Instead of showing leadership, competence,
and vision in a time of crisis, the administration has
abdicated its responsibility and forced States to fend for
themselves and find their own way out of this pandemic.
And while States and frontline healthcare workers were
pleading for personal protective equipment, testing supplies,
and other resources to protect them and their patients,
President Trump's response was to let States fight it out on
the open market.
For months, the President has refused to develop and
implement a national testing program. For months, we have been
promised millions of tests were right around the corner. The
promises have been hollow. Testing is getting better, but
nowhere where what it needs to be. It doesn't help that the
President proclaimed about testing earlier this week, and I
quote, ``We have met the moment, and we have prevailed.'' That
could not be further from the truth, Mr. President.
Dr. Rick Bright, the former director of BARDA, has come
forward as a whistleblower and made serious allegations,
including a lack of urgency by administration officials to
respond to the virus, mismanagement, and failing to procure
necessary supplies and disregard for public health and
scientific integrity. His claims lie at the heart of this
committee's concerns regarding the administration's response to
the COVID-19 pandemic. We are here today to hear the
perspective of Dr. Bright, who is positioned to discuss the
administration's preparations in response to this pandemic.
Now, the failures we have seen simply cannot persist. That
is why the Energy and Commerce Committee continues to conduct
robust oversight, and to propose bold legislative solutions. We
have been demanding answers and information from the
administration on testing, contact tracing, the supply chain,
food safety and the safety of food production workers, and
attempts to undermine science and public health. To date, we
have yet to receive any sufficient responses from the Trump
administration.
And as for legislation, Congress has already passed four
major coronavirus response packages that were improved by the
work of this committee. And now, with the sense of urgency this
moment requires, earlier this week, we proposed the HEROES Act,
which is to be voted on tomorrow by the full House. The HEROES
Act continues our ongoing commitment to providing the
healthcare resources and support needed to combat the
coronavirus crisis. Our legislation will strengthen testing and
contact tracing by finally requiring the administration to
develop comprehensive plans with clear benchmarks and timelines
and public reporting of key metrics. This will allow
transparency so we can see if the Trump administration is
fulfilling their promises and hold them accountable if they are
not.
We also provide $75 billion to support robust testing,
contact tracing, surveillance and containment activities. This
is beyond the 25 that was in the last bill. And we simply
cannot beat this virus without these efforts in place. Our
legislation also ensures that all COVID-19 treatments, drugs
and vaccines are free of cost for patients. The bill will help
us shore up our public health infrastructure for the long road
ahead.
Our top priority is the health and safety of the American
people. The HEROES Act builds on the progress we have made and
lays the foundation we will need to ease social distancing, and
safely reopen the economy.
So, I just want to thank Dr. Bright for coming forward and
for being here today. I want to thank you, Madam Chair, for
bringing him here. And I am hopeful that this hearing will help
us better understand the failures of the Trump administration
so that, collectively, we can find solutions that will help us
finally get a handle on this virus. It is the only way we will
be able to protect the American people, and safely and
confidently reopen our communities.
I thank you, Madam Chair, and I yield back.
[The prepared statement of Mr. Pallone follow:]
Prepared Statement of Hon. Frank Pallone, Jr.
Today, we are here as part of the Energy and Commerce
Committee's ongoing work to confront the largest public health
and economic crisis of our lifetimes. More than 80,000
Americans have lost their lives to COVID-19, while more than 36
million others have lost their jobs.
This is a national emergency that requires every aspect of
government to work together to reduce the spread of this
terrible virus so we can confidently begin to reopen our
economy. While this Congress and the President have worked
together to enact four laws to combat the pandemic and provide
economic assistance to the American people, new laws are simply
not enough.
President Trump and his Administration have failed to
provide the consistent and stable leadership that is necessary
to guide our nation through this public health and economic
crisis. For months, the President has delivered mixed messages
and misinformation to the American people, creating confusion
across the nation.
Instead of showing leadership, competence and vision in a
time of crisis, the Administration is abdicating its
responsibility and forcing states to fend for themselves and
find their own way out of this pandemic.
While states and frontline healthcare workers were pleading
for personal protective equipment, testing supplies and other
resources to protect them and their patients, President Trump's
response was to let states fight it out on the open market.
For months, the President has refused to develop and
implement a national testing program. For months, we've been
promised millions of tests were right around the corner. The
promises have been hollow--testing is getting better, but
nowhere near where it needs to be. It doesn't help that the
President proclaimed about testing earlier this week that, ``We
have met the moment and we have prevailed.'' That could not be
further from the truth.
Dr. Rick Bright, the former Director of BARDA, has come
forward as a whistleblower and made serious allegations -
including a lack of urgency by Administration officials to
respond to the virus, mismanagement and failure to procure
necessary supplies, and disregard for public health and
scientific integrity.
His claims lie at the heart of this Committee's concerns
regarding the Administration's response to the COVID-19
pandemic. We are here today to hear the perspective of Dr.
Bright who is positioned to discuss the Administration's
preparation and response to this pandemic.
The failures we have seen simply cannot persist--that's why
this Committee continues to conduct robust oversight and to
propose bold legislative solutions. We've been demanding
answers and information from the Administration on testing,
contact tracing, the supply chain, food safety and the safety
of food production workers, and attempts to undermine science
and public health. To date, we have yet to receive any
sufficient responses from this Administration.
As for legislation, Congress has already passed four major
coronavirus response packages that were improved by the work of
this Committee. And now, with the sense of urgency this moment
requires, earlier this week we proposed The Heroes Act, which
is to be voted on tomorrow by the full House.
This legislation continues our ongoing commitment to
providing the health care resources and support needed to
combat the coronavirus crisis. Our legislation will strengthen
testing and contact tracing by finally requiring the
Administration to develop comprehensive plans, with clear
benchmarks and timelines, and public reporting of key metrics.
This will allow transparency so we can see if the Trump
Administration is fulfilling their promises and hold them
accountable if they are not. We also provide $75 billion--to
support robust testing, contact tracing, surveillance and
containment activities. We simply cannot beat this virus
without these efforts in place.
Our legislation also ensures that all COVID-19 treatments
drugs and vaccines are free of cost-sharing for patients.
The bill will help us shore up our public health
infrastructure for the long road ahead.
Our top priority is the health and safety of the American
people. The Heroes Act builds on the progress we have made and
lays the foundation we will need to ease social distancing and
safely reopen the economy.
I thank Dr. Bright for coming forward and for being here
today. I'm hopeful that this hearing will help us better
understand the failures of this Administration so that
collectively we can find solutions that will help us finally
get a handle on this virus. It is the only way we will be able
to protect the American people, and safely and confidently
reopen our communities.
Thank you, and I yield back.
Ms. Eshoo. The gentleman yields back. It is a pleasure to
recognize the gentleman from Oregon, the ranking member of the
full committee, Mr. Walden.
Mr. Walden. Thank you very much, Madam Chair. And before I
use my time, I do have just a parliamentary question for you,
if you would yield to that. Madam Chair?
Ms. Eshoo. State your parliamentary inquiry.
Mr. Walden. So I know we are operating under really unusual
conditions----
Ms. Eshoo. We are.
Mr. Walden [continue]. Because of the masks and everything
else, which also affects the layout of the room. I know when we
do oversight and investigation hearings, and I know that is not
what we are doing here, there is script about whether an
individual is accompanied by counsel, whether they want that
counsel represented. I have got that script. The reason I am
asking is we are not in Oversight and Investigations, but it is
extraordinarily unusual to have a government witness as an
individual with private counsel at the witness table and with a
microphone. And so, I am just trying to get clarification for
future precedent setting for the committee. And that is the
only reason I am asking this, he obviously has counsel. If we
should follow the protocol that is prescribed for the Oversight
and Investigations Committee in similar circumstances.
Ms. Eshoo. Well, I think this is the first time that it
is----
Mr. Walden. That is why I ask.
Ms. Eshoo. We have another first here. When Dr. Bright came
in this morning with his attorney, she requested a microphone.
And so, as a courtesy, I extended the microphone to her.
Mr. Walden. Yes, sure.
Ms. Eshoo. Now, she is not a witness. We are not going to
ask her questions. She is simply accompanying her client. So I
don't----
Mr. Walden. And I have no objection to any of that. Could I
read you what this text is and maybe that resolves it?
Ms. Eshoo. Well this isn't Oversight and Investigations.
This is--are you suggesting that we need to follow what
Oversight and Investigations does?
Mr. Walden. I am just saying that the witness is not here
in his whistleblowing capacity is what I am told, what you
indicated. But this is his personal attorney, if I understand
correctly, but we still don't even know for sure--I know who
you are, but we haven't identified that for the record. And all
we do in Oversight and Investigations, as you know, is, you ask
if the witness wants to be accompanied by counsel; they respond
yes or no. And then counsel is allowed to move forward, sit at
the table. And then the question is asked, Will you give
testimony or not? And if so, raise your hand and do all these
things. That is all I am doing here is just--we don't usually
do this type of activity in this--in the other policy
committees. And we are not usually set up this way----
Ms. Eshoo. So would you like to ask the----
Mr. Walden. I just think we ought to follow for future
precedent issues, nothing to do with this hearing, but future
precedent is what we are dealing with.
Ms. Eshoo. It is a good suggestion.
Mr. Walden. We are all learning how to operate in this
environment.
Ms. Eshoo. Exactly.
All right. The gentleman is recognized for his 5 minutes
for an opening statement.
Mr. Walden. Well----
Ms. Eshoo. You don't think it is resolved?
Mr. Walden. Well, are we going to ask if he wants to be
represented by counsel, and who the counsel is?
Ms. Eshoo. Dr. Bright, do you wish to be represented by
counsel?
Mr. Bright. Yes.
Mr. Walden. OK. And then could she identify herself for the
record?
Ms. Eshoo. And for the record, would counsel please state
your name?
Ms. Katz. My name is Debra Katz. I am an attorney
representing Dr. Rick Bright, with the law firm of Katz,
Marshall & Banks.
Mr. Walden. All right. I think that is all we needed to do.
Ms. Eshoo. Good.
Mr. Bucshon. Could I ask----
Ms. Eshoo. The gentleman is recognized for----
Mr. Walden. Well, you have a parliamentary question.
Ms. Eshoo. The gentleman will state his parliamentary.
Mr. Bucshon. Will the witness be under oath, because if you
have a whistleblower testimony under Oversight and
Investigations, a witness would normally be under oath? And if
not today, he is under--not under oath, if we get into
whistleblower allegations, how can we be sure that the witness
is telling the truth under oath if they are not under oath? And
if they are not under oath, then how can you talk about the
whistleblower complaints?
Ms. Eshoo. I thank the gentleman.
Mr. Bucshon. In a fair and equitable manner.
Ms. Eshoo. I thank the gentleman for his inquiry. All
witnesses know that it is illegal to lie to Congress. And in
our subcommittee, unlike Oversight and Investigations, they are
the only subcommittee that--I mean, it is a practice, it is a
tradition, but we don't swear people in, but witnesses know
that it is illegal it lies to Congress.
Mr. Walden. U.S.C. 1003 or something.
Ms. Eshoo. The gentleman is recognized for his 5 minutes
opening.
OPENING STATEMENT OF HON. GREG WALDEN A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF OREGON
Mr. Walden. Thank you, Madam Chair. And I know we are
operating under unique circumstances.
The world is coping with an historic deadly pandemic that
we always knew was possible, but we prayed would not happen. In
a bipartisan way, we did everything the experts said we needed
to do to be prepared, should a pandemic or other hazard strike.
Madam Chair, the work you, Dr. Burgess, Representative
Susan Brooks, and I, and others did over two Congresses, when
each party has controlled the House resulted in one product,
the Pandemic All-Hazards Preparedness Act.
Dr. Bright, I know you were part of our efforts in writing
and reauthorizing that law, and we thank you for your work. In
fact, given the role you once played at ASPR before going to
BARDA, you had a big responsibility to make sure Congress
provided the strategic national stockpile that it needed, or to
inform us if there were shortcomings, especially as we were
modernizing the Pandemic All-Hazards Preparedness Act.
I went back over three hearings we held in the Oversight
Investigations Subcommittee of this committee, where you
testified regarding the Zika outbreak in May 23, 2017, the
seasonal flu on March 8, 2018, and the hearing on June 15, 2018
entitled the State of U.S. Public Health Biopreparedness
Responding to Biological Attacks, Pandemics and Emerging
Infectious Disease Outbreaks. You see, I wanted to make sure we
hadn't missed anything. Nothing jumped out at me as I reread
the record. Congress dramatically increased funding to ASPR and
BARDA.
We granted new authorities, we followed your
recommendations and those of others who played a key role in
this combined effort. Unfortunately, some of the systems we put
in place to prepare for a pandemic, systems designed without
actually living through something like this have not performed
as expected. We have learned we didn't have enough of the basic
supplies that we have always taken for granted. And while Chair
Eshoo and I have warned about the potential vulnerabilities of
our medical supply chains, especially from China, not enough
was done to address the problem, and it still hasn't been fully
addressed.
I am thankful that President Trump invoked the Defense
Production Act to ramp up U.S. manufacturing of masks and
ventilators. And the President has used the emergency powers
and money Congress has provided to launch unprecedented efforts
to search the globe for supplies, to rapidly advance
development of treatments and vaccines, though we still have
much bipartisan work to do to respond and adapt to the
challenges presented by COVID-19 and the lessons we are
learning.
We have asked for, and this committee should hold hearings
to find a path forward to reform the Strategic National
Stockpile, to increase domestic manufacturing of critical
supplies and disentangle our supply chains from China. We
should be exploring strategies for increased testing so we can
begin to safely reopen our economy. We need to find ways to
improve access to mental health and provide relief, both for
our healthcare providers on the front lines treating COVID-19
cases, and our healthcare workers who have been furloughed
because their hospitals are closed. We should be conducting
rigorous oversight of the trillions of dollars, and myriad of
new policies Congress has appropriated and enacted in the last
three months. And we should be investigating, really
investigating, allegations like Dr. Bright's that that raise
concern that about our Nation's coronavirus response.
That does not appear to be why we are actually here today,
and frankly, it saddens me. Dr. Bright, your allegations are
serious. They deserve a real investigation. I know the Office
of Special Counsel, with whom you filed your complaint, will do
just that. And I know they take their work seriously and will
hear you out. And importantly, will give those named in your
complaint an opportunity to have their side heard as well.
I must tell you that many of us on our committee were
confused when we learned from a tweet this hearing was
scheduled in the wake of your complaint. As you know, that is
certainly not how we do things at the Energy and Commerce
Committee. Not long after the notice of this being a
whistleblower hearing, we were advised you were here as a
government witness, not a whistleblower. But then we were told
you were not representing the government, but yourself.
The hearing title suggests the hearing is about protecting
scientific integrity, yet the Chair invited a witness who will
not be speaking to that issue. So it is all pretty confusing
and unusual, to say the least.
Here we are in the middle of a pandemic, and we aren't
given time to secure our witnesses, conduct appropriate
research or required documents that could aid in our
understanding of the situation you face and the country faces.
Our first discussion with majority unfortunately just
occurred three days ago. This is really serious business. But,
in my opinion, this is not the way we should run an
investigation. We need to get to the heart of the matter, and
we need to look forward to see what we haven't done right as a
Congress and a country, and what can we band together and fix
before fall arrives.
And so, I thank you for being here. I have enjoyed working
with you over the years and continue to look forward to working
with you and others to get this right.
And Madam Chair, we have a letter for you asking for a rule
11 hearing that we will provide to you. And with that, I yield
back.
[The prepared statement of Mr. Walden follow:]
Prepared Statement of Hon. Greg Walden
The world is coping with an historic, deadly pandemic that
we always knew was possible, but prayed would not happen. In a
bipartisan way we did everything the experts said we needed to
do to be prepared should a pandemic or other hazard strike.
Madame Chair, the work you, Dr. Burgess, Rep. Susan Brooks,
and I did over two Congresses--when each party has controlled
the House--resulted in one product: The Pandemic All-Hazards
Preparedness Act.
Dr. Bright, I know you were part of our efforts in writing
and reauthorizing that law. In fact, given the role you once
played at ASPR before going to BARDA, you had a big
responsibility to make sure Congress provided the Strategic
National Stockpile what it needed, or to inform us if there
were shortcomings, especially as we were modernizing the
Pandemic All-Hazards Preparedness Act.
I went back over the three hearings we held in the
Oversight and Investigations Subcommittee where you testified
regarding the Zika outbreak May 23rd of 2017, the seasonal flu
on March 8, 2018, and the hearing on June 15, 2018, entitled:
``The State of U.S. Public Health Bio- Preparedness: Responding
to Biological Attacks, Pandemics, And Emerging Infectious
Disease Outbreaks.''
I wanted to make sure we hadn't missed something. Nothing
jumped out at me. Congress dramatically increased funding to
ASPR and BARDA. We granted new authorities. We followed your
recommendations, and those of others who play a role in this
combined effort.
Unfortunately, some of the systems that we put in place to
prepare for a pandemic--systems designed without actually
living through something like this--have not performed as
expected.
We've learned we didn't have enough of the basic supplies
that we've always taken for granted. While Chair Eshoo and I
have warned about the potential vulnerabilities with our
medical supply chains--especially from China--not enough was
done to address the problem. And it still hasn't been
addressed.
I am thankful that President Trump invoked the Defense
Production Act to ramp up U.S. manufacturing of masks and
ventilators. And the President has used the emergency powers
and money Congress has provided to launch unprecedented efforts
to search the globe for supplies, to rapidly advance
development of treatments and vaccines.
But we still have much bipartisan work to do to respond and
adapt to the challenges presented by COVID-19 and the lessons
we're learning.
We have asked for, and this committee should hold, hearings
to find a path forward to reform the Strategic National
Stockpile, increase domestic manufacturing of critical
supplies, and disentangle our supply chains from China.
We should be exploring strategies for increased testing, so
that we can begin to safely reopen our economy.
We need to find ways to improve access to mental health and
provide relief both our healthcare providers on the front lines
treating COVID-19 cases, and our health care workers who have
been furloughed because their hospitals are closed.
We should be conducting rigorous oversight of the trillions
of dollars and myriad new policies that Congress has
appropriated and enacted in the last three months.
And we should be investigating--really investigating--
allegations like Dr. Bright's that raise concerns about our
nation's coronavirus response.
But that does not appear to be why we are actually here
today, and frankly, that saddens me.
Dr. Bright, your allegations are serious, and they deserve
a real investigation. I know the Office of Special Counsel,
with whom you filed your complaint, will do just that. I know
they take their work seriously and will hear you out, and
importantly, will give those named in your complaint an
opportunity to have their side heard, too.
I must tell you that many of us on this committee were
confused when we learned from a tweet that this hearing was
scheduled in the wake of your whistleblower complaint.
As you know, that's certainly not how the Energy and
Commerce Committee does its business. Not long after that
notice of this being a whistleblower hearing, we were advised
that you were here as a government witness, not as a
whistleblower. But then we were told you were not here
representing the government, just yourself. The hearing title
suggests the hearing is about protecting scientific integrity--
yet, the Chairwoman invited a witness who will not be speaking
to that issue.
This is all very confusing and unusual, to say the least.
Here we are in the middle of the pandemic, and we weren't
given time to secure other witnesses, conduct appropriate
research or acquire documents that could aid in our
understanding of the situation. Our first discussion with the
Majority occurred just three days ago.
This is serious business, but this is no way to run a
serious investigation.
Ms. Eshoo. Thank you. The gentleman yields back.
The Chair would like to remind Members that pursuant to
committee rules, all Members' written opening statements will
be made part of the record.
I would now like to introduce our witness, the first panel
today. Dr. Rick Bright is a highly regarded scientist with
expertise in the fields of immunology, therapeutics, vaccines,
and diagnostic development. For the last decade, he has been a
career civil servant at the Department of Health and Human
Services. In 2016, Dr. Bright was appointed the director of
BARDA, the third director of BARDA, the Biomedical Advanced
Research and Development Authority. As director of BARDA, he
has testified before Congress as a government expert numerous
times, including before this subcommittee.
I share a special pride with Senator Richard Burr, because
together, it was our legislation that created BARDA. So thank
you for your willingness to join us today and to offer
testimony, Dr. Bright. We look forward to your testimony. You
are certainly familiar with the lights. I don't need to explain
those to you. You have 5 minutes for your statement. Welcome
and you have the microphone on? There we go. Good morning to
you.
STATEMENT OF Dr. RICHARD A. BRIGHT, Ph.D.
Dr. Bright. Good morning, Chairwoman Eshoo, Ranking Member
Burgess, and distinguished members of the subcommittee. I am
Dr. Rick Bright, a career public servant, and a scientist, who
has spent 25 years of my career focused on addressing pandemic
outbreaks. I have a bachelor's degree in biology and physical
sciences, and a Ph.D. In immunology and molecular pathogenesis.
I have led teams of scientists developing drugs, vaccines, and
diagnostics in government, private industry and for nonprofit
organizations. I am here today in my private capacity. The
views are my own and not those of the Department of Health and
Human Services.
I joined BARDA in 2010, and for the last 3-1/2 years, until
April 21st of this year, I had the privilege of serving as its
director. BARDA partners with private industry and others in
government to address national health security threats.
Today, the world is confronting a public health emergency
unlike any we have seen in over a century. We are facing a
highly transmissible and deadly virus, which not only claims
lives, but also disrupts the very foundations of our society.
The American healthcare system is being taxed to the limit. Our
economy is spiraling downward and our population is being
paralyzed by fear, stemming from a lack of a coordinated
response, and a dearth of accurate, clear communication about
the path forward.
Americans yearn to get back to work, to open their
businesses and to provide for their families. I get that.
However, what we do must be done carefully, and with guidance
from the best scientific minds.
Our window of opportunity is closing. If we fail to improve
our response now based on science, I fear the pandemic will get
worse and be prolonged. There will be likely a resurgence of
COVID-19 this fall, and it will be greatly compounded by the
challenges of seasonal influenza. Without better planning, 2020
could be the darkest winter in modern history.
First and foremost, we need to be truthful with the
American people. Americans deserve the truth. The truth must be
based on science. We have the world's greatest scientists. Let
us lead. Let us speak without fear of retribution. We must
listen. Each of us can and must do our part now.
On Tuesday, Dr. Fauci delivered a message in a voice that
is clear and trustworthy, that has encouraged us to act with
caution as we return to our daily lives. We should listen to
him and other scientists sharing their expertise.
While waiting for a cure and a vaccine, which I believe
will come, there are things we must do immediately. We must
increase the public education about the basics, washing hands,
social distancing, appropriate face covering. They are simple,
but critical steps to buy valuable time until there is a
vaccine. We need to ramp up production of essential equipment
and supplies, including raw materials and critical components;
shortages of these increase the risk of our frontline
healthcare workers, and they deserve the best equipment to
protect themselves.
We need to facilitate equitable distribution of essential
equipment and supplies. And finally, we need a national testing
strategy. The virus is here, it is everywhere. We need to be
able to find it, isolate it and stop it. We need to have the
right testing for everyone who needs it. We need to be able to
trace contacts, isolate, quarantine, and appropriately, while
striving to develop a cure.
Initially, our Nation was not as prepared as we should have
been, as we could have been. Some scientists raised early
warning signals that were overlooked, and pages from our
pandemic playbook were ignored by some in leadership. There
will be plenty of time to look back to assess what has happened
so we can improve. But right now, we need to focus on getting
things right going forward. We need a comprehensive plan that
everyone knows and everyone participates in. Congress has taken
important steps to support the response, and there is much more
we can do. With your help, we can get through this crisis.
Working cooperatively with our global partners, we can and
will succeed in finding a cure for COVID-19, but that success
depends on what we do today. We will either be remembered for
what we did, or for what we failed to do to address this
crisis. I call on all of us to act. To ensure the health,
safety and prosperity of all Americans. You can count on me to
do my part.
Thank you.
[The prepared statement of Dr. Bright follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Ms. Eshoo. Thank you, Dr. Bright.
We will now move to member questions. And I recognize
myself for 5 minutes for questions.
Thank you again, Dr. Bright. You have a distinguished
career. You are one of our country's leading public health
experts on how to respond to pandemics and national security
health threats. You are the first government official who has
been on the inside, seeing everything firsthand, to come
forward and share unvarnished experiences about what really
happened from January to the time you departed BARDA in April
of this year in dealing with the virus. So I want to make sure
I understand what you are telling us.
You stated in your written testimony a window of
opportunity is closing, but it is not yet closed. What do we
need to do with the time left to get it right? And if we don't,
what do you mean when you say 2020 will be the darkest winter
in modern history?
Dr. Bright. Chairwoman Eshoo, thank you for your question.
The window is closing to address this pandemic because we
still do not have a standard centralized coordinated plan to
take our Nation through this response. I believe, with proper
leadership and collaboration across government, with the best
science leading the way, we can devise a comprehensive
strategy.We can devise a plan that includes all Americans and
help them help us guide us through this pandemic. But time is
running out, because the virus is still spreading everywhere.
People are getting restless to leave their homes. And we have
to make critical decisions on how to balance the economy and
science.
My concern about this fall is compounded by my knowledge,
and preparation, and response to many years of influenza
outbreaks, pandemic influenza outbreaks and seasonal influenza
outbreaks. In our country in 2017, we had nearly 79,000 people
die in the U.S. from influenza. That, coupled with a COVID-19
resurgence this fall, could be devastating for our healthcare
systems and for Americans. We have a limited window of
opportunity to get plans in place to address both of those.
Ms. Eshoo. Thank you.
When you look at the first four months of this year, would
you describe the government's and the administration's response
as a success or a failure?
Dr. Bright. I believe we could have done better. I believe
there are critical steps that we did not take in time.
Ms. Eshoo. Was there a failure to respond when you
correctly pushed to claim early virus samples from--or to
obtain early virus samples from China so we could develop
critical medical countermeasures?
Dr. Bright. From my perspective in working with companies
that develop drugs and vaccines and diagnostics, virus samples
are critical. As soon as we were aware this virus could pose a
significant threat to human lives, I began pushing for those
virus samples, and I met frustration and----
Ms. Eshoo. And when did you do that?
Dr. Bright. I did that in the Office of Secretary Azar in
January. The push for the virus samples initially mentioned on
January 23rd and a strong push in January 27th for those virus
samples.
Ms. Eshoo. And was there a failure to respond with the
needed urgency when you correctly pushed to ramp up production
of masks, respirators, syringes, and swabs?
Dr. Bright. Congresswoman, we have known for quite some
time that our stockpile is insufficient in having those
critical personal protective equipment. So once this virus
began spreading and became known to be a threat, I did feel
quite concerned that we didn't have those supplies, and I began
pushing urgently in January, along with some industry
colleagues as well. And those urges, those alarms were not
responded to with action.
Ms. Eshoo. Was there a failure to take immediate action
when you correctly pushed to acquire additional doses of the
drug, remdesivir, which is the only drug so far that appears to
be at least mildly effective, thank God, for treating people
with COVID-19?
Dr. Bright. There was no action taken on the urgency to
come up with a plan for acquisition of limited doses of
remdesivir, nor to distribute those limited doses of remdesivir
once we had the scientific data to support their use for people
infected with this virus.
Ms. Eshoo. And instead of acting on your recommendations,
was the response of others to try and cut you out of key
meetings, marginalize your participation?
Dr. Bright. I was told that my urgings were causing a
commotion and I was removed from those meetings.
Ms. Eshoo. My time has expired.
I now recognize the gentleman, the ranking member of the
subcommittee, Dr. Burgess.
Mr. Burgess. I thank the Chair.
Dr. Bright, I hope that it is clear to you that everyone on
this dais on both sides appreciates you coming before today,
even if we are frustrated, we are having this hearing without a
full understanding of the facts. Again, and just to clarify,
you are testifying in personal capacity and not on behalf of
the agency or the administration?
Dr. Bright. That is correct, sir.
Mr. Burgess. Thank you for that.
Let me ask you about a question about hydroxychloroquine,
really even maybe a little bit more broadly, the disease-
modifying antirheumatic drugs that have been looked at for
therapy for this disease. I ask about hydroxychloroquine,
because it does seem to be central to whatever disagreement you
had with Department of HHS and the administration, but
hydroxychloroquine was initially identified as a potential
therapeutic because, number one, of its anti-inflammatory
effects, and its ability to calm things in the immune system.
As we know, one the features of this disease is the
overwhelming cytacon response that overwhelms the host. There
also may be an effect to blocking the virus at the point of
contact with the cell, certainly something that probably
deserves a little investigation.
Again, it is not the only one. There were some other drugs.
I think, if I am correct, BARDA supported with its investments
Actemra and Kevzara, which are thought to have similar impacts
on the ability to suppress the cytacon response is
hydroxychloroquine. Am I correct in that?
Dr. Bright. There are a number of drugs that we were
evaluating initially, Congressman, that we were considering to
conduct clinical studies to get further information that they
really had an impact, and if they were safe to use in patients
infected with this virus.
Mr. Burgess. Do you have available to you the dollar
amounts that BARDA appropriated or authorized for each of those
two drugs, Actemra and Kevzara?
Dr. Bright. I don't have those numbers available with me
now.
Mr. Burgess. Would you be able to make them available to
the committee?
Dr. Bright. I believe HHS could make those available, BARDA
could probably make those investments available.
Mr. Burgess. Were you concerned with hydroxychloroquine at
the time you made those awards for Actemra and Kevzara, or was
the concern with hydroxychloroquine, which became paramount in
your disagreement with the administration, was it already
established when you made these other investments in similar
medications?
Dr. Bright. My concerns around the safety of
hydroxychloroquine in people infected with the COVID-19 virus
reflective of the scientist review that we received from an
interagency group of clinicians and regulatory experts and
scientists. At the time that we learned about
hydroxychloroquine and chloroquine, there was limited data
available. And our proposal and actions were to see if we could
identify a source of that drug so that NIH could conduct a
randomized controlled clinical study.
That is a similar action we took with remdesivir. Once we
thought remdesivir had promise from data coming from China, NIH
quickly established a clinical study, a randomized controlled
study to evaluate remdesivir. So with hydroxychloroquine, that
was also our preferred plan of action.
Mr. Burgess. And you, of course, authored the letter to the
FDA asking for the emergency use authorization for
hydroxychloroquine?
Dr. Bright. I was directed, as the BARDA director from the
Office of the HHS Secretary, to put in place an expanded access
ID program to make chloroquine donations from Bayer available
to Americans through a unique opportunity that would utilize an
app, and perhaps make it available to Americans who were not
under close supervision of a healthcare provider. During that--
--
Mr. Burgess. Of course, this hearing is not really a
hearing on hydroxychloroquine. I would personally welcome a
robust hearing on therapeutics and the research that is going
on, what we have invested in, what seems to be panning out,
what has not. I will note that both Kevzara and the other
medication may not have panned out. And I think the
manufacturing company for Kevzara announced that they will
discontinue part of the clinical study because it looked
unlikely to help COVID patients. I will tell you that since
starting this, since you identified yourself for this hearing
you got noticed, I am hearing from a lot of doctors, in my
State and around the country, who have experience using
hydroxychloroquine and chloroquine, coupled with Erythromycin
and zinc, and they are reporting significant benefit if it is
used early enough in the course, and may eliminate the need for
hospitalization and ventilatory support.
Ms. Eshoo. The gentleman's time has expired.
Mr. Burgess. I don't think it is right.
Ms. Eshoo. The gentleman's time has expired.
Mr. Burgess. But I think it is important enough that we
should look into it and would just be interested if you did
that as part of your duties at BARDA.
Ms. Eshoo. The gentleman's time has expired.
Mr. Burgess. Can the gentleman answer the question?
Ms. Eshoo. The Chair now recognizes----
Mr. Burgess. Will the witnesses be able to answer the
question?
Dr. Bright. Sir, I believe it is important. I have heard
those anecdotal stories well, and they were not conducted in
the context of randomized controlled clinical study. It is very
difficult to understand data from those types of observational
studies or anecdotal stories. So the drug might have some
benefit in some populations, but we won't know that until we
have that information from a truly randomized, controlled
clinical study.
Many of those studies are ongoing now. Some of those
studies, we are starting to see data from and those studies in
those populations tested have not shown overwhelming evidence
of benefit from the use of hydroxychloroquine in those
patients, but different studies are devised to look at
different angles, as you described.
Mr. Burgess. Most studies are at the end, when someone----
Ms. Eshoo. The gentleman's time has expired.
Mr. Burgess. You do those studies without the drug, though.
When you acquire the drug to perform the studies----
Ms. Eshoo. The gentleman's time has expired. The
gentlemen's time, please. We all want to be fair to each other.
The gentleman's time has expired.
The Chair recognizes the chairman of the full committee,
Mr. Pallone, for his 5 minutes of questions.
Mr. Pallone. Thank you, Madam Chair.
Let me just say, Dr. Bright, thank you for your courage in
being here. When I was younger, we used to read a book by
President Kennedy called Profiles in Courage. And your courage
in being here reminds me of some of the people I read about in
that book.
I am concerned, Dr. Bright, that the Trump administration
does not have plans for a nationwide vaccine program to ensure
that once a vaccine is approved, we will be able to quickly
make it available to everyone. In other words, I don't want to
see the same mistakes by the Trump administration, the
incompetence that they had with the supply chain and the
testing repeated with the vaccine. And you stated at the outset
of the pandemic in January, you began urgently pressing HHS
officials to provide the necessary resources to begin vaccine
development after your pleas fell on deaf ears. And as the
pandemic progressed, you also stated you were alarmed by the
pressures coming from some administration officials for your
agency to invest in drugs and vaccines, and I quote, ``without
proper scientific vetting or that lacked scientific merit.''
Can you tell us where we are now in the hunt for a vaccine and
where we could have been, had HHS leaders made investment
decisions sooner that were based on scientific merit?
Dr. Bright. Thank you, Congressman.
As we all know, vaccines are very difficult to make. It is
nothing they can do quickly and you need multiple shots on goal
to try to make a vaccine. There are many diseases, we have
attempted to make vaccines through history and still hasn't
been able to do so. So it takes many opportunities and many
different approaches. Right now, there are over 100 different
approaches for developing a vaccine for this coronavirus. So we
are confident that hopefully, I should say, at least one of
those or two of those will work. But you have identified key
critical challenges that we need to anticipate and prepare for
early. Number one is the supply chain for those vaccines,
needed reagents and buffers and salts, and the various
ingredients go into a vaccine, as well as the glass vials that
the vaccines are put into, and needles and syringes, and then a
carefully coordinated distribution and administration strategy.
We haven't yet gotten to those downstream strategies yet in
our government. And I think those are going to become a
significant issue down the road if we don't plan for that now.
The urgent need for funding at the outset of a pandemic is
something we have known about through many years of pandemic
exercises. Even in our August 2019 Crimson Contagion exercise,
it was highlighted that we would need at least $10 billion from
the outset of the pandemic to start the development of drugs
and vaccines. Every day we delay delays the output of that
vaccine or drug. So in those early days, my first meetings with
Secretary Azar, I asked for funding for people and for those
viruses, the three critical things to get the vaccine started.
It took some time to get the funding available through
various processes. What BARDA did is we began to look
internally at other contracts and other programs we had to
redirect some available fundings and minimal funding to even as
early as January, be able to initiate contracts or agreements
with some companies to start working on those vaccines as soon
as possible. It is because of those actions now that not only
have those vaccines started and made some progress, but also,
the United States has a placeholder with some of those
companies to be able to place orders for those vaccines when
they are available. We did everything possible to ensure that
those investments were in companies that would build capacity
in the United States to manufacture those vaccines. We had to
get in line first, even when the money wasn't fully there, to
complete the development program, that is what we did.
Mr. Pallone. I guess my concern is, I am very critical of
the administration in terms of their, I call it incompetence
with the supply chain, with lack of testing. I am afraid the
same thing is going to happen with vaccines and the
distribution. I mean, should I be concerned based on your
experience?
Dr. Bright. Absolutely, sir. We are already seeing those
challenges with limited doses of remdesivir with data that we
are getting that remdesivir has some benefit in people. And we
have limited doses, and we haven't scaled up production, and we
don't have a plan in how to fairly and equitably distribute
that drug. If you can imagine the scenario this fall or winter,
maybe even early next spring, when a vaccine becomes available,
there is no one company that can produce enough for our country
or for the world. There will be limited supplies. We need to
have a strategy and plan in place now to make sure that we
cannot only fill that vaccine, make it, distribute it, but
administer it in a fair and equitable plan.
Mr. Pallone. And that is not the case?
Dr. Bright. We don't have that yet, and it is a significant
concern.
Mr. Pallone. Thank you. Thank you, Madam Chair.
Ms. Eshoo. The gentleman yields back. I now have the
pleasure of recognizing the ranking member of full committee,
Mr. Walden.
Mr. Walden. Thank you, Madam Chair. And again, I thank the
witness for being here.
I want to get some clarification. So BARDA's job is to do
the vaccines, right?
Dr. Bright. That is one of BARDA's roles, yes, to support
industry to make the vaccines.
Mr. Walden. OK. Is it BARDA's responsibility to direct the
personal protective equipment acquisition distribution, the
PPE? Is that part of your responsibility at BARDA?
Dr. Bright. BARDA plays a role in pandemic preparedness for
our Nation. And we prepare and align and exercise with our
other Federal agencies. We also are familiar with the critical
gaps in the supply chain. While BARDA isn't responsible for
procuring those items for the Strategic National Stockpile, we
are aware of those shortages and those needs. What I was doing
in my capacity as BARDA director was raising those concerns and
needs with the appropriate group within ASPR, the strategic
national----
Mr. Walden. But ASPR basically has a responsibility to go
do that, right? That is not your direct responsibility. You are
obviously in this discussion, but that is not how it was right
in BARDA, correct?
Dr. Bright. It is my responsibility to raise a significant
concern about a limited supply or shortage that I think will
affect the lives of Americans?
Mr. Walden. Did you raise that concern with people up here
on Capitol Hill? And if so, who and when?
Dr. Bright. I raised that concern with my leadership, sir.
I raised it with the appropriate folks in the Strategic
National Stockpile and our Critical Infrastructure Protection
Program.
Mr. Walden. Not up here?
Dr. Bright. My role is to raise it to my supervisor, Dr.
Kadlec. I also did raise that concern, though, in the White
House with Mr. Navarro.
Mr. Walden. Yes, I am interested, because we are passing
these bills. In the future, I hope you would or anybody out
there listening in these agencies, if you are spotting
something not working right, we need to know.
Dr. Bright. Yes, sir.
Mr. Walden. On the first case of SARS COVID 2 in the U.S.,
it was identified, I believe, in January 22, in Washington
State. CDC put the positive specimen in culture that day,
correct?
Dr. Bright. I believe so. I think it was January 20th.
Mr. Walden. OK. It is my understanding, the samples of the
virus were made available to the U.S. Government and that the
CDC expanded the virus stocks between January 29 and February 3
and shared the BEI on February 4 to enable broad sharing.
Now, according to your complaint, after virus samples were
available to the U.S. Government from the Washington State
case, and potentially even after the CDC's effort to grow the
virus and then share with the BEI biorepository, you were still
seeking to obtain a sample of the virus, correct?
Dr. Bright. That is true, sir. But we need more than one
virus.
Mr. Walden. Right. I am going to get to that. Why were the
strains not available within the U.S. Government, not available
to you? Were they available to you?
Dr. Bright. Sir, I was asking for viruses in January
because we wanted to make sure that we had a head start on
developing the vaccine.
Mr. Walden. No, I get that.
Dr. Bright. When they became available in February, I
believe it was February 6 through the BEI resources, then those
were distributed to laboratories.
Mr. Walden. Did you ask for the virus sample from
Washington State, though, as part of that?
Dr. Bright. Absolutely.
Mr. Walden. You did?
Dr. Bright. BARDA did. We asked to make sure we had access
to those viruses, and they were distributed to the right
laboratories and the right companies.
Mr. Walden. And where did you ultimately get the virus that
you distributed?
Dr. Bright. Some of the viruses came from the BEI resources
at NIH, and some of those viruses came from laboratories that
receive the initial seed from CDC.
Mr. Walden. OK, that is helpful to know.
In some conversations I have been a part of with some at
NIH, they indicate that the real key here was to get the DNA
sequence, which China did eventually put up, I believe, the end
of December, early January, and that in terms of going after
the vaccine, it was that sequencing that really mattered most
to get started on vaccine development. And there are other
scientists who are very distinguished who believe that the
delay in getting the virus sample actually didn't set them
back. Is that an accurate assessment, or do you have a
disagreement in that view? I know scientists disagree, so do we
up here. But I am kind of hearing that having the sequencing
really mattered most--and getting the virus important, but did
not set them back in proceeding to get the vaccine development
underway.
Dr. Bright. Sir, China posted the first sequence on January
11, I believe and made it available January 10 or January 11.
It is important to understand that when the sequence is
available, some companies, or some technologies, can get
started with that sequence information. You still are
vulnerable because you have another country in their
laboratories that post on the internet or database their
sequence. So there could still be challenges, especially for
national security integrity for that sequence.
Mr. Walden. Before my time runs out--well, it has run out.
I was just going to ask, did they begin efforts at that time
once they got the sequence?
Dr. Bright. The NIH began efforts on a synthetic messenger
RNA vaccine candidate. However, without the viruses, you really
cannot tell if the neutralizing antibodies listed by that----
Mr. Walden. Right.
Dr. Bright [continue]. Or your, diagnostics, or your
therapeutics that actually work. You can try to synthesize a
virus a sequence, but it is never going to be representative of
the actual virus. And when we are spending billions of dollars
on drugs, vaccines, and diagnostics, we want to have the most
credible information possible.
Mr. Walden. Thank you, Madam Chair.
Ms. Eshoo. The gentleman yields back. A pleasure to
recognize the gentleman from New York, Mr. Engel, for his 5
minutes of questions.
Mr. Engel. Thank you, Madam Chair, for holding today's
hearing.
Doctor, if you were a betting man--oh, sorry. Thank you.
Doctor, if you were a betting man, when would you bet that
we would--time that we would have a vaccine?
Dr. Bright. That is a very difficult question to answer. I
know that there are companies and academic labs working very
hard.
Normally it takes up to ten years to make a vaccine. We
have done it faster in emergency situations, when we had the
starting material in the freezer for Ebola. But for a novel
virus, it actually haven't been done yet that quickly.
So, a lot of optimism is swirling around a 12- to 18-month
timeframe if everything goes perfectly. We have never seen
everything go perfectly.
My concern is if we rush too quickly and consider cutting
out critical steps, we may not have a full assessment of the
safety of that vaccine. So, it is still going to take some
time. I still think 12 to 18 months is an aggressive schedule,
and I think it is going to take longer than that to do so.
Mr. Engel. Twelve to 18 months from now or 12 to 18 months
from when this all started, the beginning of the year?
Dr. Bright. It would be 12 to 18 months from when the
particular manufacturers first received the material or
information that they needed to start developing that vaccine.
It is critical to note, when we say 12 to 18 months, that
doesn't mean for an FDA-approved vaccine. That means to have
sufficient data and information on the safety and
immunogenicity, if not efficacy, to be able to use on an
emergency basis, and that is the consideration that we have in
mind when we talk about an accelerated timeline.
Mr. Engel. Thank you.
I represent, in New York, Bronx County and Westchester
County, which are at the epicenter of the U.S. coronavirus
outbreak, New Rochelle, New York. While New Yorkers have really
rallied together in support of their neighbors, the
administration has failed at every turn. The President has
sidelined our best scientists, pushed baseless conspiracy
theories, and more recently prescribed unproven remedies, like
Lysol, to suffering Americans.
Since the early days of the outbreak, the President has
encouraged doctors to prescribe chloroquine to suffering
Americans despite a lack of evidence supporting its use. On
April 24th, the President's hand-picked FDA commissioner even
came out against the use of chloroquine for COVID-19 cases.
Doctor, what are the dangers of chloroquine if prescribed
incorrectly? And what happened when you raised the issue of
chloroquine use in coronavirus patients with HHS leadership?
Dr. Bright. Congressman, our concerns center around the
potential use of chloroquine in people who are infected with
this coronavirus. There are data of the effective use and safe
use of chloroquine in malaria patients and other patients and
other indications. We also knew that there were potential
safety risks with chloroquine that cause irregular heart
rhythms and even, in some cases, death.
So our concern was with limited information and knowledge,
especially of its use in COVID-19 infected patients and the
potential for those at risk, then we should make sure that any
studies with that drug were done in a carefully controlled
clinical study under the close watchful eye of a physician so
they could respond to a patient if they did experience one of
those adverse events.
There wasn't sufficient data at that time to support the
use of this drug in patients with COVID-19 without close
physician supervision.
Mr. Engel. And when you raised that issue of chloroquine
use in coronavirus patients with HHS leadership, what happened
to you? You were removed as the director of BARDA, is that not
true?
Dr. Bright. I believe part of the removal process for me
was initiated because of a pushback that I gave when they asked
me to put in place an expanded access protocol that would make
chloroquine more freely available to Americans that were not
under the close supervision of a physician and may not even be
confirmed to be infected with the coronavirus.
The scientists at FDA, BARDA, NIH, and CDC worked hard to
switch that to an emergency, use authorization with strict
guardrails: that the patients would be in a hospital, confirmed
to be infected with this virus, under close supervision of a
doctor, and who could not otherwise participate in a randomized
controlled study.
My concerns were alleviated somewhat by being able to lock
that in the stockpile with those conditions. However, my
concerns were escalated when I learned that leadership in the
Department of Health and Human Services were pushing to make
that drug available outside of this emergency use
authorization, to flood New York and New Jersey with this drug
regardless of the EUA.
And when I spoke outside of our government and shared my
concerns for the American public, that, I believe, was the
straw that broke the camel's back and escalated my removal.
Mr. Engel. Thank you.
Thank you, Madam Chair.
Ms. Eshoo. The gentleman's time has expired. A pleasure to
recognize the gentleman from Kentucky, Mr. Guthrie, for his 5
minutes of questions.
Mr. Guthrie. Thank you very much.
Thank you, Dr. Bright, for being here. We appreciate it
very much.
Reading through your complaint, I just kind of want to
point out, I think the chairman said earlier, talked about the
lack of urgency, and implies the President's lack of urgency. I
think most of my constituents want to know that things are
getting done and where is the President on this.
And you are having issues with the leadership at Health and
Human Services, and you are giving them recommendations. So if
they are not accepting your recommendations to them, I would, I
think, fairly surmise, they are not passing that on to the
White House.
So the President is probably unaware of what you are
putting forth because it says, in reading from your complaint
on page 23:``Fortunately, White House Trade Advisor Peter
Navarro shared Dr. Bright's sense of urgency.'' So that is a
sense of urgency.
So talking about the urgency in the White House. So you
have a meeting with him on Saturday. He calls you back in on
Sunday. You prepare your recommendations in a memo for Mick
Mulvaney, Chief of Staff, so essentially the President.
And then--so you meet with--you get around the leadership
of HHS, meet essentially with the President, since with Mick
Mulvaney, and it says--you have the meeting with Navarro on
Saturday, the memorandum with Mick Mulvaney on Sunday, and on
Monday, it says, the National Security Council Policy
Coordinating Committee met with Doctor-- ''met and directed Dr.
Kadlec and HHS to implement Navarro's recommendations. The push
by the White House for HHS to act more swiftly created tension
between Dr. Bright and HHS political leadership.''
So it seems--I don't know how you could be more urgent in
government than having a meeting on Saturday, a memorandum on
Sunday, and actions on Monday once it got to the President's
attention, the President's level. So we appreciate the
President moving forward on that.
I am on--the ranking member of Oversight and
Investigations, the investigations, which you have testified in
front of us before, and we appreciate that very much. So I am
going to look at more of the process of putting this hearing
together and some things.
As we read through your complaint, the only way we have it
is because you made it public. And in your complaint, there are
different exhibits that you talk about, and we are having a
hearing today, and there are actually 33 exhibits referenced in
your complaint that is not public. I think we got them from--
the majority through The Washington Post or something like
that. That is how we made documents available for this hearing,
my understanding.
So the 33 exhibits that are not made public that are
referenced in your complaint, would you make those available to
the committee?
Dr. Bright.
Mr. Guthrie. Do you have those to make them available to
the committee?
[Witness consults with counsel.]
Mr. Guthrie. I mean, if we are using your complaint for
this hearing, we need to have the documentation.
Ms. Katz. May I address that?
Mr. Guthrie. If the Chair--I don't have a problem with you
addressing----
Ms. Eshoo. [inaudible.]
Ms. Katz. Yes, we will take that under advisement and get
back to you.
Mr. Guthrie. OK. Also, when we read through the----
Voice. That is not an answer.
Ms. Katz. There may be privacy considerations in some of
the documents, so we do need to look at these documents
carefully.
Mr. Guthrie. So also if we read through the email chains
that are made available, some appear complete, but some truly
aren't. They are apparently not full email chains. And so you
will wonder if the context of the email would relate to the
inferences taken from the emails. Would you make all the
complete email chains available to us?
Ms. Katz. I would like to address that as well, which is a
problem, is when Dr. Bright was removed from his position, he
was locked out of his email. He does not have access to his
full email.
Mr. Guthrie. So the email chains that you have available,
we have? We have?
Ms. Katz. That is correct.
Dr. Bright. I can address----
Ms. Katz. He does not have a full set of his email.
Dr. Bright. I can address this too. That is exactly right.
So I was immediately locked out of my email on April 20th of
this year, and so I didn't have full records available to me on
that.
However, I believe I have laid a solid foundation in my
complaint, as detailed as I could be, for the Office of Special
Counsel to be able to conduct an investigation.
I believe as part of their investigation, they will be able
to access those emails and individuals to get the full story
and get the full information so they can get to the bottom of
it.
Mr. Guthrie. It would have been helpful for us as well.
Have you shared any of these exhibits with the majority
that has not been shared with us on the minority side?
Dr. Bright. Sir, I believe you have probably what is
available in the public domain, and I believe the rest has been
submitted to the Office of Special Counsel. And I haven't made
it available to anyone directly.
Ms. Eshoo. To the gentleman, the minority and majority
members all received the same packet of information----
Mr. Guthrie. Which is available to the public.
Ms. Eshoo [continue]. The emails, yes----
Mr. Guthrie. OK.
Ms. Eshoo [continue]. That was available, that was in the
public domain.
Mr. Guthrie. OK.
So just one more. Are there any other documents in your
possession or accessible to you that are not included as
exhibits in the complaint but are nonetheless relevant to your
allegations? If so, will you provide those to the committee?
Dr. Bright. I believe I provided the information I have
available to me at this point. If I had access to my email from
HHS, there might be additional supporting information in that
email. I do not know the status, if that has been deleted or
wiped or--I just haven't had access to it since April----
Mr. Guthrie. OK. What you have access to. I appreciate your
answers. Thank you very much.
I yield back.
Ms. Eshoo. The gentleman yields back. A pleasure to
recognize the gentleman from North Carolina, Mr. Butterfield,
for his 5 minutes of questions.
Mr. Butterfield. Thank you, Chairwoman.
And to you, Dr. Bright, thank you, sir, for coming today,
and thank you, most importantly, for your 25 years of public
service.
Dr. Bright, I would like to ask you about your efforts to
address supply shortages for administering COVID-19 tests.
According to your count, as COVID-19 testing ramped up, you
asked for an inventory of the strategic national supply
availability of testing supplies, including swabs, viral
transport materials, and extraction buffers. You learned that
the national stockpile did not stock these items.
After that, you learned that FDA's source of swabs was a
manufacturer in the region of Italy, which was the center of
the COVID-19 outbreak in Italy. It is my understanding that
this information then prompted you to reach out to the DOD
agency that had previously assisted your office with
international transportation of supplies related to Ebola.
My question is why, why, sir, did your office contact DOD
at this point?
Dr. Bright. Sir, it was quite a surprise to me that the
urgent ramp-up of testing did not include full consideration of
all the critical supplies needed to support that ramp-up of
testing, including those materials you mentioned--swabs, viral
transport media, buffers, et cetera. And I was quite alarmed to
learn, from sitting behind CDC Director Redfield, that we were
going to experience a shortage of swabs. And I was even more
surprised that our Strategic National Stockpile did not plan or
have any of those in supply.
So my urgency to find a solution to that was supported by
the FDA director of the Center for--CDRH, that is, devices and
diagnostics at FDA.
And once I confirmed that there was a shortage, it was
critical that we find a solution, and that was by partnering
with our Department of Defense colleagues who worked with us
for the Ebola response. We actually worked with them to ship
doses of Ebola vaccine from Germany to the United States so it
could be filled rapidly to respond to the outbreak in Africa.
So it was a natural occurrence or response for me and my
colleagues in BARDA to come up with a solution to that critical
supply chain.
Mr. Butterfield. Let me ask you this. Were there any
restrictions in place in Italy that would require Secretary
Azar to move forward with the request to DOD?
Dr. Bright. What we needed to enact that air bridge with
the Department of Defense we needed our Secretary of--Secretary
Azar to make a request of the Secretary of Defense. And I and
my colleague, Dr. Gary Disbrow, raised this issue with our--at
our senior leadership meeting with Dr. Kadlec, who chairs that
meeting, the ASPR, and it clearly was not a topic that he
wanted to discuss on that day. And actually we were rebuffed by
him saying that he did not really want to talk about swabs
right now. And both Dr. Disbrow and I raised this concern
repeatedly in that call.
So, knowing that it was critical and time-sensitive, and we
had a critical shortage of these swabs, I placed a call to Mr.
Navarro's office once again and asked if Mr. Navarro could
offer some assistance in contacting the Secretary of Defense to
get clearance for DOD to put those airplanes in place under the
contract we have. And that happened in a very quick turnaround,
a matter of minutes.
With that permission from the Secretary of Defense, we were
able to start those flights within two days. We have now
transferred back over 25 million swabs.
Mr. Butterfield. So you are saying that you alerted White
House adviser Peter Navarro about this issue. Is that right?
Dr. Bright. Yes.
Mr. Butterfield. And within hours, literally within hours,
he had coordinated with DOD to start these flights to transport
the swabs.
Dr. Bright. Yes, sir.
Mr. Butterfield. This seems like a logical response to the
analysis that you provided. What is truly perplexing to me is
why anyone would resist such an initiative. That is a
rhetorical question. I won't ask you to answer that.
Finally, we still don't have enough testing supplies. I
don't understand how and why that is possible. I understand
that converting an auto plant to build ventilators might take a
little time, but how can we be struggling to get adequate
supplies of simple supplies like swabs? What does this say
about the Federal response to the coronavirus outbreak?
Dr. Bright. It says to me, sir, that there is no master
coordinated plan on how to respond to this outbreak. We don't
have a strategy or plan in place that identifies each of those
critical components, and we don't have a designated agency that
is sourcing those critical components and coming up with a
strategy to make sure that we have those supplies when we need
them.
We need this comprehensive national strategy that is end-
to-end, it includes every component to make sure we can respond
and protect American lives.
Mr. Butterfield. Thank you, Dr. Bright. You are a great
American. Thank you very much.
I yield back.
Ms. Eshoo. The gentleman yields back. A pleasure to
recognize the gentleman from Virginia, Mr. Griffith, for his 5
minutes of questions.
Mr. Griffith. Thank you, Mr. Chair--Madam Chairman.
Appreciate that.
It seems like Mr. Navarro has done a pretty good job in
listening to the questions. I do wish we had more of the
information available, and it is one of the reasons why--it is
not your fault--but why I wish we had done this through the
regular channels.
But I would ask this. On some of the questions that were
just asked about supplies being available, I kind of got the
impression from prior testimony that Project BioShield, which
you urged us to put money into and we put $700 million in 2018
and $735 million in 2019, was supposed to take care of some of
that. Am I misunderstanding Project BioShield?
Dr. Bright. Project BioShield is used to invest in late-
stage development of drugs and vaccines----
Mr. Griffith. It was for the drugs.
Dr. Bright [continue]. Primarily and some diagnostics and--
--
Mr. Griffith. So that didn't help on this at all?
Dr. Bright. It didn't help on this at all, sir.
Mr. Griffith. All right. Now, that being said--and I did
say, you know, and I would hope that we would have had
everything available to us, and I understand that may not be
your fault, but it does create issues. But everything is going
crazy; people have all kinds of things going on, and this
hydroxychloroquine comes up. And there are some email exchanges
in Exhibit 54 from your documents indicate that--a Chris--
Christopher Houchens writes and he says, you know, we should
probably take a look at this--I am paraphrasing, but the line I
took out of it was--especially when we have few or no options.
One of the frustrations I have had for years with our
community trying to respond to all kinds of different diseases
is we want to have the double-blind studies in place; we want
to have all the science there, which makes sense if you have an
alternative. But when you have few or no options, it seems to
me you would go after those things that are available. And if
hydroxychloroquine is one at one point, then remdesivir I am
assuming, have they done the double-blind studies related to
COVID on remdesivir? Has that already happened?
And then I have got an article from the Richmond Times-
Dispatch, April 15th, where a doctor used high doses of vitamin
C and a drug called Actemra. Also--Actemra.
All of these are floating out there; doctors are using all
kinds of things, because we don't have other options. And so I
am wondering, what was the great hesitancy to at least let
doctors try? And even if anecdotally it was having some effect,
wouldn't you have to have that available in order to be able to
do the tests? And if you have got few or no options, why
wouldn't you want to go down that pathway?
Dr. Bright. We want to make sure that the drugs that we
consider are safe and effective. The highest priority is
safety. So many of these studies that we had or anecdotal
evidence or reports we had did not include a thorough safety
vetting of those drugs.
There are some known side effects with some of the drugs.
Many of these drugs were repurposed, so they weren't built de
novo. So we knew about some of those potential safety concerns,
and we didn't have any evidence of how those safety concerns
would appear in people infected with this virus.
This virus takes over a lot of your body. It actually
infects multiple organs in your body and causes significant
inflammation and multi-organ shutdown in some cases before
death and acute respiratory distress syndrome that really turns
your lungs into a brick.
Mr. Griffith. It is scary stuff. And you said, though on
hydroxychloroquine that, you know, one of the problems was you
might have an irregular heartbeat. If you are worrying about
not having a heartbeat at all, that is really not--you are not
worried about irregular if you don't have one at all. Am I not
correct about that?
I mean, that is the concern. People were dying out there,
and here was the first one that showed some promise. Why
wouldn't we want to accept, you know, an offer from a
manufacturer to give us a lot of this and have it out there for
widespread use, if the doctors chose, just like the doctor in
Richmond?
That didn't work in that case. They actually used it there,
in that case, and it didn't work, so he tried something else. I
mean, I think that is really what we are going to have to do in
an emergency situation. Am I not correct?
Dr. Bright. We need to do it carefully, sir. We have to
make sure that when we have that information available with
those potential drugs available, we are thinking outside the
box--
Mr. Griffith. Can't we be so careful that we accidentally
kill people?
Dr. Bright. We need to move swiftly, sir. And we have
actually shown that we can put up a clinical study in the
matter in less than a week.
Mr. Griffith. OK.
Dr. Bright. It is important to use available clinical data.
And if we know there are potential risks, and we need to make
sure that we are cognizant of those risks and make sure those
drugs are used in a very safe and controlled manner.
Mr. Griffith. Yes, sir. And I appreciate that.
And let me just say this. You know, it is our job to ask
some tough questions sometimes, but, you know, just like you
found friendly ears at the White House, you might have found
some friendly ears on our side of the aisle here as well.
And I would note that in 2018 you were talking about
vaccines, and you were talking about offshore production. And I
said, let me know what I can do to help get more production
onshore. But I never heard from you.
I am happy to help. I want onshore production. I am with
you on a lot of these issues. I don't know what is going on
behind the scenes. We have got to investigate that. Today,
unfortunately, was not the day to do that investigation. We
don't have enough information. A lot of stuff is not here for
us.
But don't hesitate in the future. If you see something, let
us know on both sides of the aisle what is going on.
I appreciate it, and I yield back.
Dr. Bright. Thank you.
Ms. Eshoo. The gentleman yields back. A pleasure to
recognize the gentleman from California, Ms. Matsui, for her 5
minutes of questions.
Ms. Matsui. Thank you very much, Madam Chair.
And thank you, Dr. Bright, for appearing before us today,
and thank you for your public service.
Dr. Bright, you have described a series of missed
opportunities that have left our country woefully unprepared
for the pandemic's impact. Many Americans are eager to return
to normalcy, as we can all understand. But to even begin safely
reopening, we need widespread testing capacity, an organized
contact tracing workforce, and a healthcare system that can
handle further surge. And, ultimately, a vaccine or therapeutic
cure is required.
I would like to ask you a series of questions about your
warnings to the administration while at BARDA. I am hoping you
can succinctly answer whether you believe each scenario will
ultimately shorten or lengthen the time it takes for our
country to safely reopen and recover from the coronavirus
pandemic.
On January 10, you began pushing HHS leadership to obtain
sequencing on virus samples. Given the importance of these
samples for vaccine and diagnostic development, has the
administration's inaction shortened or lengthened our timeline
for reopening?
Dr. Bright. Those samples were critical to get started as
early as possible. There was a delay in getting those samples.
That means there will be a delay in getting those
countermeasures. Those countermeasures are critical to
reopening our country.
Ms. Matsui. OK. Throughout the month of January, you made
HHS aware of the urgent need to increase funding to combat the
virus. HHS leadership believed that BARDA's budget was
sufficient. Has the delay of these resources shortened or
lengthened our timeline for reopening?
Dr. Bright. Delay of those resources have extended the
ability--the timeline to make drugs available and vaccines,
therefore, has extended our ability to respond to this
pandemic.
Ms. Matsui. On January 18, you pushed Dr. Kadlec to
coordinate COVID-19 planning activities across the government.
Dr. Kadlec initially rejected your request, suggesting it was
not time-sensitive. Did this delay in coordination shorten or
lengthen our timeline for reopening?
Dr. Bright. That lengthened the timeline of our reopening.
We needed those early policy discussions to happen as soon as
possible.
Ms. Matsui. From January through March, you pushed for HHS
to ramp up production of N95 masks, swabs, and syringes. HHS
failed to act quickly. Has this inaction shortened or
lengthened our timeline to reopening?
Dr. Bright. That inaction has put a lot of lives at risk in
our frontline healthcare workers, and no time to reopen our
country will bring those people back to us.
Ms. Matsui. Certainly. Thank you, Dr. Bright. Of course,
there are many decisions made outside of these scenarios that
influence when we can safely reopen, but from what I am hearing
today, HHS, if they heeded your warnings early, we could have
proactively limited the toll this pandemic has taken on our
country.
It appears clear from the whistleblower report that the
Trump administration prioritized political calculations above
public health with regard to chloroquine and
hydroxychloroquine. Despite the lack of data supporting the
clinical benefits for the treatment and prevention of COVID-19,
the Trump administration promoted the drug's use to the
American people because it was seen as a big, immediate win.
Dr. Bright, do you believe there are other instances where
the administration relied on politics rather than science to
make coronavirus response decisions? And what consequences
might those decisions have had on public health?
Dr. Bright. We have a very rigorous scientific review
process for all of the investments that we make for the drugs,
vaccines, and diagnostics through BARDA and through our
department actually. And so there were some attempts to bypass
that rigorous vetting process that caused me great concern and
actually increased the tension between me and Dr. Kadlec.
Without that scientific vetting, that does increase the
risk of a drug being evaluated or supported that could have
safety concerns. And we really needed to have the best
scientists in our country weigh in on whether or not that drug
should be evaluated and how it should be evaluated to address
those safety concerns.
Ms. Matsui. Certainly.
The Trump administration waited until April to invoke the
Defense Production Act to increase the production of life-
saving medical supplies, like masks, months after doctors began
experiencing shortages and three months after your initial
January warnings.
Should HHS have invoked the Defense Act earlier to increase
the domestic production of critical medical supplies like masks
and swabs?
Dr. Bright. I am actually not an expert on the Defense
Production Act and how it is used most effectively. I do
believe that we should have been doing everything possible--
placing orders early, ramping up supply, ramping up production
of those critical medical equipment--as quickly as possible.
Whether or not that is through the Defense Production Act or
other mechanisms, it should have been a high priority.
Ms. Matsui. OK. Well, thank you very much, Dr. Bright. I
have run out of time, and thank you very much for appearing
before us today.
Ms. Eshoo. The gentlewoman yields back. A pleasure to
recognize the gentleman from Florida, Mr. Bilirakis, for his 5
minutes.
Mr. Bilirakis. Thank you, Madam Chair. I appreciate it very
much.
And I want to thank Dr. Bright as well for your service to
our country.
I have a few questions, and I am focusing on the
hydroxychloroquine. When was the potential use of chloroquine
and hydroxychloroquine as treatment for the COVID-19 first
brought to your attention, sir?
Dr. Bright. I believe it was probably mid-March, between
March 10th and March 17th, somewhere in that timeframe.
Mr. Bilirakis. And not prior to that?
Dr. Bright. Not that I recall. The first I heard of the
drug itself was a call I received from Dr. Woodcock at the FDA
asking if I had heard of the drug. And I hadn't heard of the
drug, and I hadn't heard of its potential use for COVID-19
patients. She said there might be something interesting to look
at. And she forwarded a manuscript, a draft manuscript, and
that is the first I learned of the drug itself.
Mr. Bilirakis. So you won't--you didn't--you weren't aware
of any news articles and research papers in January discussing
the potential benefits of the drug?
Dr. Bright. I heard anecdotal stories and reports, sir.
Mr. Bilirakis. You had?
Dr. Bright. I had--I can't recall if I did it specifically
for chloroquine, but I tried to track the media and the
scientific journal as well. However, I rely on the guidance of
the science within HHS, and the first I had heard of that was
from my colleague, Dr. Woodcock, at the FDA, and then a summary
report from our scientists at FDA, CDC, NIH, and BARDA, that
indicated that the evidence for its benefit was weak and the
evidence for its safety concerns was stronger. And they did not
believe at that point it was something that should be
supported.
Mr. Bilirakis. OK. Now, again, what was your reaction
personally? Did you think it was something worth pursuing
initially when you heard it from Dr. Woodcock?
Dr. Bright. Initially, I said, I do believe--I mean, I
trust Dr. Woodcock and her scientific judgment immensely, and
if she mentioned it as something that we should look at and as
something we should consider testing in a randomized controlled
clinical study, I would be supportive of the team reviewing
that protocol and that information to see if it should be used.
Mr. Bilirakis. Sir, you know, I understand, I have heard it
from experts--and I am certainly not an expert in this area--
that the drug, the one that we are talking about in this case,
hydroxychloroquine, if it is used, first of all, timely,
because I now understand there is a window there as far as the
patient, the effective--the efficacy of the drug.
Have you heard this, that if it is administered properly,
there is a small window there for the patient as far as risk is
concerned? Can you elaborate a little bit on that if you have
heard that? And again, this is not from a layperson. This is
from an expert.
Dr. Bright. We have seen anecdotal, heard of anecdotal data
from different physicians that they believe they have seen
benefit or patient improvement from the use of this drug in
either combination with an antibiotic, azithromycin, or in
combination with zinc or other--vitamin C or other things, but
there was never sufficient evidence from a randomized
controlled study to show its benefit would actually outweigh
the potential risk.
That is why the NIH and probably 40 other institutions
around the world is conducting randomized controlled clinical
studies to look at the benefits either in late-stage treatment
or early-stage treatment. Most of the data coming out from
those clinical studies to date, haven't shown an overwhelming
level of evidence that it has benefits in those patients.
It doesn't mean that it might still have some benefits in
individuals or a case or two in different studies or that
physicians believe they see a benefit in their patients. But in
the context of a randomized controlled study, we haven't seen
an overwhelming level of benefit.
Mr. Bilirakis. Have you reviewed the studies in other
countries, such as France and possibly Japan, on these? I mean,
are you--I just want to know, because my constituents ask these
questions. Do you take those studies into consideration when
you make these decisions?
Dr. Bright. We absolutely do. We look at the quality of
those studies. We look to see if they were done with the right
controls in place and the right sample size. Was it
statistically relevant or was it just a few people, was it 20
people or was it 2,000 people? All of that adds to the power of
the data itself.
Many of studies that we saw early only included a few
number of patients, and so it was unclear, even from the
description of some of those studies that were not in peer-
reviewed journals, whether all the patients were treated the
same, whether they had full participation throughout the
clinical study itself. And looking at the statistical power of
many of those studies, they were very small. So it is really
difficult to understand the impact, the benefit.
We also saw a study that the VA hospital conducted with
hydroxychloroquine that showed people who are treated with
hydroxychloroquine appeared to have a higher rate of death than
people who were not treated with hydroxychloroquine.
So that study too has weaknesses. No study is actually
perfect. You take all of that evidence into account when you
make a decision on how to further study the drug or how to use
that drug.
Mr. Bilirakis. It is my understanding that, not my
constituent, but a U.S. citizen who--a veteran--was cured--
again, this is just what I heard--from the drug. And that was a
late-stage case, but I have also heard of early-stage cases as
well. So I wanted to get that on the record.
Thank you, Madam Chair.
Ms. Eshoo. The gentleman's time has expired. He yields
back. A pleasure to recognize the gentlewoman from Florida, Ms.
Castor, for her 5 minutes of questions.
Ms. Castor. Thank you, Madam Chair.
Dr. Bright, thank you for speaking out to save lives.
I read your whistleblower filing, and I want to ask you
about the N95 respirators. These respirators are essential
personal protective equipment. They are not the cloth masks or
surgical masks that everyday Americans are encouraged to wear
by the CDC.
Dr. Bright, are N95 respirators necessary to protect the
lives of nurses, doctors, EMTs, and those on the front line?
Dr. Bright. Yes, they are required essential personal
protective equipment to protect those frontline healthcare
workers from getting infected.
Ms. Castor. And this is not a hypothetical concern. Just
last week the L. A. Times reported a tragic story about a
heroic nurse, Celia Marcos, who appears to have died because
she lacked an N95 respirator when she rushed into a hospital
room to try to save a COVID-19 patient who had stopped
breathing.
And this brave nurse is not the only one. According to
another report, over 700 staff at just one Detroit area health
system have tested positive for COVID-19, and the CDC reported
over a month ago that over 9,000 healthcare workers had already
contracted COVID and dozens have died.
And I checked with my Tampa Bay area health providers, and
one Tampa hospital said N95s are still very difficult to
procure. She said there is a dire need for N95s. One of my
community health centers says, we continue to struggle to get
N95s.
And there are so many folks trying to sell knock-offs. And
then a large Tampa Bay area health system said the supply chain
remains inconsistent and irregular, and BayCare remains
concerned as we head into the fall for N95 masks. The demand
will continue to increase due to the flu season and the
continued presence of COVID-19.
Dr. Bright, you understood that America would face a
shortage of respirators in January. Is that right?
Dr. Bright. We understood America would face a shortage of
N95 respirators for a pandemic response in 2007. And we have
exercised and known and evaluated that number almost every year
since 2007.
It was exercised even as late as--early as 2019 August, in
Crimson Contagion, that we would need 3.5 billion N95
respirators in our stockpile to protect our healthcare workers
from a pandemic response.
Ms. Castor. And you sounded the alarm repeatedly but were
ignored by the senior leadership at the Department of Health
and Human Services. Please explain what steps that you took and
the response you received.
Dr. Bright. We knew going into this pandemic that critical
medical equipment would be in short supply. I began getting
alerts from industry colleagues in mid- and early--mid- and
late January telling me that from an outside view, from the
industry view, that the supply chain was diminishing rapidly,
telling me that other countries that we relied on to supply
many of these masks were blocking export and stopping transfer
of those masks to the United States.
I learned that China was trying to buy the equipment from
the United States producers to have it shipped to China so they
could make more.
And each of those alerts--and there were dozens of these
alerts--I pushed those forward to our leadership at ASPR, to
Dr. Kadlec and his senior leadership team. I pushed those
warnings to our Critical Infrastructure Protection team. I
pushed those warnings to our Strategic National Stockpile team
who has the responsibility of procuring those medical supplies
for our stockpile.
In each of those, I was met with indifference, saying they
were either too busy, they didn't have a plan, they didn't know
who was responsible for procuring those. In some cases, they
had a sick child and would get back to it later in the week. A
number of excuses but never any action.
It was weeks after my pushing that finally a survey was
sent out to manufacturers or producers of those masks, a 5-page
survey, asking producers or companies if they actually made
those masks.
Ms. Castor. And in your whistleblower filing you discuss a
February 7th meeting of the Department leadership group at
which you urged the Department to focus on securing N95 masks.
Can you describe what happened at that meeting?
Dr. Bright. They informed me that they did not believe
there was a critical urgency to procure masks. They conducted
some surveys, talked to a few hospitals and some companies, and
they didn't yet see a critical shortage. And I indicated that
we know there will be a critical shortage of these supplies, we
need to do something to ramp up production.
They indicated, if we notice there is a shortage, that we
will simply change the CDC guidelines to better inform people
who should not be wearing those masks so that would save those
masks for our healthcare workers. My response was, I cannot
believe you can sit and say that with a straight face. That was
absurd.
Ms. Castor. In fact, it took three months from your initial
warnings, until mid-April, for the Federal Government to invoke
its authority under the Defense Production Act, to require the
production of millions of more N95 masks. And even then the
administration required the production of only 39 million
masks, which is far fewer that you and other experts said that
we would need.
What was a consequence of this 3-month delay and inadequate
response? Were lives endangered?
Dr. Bright. Lives were endangered and I believe lives were
lost. And not only that, we were forced to procure these
supplies from other countries without the right quality
standards. So even our doctors and nurses in the hospitals
today are wearing N95-marked masks from other countries that
are not providing the sufficient protection that a U.S.
standard N95 mask would provide them. Some of those masks are
only 30 percent effective. Therefore, nurses are rushing into
hospitals thinking they are protected and they are not.
Ms. Castor. Thank you for your courageous efforts.
Ms. Eshoo. The gentlewoman's time has expired. A pleasure
to recognize our colleague from Indiana, Dr. Bucshon, for his 5
minutes of questions.
Mr. Bucshon. Thank you, Madam Chairwoman.
And thank you, Dr. Bright, for testifying. I appreciate it.
I was a cardiovascular and thoracic surgeon and been in
healthcare for over 30-some years. So I want to comment on--I
am not going to ask a question about hydroxychloroquine. I just
want to comment on how the medical community responds to this
type of thing.
Doctors across the country will use drugs off label in a
circumstance where they don't have or they don't see a viable
alternative to that, and I think this is one of those
circumstances. I am hearing from doctors across the country.
And look, I am with you. You have to have double-blind
studies, you have to have proof under normal circumstances. But
in this situation, I think a little bit of understanding and
leeway from the Federal Government is in order.
We do want to ensure the safety. This is a drug that has
been proven safe for many, many years. In the appropriate
doses, it does prolong the QT interval, as you have outlined,
which can lead to cardiac arrhythmias if not used to properly.
But I mean to tell you, when States tried to stop doctors
from using this, there was such a backlash they had to back
away from it, because the physicians and the community wanted
to use it.
And so doctors like me, out in the real world, if things
are working, even anecdotally, they are not going to wait for
the government bureaucracy to approve it. I just want to get
that on the record. I am just saying, this is why doctors are
using this drug. Whether it is right or not, data will show.
But, you know, if two years from now we have the studies,
and we say, hey, that stuff really would have worked and the
government stopped that from being used, if I was a family of a
person that was stopped from getting hydroxychloroquine, I
would be pretty mad.
I want to talk about the supply chain issues as it relates
to PPE, the personal protective equipment, and I think there is
enough blame to go around in the Federal Government about what
happened there for--you know, after H1N1, when our national
stockpiles were depleted, we didn't replenish them. We have had
people on both sides of the aisle talking about this and it
is--I think there is some--something to--some blame to go
around.
But, you know, I don't want to be accusatory, but I do want
to go over some of the facts about BARDA's situation as it
relates to the masks, OK?
According to a Washington Post report, in 2015 the Obama
administration and a company now known as O&M Howard--Halyard,
H-a-l-y-a-r-d, announced a project to develop rapid pandemic
mask production line. According to Federal contracting records,
in 2017 HHS signed off on a $3.3 million, with an ``m,''
payment to Halyard to build a machine that could churn out
millions of protective respiratory masks at a high rate of
speed during a pandemic.
However, in September of 2018 CNBC reported that the
machine was never built. And despite BARDA's $1.5 billion, with
a ``b,'' budget, The Washington Post reported there wasn't
money to pay for the project.
Why was the project scrapped, and did you sign off on that
decision?
Dr. Bright. So that project with Halyard was to build a
novel, a new machine to make respiratory protection, face masks
faster, as you have described accurately.
Mr. Bucshon. Right.
Dr. Bright. Actually, the technical team must have reviewed
that proposal on the next step or further investment in that
machine. I believe that the investment to date was made to
design the machine, build the blueprint for the machine, and I
am not even sure if it was to build an actual prototype of the
machine.
Mr. Bucshon. At that time, in September 2018, were you the
head of BARDA?
Dr. Bright. In 2018, I was the director of BARDA.
Mr. Bucshon. Right. So did you sign off on the decision?
Because I would expect a decision like that, a contract, money
was allocated apparently from HHS to BARDA to do this, I
wouldn't expect that to be scrapped without the director of
BARDA signing off on that, right? So did you sign off on it? It
is a yes-or-no question.
Dr. Bright. Not necessarily a scrapped project, sir. I
don't know what the proposal was. We rely on a very thorough
vetting process----
Mr. Bucshon. Understood.
Dr. Bright [continue]. Through our contracting office. So
that proposal to further continue that project never made it to
me. So if it wasn't approved, it didn't make it through the
proper vetting process in BARDA. The decision to end or
continue that project was not brought to me.
Mr. Bucshon OK. I find that surprising, but I will take
your word for it.
Nicole Lurie, who hired you, told The Washington Post that
the Halyard contract was part of an explicit strategy to ensure
we could surge mask production in the next crisis. Well, now we
are here and we don't have it. So we are dealing with the
consequences of that decision.
And in addition, I guess, to the Howard--Halyard--I keep
saying that wrong--it is my understanding--well, I am running
out of time. So what I am going to just say is, look, to
doctors across America, you know, it is easy for us to sit in
Washington, D.C., whether we are Members of Congress or whether
we are agencies, and talk in the abstract about people dying in
our intensive care units, but when you are the physician at the
bedside and there is a medication that has promise and that has
a safety profile that we understand, doctors will use this
medication off, you know, offline. And that is what is
happening. And, you know, whether that is right or wrong, we
might take years to prove, but in the meantime people can die.
I yield back.
Ms. Eshoo. The gentleman's time has expired. It is a
pleasure to recognize the gentleman from Maryland, Mr.
Sarbanes, for his 5 minutes of questions.
Mr. Sarbanes. Thank you, Madam Chair.
Dr. Bright, welcome back to this committee.
The United States Government deploys millions of dedicated
public servants working together to achieve our shared goals as
a Nation, to promote effective government and to protect the
public interest, in this instance, to protect the public
health. As a scientist and public health official, that was
your charge, and you took it seriously.
Unfortunately, the record shows that your superiors at HHS,
and potentially beyond, instead of valuing your expertise and
experience, squandered it in ways that in this moment, in the
face of this crisis, amount to gross negligence. They ignored
your science-based pleas to pursue critical strategies, for
example, your repeated calls to obtain virus samples from China
and to find supplies, masks, respirators, and swabs. They
dismissed your science-based warnings about pursuing unproven
strategies. They dismissed your concern, for example, about the
stampeding towards hydroxychloroquine. We have heard about that
today.
And they sent you on errant missions to find treatments
with little therapeutic value, all for the sake of satisfying
political cronies. And you have testified about the miracle
cure drug that was an example of that.
Ignoring, dismissing your input, was not harmless
malpractice, because there is every reason to believe that if
that input had been heeded, particularly your pleas for action
in the early days of the pandemic, it might have saved
thousands of lives.
I want to thank you for coming forward. I want to thank you
for blowing the whistle on the misguided and chaotic response
to this pandemic.
I am sure there are specific conversations, emails, moments
in time that you remember like they happened yesterday, the
inflection points where if the response to your warnings had
been heeded, things might have been different. And I am sure
they haunt you and keep you up at night.
From January of this year, tell me about just one specific
moment when you had that sinking feeling in the pit of your
stomach because you were not seeing a response that you knew
needed to happen.
Dr. Bright. Congressman, I will never forget the emails I
received from Mike Bowen indicating that our mask supply, our
N95 respirator supply, was completely decimated, and he said,
we are in deep shit, the world is, and we need to act.
And I pushed that forward to the highest levels I could in
HHS and got no response. From that moment, I knew that we were
going to have a crisis for our healthcare workers because we
were not taking action. We were already behind the ball. That
was our last window of opportunity to turn on that production,
to save the lives of those healthcare workers, and we didn't
act.
Mr. Sarbanes. Thank you.
Listening to your testimony gives me chills because it all
adds up to one inescapable conclusion: It didn't have to be
this way. There was another path. Things could have gone
differently. The Federal response to the pandemic could have
been much more effective.
So here we are at a moment when our country needs the kind
of expertise and science-based guidance that you and others
like you can offer us. These voices are too often being
sidelined. Things are upside down. In you we have someone who
made the right call in the early days and has been removed from
your position, while so many people who made the wrong call
still have their jobs.
Dr. Bright, when the counsel that you and others offer is
cast aside--and I know you know this--it means that science and
reason are also being cast aside. That is a dangerous impulse.
It is an attitude that deprives our country in this critical
moment of any real chance of getting ahead of this pandemic.
But hopefully we can learn from this. There is still time
to put science and reason back into the national strategy for
fighting COVID-19. We need people like you to help lead us
through this.
The Federal response has got to get smarter. It has to put
science ahead of politics and cronyism and wishful thinking.
Our committee will continue to press for that in the days
ahead, and I know that you want to look forward. So tell us,
what can we do now to learn from the mistakes of January and
February and March and make sure that we navigate and lead our
country through this public health crisis?
Dr. Bright. Congressman, we need to install and empower
leadership, and we need to unleash the voices of the scientists
in our public health system in the United States, so they can
be heard. And their guidances need to be listened to, and we
need to be able to convey that information to the American
public so they have the truth about the real risk and dire
consequences of this virus, and they have the truth about the
consequences of their actions if they don't follow those
guidances.
And we don't have a single point of leadership right now
for this response, and we don't have a master plan for this
response. So those two things are absolutely critical.
I would also encourage Congress to ensure there is
oversight in this response. Large sums of funding have become
available to help us, as scientists and others, respond to this
outbreak, and without proper oversight of those dollars, I am
concerned that they could be misdirected and lost and not put
to the right fight.
So I would urge Congress to continue and increase their
oversight in how those funds are being spent and making sure
they are prioritized and used appropriately to end this
pandemic.
Mr. Sarbanes. Thanks for that caution. I yield back.
Ms. Eshoo. The gentleman's time has expired and he yields
back. A pleasure to recognize the gentlewoman from Indiana,
Mrs. Brooks, for 5 minutes for her questions.
Mrs. Brooks. Thank you, Madam Chairwoman.
Dr. Bright, with all due respect, the Vice President was
named the head of the coronavirus White House Task Force, which
was actually a recommendation from a bipartisan blue-ribbon
study panel that issued recommendations years ago and thought
the Office of the Vice President ought to be in charge of the
response. And so, with all due respect, I believe there is that
coordination.
And part of what I am very, very concerned, relative to
this hearing, is that there is the impression being made that
there has been no plan. And, in fact, that is part of what the
reauthorization of PAHPA, that I worked closely with you, Dr.
Kadlec, that Congresswoman Eshoo, Dr. Burgess, so many of us
relied on you all to share with us what we needed to do to
reauthorize PAHPA, which most Members of Congress really didn't
know what that was, Pandemic All-Hazards Preparedness Act. Most
Members of Congress and most members of the American public
didn't know we had strategic national stockpiles and that we
might actually be short some of these things, until this all
hit.
But we did get that reauthorized, and it was signed into
law in June of 2019. Do you recall that?
Dr. Bright. Yes.
Mrs. Brooks. And, Dr. Bright, you joined BARDA to lead the
influenza division in 2010, right after H1N1, because of your
expertise, and we rely on your expertise, and you became
director in 2016. After--and you mentioned it in 2007, but
after the 2009 H1N1 pandemic, the supply of masks in the
Strategic National Stockpile was not resupplied. You have
mentioned that actually you have had a problem since 2007.
But I have to share with you, Members like Congresswoman
Eshoo and I, who have had discussions about this, many of us
really didn't know that. We, as members of this committee, did
not know and were not told of these shortages of masks as we
worked through reauthorization of this important law.
Were you aware of this issue, and did you push HHS to
maintain mask production for purposes of replenishing the
Strategic National Stockpile before this happened in January?
Dr. Bright. Before 2017, we actually held an annual review
of the Strategic National Stockpile. That was chaired by Dr.
Lurie, the previous ASPR.
Since we moved the Strategic National Stockpile from the
CDC management, under the ASPR management, we have not yet had
an interagency, across-departmental review of the supplies in
that Strategic National Stockpile. We went through an annual
prioritization process. There has always been limited funding
and never enough to completely top off the stockpile.
Mrs. Brooks. Did you know Greg Burel?
Dr. Bright. I do.
Mrs. Brooks. He retired prior to all of this happening.
Dr. Bright. Yes.
Mrs. Brooks. He led the Strategic National Stockpile. Did
you have conversations with Greg Burel from 2009 until 2020
about what was in the Strategic National Stockpile?
Dr. Bright. Absolutely. The Flu Risk Management Meeting met
on a monthly basis, and each year they reviewed and prioritized
items that should be purchased by the Strategic National
Stockpile.
Mrs. Brooks. OK.
Dr. Bright. That body--which I actually directed for some
time--made recommendations and prioritizations to the Strategic
National Stockpile. However, it was the Strategic National
Stockpile's responsibility to make those purchases.
Mrs. Brooks. And how about PHEMCE? Does BARDA participate
in PHEMCE? And would you please--very, very briefly, because my
time is limited--explain what PHEMCE is? This is a plan that
experts like yourselves participate in.
So I want the American people to know there have been
plans, there have been plans, that PHEMCE had forth a 2017-2018
implementation plan. The White House put forth in September of
2018 a National Biodefense Plan. Did you participate in that
National Biodefense Plan?
Dr. Bright. I did, and many of us did.
Mrs. Brooks. And it was the first time that our country had
actually put forth a National Biodefense Plan. Many said it was
kind of landmark, and same thing with PHEMCE putting forth many
plans.
So I want the American people to know a lot of folks, over
a long period of time, have been focused, but yet we did not
still have enough. We didn't have enough swabs. We didn't have
enough masks. We don't have enough gowns for all those
incredible healthcare providers.
So I don't want everyone to be given the impression that
you raised the flag just in January, OK, when you saw it was
short, because you hadn't gotten the job done prior to January.
And you were at those tables, as were so many others. This
happened over a very, very long period of time. And those of us
have been very the disappointed to learn what was and what was
not in the Strategic National Stockpile.
I thank you for your service. I thank you for your
expertise. But across the board, over many administrations, we
did not do enough.
And I yield back.
Ms. Eshoo. Do you want to respond, Doctor?
Dr. Bright. I can say that those plans have been in place,
and it was disappointing they were not pulled out in January of
this year and followed. They were not put on the table with a
strong leader indicating these are our plans, everyone falls in
line and follows through with this plan.
I can also--I think it is important to emphasize the
PHEMCE, it is the Public Health Emergency Medical
Countermeasure Enterprise, which is comprised of many great
scientists from across our government who put these plans in
place, but since 2017 we have largely disbanded, dismantled
that PHEMCE organization. We have not had those interagency
discussions for a number of years, the Executive Enterprise
Committee and the Executive Leadership Committee. We may have
had one or two meetings at most in a new restructured or
reorganized PHEMCE organization.
So the partners and colleagues across government haven't
had those venues to even talk or coordinate for a number of
years to understand what that plan looked like and how they
would work together to implement that plan when the day came to
need it.
Ms. Eshoo. The gentlewoman's time has expired and she has
yielded back. A pleasure to recognize the gentleman from New
Mexico, Mr. Lujan, for your 5 minutes of questions.
Mr. Lujan. Thank you, Madam Chair.
Dr. Bright, you have described pressure from senior Trump
administration officials to promote the malaria drug
chloroquine and hydroxychloroquine to treat COVID-19 despite
the lack of scientific support for this treatment. According to
your account, when they are offered to donate chloroquine pills
to the Strategic National Stockpile on March 17, your team of
experts at HHS determined that, quote, ``There are safety
liabilities associated with the drug,'' close quote, and that,
quote, ``accepting the donation could lead to widespread use
that is not supported by any clinical data,'' close quote.
Further, one of the public health experts advising you
said, quote, ``No data available to support that chloroquine
provides clinical benefit to the treatment or prevention of
COVID-19'' close quote.
Yes or no, Dr. Bright, are there safety liabilities
associated with chloroquine?
Dr. Bright. There are, yes.
Mr. Lujan. According to your whistleblower complaint, at
the time of the Bayer offer the consensus from BARDA and FDA
scientists was that it was advisable to wait for additional
clinical data before making any recommendations on the use of
chloroquine to treat COVID-19.
Is that correct, yes or not?
Dr. Bright. That is correct.
Mr. Lujan. Yet on March 19th, Bayer moved forward and
announced the donation of chloroquine and President Trump told
the country at a White House press conference that the drug
had, quote, ``shown very, very encouraging early result,''
close quote.
Yes or no, was the President's statement accurate?
Dr. Bright. I do not think that was the best-informed
statement.
Mr. Lujan. At that press conference the President also said
had that the drug had, quote, ``been around for a long time, so
we know things don't go as planned. It is not going to kill
anybody,'' close quote.
Yes or no, is that statement accurate?
Dr. Bright. The drug had been around a long time for its
use in malaria, but it had not been around for a long time for
its use in COVID-19 patients. That is a different indication,
different clinical outcome, and the drug can behave differently
in those people.
Mr. Lujan. Yes or no, is it true that within days of that
press conference, you received urgent instructions from HHS
general counsel, passed from the White House, directing you to
obtain the authorization necessary to make the drugs widely
available to the public?
Dr. Bright. That is true.
Mr. Lujan. Yes or no, did the pressure from the White House
and HHS general counsel put you in a difficult position?
Dr. Bright. Yes.
Mr. Lujan. And how did you handle this pressure while still
trying to protect the American people?
Dr. Bright. We had to come up with an alternate solution
that our administration would accept.
Mr. Lujan. Yes or no, did the administration respect this
compromise?
Dr. Bright. They accepted it eventually. The emergency use
authorization use option was accepted by Dr. Kadlec and the
administration, yes.
Mr. Lujan. What I am aware of, and I would agree with that,
that the HHS assistant secretary for health, Admiral Brett
Giroir, on April 4 the said, this compromise, quote, ``matters
not,'' close, and that the drug needed to go to pharmacies, as
well as hospitals.
Dr. Bright, there are only 24 hours in a day, and every
hour you and your team had to spend on chloroquine is an hour
you couldn't work on fighting this virus.
Yes or no, did the President's obsession with this issue
distract you and others on your team from your mission of
saving lives?
Dr. Bright. The directive we received to prioritize and put
an expanded access protocol in place within 48 hours was
extremely distracting to dozens of Federal scientists who were
focused on the coronavirus outbreak. They had to set aside all
other work to try to put together this protocol in the 48-hour
directed time period.
Mr. Lujan. Yes or no, did it distract from efforts to
prepare for this crisis, including securing PPE and wrapping up
testing and the production of other essential supplies?
Dr. Bright. It distracted them from their efforts of
developing other vaccines and drugs that they were focused on
at that time. It was a different group of individuals who were
focused on procuring PPE.
Mr. Lujan. Dr. Bright, just yesterday the President
questioned the testimony of Dr. Fauci when discussing children
and schools. The President insisted that, quote, ``It has very,
very little impact on young people.''
Dr. Bright, yes or no, do we know that the President's
statement is accurate.
Dr. Bright. There is a lot we don't yet know about this
virus. And it is really concerning over the last few weeks that
we are getting more and more data out of New York and other
places where they have had high numbers of infections of the
impact of this virus in children. It is a very different
presentation and outcome in children that we see in adults and
it is very concerning and we don't yet have an answer for that.
But we should proceed very cautiously and not have any hope or
knowledge that we know everything about this virus.
Mr. Lujan. Dr. Bright, I want to end by quoting your
testimony. Quote, ``Without clear planning and implementation
of the steps that I and other experts have outlined, 2020 will
be the darkest winter in modern history.''
The darkest winter in modern history.
Yes or no, do you believe this administration is doing
everything it can to prevent the darkest winter? And what more
should they be doing?
Dr. Bright. I believe there is a lot of work that we still
need to do. And I think we need still--I don't think, I know--
we need still a comprehensive plan, and everyone across the
government, and everyone in America needs to know what that
plan is and what role they play.
There are critical steps that we need to do to prepare for
that fall, for that winter coming. We do not still have enough
personal protective equipment to manage our healthcare workers
and protect them from influenza and COVID-19. We still do not
have the supply chains ramped up for the drugs and vaccines.
And we still don't have plans in place in how we distribute
those drugs and vaccines. And we still do not have a
comprehensive testing strategy so Americans know which test do
what, what do with that information, and we know how to find
this virus and trap it and kill it. There is a lot of work we
still have to do.
Mr. Lujan. Thank you, Doctor.
Ms. Eshoo. The gentleman yields back. A pleasure to
recognize the gentleman from Oklahoma, Mr. Mullin, for his 5
minutes of questions.
Mr. Mullin. Thank you, Madam Chair. And I would be remiss
not to thank you for your continued prayers for my son. That is
very kind of you and I really appreciate it.
Dr. Bright, you are here on your own time as an individual
that. Is that correct?
Dr. Bright. Yes.
Mr. Mullin. Where are you currently employed?
Dr. Bright. I am currently an employee of the Department of
Health and Human Services. And I am in the middle of a
transition, I guess you would say, between BARDA and NIH.
Mr. Mullin. So you have accepted the reassigned position to
NIH?
Dr. Bright. That position is under discussion at this
point. I have not yet accepted that role.
Mr. Mullin. So are you currently being paid?
Dr. Bright. I am currently being paid.
Mr. Mullin. Where are you being paid from, out of BARDA or
from NIH?
Dr. Bright. It is not completely clear to me, but I believe
it is out of NIH.
Mr. Mullin. So are you getting a paycheck since you have
been--you have been over there since mid-April, right? That is
correct?
Dr. Bright. I have received one paycheck, sir. And it is my
understanding--
Mr. Mullin. From NIH?
Dr. Bright. I think it was still part BARDA and part NIH. I
have had discussions about my onboarding at NIH.
Mr. Mullin. So are you--at BARDA you made $285,000. Is that
correct?
Dr. Bright. That is true.
Mr. Mullin. So how much are you currently making at NIH?
Dr. Bright. I don't think my salary has changed.
Mr. Mullin. It is still the same? So you have been there
over there for approximately four weeks, a month?
Dr. Bright. It has been about three weeks since I was
removed from my office at BARDA.
Mr. Mullin. So have you reported to NIH, yet.
Dr. Bright. I have checked in with the NIH director's
office and we have discussed the onboarding process, the
fingerprinting process. And we had a call just last evening to
discuss the framework of my responsibilities that they have
envisioned for me at NIH.
Mr. Mullin. So haven't actually reported to work, but you
are still getting paid, correct?
Dr. Bright. I have been on sick leave since I was pushed
out of my position at BARDA.
Mr. Mullin. Sick leave for what?
Dr. Bright. For very high blood pressure, and I have been
under treatment from my physician.
Mr. Mullin. For hypertension?
Dr. Bright. For hypertension, sir, yes.
Mr. Mullin. So you are on medical leave.
Dr. Bright. I have been on medical leave. This week,
however, I transitioned from that medical leave to annual leave
so I can manage this.
Mr. Mullin. What is annual leave? What do you mean?
Dr. Bright. Vacation time.
Mr. Mullin. So you are on vacation time right now?
Dr. Bright. I am on vacation time.
Mr. Mullin. Did you inform your supervisors about you
coming here today or did you need to do that?
Dr. Bright. I have informed them about my leave status. I
had a conversation with them last night.
Mr. Mullin. So you transferred from medical leave to
vacation this week or does it start next week?
Dr. Bright. I had a conversation with my physician about my
hypertension and how we have been managing it over the last
three weeks because this has been very stressful to be removed
suddenly without explanation from my role and position. It is a
life change for me. And my physician has been working very
closely with me to manage my hypertension and stress. And the
conversation I had with him last night indicated that----
Mr. Mullin. I guess I am kind of confused here, because you
say you have hypertension, but yet you were are able to do
these interviews, you are able to make the report, and you are
able to prepare for this hearing. Yet, you are too sick to go
into work, but you are well enough to come here, while you are
still getting paid from the United States Government. Is that
correct?
Dr. Bright. Sir, I have been under medical leave until----
Mr. Mullin. I get that. But if you have been on medical
leave, too sick to do that, but yet you can prepare for a 2-
hour hearing. I am just having a hard time tracking that. I
have a hard time understanding that. And if you have
hypertension and you are too sick to go to NIH, but yet you
are--but you didn't ever experience that in BARDA, right, you
never had issues in BARDA with hypertension?
Dr. Bright. I didn't have the level of stress of being
removed from my position while I was in BARDA. So this has been
very stressful. And my physician was very concerned and we have
working on managing that.
Mr. Mullin. No, I get it. People handle pressure quite
differently. But as the director of BARDA I would feel like you
are in quite a bit of a stressful position when you are trying
to manage a pandemic, but you can't manage that--or you could
manage that, but you can't manage your own hypertension when it
comes because you got removed from the office. But yet, you can
still receive pay from NIH, but you can't show up for work. And
then all of a sudden you can prepare for this, but you can't do
that.
I just have a hard time understanding it. I know you are a
bright individual and very smart, but you are an employee of
the Federal Government. And I just want to make sure you are
not doing something to deceive the American people at this
time, getting paid from the United States Government.
With that, I am going to yield to Ranking Member Walden.
Mr. Walden. I thank the gentleman.
Dr. Bright, your lawyer appears to have a pretty
substantial binder there. And I know Mr. Guthrie asked about
the documents that are there on the table. Are those the
exhibits to your complaint to the Office of Special Counsel?
Dr. Bright. I don't know what my--I don't know----
Mr. Walden. I will direct it to the Counsel, then, since
she is answered other questions.
Are those the exhibits to the complaint to the Office of
Special Counsel.
Ms. Katz. Some are and some are my work product and some
are my notes, and they are not appropriate to turn over to
Congress.
Mr. Walden. So is it appropriate to turn over the documents
that are referenced in the complaint--not your work product, I
respect that--to this committee? And would you do that?
Ms. Katz. You asked that question initially and I said we
would look at the documents to determine whether they are
appropriate to turn over.
Mr. Walden. I am just talking about the ones--we have
partial email chains, we have screen shots of emails. I think
we should have the right to see those documents if we are going
to effectively know the full extent of this complaint. And I
just wish you would commit to turning those over.
Dr. Bright, will you turn those over?
Ms. Katz. I think I addressed that.
Mr. Walden. Dr. Bright. I am asking Dr. Bright now.
Are you willing to turn over----
Dr. Bright. I have submitted my full complaint to the
Office of Special Counsel and that is the process I know to
follow.
Mr. Walden. But you are here as an individual citizen
whistleblower.
Ms. Eshoo. The gentleman's time has expired.
Mr. Walden. We just want to see what you have submitted so
we can evaluate it ourselves.
Dr. Bright. Sir, I don't understand the full process, other
than I was supposed to submit it to the Office of Special
Counsel, which I have done so. I don't understand the
legalities of sharing that before they have had their
opportunity to review that.
Mr. Walden. They have certainly been shared out into the
public and press. The Washington Post has them from some
source. They look a lot like what is referenced in your
complaint. None of us--I don't know where those came from. But,
you know, other media outlets are certainly seeing them.
Ms. Eshoo. The gentleman's time has expired.
Mr. Walden. I just think as part of this investigation,
Madam Chair, you should request them.
Ms. Eshoo. We will seek all information that is appropriate
to be submitted to the committee. And what I circulated--or we
circulated--to all members of the subcommittee were the emails
that were public, as well as the complaint. That is what was
out there.
Mr. Walden. I know, but----
Ms. Eshoo. I haven't tracked daily who says what. I mean,
Politico has something too. I don't know the veracity of----
Mr. Walden. But, you know, any other investigation we would
both be going we need to see all the documents as a committee.
So that is all I am asking.
Ms. Katz. Madam Chair, may I address one point?
Ms. Eshoo. No. I think that we need to move on.
The gentleman from Oregon is recognized, Mr. Schrader.
Mr. Schrader. Thank you.
Thank you for being here, Dr. Bright. Really appreciate it.
Tough to do. Very impressive that you are here.
Could you describe the tone and reactions of Dr. Kadlec and
Dr. Azar, in your January 23rd meeting when they had the all-
agencies meeting on the COVID virus? Could you describe how up-
to-speed they seemed to be?
Dr. Bright. In that meeting, sir, it was one of our first
meetings that we had about how to address the outbreak, and
because we had practice, I came in with my list of needs and
those lists for money, people, and viruses.
My request was met with a bit of surprise and puzzlement. I
remember Secretary Azar looking around the room and saying:
Money, you need money? Maybe there is money somewhere. I mean,
it was just something----
Mr. Schrader. This is despite the fact that we had had the
outbreak in China for some time?
Dr. Bright. This was January 23rd at this point.
Mr. Schrader. Could you describe January 25th, if you
remember, email exchange with Mr. Bowen on the mask situation.
Dr. Bright. I don't remember that specific, but I am sure
it was urgent. I am sure that Mr. Bowen was sending me a notice
saying--asking if this----
Mr. Schrader. So you didn't ask him to come and talk to
you; he just reached out to you?
Dr. Bright. Yes, sir.
Mr. Schrader. OK. How about an email exchange with Dr. Kerr
on January 27th? Did you reach out to Dr. Kerr? Did he come and
ask----
Dr. Bright. Dr. Kerr reached out to me, I believe. This was
because, again, he is a pandemic influenza expert as well
response and he knows the vital nature of needing those
viruses. And he was involved in prepping our Secretary for a
call he had with minister, Vice Minister Ma in China. And we
knew a high priority was for our Secretary to ask for those
viruses.
We have had challenges in the past of getting viruses from
China from avian influenza strains and viruses. So this was a
high priority because we needed that to get started. And he was
alarmed when he wrote to me that morning indicating that the
CDC director had reprioritized and actually indicated that we
did not need to--or he did not need to--the Secretary did not
need to ask China for viruses. And it was alarming to us
because we knew how critical it was.
Mr. Schrader. That sounds incredible in light of what has
transpired since then.
So I guess my major point here is that we have a brave
individual coming forward as a whistleblower. But he is not
alone. There are many other experts, scientists and
manufacturers, that realize we were in, if I may say, deep
shit, not--a long time ago, long before the administration and
the White House began to wake up.
What do you think would have happened if Mr. Navarro had
not reached out to you and actually responded to you? Where
would we be now if you hadn't been able to at least get one
person in the White House's attention.
Dr. Bright. It is difficult to speculate where we were,
sir. Even when Mr. Navarro reached out and strongly suggested
action be taken on February 10th--February 9th is the email,
February 10th it was conveyed to Dr. Kadlec that we needed to
ramp up production of N95 masks--that order did not go out,
that solicitation did not close until March 18th.
So even with the pressure of Mr. Navarro, who I think
shared the sense of urgency about this outbreak, that pressure
alone still did not spur Dr. Kadlec and our Strategic National
Stockpile to that urgently needed action.
Mr. Schrader. That is very disconcerting and the reason we
are here today, perhaps.
Last question, if I may, switching gears and going to the
other side of the spectrum. While it has been hard to get
folks' attention here in Washington, DC, in the administration
on the seriousness of this, I think most people now are
convinced this is a very serious issue. And I am a little
concerned we are going too much the other way in terms of
information.
You alluded to here on the vaccines. I think some people
are under the impression there is a vaccine going to be
developed in a couple of months and everything is going to be
fine and I can go back to work. And, you know, we,
unfortunately, have to juxtapose economic issues, they have to
have realistic expectations at home. And you, I think,
accurately indicated, well, it can take up to ten years. And
the quickest we did I guess was Ebola and that was, I believe,
five years.
So it is a tough question to as;, I suppose, you don't have
to answer. But to be--I don't want America to think they can
just not get back to some semblance of a new post-COVID life
until a vaccine comes out, because that could take years. And
there is a chance the vaccine will maybe not be as effective,
much like our flu vaccines with the flu mutating year to year.
So I just want to make sure that you would--well, I would
ask you if you would agree that we can't wait to open up
America up entirely until a vaccine is there, we have to use
some of the other parameters you have already suggested.
Dr. Bright. We have to make sure that we have some
scientifically led and driven decisions on how and when it is
safe to reopen America. If it happens before we have a
vaccine--I mean, if we have a vaccine faster, that is great.
But we do need to open America up sooner. We need to make sure
everyone understands the risk, and understands the risk of
their activities, and everyone has to play a critical part in
following those activities to reduce the risk.
We have to have a testing plan in place, and enough tests
to make sure that we know when people are exposed so they can
be quarantined and isolated and not continue to infect others.
And we are also developing a number of therapeutics that
could offer some potential benefit prophylactically or protect
you almost like a vaccine before you are infected. Those are
being developed and maybe even faster than a vaccine. And if
healthcare workers and frontline workers can use those
therapeutics, that might offer them some protection as well
until there is a vaccine.
So there are a number of steps in between now and a
vaccine. I believe if we let science lead the discussion, and
we inform America of the risk and the clear guidance on what
needs to happen, and people follow that guidance, then there is
a step-wise process to getting back to work and back about out
of our homes.
Mr. Schrader. Thank you very much. I yield back.
Ms. Eshoo. The gentleman's time has expired and he yields
back. A pleasure to recognize the gentleman from North
Carolina, Mr. Hudson, for his 5 minutes of questions.
Mr. Hudson. Thank you, Madam Chair.
First let me say, I believe any whistleblower should be
respected and allowed to be heard as a core component of
keeping our government accountable and running smoothly. But
this hearing is not about a whistleblower complaint. It is
about undermining the administration during a national and
global crisis, as evidenced by the fact that hearing is being
held in the wrong subcommittee and well before the Office of
Special Counsel finishes its work.
To disregard the minority so spectacularly in the
organization of this hearing only highlights the partisan and
political nature of this hearing. I hope today will be held up
in the future as a lesson of what not to do and the respect and
gravity that should be given to whistleblower complaints so
that they are not abused for political expediency.
More importantly, though, we have vital work we should be
doing. My constituents want Congress to get back to work. So I
am glad to be here to highlight the important work that needs
to be done.
I heard from an ophthalmologist in my district this week
about the need for relief. She says she will consider this year
a success if her practice group even breaks even.
Long story short, we should be examining the $175 billion
authorized and appropriated in a bipartisan manner for
providers, and what providers still need, and recommendations
for moving forward.
We should also be examining why there are gaps in outcomes
and assess for minority communities. Fayetteville, North
Carolina, in my district, has a large and diverse community,
and understandably the folks back home are scared because
coronavirus hits them hardest. Why are we not spending our time
today examining this crisis within a crisis more closely?
I hear from providers and hospitals about issues with PPE.
I know this administration has done extraordinary things to
secure more PPE. I want to thank President Donald Trump for his
strong leadership. Not only did his administration moving
quickly to coordinate a response, but his travel ban on January
30th was a bold move, though it was panned by his critics as an
overreaction at the time.
The administration has gone to great lengths to overcome an
inadequate system they inherited, and as you testified earlier,
moved quickly to start programs like Project Airbridge to
expedite more PPE coming in. But questions remain about why
there is a global shortage and what more Congress can do to
support the administration's efforts to secure sufficient PPE.
This committee should be working on that question.
We have multiple pieces of bipartisan legislation waiting
to be considered to improve the operations of the Strategic
National Stockpile. We should be examining why our stockpile
was allowed to dwindle under previous administrations.
The answers to these questions and solutions to these
problems are timely and critical to helping this administration
combat this virus and the deadly disease it causes.
I hear from constituents every day who are suffering under
these stay-at-home orders. This crisis is hard for anyone, even
if they weren't suffering from substance use disorder or mental
health challenges before they were confined to their homes, and
this crisis has exacerbated this problem. Why are we not
examining access issues to mental health providers and the
effects this crisis has had on our constituents' mental health?
Dr. Bright, you are no doubt an accomplished scientist, and
I appreciate the service you have rendered this country. You
deserve to be heard and your whistleblower complaints should be
given the serious consideration any whistleblower complaint
deserves.
But we also deserve to have the opportunity to ask
questions about serious allegations that have been made against
you. And I will note again, this is not the time or place for
that hearing. The time is after the Office of Special Counsel
has completed its work and the place is the Oversight and
Investigations Committee.
But, Dr. Bright, building on questions from Mr. Walden and
others, Politico released an article yesterday stating that
your complaint left out a lot of information and context
regarding agency decisions to require hydroxychloroquine. You
chose not to elevate your concerns to the Office of Inspector
General, but instead kept selective screen shots that didn't
include full context.
Another example, The Wall Street Journal reported on an
email today that seems to show that you were in support of
acquiring and using hydroxychloroquine.
Can you elaborate on what was missing from your screen
shots and why you didn't elevate your concerns at any to the
Office of Inspector General?
Dr. Bright. So the early days when I was aware that
hydroxychloroquine, we were interested in acquiring that drug
for its used in the randomized controlled clinical study.
Actually, when I heard from Dr. Woodcock that it is something
that we should try to investigate in a randomized controlled
study, I even reached out to a company that was licensed and
approved to make that drug in the United States to see if they
could donate that drug to the NIH to conduct those clinical
studies.
I was aware of other efforts that were ongoing to try to
acquire some of that drug for its use in randomized controlled
clinical studies. As long as it was going to be used at that
time for those randomized controlled clinical studies, I
thought we should look into the supply chain the same way I did
with remdesivir.
It was only after I learned that that supply that was being
discussed was coming in from Pakistan and from India, from
facilities that were not approved by the FDA, and the drug was
not approved for use in the United States, I became
increasingly alarmed of having that drug in the United States.
Second, it was when I learned that the plan was to make
that drug available through an expanded access program so
people could potentially get that drug and not be under the
close supervision of a healthcare provider, that caused
particular concern.
It was because of that in the cascading days afterwards,
that we put in that emergency use authorization with the safety
bumpers and barriers that we could feel comfortable with that
drug would only be used under close clinical supervision.
In the earlier days, in that email exchange that you are
referring to, was before we knew about this information on
Pakistan, before we knew it was going to be used for expanded
access clinical--expanded access protocol. It was when I
thought our efforts to obtain some of that drug would be used
at the NIH to conduct randomized controlled clinical studies.
So I was relieved that we did identify some supplies of that
drug for those clinical studies.
Mr. Hudson. My time has expired, Madam Chair. I yield back.
Ms. Eshoo. The gentleman yields back.
A pleasure to recognize the gentleman from Massachusetts,
Mr. Kennedy, for his 5 minutes of questions.
Mr. Kennedy. Dr. Bright, thank you very much for being here
and thank you for your service to our country.
Let's ground this hearing a little bit. As of this morning,
which means these numbers have increased, there are nearly 1.4
million cases diagnosed of COVID-19 in the United States and
over 80,000 fatalities. Experts believe both of those numbers
are an undercount because after five months of this virus being
on our shores, we have still have a systemic problem with
regards to robust testing. Is that right?
Dr. Bright. [Nonverbal response.]
Mr. Kennedy. Cases in many States across the country are
still actually increasing in number, despite that lack of
testing. Is that right?
Dr. Bright. [Nonverbal response.]
Mr. Kennedy. You have mentioned in your testimony that,
quote, ``We missed early warning signs and forgot important
pages from our pandemic playbook.'' Is that right?
Dr. Bright. Yes.
Mr. Kennedy. Sir, you have been the head of BARDA since
2016. Is that right?
Dr. Bright. Yes.
Mr. Kennedy. Until recently.
Have you experienced any pandemics prior to this one over
your course of time either there or in your prior government
service?
Dr. Bright. We responded to the Zika outbreak, we responded
to the Ebola outbreak. They didn't rise to the level of
pandemic.
Mr. Kennedy. Of course. Thank you for the clarification.
Sir, you are aware at the end of the Obama administration
the Obama team put together a playbook to try to guide
succeeding administrations in how to handle an outbreak,
correct?
Dr. Bright. Yes.
Mr. Kennedy. Sir, you are also aware that there was a
simulation done from an outgoing Obama administration in
early--in January 2017 with an incoming administration about
how to respond a pandemic. Is that right?
Dr. Bright. Yes.
Mr. Kennedy. And you are aware that the Trump
administration cut the number of CDC staff located in China
from 47 to 14. Is that right?
Dr. Bright. I don't know the exact number. I know it was
reduced.
Mr. Kennedy. OK. And, sir, you referenced already the
simulation called Crimson Contagion. That was a simulation done
by HHS began in January 2019. Can you shed just very briefly a
little bit of light as to what the findings of Crimson
Contagion were?
Dr. Bright. Significant findings. It was actually
participants where beyond HHS, it covered broad areas of
government, in Federal, State, and locals. Some of the
significant findings were the need for improved coordination
and communication, an alignment between the Federal, State, and
local, Tribal territory governments, and the significant need
for personal protective equipment, and the shortage, and the
significant need for funding initially.
Mr. Kennedy. And, sir, simulation was based off of a flu-
like virus that was initially detected in China, spread by
global air travel, and resulted in the infection of 110 million
Americans, leading to 7.7 million hospitalized and nearly
600,000 dead. Is that right?
Dr. Bright. Yes.
Mr. Kennedy. Sir, when did you first have concerns about
the potential impact of COVID-19 on the United States?
Dr. Bright. In early January.
Mr. Kennedy. And were you aware that your supervisor, Dr.
Kadlec, suggested that--the activation of the Defense
Production Act in mid-January?
Dr. Bright. I wasn't aware of him are doing that. No.
Mr. Kennedy. OK. You mentioned that you had two meetings
with Secretary Azar, I am sure you had others, but you
referenced so far in your testimony meetings on January 23rd
and 27th, where you raised concerns directly to the Secretary.
Is that right?
Dr. Bright. Yes. The Secretary was not at the second
meeting. Deputy Secretary Hargan was there.
Mr. Kennedy. Thank you.
You are aware that top National Security Council staff,
including National Security Advisor Mr. O'Brien and his deputy,
Matthew Pottinger, raised significant warnings that China was
downplaying the impacts of this virus.
Dr. Bright. I did learn of that in a meeting at the White
House, yes.
Mr. Kennedy. You are aware that we sent 17.8 tons of
medical supplies to China in early February?
Dr. Bright. I have learned of that.
Mr. Kennedy. Are you aware the Trump administration's
budget proposal released in February of 2020 called for a cut
to CDC by nearly $700 million?
Dr. Bright. I am not aware of that. I have heard of it.
Mr. Kennedy. Are you familiar with a memo written by Peter
Navarro that warned of the impact of the virus?
Dr. Bright. Yes.
Mr. Kennedy. Are you aware that it was spread among senior
administration and White House officials?
Dr. Bright. Yes.
Mr. Kennedy. Are you aware that it was on about April 2nd
when the Trump administration finally activated and expanded
the Defense Production Act months after being warned by you and
other senior administration officials?
Dr. Bright. I have learned of that.
Mr. Kennedy. Are you aware that that order itself did not
extend to the full authority of the DPA and left a haphazard
allocation process to States and hospitals to compete against
each other?
Dr. Bright. I don't know the details of that authority,
sir.
Mr. Kennedy. Has the Coronavirus Task Force actually
developed a plan for reopening the country?
Dr. Bright. I am not aware of the full plan to reopen, sir.
Mr. Kennedy. Have they developed some principles that the
White House has touted as some principles or guidelines as to
how to reopen the country?
Dr. Bright. I have heard of some principles.
Mr. Kennedy. Are States following that plan?
Dr. Bright. It doesn't appear that there is a nationwide
coordinated plan that States are following, sir.
Mr. Kennedy. So after this recitation of the actions and
inactions of this administration over the course of the past 6
months or so, can we possibly say that this administration has
prepared our country for the moment that we are in and how we
could possibly be prepared for the distribution--development,
manufacturing, and distribution of a vaccine to try to address
330 million Americans over the course of the months ahead?
Dr. Bright. I think we have a lot of work to do to be
prepared, sir, to be fully prepared.
Mr. Kennedy. Thank you, sir. I yield back.
Ms. Eshoo. The gentleman yields back. A pleasure to
recognize the gentleman from Missouri, Mr. Long, for his 5
minutes of questions.
Should we go to--you want to pass?
OK. You can reserve and we will go to the gentleman from
California, Mr. Cardenas, for his 5 minutes of questions.
Mr. Cardenas. Thank you, Dr. Bright, for being here today.
And I just want to tell you that my family, my community, and
myself, we appreciate your 25 years of focused service,
specifically when it comes to addressing pandemic outbreaks.
And it is my understanding that you have spent those 25 years
leading teams of scientists when it comes to drugs,
diagnostics, and vaccine development, and we appreciate that.
When an administration or decisionmakers prioritize
politics over science, does that tend to increase or decrease
the likely results of the loss of life in the middle of a
pandemic?
Dr. Bright. I believe that scientists are best equipped to
understand how to manage a public health crisis and I believe
scientists should lead.
Mr. Cardenas. And therefore, to my question again, I will
phrase it differently, if the scientists are not leading and
the politicians are leading with the final decisions when
trying to address the issues of pandemics that are taking
people's lives, that way of handling it, does that likely
increase the loss of life, or it likely to increase the loss of
life?
Dr. Bright. I believe that scientists leading will actually
increase the likelihood that we can survive this pandemic and
move through it. So if scientists are not allowed to lead and
speak up, I believe it could increase the loss of lives.
Mr. Cardenas. Thank you.
How many times in your career have you personally activity
said, ``I need to enact my right to be a whistleblower?''
Dr. Bright. I am sorry, could you repeat that?
Mr. Cardenas. How many times in the last 25 years have you
decided to enact your right to be a whistleblower?
Dr. Bright. This is my first time, sir.
Mr. Cardenas. OK. I just--I knew that answer was simple and
I think I confused you because I made it so simple. And the
reason why I want to say that is because I believe that you
have been incredibly consistent in your willingness to dedicate
yourself, your expertise, and your career to saving lives.
Is the loss of life on your mind, was that on your mind
when you decided that you needed to enact your right to be a
whistleblower?
Dr. Bright. I have spent my career focused on saving lives.
And, sir, everything I have done to come forward now is to
raise awareness of challenges we have, things that are not
getting done, because I do think it will save more lives.
Mr. Cardenas. Are you aware of the fact that the lack of
testing in the United States America is affected by many pieces
of the puzzle in order for people to get testing, whether it is
swabs, whether it is N95-rated equipment for the caregivers to
be able to enact safely with the public? Are those all factors
that have contributed to our lack of having adequate testing in
America?
Dr. Bright. They are factors, sir. I don't think anyone has
thought through the entire plan completely to understand those
critical components for testing. I think there is a lot of
confusion about the different types of tests, and I think our
national narrative is focused on a number of tests, and it is
not about the number so much as the right types of tests and
Americans know how to use them and what to do with that
information. And no one has really thought through the raw
material supply chain to make sure we can sustain the need to
test.
Mr. Cardenas. OK. That sounds a little confusing from
somebody who actually had been working at a high level of the
United States Government in this space that we are discussing
at this moment.
So my question is, if we are not implementing in this
pandemic to the degree or ability that the United States should
or could, what has contributed the most to that? Was it the
lack of scientists recommending up the chain of command or was
it the people at the top of the chain of command deciding to do
things differently than the scientists are strongly
recommending.
Dr. Bright. There is evidence of scientists raising
concerns about shortages and other actions that are important
to take that were not being taken. It is a different level. In
my personal situation as the leadership at HHS and my ASPR Dr.
Kadlec that I believe was dismissive of the early warnings that
I was raising.
Mr. Cardenas. OK. And you said early warnings. And despite
the early warnings, have there been other examples where
warnings and strong recommendations were either being ignored
or set aside and other actions were taken?
Dr. Bright. Sir, I believe that I have learned from others.
I think the CDC has written several guidelines for reopening
America and getting people out of their homes and back to work.
I am not sure if all of those guidelines have been reviewed or
are being publicly considered at this point. So there is
another example of I think really hardworking career scientists
and their information and their hard work not probably getting
the proper vetting and proper exposure to the American public.
Mr. Cardenas. One of the things--I have no idea how much
time I have, because the clock has been slipping back and
forth, but hopefully I have a little bit of time.
Ms. Eshoo. You are almost out of time.
Mr. Cardenas. We have heard boasting from the White House
about millions of personal protective equipment, PPEs as
everybody knows them as, millions have gone out to America. But
fact, to date, we should have had billions gone out throughout
America. Isn't that the disparity?
Dr. Bright. It is a huge disparity. And healthcare workers
are having to compromise their protection and their health and
safety because they are having to be creative and reuse a
single mask for the entire week or come up with novel
sterilization practices that are not proven or tested yet.
So that disparity actually is impacting our frontline
workers and those are the people whose lives we really need to
preserve so they can treat others.
Mr. Cardenas. I have family members who are working in
hospitals today on the front lines who have been telling me
that they are wearing equipment for days at a time that they
are supposed to be disposing of several times a day and are
having to use them over and over.
Ms. Eshoo. The gentleman's time has expired. I thank the
gentleman.
Mr. Cardenas. Thank you very much, Madam Chair. And if
somebody could do a better job with the clock, I would
appreciate it. It kept flipping back and forth. I was trying
to----
Ms. Eshoo. You are absolutely right. It went from--it got
stuck at 4:44, went to zero, and popped up to 1:21. So I am
watching too. My father was a watchmaker, and clock repairman.
Where is daddy when we need him?
A pleasure to recognize Mr. Long from Missouri for his 5
minutes of questions.
Mr. Long. Thank you, Madam Chairwoman.
And, Dr. Bright, you contend that your removal was because
the Trump administration and HHS leadership, in particular
lacked scientific integrity. Do you think that Dr. Fauci lacks
scientific integrity?
Dr. Bright. Sir, I don't think my removal was anything
associated with Dr. Fauci at all. I think my removal was
because of tensions and actions I took between my supervisor,
Dr. Kadlec, and myself.
Mr. Long. You know about Dr. Fauci's testimony two days
before at the Senate HELP Committee?
Dr. Bright. I am aware of that testimony, yes.
Mr. Long. If HHS leadership is so hostile to scientific
integrity as you say, as you allege, how do you explain Dr.
Fauci being allowed to testify forthrightly, to serve in a
prominent role on the White House task force, the
administration, and direct NIAID's extensive research efforts?
Dr. Bright. Sir, I am not sure what decisions are involved
in allowing Dr. Fauci to testify or not. That is not
something----
Mr. Long. Can you say that again? I am having----
Dr. Bright. I am not sure--I am not aware of what process
or decisions are involved in allowing Dr. Fauci to testify or
not.
Mr. Long. But he was allowed to testify.
Dr. Bright. I know he was, but I thought I understood you
to ask me if that was appropriate or if he was not being
allowed to. Maybe you can repeat your question if I
misunderstood it.
Mr. Long. OK. What I am saying is you are saying HHS is
hostile to scientific integrity. And if that is the case, can
you explain why Dr. Fauci was allowed to testify forthrightly
in the committee? If they are hostile, why would you let him
come out and testify without any--no holds barred?
Dr. Bright. I am saying that my supervisor was not
following proper scientific process that we have in place for
BARDA. I am not actually saying the administration is hostile
against scientific integrity in all cases. So I am saying in my
particular situation, as in my claim, my supervisor was
conducting inappropriate activity that was going around proper
scientific vetting. That is what I put in----
Mr. Long. Why did you not bring these concerns to Secretary
Azar, or his chief, or the inspector general? Why did you not
bring any of them into the loop and say, ``Hey, I have these
concerns?''
Dr. Bright. Sir, I believe some of the activities were
not--it is isolated with Dr. Kadlec. I think some of his senior
staff were also aware of some of the processes that were being
utilized to go around our traditional review process,
scientific review process.
Mr. Long. But wouldn't normal protocol in any situation be
that you go to the Secretary at HHS, or his chief of staff, or
the inspector general with your concern, instead of just
gathering them up and deciding that one day you are going to--
--
Dr. Bright. Well, I didn't decide that. I was pushed out,
sir, and involuntarily transferred, without my knowledge.
Mr. Long. But you had these concerns. So why didn't you
take them to your superiors when you had the concerns and maybe
none of this--maybe we wouldn't be here today? It wasn't easy
for any of us to be here today.
Dr. Bright. Sir, I requested an IG investigation, as in my
claim, I think it was in 2018, that they looked into what I
believe was inappropriate pressure, political pressure on some
of our contracting activities and discussion about procurement
integrity. And I do not think that that was ever followed
through on. So----
Mr. Long. Did you bring your concerns to the inspector
general?
Dr. Bright. I do not believe they were followed through and
submitted to the inspector general. I raised those concerns to
our HHS----
Mr. Long. But you personally didn't talk to the inspector
general, didn't raise concerns with the inspector general----
Dr. Bright. I did not.
Mr. Long [continue]. Or with Azar's chief or with Azar,
correct?
Dr. Bright. I raised those with the Secretary's Office of
General Counsel, they were present in the meeting, sir.
Mr. Long. I will take that as a no. OK.
You state in your testimony that HHS leadership was
dismissive about your predictions about the broader outbreak
and the pressing need to act. However, it is my understanding
that it was Dr. Redfield at CDC who alerted the White House's
National Security Council about the risk of the virus on
January the 2nd and a high level team with the NSC's
Counterproliferation and Biodefense Directorate quickly began
meeting to address the possibility of a pandemic. Do you
consider Dr. Redfield's actions here to be dismissive about the
threat of a coronavirus?
Dr. Bright. Sir, people were aware of the urgency. What was
lacking was the action and how to address the urgency. So when
we were raising issues on critical supply chain of medical
equipment to protect doctors and nurses, if they are aware the
urgency of the situation and still failed to act, I think that
is even more unconscionable than not being aware of the
emergency and not acting.
Mr. Long. In your new position, I would recommend that if
you have issues, you might go to the head of the department,
his chief, and some folks like that.
I yield back.
Ms. Eshoo. The gentleman yields back. A pleasure to yield
to the gentleman from Vermont, Mr. Welch.
Mr. Welch. Thank you very much.
Your job, our job, is to protect the American people. And
this fierce virus can be managed if done correctly, correct?
Dr. Bright. I believe so.
Mr. Welch. And in fact the playbook is established. It is
testing, contact tracing, and then isolation, starting with
first social isolation, correct?
Dr. Bright. Yes. Those nonpharmaceutical interventions and
testing are critical first steps.
Mr. Welch. Right. And in fact this virus is across the
world, and many countries that have followed that tried and
true protocol have done far better than the U.S. Is that
correct?
Dr. Bright. We have seen differences in the response and
the outcomes of that response around the world.
Mr. Welch. I will go through some of those. You know, the
Johns Hopkins study that said that the U.S. had the best
preparedness, it turned out we have the worst response,
correct, with the most cases and the most deaths?
Dr. Bright. We had the most cases and the most deaths.
Mr. Welch. And I did some calculations. On January 19th,
South Korea determined its first case. On January 19th, the
U.S. determine its first case, correct?
Dr. Bright. January 20th was the U.S. case, yes.
Mr. Welch. And if we have the same response in South Korea
by population, they had 33,000 deaths, we would have saved
50,000 lives.
In Taiwan, they had the same virus, 22,000 deaths. And
again, adjusting for population, that is 60,000 more deaths we
have had here. Singapore, 82,000 more deaths. New Zealand,
65,000.
The question for us here, and for the American people, is,
why, when we had the best plan, we had the worst execution?
So let me go through a few things that you have
established. One, beginning in January, before that case here,
FDA chief Hahn asked the HHS if he could start contacting
companies about possible shortages of protective equipment and
he got blown off by HHS, correct?
Dr. Bright. What I understand.
Mr. Welch. And on January 18th, before our first case, you
pushed Dr. Kadlec to convene high-level meetings about the
virus but that was initially rejected, correct?
Dr. Bright. True.
Mr. Welch. And then On January 23rd you demanded urgent
access to funding personnel and clinical specimens to develop
lifesaving medicines, but you were told that the spread was
under control, correct?
Dr. Bright. There wasn't a shared sense of urgency.
Mr. Welch. On January 25th you warned others in the
administration there is a critical need for procuring surgical
masks. That was ignored, correct?
Dr. Bright. True.
Mr. Welch. On January 27th you participated in the daily
COVID-19 meeting where you expressed frustration with the slow
pace of accessing virus samples and clinical specimens from
China. You were reprimanded and you were no longer part of
those meetings. Is that right?
Dr. Bright. That is true.
Mr. Welch. So you and others actually were seeing over the
horizon what was coming to our shores, even before our first
case was confirmed, correct?
Dr. Bright. We had spent many years preparing for a
pandemic, sir. And we understood the threat, we understood what
we needed to do.
Mr. Welch. Exactly. It is knowable and it is manageable. It
is fierce and fearsome. But what you have to do is established.
Is that more or less correct?
Dr. Bright. Yes, sir.
Mr. Welch. We just didn't do it.
February 25th, President Trump gave an assurance that the
stock market is starting to look very good and the coronavirus
was very much under control. Were you aware of any medically
involved people who had the view that the virus at that time
was very much under control?
Dr. Bright. No, sir. I don't think the virus was under
control. I don't think many people would agree with me in the
scientific realm.
Mr. Welch. Now, in those countries I mentioned, that
includes Germany, Taiwan, New Zealand, South Korea, Singapore,
the leaders of those countries accepted that there was a role
only the nation could play and the provinces would have to
depend on them for that. And I want to go through some of those
things.
One, establishing a testing protocol. Was that done here.
Ms. Bright. No.
Mr. Welch. Two, acquiring and allocating and distributing
the personal protective equipment to where it was needed when
it was needed. Was that done here?
Dr. Bright. No, sir.
Mr. Welch. In fact, we had governors and hospitals
competing with each other to try to get desperately needed
equipment. Isn't that correct?
Dr. Bright. There was a lot of confusion, and a lot of
competition, and bad decisions made to acquire poor-quality
product.
Mr. Welch. In any of those other countries that I just
mentioned, are you aware of the leader of that country at a
press conference making recommendations on what kind of
medication people should use?
Dr. Bright. I don't know the details of what happened in
those countries, sir, so I don't know.
Mr. Welch. All right. We had governors here, Republicans
and Democrats, Republicans like Hogan, like Phil Scott from
Vermont, who have done a tremendous job, but no matter how good
they do their job, can they protect their people without the
aggressive intervention of the Federal Government playing its
role?
Dr. Bright. I think the Federal Government plays a critical
role in coordinating and aligning and making an equitable
distribution of those critical supplies. I believe that is what
we practice and exercise in the past that there would be a
critical role for the Federal lead in coordination at the
State, local, and Tribal and territorial levels.
Mr. Welch. Thank you Dr. Bright.
I yield back.
Ms. Eshoo. The gentleman yields back. A pleasure to
recognize the gentleman from Georgia, Mr. Carter. Do you wish
to question or do you want to pass?
Mr. Carter. I will reserve it.
Ms. Eshoo. You reserve. OK.
The gentleman from California, Mr. Ruiz, is recognized for
5 minutes of questions. Dr. Ruiz.
Mr. Ruiz. Thank you.
Thank you, Dr. Bright. Thank you for your testimony here
and thank you for your service to our country.
My heart aches for the family and friends of the over
80,000 in America who have died of COVID-19 in such a short
period of time. In fact, my heart aches for those closer to me.
Riverside County has reported 228 deaths.
As a doctor, I appreciate your written testimony that
states that science, not politics or cronyism, must lead the
way to combat this deadly virus. There has been a lot of hype
about cures for COVID that have been shown to be ineffective
and even dangerous. We are now seeing the very real dangers and
consequences of not making decisions based on science.
Hydroxychloroquine, which FOX News commentators and then the
White House repeatedly touted and actually encouraged people to
use, is Exhibit A on this list.
But there is one drug that appears to provide some
therapeutic benefit, remdesivir. Two weeks ago, Dr. Fauci
announced that remdesivir showed a clear-cut, significant,
positive effect in diminishing the time to recovery.
My understanding is that in January and early February you
launched a comprehensive review to assess which existing drugs
may prove a therapeutic benefit and you quickly identified
remdesivir as the most likely drug to be effective against
COVID-19. Can you describe how you came to that conclusion, who
you told within HHS and what the response was?
Dr. Bright. Yes, sir. That conclusion came about by a
technical review from a number of scientists within HHS, the
CDC, FDA, NIH, and BARDA. It was also aligned with a scientific
assessment from WHO and a number of global experts who rapidly
looked at every potential drug and ranked remdesivir as the
drug that had the most potential for benefit.
Mr. Ruiz. Who did you tell and what was their response?
Dr. Bright. We shared that information with Dr. Kadlec. We
shared that information within HHS leadership as well. We had
discussions about the actions that could be considered for
acquiring the limited supply of remdesivir.
Mr. Ruiz. What was the response?
Dr. Bright. We had discussions about how to ramp up
production of more remdesivir in case the randomized controlled
clinical study that the NIH was conducting came through with
positive----
Mr. Ruiz. So you had a discussion and what was the
response? Did anything happen?
Dr. Bright. No decision was made at that time.
Mr. Ruiz. OK. My understanding is that Peter Navarro, the
White House trade advisor, reached out to you on February 7th
to seek your counsel. You told them about your top three
concerns: the shortage of N95 masks, the need for a, quote,
unquote, Manhattan Project to develop vaccines, and securing
adequate supplies of remdesivir. Can you tell us if Mr. Navarro
agreed with you and what steps you and he took?
Dr. Bright. Mr. Navarro did agree with me on the
remdesivir, the N95 masks, and the vaccine Manhattan Project,
and he drafted a memo on February 9th to the White House chief
of staff and Mick Mulvaney to share with the White House task
force.
Mr. Ruiz. The directive for HHS to act on remdesivir
occurred on February 10th. What happened next? And did the
Department promptly procure the needed supplies of remdesivir?
Dr. Bright. We did not proceed with procuring any supplies
of remdesivir.
Mr. Ruiz. OK. You were removed from your position on April
22nd. By the time you were removed, had the Department settled
on a plan and procured the remdesivir?
Dr. Bright. No, sir. They were still discussing with slide
presentations about potential donations of remdesivir at that
time.
Mr. Ruiz. So what you are describing is a gang that
couldn't shoot straight. And yet, we are in the middle of a
pandemic. There is one drug the experts say could make a
difference and in fact has been shown to make a difference.
Yet, the Department can't seem to figure out how to acquire it.
A week ago The Washington Post published an article on the
rollout of remdesivir, describing it as, quote, ``confusing,
unfair, and marred with incomplete medical information''
unquote. Doctors described how they can obtain the drug and
don't understand the process for accessing it. Dr. Benjamin
Linas from the Boston Medical Center said, quote, ``There is no
transparency. The process is just a staggering injustice.''
Dr. Bright, you were warned about this over three months
ago. If the Department had listened to you and the other
experts at your agency, could this fiasco have been avoided?
Dr. Bright. We would have had a plan, sir. We should have
had a plan for that drug and any other drug in limited supply.
Mr. Ruiz. So it didn't have to be this way.
Dr. Bright. Right.
Mr. Ruiz. Here is what I don't understand. You were right
about the dangers of hydroxychloroquine, you were right about
the benefits of remdesivir, you were right about N95 masks and
other critical issues, yet you got fired from your job, while
officials who botched the response and ignored your warnings to
stay in theirs. Not only is this unfair to you, it is
completely dangerous to the American people.
I yield back my time.
Ms. Eshoo. The gentleman yields back. I would like to
clarify something just very quickly. Relative to your leave,
Dr. Bright, are you on accrued vacation time now?
Dr. Bright. I am sorry?
Ms. Eshoo. Are you on accrued vacation time now?
Dr. Bright. I am on approved vacation leave today, yes. I
talked to the----
Ms. Eshoo. And would you be willing to share the exhibits
once you personally--once you remove personally identifiable
information?
Dr. Bright. Congresswoman, I am having trouble
understanding you through the mask.
Ms. Eshoo. Oh, I am sorry.
Dr. Bright. Sorry.
Ms. Eshoo. I am getting so comfortable wearing a mask, I
forgot I had it on. Would you be willing to share the other
exhibits once you remove personally identifiable information?
Dr. Bright. Yes.
Ms. Eshoo. Thank you. All right.
Ms. Katz. Chairwoman, we will make them available after the
hearing today when we have had a chance to review it.
Ms. Eshoo. Thank you.
Mr. Walden. Madam Chair, will they be made available to the
minority as well as the majority?
Ms. Katz. Absolutely.
Ms. Eshoo. They will be made available to the entire
committee.
Mr. Walden. Perfect. Thank you.
Ms. Katz. We have never shared anything with the majority
that hasn't been shared--
Ms. Eshoo. Right.
Ms. Katz [continue]. This is a bipartisan issue.
Mr. Walden. Thank you.
Mr. Griffith. Madam Chair, if there is anything in those
exhibits that hasn't already been released to the public that
might be degrading, will that be kept in confidence amongst
committee members?
Ms. Eshoo. I am sorry. I didn't hear you.
Mr. Griffith. Not knowing what is in the emails, I am
wondering if there is any information in there that might be
deemed to be degrading, would that be kept in confidence
amongst the committee members as opposed to being released to
the public?
Ms. Eshoo. We will follow the rules.
Mr. Griffith. And that is in compliance with rule 11. Thank
you.
Ms. Eshoo. Thank you, sir.
OK. I now have the pleasure of recognizing the only
pharmacist in the United States Congress, Mr. Carter.
Mr. Carter. Thank you, Madam Chair.
Thank you, Dr. Bright, for being here, and thank you for
your service to our country. And before I begin, let me extend
my condolences to those 80,000-plus who have lost their lives
and to their families as a result of this pandemic, and a
shout-out to all of our healthcare professionals, as well as
our other essential workers who have put their own health in
danger in order to provide services to our citizens.
Dr. Bright, it is my understanding that in 2017, BARDA-
funded a project with Applied Research Associates of
Albuquerque to develop respirators that could be sanitized and
reused during public health emergencies, such as what we are
going through today. However, according to recent reports by
The Washington Post, none of these next-generation respirators
are available for us today. Why is that? Do you have any idea?
Dr. Bright. I am not aware of those. Are you talking about
the ventilator, sir, that we developed?
Mr. Carter. That is correct. I am talking about those that
were developed, the respirators that were developed and could
be sanitized and reused during public health emergencies. It is
my understanding that that was contracted and that that project
was scrapped.
Dr. Bright. Sir, I am not familiar with that project to
resanitize the respirators.
Mr. Carter. You are not familiar with that project, and you
didn't sign off on that project, to your knowledge?
Dr. Bright. I am not familiar with that project to
resanitize respirators.
Mr. Carter. OK. Fair enough if you are not familiar with
it.
Let me ask you this: We have had a lot of discussion today
about hydroxychloroquine, about chloroquine, and I am a little
bit confused here because it is my understanding that this is
what BARDA--do you want to clarify something here? I see you--
OK. It is my understanding that that is what the role of BARDA,
the mission of BARDA is, to look at things like this, in fact,
when we in Congress appropriate, allocate money to go toward
this, that you are supposed to be looking--that BARDA is
supposed to be looking at things that could possibly have
merit, such as hydroxychloroquine and chloroquine. And early
on, it appeared that you embraced that.
And early on, it seemed that you were in favor of looking
at that. And I am just wondering because of this pandemic,
because we didn't have any vaccine or any kind of agreed-upon
treatment, we should be testing, and we should--that is what we
are appropriating that money for. Would you agree with that,
that that is what we are trying to do is to look at what could
possibly work, and work with public companies to try to
encourage them to come up with those kinds of solutions?
Dr. Bright. Absolutely. We should look at all options and
make sure we evaluate the potential risk and safety and benefit
of those in the context of a randomized controlled clinical
study. In the context of emergency, we should move swiftly and
get that clinical data as urgently and quickly as possible,
that we should not proceed recklessly without that clinical
data on its potential adverse events in an emergency.
Mr. Carter. So you are referring--when you say, we should
not proceed adversely, you are referring to hydroxychloroquine
and the chloroquine?
Dr. Bright. We are--we were promoting the standing up of
randomized controlled clinical studies at the NIH with
hydroxychloroquine. I worked with a company to even ask if they
would donate drug to the NIH to be used in the context of a
randomized controlled clinical study.
Mr. Carter. Right.
Dr. Bright. Yes. So that is what BARDA would do.
Mr. Carter. And, in fact, I think you worked with the FDA
to get an emergency use for hydroxychloroquine. Is that
correct? And it was actually approved by the FDA.
Dr. Bright. That was in the context of the directive we
received from the Secretary's office to stand up an expanded
access protocol. Our clinicians----
Mr. Carter. So are you saying you were instructed to do
that, and you did it against your will, or----
Dr. Bright. Sir, we were instructed to put in place an
expanded access protocol. So in the context that Americans be
able to access this drug and not be under the close supervision
of a physician. The scientists at FDA, NIH, CDC, and BARDA
worked together to change that directive to the context of
emergency use authorization with guardrails in there so
patients would be under the close supervision of a physician.
Mr. Carter. Understood. Let me ask you this: Initially, you
appeared to be encouraged by what could possibly be a result of
the effect of hydroxychloroquine. When did that change? When
did you sour, if you will, on the use of hydroxychloroquine?
Dr. Bright. I believe that we have seen many drugs that
could have benefits, and some of these are really interesting
things we have never heard of, some we have.
Mr. Carter. I understand that, but my question was, when
did you sour on it?
Dr. Bright. When it was determined that this drug should be
made available to Americans outside the context of a close
physician supervision. So I supported conducting a randomized
controlled clinical study for hydroxychloroquine at the NIH.
When I learned that there was a directive to make it more
broadly available, not under close supervision of a physician,
I was--
Mr. Carter. When was that? When did that directive go out?
Dr. Bright. That was March 23rd.
Mr. Carter. March--and that is the time that you decided,
no, this is not what we should do, and we should not be looking
at hydroxychloroquine at all?
Dr. Bright. I didn't think that was the proper, safe way to
evaluate that drug in the context of this outbreak. I believe
it should be only done under close supervision of a physician.
When we put the EUA in place that locked this drug down, to
only be used in patients under close supervision of a
physician, we were satisfied we had those guardrails in place.
When an email string followed a week later saying ignore the
EUA, push this drug into the retail pharmacies in New York and
New Jersey, that is when I became more concerned.
Mr. Carter. And who put that directive out?
Ms. Eshoo. The gentleman's time has expired.
Mr. Carter. Who put that directive out?
Ms. Eshoo. The gentleman's time is expired. You can answer,
Dr. Bright.
Dr. Bright. Which directive, sir?
Mr. Carter. That it should be put out to the public without
physicians approving it.
Dr. Bright. That directive was an email string that had a
number of individuals on it, and I believe it first came from
Dr. Giroir, the Assistant Secretary of Health, that indicated
the White House was asking for that drug to be more broadly
available.
Mr. Carter. So was it because the President was encouraged
by the use of this drug that you became discouraged by it?
Dr. Bright. It had nothing to do with politics, sir. I
wanted to make sure that Americans were aware of the risk of
this drug. It was only available under very----
Mr. Carter. But it is a drug that is indicated and has been
used safely in the past.
Ms. Eshoo. The gentleman's time has been exceeded by
almost----
Dr. Bright. In one area.
Ms. Eshoo [continue]. One-and-a-half minutes.
You can finish your answer, Dr. Bright, and then we are
going to move to the next member.
Dr. Bright. The drug had been used safely for malaria for a
number of years. We didn't have a database----
Mr. Carter. But it is being used in the same dosage as it
is for malaria.
Ms. Eshoo. The gentleman's time is--please, please. I know
that I am overly generous with both sides of the aisle, but I
think that we need to move on. I mean, two minutes of extra
time is two minutes of extra time, and I am not going to ask
that it be shared over here. The gentleman's time is expired.
It is a pleasure to recognize the gentlewoman from
Michigan, Mrs. Dingell, for her 5 minutes of questions.
Mrs. Dingell. Thank you, Madam Chair. Thank you to both you
and Ranking Member Dr. Burgess, and Dr. Bright, for your being
here today. You are doing a great service.
I think we are here today because COVID is real. I share
the sentiments of many of my Republican colleagues that have
expressed thanks to the frontline workers asking questions. I
want to look at the last few months. COVID's really real in my
State. Michigan's the 10th largest State in the country, and we
were third in the number of cases for weeks. We were third and
remained there until this week in the number of deaths. We
managed to move to fourth place two days ago, which is not a
number anybody wants to be. My family alone, a cousin woke up
with 104 temperature and was dead that afternoon.
There are people still dying every single day. I have lost
someone I have known. Sunday, Monday, a brother, a brother-like
friend to me, Tuesday and Wednesday. And then we hear the
scientific experts, yourself, but Dr. Fauci, other scientists
around the country saying to us, if we don't listen to them, we
could begin to see--we are going to see a return. You call it a
dark winter. I call it, I don't want to see any more spikes. I
don't want to see anybody else die. I am losing too many
friends that I know, and people across the country are.
So I want to focus on an area that is not your area of
expertise, but it is mine; car safety. We expect our cars to be
safe. And we expect car manufacturers to be responsible and
making sure defective cars aren't sold. And if they fail in
that responsibility, we hold them accountable. If an engineer
in a car company realized a model had serious defects and
warned her management about that, we would all think she had
done her job responsibly. And if management ignored her, and
our committee found out, I will bet you right now, we would be
having hearings. And if Americans died driving those cars, the
companies would be sued, and they would be charged with
criminal negligence.
In fact, several years ago, before my time, this committee
investigated airbag defects and vehicle safety. At the time,
the subcommittee's ranking member, Dr. Burgess, sad, there are
no room for going slow when it comes to safety. And certainly
deception cannot and will not be tolerated. Dr. Burgess was
right then, and our car makers have to be accountable. But what
I am concerned about is that we aren't applying these same
standards to coronavirus. And I want to learn from what has
happened, so we keep that dark winter you are talking about
from happening.
It seems to me, Dr. Bright, you acted the same way the auto
engineer I mentioned should act. You identified serious
problems, and then suggested fixes when it came to diagnostics,
N95 masks, other equipment, and medicines. Is that right?
Dr. Bright. That is true, and, Congresswoman, we still have
those challenges.
Mrs. Dingell. Do you believe if your suggestions were
implemented, lives would have been saved, and the severity of
the pandemic might have been lessened?
Dr. Bright. I believe lives would have been saved if we had
proper medical protective equipment for our healthcare workers,
yes.
Mrs. Dingell. So people died because you weren't listened
to?
Dr. Bright. People died because they didn't have
appropriate protective equipment to save their lives and
protect them from getting infected.
Mrs. Dingell. The problems aren't limited to just ignoring
your advice. The American people are confused, given mixed
signals, and quite frankly, some days just simply deceived. Let
me give you an example. There was a visit to the CDC on March
6, and at that visit, the administration said, anybody who
wants a test will get a test. Was that true then?
Dr. Bright. There still are not enough tests.
Mrs. Dingell. So even this week as we are being told,
anybody who wants a test can have a test. Is that true in the
United States of America?
Dr. Bright. No.
Mrs. Dingell. In fact, all the experts say we are doing is
only a small fraction of the tests we need to do to reopen
safely. I am running out of time, so let me ask you about
vaccines. We keep being told by the White House that we have
heard very soon, quick numbers, a matter of months for that
vaccine to be developed. This is your area of expertise. You
are a top immunologist in the world. Was there any scientific
basis to suggest in March that we will have a vaccine in the
next few months?
Dr. Bright. There is a lot of optimism, there is a lot of
hope, but that doesn't make a vaccine. There is a lot of work
that needs to be done to make a vaccine.
Mrs. Dingell. Will we be able to vaccinate people in the
next few months?
Dr. Bright. It is very unlikely.
Mrs. Dingell. Thank you, Doctor.
Ms. Eshoo. The gentlewoman yields back. It is my
understanding the minority is passing, reserving. So with
pleasure, I recognize the gentlewoman from New Hampshire, Ms.
Kuster.
Ms. Kuster. Thank you, Dr. Bright, for being with us today.
I want to thank you for your courage, for helping us to do our
job to protect the American people.
I want to start today by restating what I said at a hearing
February 26th with Secretary Azar, right here, right at that
table. The key to a public health crisis is trust and
credibility. On that day, I urged Secretary Azar to provide
clear, credible updates from this administration to the
American public. However, your whistleblower complaint and
testimony today unveil unheeded warnings about personal
protective equipment, testing supplies, and vaccine supplies.
Over the past several months, I have held countless
conversations with doctors and nurses and hospitals and
community health centers and our Republican Governor and every
other person in New Hampshire, trying to get access to personal
protective equipment, to protect our frontline workers, to
protect our grocery clerks.
We have been trying to get testing supplies, and we were
told that because we were not a hotspot, we were on our own.
And we literally had to turn to entrepreneurs. Thank God they
exist, and thank you to them for flying to China and bringing
us the equipment we need that should and could have been
distributed, had we planned ahead.
These conversations have informed my roadmap to recovery on
how to safely reopen our economy, and key to those efforts is
adequate testing, contact tracing, supported isolation, and
vaccine development--your specialty. So I want to focus on your
role as Director of BARDA in vaccine development and
distribution.
On page 28 and 29 of your addendum to your complaint, it
states that BARDA estimated that between 650 million and 850
million needles and syringes would be needed for a vaccine to
be administered here in the United States for everyone to be
safe. Your team at BARDA also estimates it could take up to two
years to manufacture these vaccine delivery supplies.
To your knowledge, Dr. Bright, at this time, has the
administration placed any orders to prepare for how a vaccine
will be delivered when one becomes available to every American?
Dr. Bright. I learned that they placed an order; the first
order for needles and syringes on May 1st, and another order
was placed today.
Ms. Kuster. And were the amounts adequate?
Dr. Bright. I believe it is for 320 million needles and
syringes.
Ms. Kuster. And could you please describe the situation if
every American does not have access to the vaccine due to a
supply shortage?
Dr. Bright. That situation would be catastrophic, honestly.
The decisions have not been made yet who to vaccinate first,
how to identify those individuals, and how to stretch those
limited supplies appropriately. And it is important to
remember----
Ms. Kuster. Let me ask you a simple question.
Dr. Bright [continue]. That it is not just the United
States, so there is has limited supplies. When I said it would
take 2 to 2-1/2 years to make those, that was assuming there
wouldn't be global competition for those limited supplies.
Those are not made in the United States, some of them, so----
Ms. Kuster. Does a lack of preparation in vaccine supplies
make us more vulnerable to future spikes in COVID-19?
Dr. Bright. Absolutely.
Ms. Kuster. And do we have enough supplies to distribute
both the flu vaccine next winter as well as the coronavirus
vaccine?
Dr. Bright. It is going to be extremely challenging.
Ms. Kuster. Do we know yet of the interactions of the full-
fledged flu season in combination with COVID-19?
Dr. Bright. We haven't seen that yet. Luckily this spring,
flu was winding down when COVID-19 was emerging.
Ms. Kuster. And without adequate supplies to vaccinate all
Americans for COVID-19, does this slow down the goal of fully
reopening our economy, and getting back to the normal that
every American wants?
Dr. Bright. It certainly brings caution and significant
consideration that must be taken into consideration before
reopening. We need to make sure that not only the guidelines
for reopening are clear to each individual, and each individual
follows those guidelines. Otherwise, it puts us all at risk.
Ms. Kuster. So can I ask you a question? I know you are not
political, and certainly, we are all trying not to be
political. In fact, I am very proud in our State that our
delegation and our governor are working so well together. But
Dr. Bright, does this virus give a damn whether a patient is
Republican or Democrat?
Dr. Bright. No, it doesn't. This virus just wants to infect
people, and unfortunately, a lot of those people get really
sick, and many of them die.
Ms. Kuster. Thank you. I am so grateful, not just for your
knowledge, for your humility, and for your service to our
country. Thank you, and I yield back.
Dr. Bright. Thank you.
Ms. Eshoo. The gentlewoman yields back. Minority reserves?
Pleasure to call on the gentlewoman from Illinois, Ms.
Kelly, for her 5 minutes of question.
Ms. Kelly. Thank you so much, and thank you for being here
and your patience. As chair of the Congressional Black Caucus
Health Brain Trust, I am deeply concerned by the disparities
that this pandemic has brought to light due to our Nation's
history of discriminatory policies, leading to differences in
health outcomes for people of color. Time and time again, when
resources are scarce, some communities are forced to do without
the goods and services they need. You identify multiple
situations in which the United States would face a shortage of
supplies needed to respond to COVID-19, from masks to swabs and
other testing materials, and potentially, the supplies that
deliver a vaccine when one is ready.
During COVID-19, we have seen some States forced to pay
significantly more because they are on their own to procure
those medical supplies. Not every State or locality can afford
to do this. Knowing what we do know about how scarce resources
are procured and distributed, what impact will shortages have
on lower-income communities?
Dr. Bright. The syringes will impact across all of America,
and unfortunately, it actually increases the concern in
communities that aren't part of the mainstream and might have
lower socioeconomic status. So I think it has a significant
chance of increasing the risk in those communities.
Ms. Kelly. How have you seen this impact the devastation of
the disease in these communities?
Dr. Bright. In these communities, the data are showing that
they are hit very hard, and we don't actually have the
information yet to understand fully what is behind that or why,
and health status or access to healthcare or other immunization
status or healthcare status. So, we are still learning a lot
about that.
However, it is really important to think about when we have
diagnostic tests and other things available, that they are
available to everyone. And many of these tests that we are
developing today are very expensive, or are in very rare
supply. So we need to make sure that we are developing and
making available tests that are not just rapid and accurate,
but low cost, and so everyone who needs a test can access those
tests.
Ms. Kelly. Did you attempt to urge HHS leadership or the
administration to consider preparedness, outreach, or targeted
resources for these populations, or are you aware of any HHS
administration actions to target resources outreach to these
vulnerable groups?
Dr. Bright. I am--I have had some conversations. There have
been some conversations, I should say, focusing on groups that
are harder to reach and in different socioeconomic statuses. I
am not sure that there is a solidified plan in place just yet
to make sure that it is more than a conversation.
Ms. Kelly. Doesn't sound like there is. In your testimony,
you recommend establishing a national standard and coordinating
equitable distribution of equipment and supplies. Will this
help to ensure that every community can access the equipment
and supplies they need?
Dr. Bright. That is what is needed.
Ms. Kelly. Will more equitable distribution of equipment
and supplies help to address the inequities we are seeing in
the impact of COVID-19 on communities of color?
Dr. Bright. Yes, absolutely.
Ms. Kelly. And do you feel that in the last bill that we
passed, we made sure that there was passed in the bill better
data, as far as race and not just who died, but who was
hospitalized and so on and so forth? Because we are hoping that
better data will inform policy. How do you feel like that will
help?
Dr. Bright. I think that is very important. I think it is a
wise move.
Ms. Kelly. OK. Good. And we are supposed to get a report 21
days from when the President signed the bill, then 30 days, and
then 180 days.
Dr. Bright. I am not aware of those guidelines. It comes in
a different area, but I think reporting and oversight of that
is important.
Ms. Kelly. And then lastly, you have been sitting in that
seat for a while, but is there anything that we haven't asked
you that you want to say?
Dr. Bright. It is a really important question, and I have
thought a lot about that. I want to, I think, highlight the
things I talked about in my opening statement: we need
transparency in the science, and America needs to know the
truth. This is a devastating pandemic and not just for health,
but also for society, our economy, our jobs, and our
livelihood. And if we do not take it seriously the call for
action to put specific things in place, a coordinated national
plan for testing and response, an equitable distribution of
these limited supplies, and ramp up and prepare for what will
be a very devastating fall if we don't have the right supplies
in place and raw materials, then this virus will overcome us in
significant ways still.
So we have limited time. My message is, we have limited
time. We have the ability to do it. We have the greatest
scientific minds in our country to do it. We need to listen to
them, put the plan in place, and everyone get busy stopping
this virus.
Ms. Kelly. Right. I know it is very--I have had three
people in my family with it, and I lost my uncle, maybe, like,
ten days ago now from the virus. So it does definitely touch
everybody. Thank you, and thank you for your patience.
Dr. Bright. Thank you.
Ms. Eshoo. The gentlewoman yields back. The minority
reserve?
All right. Then we will go to the gentlewoman from
California, Ms. Barragan, for her 5 minutes of questions.
Ms. Barragan. Thank you, Madam Chairwoman.
Dr. Bright, one striking aspect of your account in your
complaint to the Office of Special Counsel is the contrast
between the public updates by the President and Secretary Azar
on COVID-19 versus the analysis you and other experts were
providing behind the scenes. I would like to explore this
disconnect, and ultimately that the administration shared
information that I believe was misleading. We need to do this
to better understand what happened, and how we can ensure that
the administration provides the public accurate and
constructive information going forward.
Dr. Bright, you had learned of the COVID-19 threat by in
early January. Is that correct?
Dr. Bright. Yes.
Ms. Barragan. And according to your complaint, it was clear
to you, almost immediately, that the, quote, ``virus was highly
contagious, spreading rapidly, and could have a high mortality
rate,'' end quote. Is that correct?
Dr. Bright. We were learning that from the outbreak in
China at the time, yes. And each day we learned more
information, it was actually more concerning.
Ms. Barragan. And the World Health Organization confirmed
your view that the virus was a big problem in a January 20 call
to agencies, including HHS. Over the course of January, you
pressed HHS leadership about the urgent need to devote
increased resources to address the outbreak. On January 23rd,
you briefed Secretary Azar directly that funding, personnel,
and clinical specimens, including viruses, were critically
necessary to begin development of life-saving medicines needed
in the likely event the virus spread beyond Southeast Asia.
Yet, on January 24th, in a tweet regarding the virus, the
President asserted, quote, ``It will all work out well,'' end
quote.
On January 29, Secretary Azar reportedly told the President
that the epidemic was, quote, ``under control,'' and the
President echoed that comment publicly the following day. This
disconnect between the analysis of public health experts and
the public statements by the administration leaders continued
through February.
Let me give you some more examples. In early February, you
continued to raise the alarm bell within HHS about the imminent
mask shortages and the lack of preparations for the wave of
infections that you saw coming. Thank you for doing that. Yet,
in public remarks on February the 10th, President Trump stated,
``It looks like by April, in theory, when it gets a little
warmer, it miraculously goes away,'' end quote. Then he added,
``I think it is all going to work out good. We only have 11
cases, and they are all getting better,'' end quote.
You said that experts knew that the number of N95
respirator masks needed to protect healthcare workers and other
Americans in a pandemic was close to 3.5 billion. Yet, in
testimony on February 25th, Secretary Azar said the U.S. would
only need 300 million N95 respirators. That is an order of
magnitude so much less than what you stated.
Throughout February, you continued your warnings. I would
say that your hair was on fire about the dangers millions of
Americans faced from this virus. But on February 26, President
Trump characterized the number of cases this way. Quote, ``When
you have 15 people, and the 15 within a couple of days is going
to be down to close to zero, that is a pretty good job you have
done,'' end quote. By March 10th, there were over a thousand
diagnosed COVID-19 cases in the United States, and over 30
deaths had been attributed to the virus in this country. Yet,
the President that day told the country, quote, ``It will go
away. Just stay calm. It will go away,'' end quote. He couldn't
have been more wrong. Today, we have over 1.4 million cases.
Dr. Bright, what impact do you believe that statements by
the administration leaders downplaying the COVID-19 crisis
throughout February had on the ability of our public health
system to mount an effective response to the COVID-19 virus?
Dr. Bright. I believe Americans need to be told the truth.
I believe that the best scientific guidance and advice was not
being conveyed to the American public during that time. I
believe by not telling America the truth, or being fully
transparent regardless of where the information was coming
from, people were not as prepared as they could have been and
should have been. We did not forewarn people. We did not train
people. We did not educate them on social distancing and
wearing a mask as we should have in January and February. All
of those forewarnings and all of those educational
opportunities for the American public could have had an impact
on further slowing this outbreak and saving more lives.
Ms. Barragan. Well, thank you, Dr. Bright. I want to thank
you for sharing your perspective with us today. I hope that
over the course, I hope that your courage in coming forward
helps our country forge a better path than the disastrous
course charted by this administration to date. I yield back.
Ms. Eshoo. The gentlewoman yields back. Minority reserves?
Pleasure to recognize the gentlewoman from Delaware, Ms.
Lisa Blunt Rochester----
Ms. Blunt Rochester. Thank you.
Ms. Eshoo [continue]. Five minutes for questions.
Ms. Blunt Rochester. Thank you, Madam Chairwoman, and thank
you, Dr. Bright, so much for your testimony, but also for your
courage here today. As you can hear from our colleagues, there
is not a person in this room or in this country who hasn't been
personally touched by COVID-19. And your statement that we need
to be told the truth is probably the most important statement
we have heard all day, because we know that if we don't face
it, we can't fix it. So I want to personally thank you on
behalf of all Americans for your courage to testify before us
today.
And I want to say that my focus for this hearing is really
on three things: Number one, what have we learned? Number two,
what do we need to do now? And number three, what can we do to
prevent or mitigate the risks of an additional wave of COVID-
19?
It is clear since January of this year that there has been
a failure on the part of the administration to use the
scientific evidence that has been prevented by the Nation's top
public health officials to take comprehensive--and I will use
that word again--comprehensive, appropriate, and urgent action
to respond to COVID-19.
One of the most pressing outstanding needs that has yet to
be addressed is the need for a national testing strategy. Dr.
Bright, in your testimony, you mentioned the need for such a
strategy that ensures tests are, among other things, available
to everyone who needs them. I, along with Congressman Collin
Peterson and Representative Vela from Texas, wrote a letter to
the Democratic and the Republican House leadership in the House
and the Senate, and we really impressed upon them the need for
outlining the importance of a robust testing plan for testing
and tracing. And while current testing capacity is 1.6 million
diagnostic tests per week, healthcare experts say that we are
woefully short of the estimated 30 million tests per week that
we need to get America back to work as safely and confidently
as possible, and to avert or mitigate a second wave of COVID-19
which is one of my biggest concerns.
Dr. Bright, what are the immediate steps that HHS needs to
be taking to ramp up testing capacity now through the fall, and
what targets should they be held accountable for?
Dr. Bright. I think what is really interesting about the
testing story that gets lost in the narrative sometimes is the
confusion about the different types of tests. There is an
antigen test that tells you if you have the virus in you. There
is a PCR test that says it is made of fragments of the virus,
and there is an antibody test that looks at your antibody titer
to try to tell you you have been exposed already and may be
immune to that, the virus.
There is a lot of confusion, and I think the first thing
HHS needs to do is determine which of those tests is, most
important, to achieve which objective. If the antigen test is
what is needed because it is faster and lower cost, and more
readily available in some cases, what does it tell Americans?
What does it tell employers? What does it tell schools about
the potential for an individual who has a positive or negative
on that test and their potential to have a different result the
next day or later that day?
There is a lot of confusion about these tests. So I think
the first thing that HHS should do is determine the type of
test, and how that test would be used effectively and then make
sure that we have enough of those types of tests, and they are
in the right place, and the people using them know what the
data tells them and how to do it effectively.
I think there is a lot of confusion there, and they need
leadership in HHS to distinguish those challenges and clarify
that for the American public. It is not just a test. There are
many different tests, and they tell you different things.
Ms. Blunt Rochester. Thank you. Thank you. And why do you
think that our Nation has struggled with ramping up the testing
capacity, unlike other countries? And were there contingencies
in place or a backup in light of this situation we are in now?
Dr. Bright. I think part of the struggle is waiting too
late to think about it and to get it started. And when we have
had conversations with some manufacturers, they have been very
creative in how they can ramp up. Another part of the challenge
is we have allowed many of these capabilities to be offshored.
And, so, we have much more capability in expanding domestic
capacity when it is in our country, and we can ramp up and
bring innovation to those companies in the U.S. But if the
supply chain is offshore, and there is a global need and
competition for that supply chain, that also significantly
impairs our ability to ramp up.
Ms. Blunt Rochester. Again, I just want to thank you so
much for the time that you have contributed to our country, but
also, for your courage to be here right now. Many of us are
challenged, as Democrats and Republicans, to make sure that our
country is safe and healthy, and it really is--it really--I
don't think I have ever in my lifetime seen anything like this,
and it does require us to look back, and at the same time look
forward, and make sure that we have what we need as a country.
So I thank you again, and I yield back the balance of my time.
Ms. Eshoo. The gentlewoman yields back. Does the minority
reserve?
Voice. We don't have any further questions.
Ms. Eshoo. All right. Then it is a pleasure to recognize
the gentleman from Illinois, Mr. Rush, for his 5 minutes of
questions.
Mr. Rush. I want to thank you, Madam Chair--Chairwoman.
Ms. Eshoo. Do you have your microphone on?
Mr. Rush. I have it on now.
Ms. Eshoo. Good. Now I can hear you. OK.
Mr. Rush. I want to thank you, Madam Chairman.
Dr. Bright, it is so good to see you. I have been watching
you this morning, and it just amazes me about your courage and
your insight and your commitment, and I am just so delighted to
be in the same room with you. Your contributions are
impressive, and your reports on how the scientific process was
pushed aside for short-term political points are extremely
troublesome to me and to the American people, I am sure.
I am absolutely convinced that both you and the Chinese
doctor, Dr. Li, the doctor who first raised the alarm over the
coronavirus while in China, you two will be remembered as two
titans of this pandemic. You took the path that was right
rather than the path that was easy, and I commend you for it.
And that said, Dr. Bright, it has been widely reported that
President Obama's White House National Security Council left
the administration a detailed, very thorough document on how to
proceed through a pandemic. And did you have any input in that
playbook?
Dr. Bright. Yes, sir, I did. A number of our agencies
across the government had input in that playbook.
Mr. Rush. And as far as you know, have any of those
recommendations been enacted upon in this administration?
Dr. Bright. I believe some of those principles have been
reviewed and considered, but I think the playbook has changed
in this outbreak. I don't think they followed that playbook.
Mr. Rush. Like you, I think it is critically important that
we focus on the path forward. While we must learn from the past
and correct as they occur, our response has to be forward-
thinking, forward-moving. And I am the sponsor of a bipartisan
COVID-19 Trace Act. I have been working on developing a
comprehensive, $100 million strategy for mobile testing and
door-to-door tracking. And my legislation--my bipartisan
legislation empower community groups to hire and train and pay
workers to engage in testing and contact tracing. It
prioritizes hotspots in medically underserved areas, as well as
entities who are hiring locally, and as such, I was very
interested in your view on the national testing and tracing
strategy. In your testimony, you said, the virus is out there.
It is everywhere. We need to be able to find it, to isolate it,
and to stop it from affecting more people. And with that, I
could not agree with you more.
My question might be outside of the scope of the NIH or
BARDA, I believe that it should, that it is a question that is
relevant to today. And I need to hear more about what you, as
an expert on pandemic outbreaks, believes should be our
national strategy for testing and tracing.
Dr. Bright. Sir, I think it is important. You are spot on,
that we need to have a strategy that everyone follows, the same
strategy, to test for where the virus is, who is infected with
this virus. Then we have to appropriately isolate that person
and quarantine so they don't infect others. And we rapidly need
to trace their contacts, understand who they may have been
exposed to, and be able to test those individuals. And if they
have been infected as well, we need to be able to isolate
those.
Through concerted, coordinated effort across the country,
we can be able to identify where that virus is, who has been
exposed, give those people proper treatment and isolation, and
can slow the spread of this virus significantly. But that has
to be in a coordinated way. We have to have the right tests and
enough of those tests. It is not something we do once and we
are done. It is something we have to continually do in a
community. So it is not just that we need one test for every
person in America; we need multiple tests, and the right types
of tests, and we need the right types of individuals and
professionals who know how to use those tests to trace the
individual contacts and to isolate that virus and stop it from
spreading.
Mr. Rush. Well, I certainly thank you so very much, and
thank you for, again, for being here and letting the American
people know what really is going on in our Nation with this
pandemic. I thank you. And Madam Chair, I yield back the
balance of my time.
Dr. Bright. Thank you.
Ms. Eshoo. I thank the gentleman. The gentleman yields
back. There is no request from the--
Mr. Walden. We are out of speakers.
Ms. Eshoo. You are out of speakers. OK.
It is a pleasure to recognize the gentleman from Arizona,
Mr. O'Halleran, who is a member of the Energy and Commerce
Committee, and according to our rules, we can, as members of
the full committee, we can waive onto a subcommittee. And so we
welcome you this afternoon and recognize you for 5 minutes of
questions.
Mr. O'Halleran. Thank you, Madam Chair.
Ms. Eshoo. Put your microphone on.
Mr. O'Halleran. Thank you, Madam Chair, and, Dr. Bright,
thank you for your remarks today, your insight, your knowledge,
and your caring for the American people. You have touched on
several concerns I share with my colleagues about how the
United States has responded to COVID-19. We must address the
health crisis head-on if we want to tackle the economic crisis
that has overtaken our country.
We are going to need a coordinated, as you mentioned,
national testing and contact tracing plan, spearheaded by the
Federal Government, to prevent States from competing with one
another for resources and planning for hotspot attacks and
other issues that will come up. This is the only way that
people will feel safe returning to work, eating at restaurants,
enjoying Arizona's public lands, and being out in public and
close to others. This flexibility piece is critical, and you
can't have that unless you have a coordinated process.
In my district, the Navajo Nation has, for months, been
going under this process, and it is 170,000 people. The area is
the size of West Virginia. So they are not all gathered in a
group, though. So this fallacy that only urban areas are
impacted is--and that it can't spread very fast, 16 people died
yesterday. And, in fact, on a per capita basis, this currently
has more cases than any State in the country, and yet, this
hotspot is still not being addressed in the appropriate way.
More resources are needed, and they are needed now, and they
were needed more than a month ago when we started trying to get
this done.
They continue to struggle to see the Federal Government's
promised payments in a timely manner. It came through finally,
but it has to be timely in order to respond. This will bolster
the health system and provide people with water, food, and
supplies during this time of great crisis.
Dr. Bright, as an infectious disease expert, what is the
one thing that the Federal Government must do to ensure that
hotspots, like Navajo Nation, or anywhere else in our country,
are successfully mitigated in a timely way so that this virus
does not continue to spread throughout communities and to bring
back the faith of the citizens of our country, to be able to
understand that we will respond quickly with the necessary
supplies?
Dr. Bright. Congressman, that is an excellent question. I
believe that there is a need to recognize that it is a hotspot,
and understand the per capita outbreak of a number of
infections in different areas and not treat every area in the
United States the same. The rural areas, the less dense areas,
are not the same as a dense city, such as New York City.
However, you can have just as significant a challenge in a
rural area or a less dense area as you described in Arizona.
So I think the first recognition is to get the data across
the country into the Federal Government, so they can make the
right prioritization decisions and allocation--equitable
allocation of those limited supplies and resources to areas
such as yours with a hotspot area. I don't think there is a
full recognition yet of how to define necessarily the hotspots
in a standardized way across the country. So we need to have
the scientists review this challenge and come up with an
equitable distribution and recognition of those areas.
Mr. O'Halleran. Thank you, Doctor. I want to point out that
this enemy goes much faster than one of our jet planes. Our
fighters go fast, but this goes microseconds, one person to
another, and it passes on and on and on. So I appreciate your
comment. But statistics have to be relevant and timely.
Dr. Bright. Yes.
Mr. O'Halleran. In order to be able to do that, it needs a
central database. Dr. Bright, we are currently seeing the
number of COVID-19 tests that are being administered increase
nationwide. What major hurdles stand in our way from increasing
our testing capacity quickly, moving forward, and how can the
Federal Government address these now or within a quick period
of time? It has taken--White Mountain Apache are going through
a hotspot right now in my district. They cannot get tests, and
that is--they have had 400 cases out of 14,000 people. I mean,
this is a critical issue. Please.
Dr. Bright. Sir, I still think we need to recognize the
importance of the different types of tests. And when we
identify those different types of tests are essential for what
we need to do to isolate the virus, or identify people infected
with the virus. Then we need to put all efforts into ramping up
production of all supplies for those tests.
We found many times that we have ramped up now test
production, but we have not thought about the critical reagents
that accompany those tests. We haven't thought about the swabs.
We are asking equipment--diagnostic equipment that might
normally run 100 tests a day, to run 10,000 tests a day in a
24-hour period. So there hasn't been a real thought-through
plan about how to maintain that equipment, and that equipment
now is failing in many places.
So as we ramp up capacity to test, and we haven't thought
all the way through the raw materials and maintenance of that
equipment, those supplies, then we can find ourselves a few
days down the road, not having the tests we thought we had, not
having the supply we thought we needed. So again, this is where
a coordinated strategy and plan for testing comes into place,
not just how to use the tests, but how to make sure we are
sustaining that supply, how to make sure that we have thought
of every component, if it is a swab, if it is a buffer, if it
is a lubricant for the instrument itself, making sure that all
of those things are considered and in that national strategy,
so we don't ramp up in one area and crash in another. We have
to ramp up in all areas at once.
Mr. O'Halleran. Thank you, Doctor, and Madam Chair, I
yield.
Ms. Eshoo. The gentleman yields back. Seeing no other
Members to speak, I want to close. Dr. Bright, you have been
here for just shy of four hours of straight testimony, and my
observation is the following: I think that you are the finest
ambassador in our country for scientists. Your encyclopedic
knowledge, the depth and the breadth of it, I think as the
American people have listened this morning, that you have given
them confidence. You have also issued your warning. And I
pray--and I sincerely mean that word--I pray that we will work
together successfully so that that window that is closing, we
will optimize the time that we have while it is still open.
You know, facts are really stubborn things, and sometimes
it is uncomfortable to have to deal with the facts that we are
facing. But we, the United States, still has more cases, more
deaths, by far, than any other nation on earth. And by that
definition, we have, in my view, a profound failure. You have
given this committee a roadmap today, and we all have been--
witnessed your integrity. So thank you for your service to our
country. Thank you for your willingness to testify here today.
Thank you for your courage, which has raised your blood
pressure with all of what one contends with when you become a
high-profile witness. But I think you should rest assured that
you have made a difference today. And on behalf of all of my
colleagues, I thank you and salute you and thank you for your
family being here as well. Thank you.
Dr. Bright. Thank you.
Ms. Eshoo. I will ask the--yes?
Mr. Burgess. I was going to ask if I could be recognized
for concluding remarks.
Ms. Eshoo. Yes, I would be glad to. Dr. Burgess, you are
recognized.
Mr. Burgess. Thank you. And as I outlined at the beginning
of this hearing, there are a number of things that we do need
to look into, and I hope that we will. This crisis has been
going on for several months. We had an hour tacked onto a
budget hearing at the end of February, and then this is the
first glancing blow we have had against this crisis. So I
welcome the hearing today. I think it is important, I
appreciate Dr. Bright being here. I appreciate him bringing his
guest.
I do think we need to look into the issue of testing. I
simply do not understand how the CDC got so far behind the
curve at the beginning, and I would like to know that. But I
also feel like there has been--in previous administration,
there was an effort to really regulate what are known as
laboratory-developed tests and move those away from clear
regulated products to FDA-regulated products, and that really
did put us behind. The innovators have now stepped up. I am
thankful that they have, but we shouldn't have excluded them in
the first place. And I think when we look back on this, that is
going to be one of the failings at the Federal level. And that
is not a recent failing. That goes back to guidances and rules
that were issued back in 2012, 2014.
As far as testing are concerned, and the ancillary
supplies, there are tests that might just involve taking a
salivary sample. That would be great. Spit into a cup, not have
to deal with those obnoxious swabs going halfway down your
throat. I suspect those cups are probably in greater supply and
more readily available.
And then, Dr. Bright, you will remember I had an
interaction with you in March. I have had people pounding on
the door with all kinds of ideas. I had people that wanted to
make personal protective equipment. They turned their furniture
shop into a PPE manufacturing shop. They had difficulty getting
through the bureaucratic cul-de-sacs of the various Federal
agencies. I have got a man that has got a breathalyzer test for
COVID-19. I don't know whether it works. If it does, it is
pretty intriguing. A mobile unit, about the size of a bread box
that you can take from place to place. You simply blow into a
tube and--we would have to have more straws. We have outlawed
them recently, but that could be dealt with. There are some
innovative things out on the horizon.
The vaccine worries me, too, because I recognize there are
some illnesses for which we have never found a vaccine--H1N1.
And I realize it is different because that was a flu vaccine,
but that did happen in about eight months if I recall
correctly. The outbreak happened at spring break. We didn't
know if we were going to be able to open the schools in
September, but the vaccine was generally available mid-
September to early October, depending on what part of the
country you were in.
So that success story gives me some hope that perhaps there
is going to be life at the end of this tunnel in the form of a
vaccine, but I do welcome that we had the hearing today. I look
forward to a number of additional hearings.
The ranking member of the full committee was quite correct
to invoke rule 11. We will keep that as an option going
forward. And I thank our witnesses for being here today, and I
will yield back.
Ms. Eshoo. The gentleman yields back. Thank you, again, Dr.
Bright. And the first panel has completed testimony, and I
would just ask the staff to prepare the table for our next
witness, and then we will begin in just a few minutes.
[recess.]
Ms. Eshoo. Mr. Bowen, you can be seated at the witness
table. Good afternoon and welcome to you. I know Members have
really missed being together, but we are going to begin our
second panel. I want to introduce Mr. Mike Bowen. Mr. Bowen is
the executive vice president of Prestige Ameritech, which is
America's largest domestic surgical mask maker.
I want to thank you, Mr. Bowen, for flying from Texas to be
with us today. Your story is a very powerful one. And to my
colleagues, Mr. Bowen has been, I think, really, he wins an
award for tenacity, because over three presidential
administrations, he has been banging on the door, warning,
asking for, pointing out, that America has a dangerous
dependence on foreign countries for products that we need here
at home. So this is a very important testimony, and we welcome
you; we thank you for traveling to be with us today, with all
of the extenuating circumstances to travel, and we are very
grateful to you. So you are now recognized for your statement,
and then we will--and then you will hear from the Members, and
I am sure both your statements will provoke questions and that
you will get good ones from both sides of the aisle.
I should add something here, and that is this issue of our
terrible dependence on foreign countries for not only our
drugs, our Nation's critical drug supply, but also all of the
materials that we have been talking about, is an issue that has
been--is shared, the concern is shared on both sides of the
aisle. As I said previously today--I think it was this morning
and not this afternoon--that we have had bipartisan legislation
on it.
But we want to hear from you. We want to hear your story. I
think it is a very important one and I know the members will as
well. I want to invite at this point the ranking member to
welcome our guest because he is his constituent. So to Dr.
Burgess.
Mr. Burgess. Always good to welcome a Texan to our
committee. It is always a good day when we have a Texan at the
witness stand. We know we are going to hear the truth. I will
say, I have been on this committee since 2005. In my second
term on the committee, in the year it started, 2007, then-
Chairman Dingell had a hearing on the amount of active
pharmaceutical ingredients that we imported from other places,
in particular, China. Shortly after that, we had a problem with
heparin contamination. We have had a number of hearings on this
with lead-based toys, melamine in our pet food, and there has
been a number of concerns about why we continue to use a supply
chain when, from time to time, it is detrimental to us.
So if there is any bright spot in this current crisis that
we are in, it may be that finally, after 13 or 14 years, we
seriously move to make stuff here, be our providers for
ourselves, and quite frankly, you know, America first really
should mean something. But I welcome you here today, Mr. Bowen.
We are anxious to hear what you have to say.
Ms. Eshoo. I think made-in-America. Anyway, welcome, Mr.
Bowen, and it is your--you have the floor now. You have 5
minutes for your testimony. If you want to place your statement
in the record and just speak or readit , it is up to you, but
welcome and thank you for joining us today.
STATEMENT OF MIKE L. BOWEN
Mr. Bowen. Good morning.
Ms. Eshoo. It is already afternoon. You need to turn your
microphone on.
Mr. Bowen. Good morning, Chairwoman Eshoo, and Ranking
Member Burgess. Thank you for your invitation. It is my
pleasure to testify.
My name is Michael Bowen and I am the executive vice
president of Prestige Ameritech of North Richland Hills, Texas.
And I have been in the medical industry since 1986 and with
Prestige Ameritech since 2006.
Prestige Ameritech was founded by President and CEO, Dan
Reese in 2005. I am going to give a brief overview of my
interactions with BARDA and its directors, but first, I will
give you some pertinent mask industry history.
Until 2004, 90 percent of all surgical masks worn, and I am
including surgical respirators, were domestically made. That
year or around that year, all of the major domestic mask
sellers switched from selling domestically made masks to
selling imported masks.
Prestige Ameritech was founded in 2005, recognized this as
a security issue in 2006. We thought that once America's
hospitals learned that their mask supplies were subject to
diversion by foreign governments during pandemics, they would
switch back to U.S. made masks. We were wrong.
In November of 2007, we received a phone call from BARDA,
asking for a tour of our mask factory. BARDA was acting on
George W. Bush's Presidential Directive 21, the purpose of
which was to review America's disaster plans. Brenda Hayden
with BARDA gave a presentation which showed that BARDA was
concerned about the foreign controlled mask supply. We were
thrilled that BARDA had discovered the issue until Brenda said
that BARDA was only charged with studying the problem.
We were disappointed but we took consolation in the fact
that we finally a Federal agency knew that the mask supply was
in danger. We were very happy to have an ally. Two years later,
I received a call from Brenda Hayden, she started the
conversation by saying, we have a situation. Her serious tone
caused me to ask her if she was talking about a pandemic. And
she said yes. She asked if we could ramp up production and I
said, yes. We built more machines, bought an abandoned Kimberly
Clark mask factory and tripled our workforce. America's
hospitals needed us and we rose to the occasion. We told them
about the high cost of ramping up. And they said they would
stay with us. Unfortunately, most returned to buying cheaper,
foreign made masks when they became available. The company
survived by laying off the 150 people who helped save the U.S.
mask supply by taking pay cuts and by taking on more investors.
The H1N1 pandemic, this is 2009, 2010 wasn't severe enough
to cause the foreign health officials to cut off mask shipments
to America so our predictions didn't come true yet. In a
weakened state but undaunted, Prestige Ameritech continued
saying that the U.S. mask supply was headed for failure; we
just didn't know when.
In 2004, to give my security story more issue, I formed the
Secure Mask Supply Association. You can find it at
securemasksupply.org. Paraphrasing Ben Franklin, I told three
competing domestic mask makers that if we didn't hang together,
we would hang separately, as China was poised to put all of us
of business and put the country at even greater risk. Crosstex,
Gerson, and Medicom, all with domestic mask-making factories,
agreed and joined the SMSA. Unfortunately, the Secure Mask
Supply Associations's warnings were also unheeded.
During my quest to secure the U.S. mask supply, I had the
privilege of working with three BARDA directors, Dr. Robin
Robinson, Dr. Richard Hatchett, and Dr. Rick Bright. They were
helpful and they encouraged me to continue warning people about
the mask supplier. I will say a little bit more about that.
After years of doing this, I quit many times and the only
reason I kept doing it is because of the directors at BARDA,
they would encourage me and ask me not to quit. They said that
they would express their concerns about the mask supply to
anyone that I could get to call them, anyone except reporters.
They weren't allowed to talk to reporters, which was very
frustrating to me.
They also weren't allowed to endorse the Secure Mask Supply
Association. Dr. Robinson was going to do so until HHS
attorneys told him that it could cost him his job. He called me
personally on vacation to tell me that.
I can confirm that the emails in Dr. Bright's complaint are
mine. They are merely the latest of 13 years of emails I sent
to BARDA in an effort to get HHS to understand that the U.S.
mask supply was destined for failure. Robinson, Hatchett, and
Bright all wanted to remedy the problem. In my opinion, they
didn't have enough authority. Their hearts were in the right
places.
America was told after 9/11 that governmental silos had
been torn down so that different Federal agencies could work
together for national securities. But I didn't see any of that.
The DOD, the VA, the CDC, and HHS could have worked together to
secure America's mask supply. I had suggested this to BARDA and
to the CDC on several occasions.
I will be happy to answer any questions that you have about
Prestige Ameritech, the U.S. mask supply or my interactions
with BARDA, the CDC or Rick Bright. And again it is my pleasure
to be here. Thank you.
[The prepared statement of Mr. Bowen follows:]
[GRAPHIC] [TIFF OMITTED] T3689.187
[GRAPHIC] [TIFF OMITTED] T3689.188
[GRAPHIC] [TIFF OMITTED] T3689.189
Ms. Eshoo. Thank you very much Mr. Bowen, again for
traveling across the country to be with us and for your
testimony. We will now move to Member questions, an I will
recognize myself for 5 minutes.
You already touched on your acknowledgment of your emails
or description about your actions that were in Dr. Bright's
complaint so I will move past that. To the best of your
knowledge, is the section of Dr. Bright's complaint about the
mask supply accurate?
Mr. Bowen. Yes.
Ms. Eshoo. Should HHS and the administration have been able
to foresee, in your view, the mask shortages caused by the
pandemic?
Mr. Bowen. Yes.
Ms. Eshoo. How many of your mask lines are not activated
right now?
Mr. Bowen. Four.
Ms. Eshoo. Four. My goodness. And as we have a run, a run
on supplies, you have four lines that could be working and
manufacturing high-grade masks for those that need them in our
country?
Mr. Bowen. Yes. But not like turning on a light switch. It
is a very large process.
Ms. Eshoo. And just spend a moment to tell us what it takes
to bring those up.
Mr. Bowen. Well the machines were built----
Ms. Eshoo. If you were to receive orders now to activate
those lines, explain that to us. And how many more masks could
you be manufacturing right now?
Mr. Bowen. We could be making about seven million N95
respirators a month. However, again----
Ms. Eshoo. Did you say a month?
Mr. Bowen. Yes, a month.
Ms. Eshoo. Say that again the number of masks.
Mr. Bowen. Seven million N95 respirators per month. But
again its not like turning on a switch. We didn't build these
particular machines; they were from China and we got them in an
acquisition several years ago. So my email to Rick Bright, in
that email I said, I think we are in trouble. We have these
machines, it would be expensive and hard to get them going, but
if we are--if this is going to be bad, that could happen, so
that was my offer.
Ms. Eshoo. Very often, especially for lawyers in courtrooms
and elsewhere, when you are going to ask a question, they say
you should know the answer. I think I know the answer to this
question, but I want to hear your view on it. We have lost--we
have allowed, we have allowed this supply, this very important
supply of protective articles to other countries. Do you
believe it is because of saving nickels, dimes, and quarters?
Mr. Bowen. I call it chasing pennies to China. It is that
insistence----
Ms. Eshoo. And look what it has cost us.
Mr. Bowen. It has cost us lives.
Ms. Eshoo. It has cost us lives. It has cost us lives.
If there is someone that would like me to yield the rest of
my time, I would be glad to. If not, we can go to the ranking
member of the full committee, Mr. Walden.
Thank you, Mr. Bowen.
Mr. Bowen. Thank you.
Mr. Walden. Thank you, Madam Chair. And I will let you
reset the clock too, so I don't go over my allotted time. There
we go.
And Mr. Bowen, thank you. Thank you for being here. And I
appreciate your testimony, which I read last night. Toward the
end of the last panel, I received a copy of an email that you
sent to Dr. Bright on January 31 of this year. This email
appears to be the one included in Dr. Bright's complaint.
Though it is one of the exhibits that was not publicly posted
by the Washington Post, interestingly enough. Here is what the
complaint says, two days later Mr. Bowen of Prestige Ameritech
sent yet another email to Dr. Bright and Dr. Wolf once again
issuing a dire warning about the imminent mask shortage. Among
other things he advised, and I quote, ``This week we sent 1,000
masks to China and Hong Kong. Now I believe your email actually
says a million masks to China and Hong Kong. He continued,
quote In all my years of predicting the U.S. mask supply would
one day collapse, I never pictured myself selling masks to
China. I have it from two reliable sources China's he begun
telling Chinese mask makers not to let masks leave China.''
close quote. He concluded, I think China will cut off masks to
the USA. If so, U.S. hospitals are going to have a very rough
time as up to up to half the supply is made in China, a
horrible situation will become unbearable.
Mr. Bowen. That is my email. Yes, sir.
Mr. Walden. That is your email, OK. In the complaint this
is cited an email from L. Wolf to R. Bright on January 29, 2020
I think that citation is obviously wrong since even the
complaint acknowledges that it is an email from you, Mr. Bowen,
to Dr. Bright, right? That is your email.
Mr. Bowen. That was my email. I don't know how it got to
him. I mean, I don't know what email chain you are looking at,
but yes, sir, that was my email.
Mr. Walden. I was reading from Mr. Bright's complaint and I
just received I think what appears to be a copy of this email.
But I think it is cited wrong in the complaint.
The email I received is dated January 31, 2020. It includes
all the language that I read to you from the complaint. And
this is exactly why the committee--and I know it needs all the
exhibits cited by Dr. Bright, not just the ones selectively
obtained by the Washington Post. And needs the full email
chains, not the selective excerpts from Dr. Bright.
Because this document also says and I will quote, this is
your email to Dr. Bright and to Laura Wolf, it says, and I
quote, ``My government strategy is to help the U.S. Government
if and only if the VA and DOD become my customers after this
thing is over.''
Mr. Bowen. Yes, sir.
Mr. Walden. So Madam Chair, I would like to submit the
email for the record. We will send you an electronic copy as
per our agreements here.
Ms. Eshoo. So ordered.
[The information follows:]
Mr. Walden. Mr. Bowen, you said you want to help U.S.
Government, you want to help Americans get the masks.
Mr. Bowen. Yes.
Mr. Walden. Yet it appears that there seems to be a
condition here--I assume that is because in the past, you
ramped up, things went away, and people bought from other
manufacturers. And so here you are saying, and I have it here
in the email, my strategy is to help my existing customers and
only bring on new customers who are willing to sign a long-term
contract. My government strategy is to help the U.S.
Government, if and only if the VA and DOD become my customers
after this thing is over. And here we were in a crisis as masks
were going overseas.
Now, the U.S. Government is not your only purchaser, right?
Mr. Bowen. The U.S. Government has never bought from me
except during a pandemic, sir. And that email, and that
statement was basically saying that I don't want the government
to only call me in a pandemic.
Mr. Walden. OK.
Mr. Bowen. Give me business during peace time so that I can
survive to help you during a pandemic.
Mr. Walden. Did you ever ask for a sole-source contract?
Mr. Bowen. I have bid on the DOD and the VA business and I
continually lose to masks that are made in Mexico, because the
DOD does not obey the Berry Amendment. They buy foreign masks
made in Mexico because Mexico is a friend of ours and it is
called a TAA-compliant country----
Mr. Walden. Were your masks NIOSH-n95 approved----
Mr. Bowen [continue]. Make the decision based on price,
national security----
Mr. Walden. Sir, if I could reclaim my time.
You said you couldn't turn on these lines of manufacturing
very quickly. How long, if you got a big order from the
government today, would it take you to produce masks?
Mr. Bowen. Three or four months. And the government wants
to do that right now. HHS is asking me to do that. I told
them----
Mr. Walden. Three or four months?
Mr. Bowen. Yes. I told them it is going to take 3 or 4
months. They only want masks to the end of year. So I would
have to hire 100 people, train 100 people and then fire them at
the end of the program. I am not going to do that. Again, I
don't want the government to only deal with me when----
Mr. Walden. My time has expired, Madam Chair. I yield back.
Ms. Eshoo. The gentleman yields back.
It is a pleasure to recognize the gentleman from New York,
Mr. Engel, for his 5 minutes of questions.
Mr. Engel. Well, thank you. Let me get this down. Voila.
Thank you, Mr. Bowen. And thank you, Madam Chair, this is an
excellent hearing and it is an issue that we need to focus on
because it has repercussions that just continue and continue.
Every day I hear from my constituents, including doctors
and nurses serving on the frontlines of this pandemic about the
dire shortages of personnel, protective equipment and
therapeutics, PPEs as they call them. Recently, I helped to
author the Preventing Drug Shortages Act with several of my
colleagues on this subcommittee, provisions which were included
in the recently enacted CARES Act. This all ties together. I
have used my role as chairman of the Foreign Affairs Committee
to cut through red tape and bring much needed supplies, like
100,000 antibody tests to New York City from China.
All these actions as you point out, Mr. Bowen, are symptoms
of a larger problem most U.S. medical products are manufactured
abroad. And as this pandemic has highlighted, this leaves the
United States vulnerable in public health crises and obviously
poses a national security threat the way I look at it.
So Mr. Bowen, as we can tell this afternoon in reading all
about you, the things you have said, the things you have
written, you have certainly being a leading advocate for this
issue, specifically as it pertains to face masks, which have
never been more in demand it than now.
In your written testimony, you note that in 2004, major
domestic surgical mask sellers switched from making surgical
masks domestically to importing them. I know you spoke a little
bit about it, but can you go into more detail and explain what
prompted this change?
Mr. Bowen. Mask companies wanting to make more profit. So
they go to countries--well, it is not just mask companies, it
is people who are in the hospital industry, who are competing
for contracts for supplies and it is a bid-type situation most
of the time. And the way you make products cheaply is to make
them in China and Mexico and other places.
So that is why the U.S. mask supply left. It wasn't a
coordinated effort, it was a bunch of companies coincidentally
deciding to save money at the same time and destroying maybe
4,000 jobs in America and putting the U.S. mask supply under
foreign control and that has been my message since 2006
actually.
Mr. Engel. Well it is really unbelievable because it isn't
just foreign control; it is, to a very large degree China
control. I am chairman the Foreign Affairs Committee, when we
look at the geopolitical parts of the world, China is probably
the biggest adversary to the United States. And not only are we
leaving it in their hands, we are leaving it in the hands of an
adversary. We are sort of beholden to that country. And I
cannot think of much that is more dangerous than that. I am
sure you agree.
Mr. Bowen. China controls most of the world's mask supply.
China can sell a box of max for $1 a box--no, let me say thins,
China sells a box of masks for $1. I don't think anybody is
making any profit doing that, because I sell them for about $5.
So their prices are so cheap that they have captured most of
the world's mask market.
Mr. Engel. Does the government subsidize, the Chinese
Government, the Beijing Government?
Mr. Bowen. I don't know that. All I know is their masks
cost less than the materials. If I take my labor costs totally
out, I am still nowhere near the cost of their products.
Mr. Engel. Do the Chinese masks meet our standards?
Mr. Bowen. Some do, some don't.
Mr. Engel. What steps can the Federal Government take to
incentivize more medical manufacturing of critical equipment
like surgical face masks in the United States?
Mr. Bowen. Well, as in a letter that I sent to President
Obama, I don't think it requires money. I think it requires the
government saying it is a national security problem. It
requires the CDC telling America's hospitals they are too
dependent on foreign made masks and put them in legal
liability. They have to protect their patients and staff. If in
a public forum like this you say, this, is a national security
issue, then those hospitals' attorneys are probably going to
get on the ball and tell their hospitals to buy American made
products. And they don't cost that much.
The whole market is only a couple of hundred million
dollars. This is a $30 million problem, folks, just for people
trying to save pennies across the whole United States. It is
not some multi-billion dollar problem.
Ms. Eshoo. Would you repeat that again? And lean forward
into that microphone so that everybody hears it again.
Mr. Bowen. I said this is a $30 million problem. It is not
billions and billions of dollars. I have never asked for money.
In a letter to President Obama, and I wrote President Trump as
well, but in a letter to President Obama I said, this isn't
about money, this is about information. Tell America's
hospitals that they are going to be in a position to not be
able to protect their staff and their patients. And their
attorneys, those hospital attorneys, will tell their hospital
to buy American made masks. I don't need your money. I don't
need subsidies. Just tell people about the problem.
And that was my problem with BARDA. Not my problem, BARDA
wanted to do it, but they weren't allowed it. This issue needed
publicity and try to get them to talk to the infection control
prevention magazine--Infection Control Today. Sorry. I wanted
them to talk to the New York Times. Every time we had some kind
of a flu bump I wanted them to be able to talk and they
couldn't do it.
Mr. Engel. Well, thank you very much; your testimony has
certainly been very enlightening. I know the chairwoman and I
are kind of looking at each other, almost in disbelief. I
certainly think that this is something that the Congress has to
get involved with and the sooner the better.
Thank you very much for your testimony.
Mr. Bowen. Can I point out something?
Mr. Engel. Sure.
Mr. Bowen. I have watched all of this in a room a little
while ago. It seemed like everybody who was beating up on Mr.
Bright, Dr. Bright was a Republican and everybody who was
defending him was a Democrat. I am a Republican, I voted for
President Trump. And I admire Dr. Bright. I don't know what he
did in all of his other activities, but I think everything I
have heard, and every time I have talked to him, and everything
he said here made a lot of sense, and I believe him.
Ms. Eshoo. Thank you, Mr. Bowen.
I now have the pleasure of recognizing the gentleman from
Kentucky, Mr. Guthrie for his 5 minutes of questions.
Mr. Guthrie. Thank you very much. I appreciate that. I
appreciate you coming today. I have a manufacturing background
myself. And I know that the President has asked General Motors
and Ford to make ventilators and everybody's business is their
business. They make decisions based on what is right for their
business.
But during a pandemic, there is an upload and if every
business person says, we are not going to adjust our lines for
a pandemic--and understand Ford and GM have different access to
capital than some others. It is just something that everybody
needs to be concerned about, because in a pandemic, you do have
increased orders, but I understand you want some long-term
guarantees as well, but there are a lot of people making
decisions. There are people now with their businesses shutdown
because of what is going on with the pandemic.
I am just trying to understand the mask manufacturer
process. And so my questions are what masks, what type of masks
do you manufacture? And do they represent the totality of mask
variations solved by the Strategic National Stockpile? And--if
we can get all these questions in--do you make all masks that
are in demand that other domestic product producers make?
Mr. Bowen. The only mask that I don't make is a cone style
mask, the hard cone style. All the masks like you all are
wearing, we make all of those, and we make N95 respirators,
yes----
Mr. Guthrie. So you make the N95----
Mr. Bowen. And our factory used to make 87 percent of the
U.S. masks supply.
Mr. Guthrie. So as you know, the Strategic National
Stockpile procedure procures medical countermeasures and other
supplies to be deployed in a public health agency.
Mr. Bowen. Yes, sir.
Mr. Guthrie. I understand you worked with Dr. Bright at
BARDA to get Federal funding to produce masks. Did you have any
conversations with Steven Adams, the acting director of the
Strategic National Stockpile?
Mr. Bowen. Let me go back before that. The Strategic
National Stockpile I met with Greg Burel face to face 5 or 6
years ago. And Greg Burel had no problem whatsoever buying
Chinese masks. And I had a conversation with him in the hallway
after a meeting when I said, don't you find this a problem that
America is dependent on Chinese masks? And he said, no, I
don't. And I--as far as Mr. Adams, I believe I may have emailed
him. I don't know, sir. The last 100 days, I have talked to so
many people. I don't know what day it is most of the time.
Mr. Guthrie. So you thought it was necessary to through Dr.
Bright. You couldn't get anybody else to listen to--Dr.
Bright----
Mr. Bowen. No, no, no. You have go it all wrong.
Mr. Guthrie. I am just trying to find the information so
yes.
Mr. Bowen. First of all, I wasn't looking for business. I
opened my email, I don't need your business. My phones are
ringing off the wall. I thought of BARDA, Dr. Robinson, Dr.
Hatchett, and Dr. Bright. I thought of them as brothers at
arms. They knew they couldn't buy my products. I knew that. But
they were the only people who believed it.
I would like everybody to go to YouTube put in Michael
Burgess and Prestige Ameritech, you will see Mr. Burgess
talking at our factory ten years ago. You see him say that only
ten percent of the mask supply is made in the United States. I
talked to Michael Burgess, Ron Wright, Joe Barton, Patrick
Leahy. My associate Matt Conlon talked to Chuck Schumer.
I wrote Barack Obama sub 20 letters, wrote President Trump
and everybody in his early administration. Defense Secretary
Mattis, General Jeffrey Clark, Nicole Lurie, Anita Patel with
CDC, National Academies of Sciences, Greg Burel, hundreds of
hospitals, hospital purchasing groups, the hospital risk
managers association. Hospital Risk Managers Association, told
them the mask supply was going to collapse, this is a risk.
Nobody listened. Association of Operating Room Nurses, the
Defense Department, the Veterans Department, Texas governor
Rick Perry, State Texas rep Bill Zedler. By the way, Bill
Zedler, Bill Zedler got it. Dozens of reporters, I have been on
every news show. I have done this for 13 years. Nobody
listened.
And my conscience is clean, Mr. Guthrie. I have been
working on this damn issue for 13 years, trying to save lives.
Nobody listened and now I am not going to take any of this,
what you are trying to do.
Mr. Guthrie. I am not sure what I am trying to do. I am
just trying to find out about who you talked with before.
Well, the issue is is that we do have to figure out what is
strategic and move forward and there is a lot of stuff, not
just masks, a lot of stuff comes from China. A lot of our
pharmaceuticals and so moving forward, and that is something
this committee needs to dig in and move forward and figure out
what is moving forward. But I am not sure why you are accusing
me of trying to do, but I will yield back.
I apologize if I offended you. I didn't intend to.
Ms. Eshoo. The gentleman yields back.
I think my colleagues will agree that my description of Mr.
Bowen is that he is a force of nature. I mean, he has refused
to give up since what year 2006 you began your crusade?
Mr. Bowen. 2006.
Ms. Eshoo. 2006.
It is a pleasure to recognize the gentlewoman from
California, Ms. Matsui, for her 5 minutes of questions.
Ms. Matsui. Thank you very much, Madam Chair, for convening
this hearing. And, Mr. Bowen, thank you very much for being
here today.
Mr. Bowen. My pleasure.
Ms. Matsui. Mr. Bowen, having been in the PPE business for
over a decade, I understand you have worked with several
administrations and BARDA directors in your efforts to secure
the Federal Government's mask supply. Were you utilizing formal
channels with BARDA, including Dr. Bright?
Mr. Bowen. I am not sure what your question is.
Ms. Matsui. Well, were you going towards not only Dr.
Bright, but other people above him also at the same time?
Mr. Bowen. No. I never spoke with anyone above the
director.
Ms. Matsui. OK.
Mr. Bowen. Well, actually that is not true. I did
correspond with Nicole Lurie one time.
Ms. Matsui. OK. All right. While facts are not completely
known, this reporting indicates there might have been
favoritism among administration officials regarding companies
awarded supply production contracts.
Mr. Bowen, I understand your company was eventually awarded
a $9.5 million FEMA contract for the production of masks on
April 7th.
Mr. Bowen. Yes.
Ms. Matsui. OK. It was reported in the Washington Post that
senior U.S. official said that the government did not have the
money to take you up on your offer to help procure masks when
you initially reached out in January, but the government
alternately awarded contracts to inexperienced manufacturers
that charged as much as $5.55 a piece for masks, nearly seven
times the 79 cents per mask you offered. Given this, do you
think it is fair to say that the government ultimately lost
money by not partnering with Prestige to procure masks earlier?
I think it is an easy question.
Mr. Bowen. Well, yes. My masks would have cost 79 cents,
yes.
Ms. Matsui. Right, exactly. I think even more important is
is that we would have had more masks earlier.
Mr. Bowen. Yes, but in their defense again, it wasn't just
like turning on a switch. This was a difficult process and I
think they had to look at it like, OK, it is going to take
these guys four months to ramp up. Is it worth it? And it is an
evolving situation. I don't want to hammer on--you know, when I
was talking to Mr. Navarro, he was acting in good faith, I was
acting in good faith and I wouldn't beat anybody up about that.
Ms. Matsui. OK. Well, thank you, Mr. Bowen. I do still have
serious concerns with the way this administration has assessed
the risk and need for supplies.
And I believe, Madam Chairwoman, that the committee should
continue to investigate the administration's emergency
purchasing processes so we are procuring medical equipment and
protective gear in the most efficient and transparent way
possible.
Now, we are preparing for a second wave of COVID-19
outbreaks that could coincide with the fall flu season. Mr.
Bowen, from your perspective you have had experience in this,
what gaps remain in the mask supply chain? And where should we
be focusing our efforts now to ensure we are prepared to
protect public health for the remainder of 2020?
Mr. Bowen. Well, this is an unprecedented situation. There
is no way anybody could have made enough masks to protect all
of American citizens. But we could have done a lot better to--
we could have protected America's healthcare workers and
patients. And that is more where my world is. That is the
products that we make and that is what we have tried to do.
And in this pandemic, for instance, we were making 75,000
respirators a month. That is not a lot. And we have been making
them ten years, we just couldn't get business because our
products are made-in-America and they are more expensive.
Now we are making 2 million, from 75,000 to 2 million, we
are bringing on another 2 million. And these are machines that
we have built. So you know--I have seen a lot of people kind of
like what he was saying, you got four machines, what is up? Why
are you not running those machines? We are not sitting on our
hands, folks. We have gone from one shift to three, we have
gone from 80 people to 200. We are working our tail off and
producing millions and millions of products.
Setting those machines up is going to be difficult, and
expensive, and it requires a long-term commitment from a
partner, not somebody who can just say, hey, do this. Because
we are a small business. Again, I am not 3M. And if we do
this--my partner and I euphemistically called it a suicide
mission. Yes, OK, let's go. Let's hire 100 people and order
truck loads of material and then somebody says the pandemic is
over and we are stuck with it again. We don't want to do that.
So we are not mercenary. Like I say, my conscience couldn't
be any cleaner. You know, I have been telling this message
forever. For somebody to say you could have done better, I am
offended by that.
Ms. Matsui. No, I am not saying that at all.
So thank you very much, Mr. Bowen, for coming before us.
You have brought a lot of things to our attention that I think
are necessary so thank you so much.
Mr. Bowen. It was my pleasure, my pleasure to be here.
Ms. Eshoo. The gentlewoman yields back.
It is my pleasure to recognize the gentleman from Virginia,
Mr. Griffith, for his 5 minutes of questions.
Mr. Griffith. Thank you very much, Madam Chair.
I represent that line of Virginia down there on the south
side right next to North Carolina and a lot of our folks had
experience in the industry, in the textile industry, before
both Mexico and China did the same thing that they have done to
you. And they have ramped up and they are making all kinds of
masks and so forth. And their concern is is if we ramp up, will
there be something down the road where buy made-in-America. And
I agree with you on that. We need to figure out a way to do
that, not only on masks and PPE but on drug supply, et cetera.
We need to make sure a significant portion of that is made in
the United States so we don't find ourselves in this situation
again.
That being said, your phone is ringing off the hook. And I
think maybe you have already answered this, but if you could
just briefly just state why. If your phone is ringing off the
hook, why do you need to have a guarantee on the other end,
knowing that the policy is going to shift, but we may not be
able to give you a contract in advance.
Mr. Bowen. Well, for me to hire the people and build the
machines, I can't do that for a temporary need.
Mr. Griffith. So you don't have the machines built right
now?
Mr. Bowen. No. I am saying to go more than we have already
gone, which we have already built as much as we can risk.
Mr. Griffith. OK. But you said you had four lines sitting
empty so I thought the machines are already there. Is that not
accurate?
Mr. Bowen. Yes, yes. Please ask your question again, I am
confused.
Mr. Griffith. I am trying to figure out understanding that
how somehow the policy is going to change. We can't guarantee
you a contract, but I think everybody agrees we have go to have
more made-in-America.
Mr. Bowen. Right.
Mr. Griffith. Why not ramp up with the understanding that
the policy is likely to change and I think it will change,
because I think we don't--whether it be masks, or other PPE, or
drug supply, we are going to have to have a significant portion
of these items made in the United States going forward.
Mr. Bowen. Yes.
Mr. Griffith. Knowing that, and your phone is ringing off
the hook, why not ramp up those four lines?
Mr. Bowen. Because one day the pandemic is going to end and
the usage will go down to the basement again where it was.
There will be ten times less usage and I will have all these
machines, and people, and these materials that and have nothing
do with them. And that is what happened to us before. This is a
very difficult thing to ramp up.
Let me say this again: let me remind you that we have
ramped up. We have gone from making 75,000 respirators a month
to about--in 40 days, we will be ramped to making 4 million
respirators per month. So don't concentrate on these four
Chinese machines that we really don't know much about and would
be a total pain of going, on top of I am trying not to kill my
business partner who is in charge of getting all this stuff
done.
He is working 20 hours a day now with all the projects we
have already got, now to dump on this on top for some business
that may or may not come, absolutely not.
Mr. Griffith. Well, I would say to you that I believe I
think the folks in my district who are doing this, there are
four or five companies that have retooled and gone back up, not
to your size, but----
Mr. Bowen. They are making things that look like masks.
They are not making masks. They are making things that look
like masks.
Mr. Griffith. One of these companies used to make masks
before they got run out of the industry. With that being said,
I believe that Americans are going to be wearing masks a lot
more at various places, movie theaters and so forth. I don't
think the number is going back down.
All right. In your testimony you stated that in 2009 you
were instructed by then BARDA director Brenda Hayden to ramp up
mask production to respond to H1N1 pandemic. Did you have a
contract with the Department of HHS to produce masks at that
time? And if not, why not?
Mr. Bowen. No, we didn't and----
Mr. Griffith. OK. The after H1N1, did you continue to
produce masks for the purposes of restocking the Strategic
National Stockpile?
Mr. Bowen. I can't do that without the Strategic National
Stockpile wanting to buy them.
Mr. Griffith. Did you have conversation with BARDA, SNS,
and HHS at that time about supplying the masks for the national
stockpile?
Mr. Bowen. I have talked to Greg Burel on many occasions,
sir. And have I also offered those machines to him. And I have
offered those machines to the Department of Defense.
Mr. Griffith. You are just going to give them the machines
or you are going to give them production?
Mr. Bowen. No, no. Listen it on this, here is what I wanted
to do. I wanted CDC, and VA, and DOD to get together. I had
four machines. I had very little money and they could make a
whole bunch of masks and for years--I have 13 years worth of
emails, I can document all this stuff--I said to the CDC, hey,
we can fix--we can make sure that the Department of Defense and
the Veterans Administration always has masks. I have got these
four machines sitting here doing nothing.
Mr. Griffith. You were willing to give them production but
not the machines.
Mr. Bowen. No. Well, let me finish the----
Mr. Griffith. I am just trying to sort it out.
Mr. Bowen. Well, here is what I was going to say. Let's use
one machine, it will make your whole annual usage for one
machine and we will let three of them sit there in our factory
just ready to go. When you need them, we can turn those things
on. And I couldn't get anybody interested in them.
Mr. Griffith. Were you going to give them to them or lease
them?
Mr. Bowen. It didn't matter. I didn't have any money in
them. I said, give me your peace time military hospital
business and we will give you these machines, they will just
sit there. Now, we would have had to have had some kind of a
plan kind of a plan, you know, to get materials and thing like
that. But I was basically saying, we have got a warm base
operation and it is not going to cost you guys anything. I made
that offer to several agencies.
Mr. Griffith. I see my time is up. I yield back, Madam
Chair.
Mr. Bowen. And by the way, forgive me for being angry. I am
angry because I have done this for so, so long. And I have been
ignored for so long and I apologize.
Ms. Eshoo. Well, Mr. Bowen, I don't think you need to
apologize; at least that is my view. I think shame on us. I
think shame on all of us that we have allowed this to happen.
And this is powerful testimony. It underscores what we need to
do, the position that we are in, our crippling dependence on
foreign countries for what is--we all realize now with this
pandemic what has been laid bare.
Mr. Bowen. I totally agree.
Ms. Eshoo. So your testimony is I think, some of the most
important testimony that Congress could be hearing.
I now have the pleasure of recognizing the gentlewoman from
Florida, Ms. Castor, for her 5 minutes of questions.
Ms. Castor. Yes. Thank you, Mr. Bowen, I think you heard
Dr. Bright as well this morning say the inaction has cost us
lives. And I relayed some of the--what I understand is that you
were first contacted by the Department of Homeland Security in
January because they wanted masks for airport screeners. Is
that correct?
Mr. Bowen. Yes. And let me clarify. That was probably a
low-level purchasing person looking for products. And a lot was
going on. And I am trying to figure out if this is real. And so
they were asking for masks. And I said, I can't help you. But I
said tell me, just tell me as two Americans over the back
fence, are you worried about this? And he said, I am really
worried about it.
Ms. Castor. So that flipped a light switch for you in
January?
Mr. Bowen. That and a lot of other things. At the end of
January my phone started exploding. And it was really weird. It
was Chinese Americans calling to buy masks and they were
sending them home. So--by the way, the reports that I was
sending masks to China is inaccurate. I was sending masks to
Americans who were sending masks to China.
Ms. Castor. And then I understand that you began emailing
with Dr. Bright in--was it January 26 when you emailed Dr.
Bright and said that here in America, our mask supply is in
imminent risk.
Mr. Bowen. Yes. Again, as I said in my opening statement,
those emails were just the latest of 13 years of emails to the
directors of BARDA. I consider them my only allies. I couldn't
get anybody in else in the government to understand the issue,
they understood it. So any time something would happen, we get
a flu or the MERS comes out in the Middle East or whatever I
would send them an email, hey is this a big one? Should I ramp
up?
Ms. Castor. And then Dr. Bright, as he testified, he
elevated your concern and sent it to Dr. Robert Kadlec, the HHS
assistant secretary for preparedness and emergency response.
Did you hear at that point from Dr. Kadlec?
Mr. Bowen. No, I never met him--or never talked to him
before.
Ms. Castor. And do I understand from the accounts you have
previously provided, you did not hear back really until a month
later when you received a form letter from FDA?
Mr. Bowen. I don't relate to those two events. And the
timing I would have to go back and look at emails. But the form
letter from the FDA, I don't think had anything to do with
those other things. I think that was separate.
Ms. Castor. Well, here is the frustration that I have. This
continues to be a problem. After you sent that original notice
email and Dr. Bright elevated it to our assistant secretary for
preparedness and emergency response, at the end of January, it
is February, March, April, May. And what I heard from my
hospitals just today and yesterday N95s are still very
difficult to procure. They are in dire need for N95s. Another,
my community health center, we continue to struggle to get N95s
and there are so many folks trying to sell knockoffs.
And one of our largest health systems says the supply chain
remains inconsistent and irregular. They remained concerned as
they headed into the fall. They are going to be squeezed
because of flu season and the coronavirus. I mean, why haven't
we been able to get a handle on--I know that they have issued
contracts. And what do you have to say? There was a contract
apparently issued for $55 million to a company with no history
of procuring medical equipment for a cost of $5.50 apiece. What
do you know about that?
Mr. Bowen. Just what I read in the paper. Nothing more than
you do.
Ms. Castor. What do we say to my hospitals, my nurses, my
doctors, the EMTs on the frontline right now that it is months
later and they are still struggling with the supply chain and
they are worried.
And we have nurses dying who could in to save a COVID
patient who stopped breathing. In Detroit area, they have 700
staff members in one health system and dozens of doctors, what
do you----
Mr. Bowen. I say that we, as a country and as the people
who are supposed to be on top of this stuff, messed up. And it
is not what happened in January. It is what has happened since
2007, actually since 2004, you know. Presidential Directive 21
by George Bush identified this as a problem in 2007. I have
been on CNN, and Lou Dobbs and Neil Cavuto ad infinitum for all
this time. And----
Ms. Castor. Is there not something a little more insidious
here when you have an administration who downplayed it, and
said that it was going to disappear, and didn't follow the
scientists, and told Dr. Bright instead, of we respect you and
hear you, in fact, we are going to can you, and we are going to
reassign you, and we are going to bury you, because you are
speaking truth to power? Isn't that a little bit different
right now?
Mr. Bowen. Now that you ask, again, I am a Republican, I
have been a lifelong Republican. And I am embarrassed by how
that has been handled. Like Rick Bright said, it is the
scientists we need to be listening to and we are not. That has
got to change or more lives are going to be lost.
Ms. Castor. Thank you.
Ms. Eshoo. The gentlewoman's time has expired.
It is a pleasure to recognize the gentleman from Florida,
Mr. Bilirakis, for your 5 minutes of questions.
Mr. Bilirakis. Thank you. Thank you, Madam Chair, I
appreciate it. Thank you, Mr. Bowen for testifying or
presenting today.
Considering the made in China 2025 initiative, can you
describe how China is working to corner the Personal Protective
Equipment, the PPE market? If you can't, I understand, but if
you can, it would be very informative.
Mr. Bowen. Well It is--America has a weakness for low
prices. And the--I think Chinese prices are so low--you know, a
few years ago I decided to go buy 12 things from Lowe's, Lowe's
Home Improvement Center. And I decided I was going to pay
whatever it took to buy American. I couldn't make that
decision. That decision was taken away from. I bought one item,
it was a plunger, a toilet plunger was the only thing I could
find that was made-in-America. What it is is it is the people
like the Lowe's, and the Home Depot, and the Walmarts, and the
medical companies that the way they want to make money is to
lower their costs. The way they lower their costs is to go to
China. The line is long and wide for people going to China. And
that is why we are dependent on them for everything.
I mean, go look in your closet, look at your tools, look at
everything, it is all from China. And the stuff that is in from
Mexico, let me say this: half of the U.S. mask supply is in
Mexico it has got reservations to go to China. Mexico is not
cheap enough. And hospitals are cash strapped and they are
bidding out things.
If this hadn't have happened, Mexico would have lost the
business and in five years, China would have made all masks and
respirators, like they do the gowns.
Mr. Bilirakis. Thank you.
What safeguards does the U.S. have against substandard PPE
infiltrating critical industries like the medical industry,
which they have? What standards do we have? What safeguards do
we have in protecting our constituents?
Mr. Bowen. Well, that is not a question I can answer. That
is up to the FDA.
Mr. Bilirakis. OK.
Mr. Bowen. And NIOSH.
Mr. Bilirakis. I understand.
OK. In addition to reports of substandard Chinese masks
infiltrating markets like Canada and the price gouging that is
going on, even here in the United States, I have also seen the
discontinued masks for sale on e-commerce sites here in the
U.S. along with fake websites and email addresses utilizing
American brand names.
How is Prestige Ameritech working to crack down on
potential counterfeiting and price gouging of its products, of
your products in other words? How are you protecting yourself,
and your business.
Mr. Bowen. We are a small company. We are a family company.
We don't have people to do that. But we never had to do that
before, nobody cared about our products. My phone never rang.
And now I am working with the FBI on a daily basis because I am
getting myself and my business partner have been impersonated.
Mr. Bilirakis. That happens frequently, obviously,
impersonating.
Mr. Bowen. Yes our website has been copied, our images have
been copied.
Mr. Bilirakis. Continue to elaborate on that, please.
Mr. Bowen. Well, here is how it goes. I will get an email
from someone--I got an email from the CEO of a company in
Dallas last month that said I am about to wire you $1.6
million. I just got a feeling I want to make sure you are for
real. I said, that is not me. And someone in India copied our
entire website. And what they are trying to do is use our good
reputation and our worldwide press coverage now and they are
saying, hey, we are with Prestige Ameritech, we are offering
you hundreds of millions of masks and wire money to this
account. They even have Texas phone numbers. So anybody
watching this who is being offered a lot of Prestige Ameritech
masks, don't--don't do it.
Mr. Bilirakis. OK. Give us some advice, how might Congress
further support efforts to protect consumers from price gouging
and counterfeit goods? What would you recommend? Do you have
any advice for us with regard to legislation, or ideas, what do
you think?
Mr. Bowen. No, actually, that is something I haven't
thought about. If you gave me a couple of days, I could think
about it.
Mr. Bilirakis. OK. Well, yes, if you could get that
information to us we would appreciate it very much.
Mr. Bowen. I probably won't remember it after this. If
someone could send me a letter, that would be great.
Mr. Bilirakis. Well, Madam Chair, maybe we can communicate
with him. Thank you very much, sir.
Mr. Bowen. My pleasure, sir.
Ms. Eshoo. The gentleman yields back. Every member will
have the opportunity to submit questions to our witnesses. So
you will have those questions, Mr. Bowen. And as timely as
possible, then you can respond to the gentleman's question and
anyone else who submits one to you.
Mr. Bowen. I would be happy to.
Ms. Eshoo. OK? All right. Now I would like to recognize the
gentleman from Maryland, Mr. Sarbanes, for his 5 minutes of
questions.
Mr. Sarbanes. Thank you, Madam Chair. Thank you, Mr. Bowen.
You don't know me, but I feel like I know you because when
I listen you to you talk, I think about a lot of people in my
district, Republicans, Democrats, Independents who scratch
their head a lot of the time and wonder why we can't get these
things fixed, why we can't do simple stuff. Why we can't get
from point A to point B. And I would say to you that I think
your composure today has been remarkable, given the fight you
have been waging for 15 years.
In ancient mythology there is a character called Cassandra.
Cassandra had the ability to see into the future, but was
cursed by Apollo that no one would ever believe her prophesy.
And sitting here, listening to you today, that is immediately
what I thought of. And so thank you for maintaining composure
at a time when you could literally, without apology, stand on
that desk and just scream at the top of your lungs, I told you
so over, and over, and over, and over again.
This is a report from 2007, the U.S. Department of Health
and Human Services discussion with respirator protection device
manufacturers on preparedness and surge capacity.
The first page is the bottom line. I am just going to read
some of these things. 2007, there will be a significant
increase in the need for respiratory protection devices, RPD,
during an influenza pandemic. There will be significant needs
across all sectors: healthcare, public safety, business,
government, public. The industrial surge capacity of RPD will
not be able to meet needs and supplies will be short during a
pandemic.
There are several RPD options. I am sure you probably
described some of them. They can be employed to meet the
projected needs. All sectors must contribute to efforts to
prepare in order to meet the needs for RPD or find safe ways to
work around limited supplies during a pandemic.
So this is 2007. This is when you were starting on your
crusade, well-founded obviously, given what the Department was
identifying as needs at that time. And here we are 13 years
later, in the midst of a pandemic, that you and others
cautioned us about and we are not ready.
And I have to say that I am embarrassed on behalf of the
government's failure to respond to these warnings for so many
years. I actually was elected in 2006 and came here in 2007. So
my time here kind of tracks your journey to try to get us to
wake up to this pandemic, to get things to be made again here
in America.
And I have been an advocate for those things, but not
enough of an advocate, I confess, given what you are saying. So
I apologize on behalf of the U.S. Government that we have not
responded better to the warnings that you have given us for so
many years. And now we are paying for it and the cost is lives
unfortunately. So shame on us.
And, you know, ten years from now they will play back a
video of this hearing and will we mark that as the beginning of
getting with the program finally and actually changing our
policy, and beginning to make things here, protecting our
national security as you say. And that is absolutely the right
frame in this moment and in the midst of this crisis.
Shame on us if we don't learn from this. And I am sure
people said it before, policymakers behind microphones and here
we are.
So I hope the public measures our commitment to change on
this and to stand up what America needs to do to anticipate
these things in the future.
Mr. Sarbanes. I have almost run out of time, but let me ask
you a question. Do you think we can do it?
Dr. Bright. I think----
Mr. Sarbanes. Do you think--do you believe that if we put
our minds to it, that if we collaborate, the private sector and
government, to create these manufacturing supply chains, to
bring this back from offshore, that we can do what we need to
do to keep our people safe? Do you believe that?
Mr. Bowen. I can give you a confident yes.
Mr. Sarbanes. Thank you. Thank you.
Mr. Bowen. Because I am being contacted by a lot of the
healthcare organizations that didn't listen, and they are
coming to me and saying, you were right, let's fix this.
Mr. Sarbanes. Well, let's fix it. Thank you for being here
today.
I yield back.
Mr. Bowen. My pleasure.
Ms. Eshoo. The gentleman yields back. I want the gentleman
to know that I especially appreciate your Greek oratorical
skills.
Mr. Bowen. Oh, by the way, I would like to say that I
didn't know about Cassandra until just recently and was told
about that myth by Maryn McKenna. She is the author of
``SuperBug,'' and she has been one of my sisters in arms on
this, and she told me about Cassandra.
Mr. Sarbanes. OK.
Ms. Eshoo. All right. It is a pleasure to recognize the
gentleman from Missouri, Mr. Long, for his 5 minutes of
questions.
Mr. Long. Thank you, Madam Chairwoman.
And thank you, Mr. Bowen, for being here today.
Earlier I was a little confused, so I want to ask you about
what type of masks you make. And I thought you said you did not
make the hard masks, that you make more of the masks like we
are wearing today when we are not on a microphone. Your FEMA
contract for nine-point-whatever million dollars, was that not
an N95 mask contract?
Mr. Bowen. Yes. That is an N95, but it is a flat mask, not
a cone mask.
Mr. Long. OK.
Mr. Bowen. It is more of a pocket-style mask.
Mr. Long. OK. Well, that is fine. I just was wanting some
clarification there.
How are those packaged, roughly? I mean, how many are in a
box or whatever, when you ship them out to FEMA and they ship
them to our States?
Mr. Bowen. Ours are packaged 50 per box, and six boxes per
case.
Mr. Long. OK.
Mr. Bowen. Three hundred per case.
Mr. Long. We have been fighting this battle to get more N95
masks for our States and fighting back and forth between States
and getting them from FEMA. So if our State received N95s from
FEMA within the last 20 days, let's say, would those have been
your masks?
Mr. Bowen. Well, I think they have contracts with multiple
people, so they could have been my masks, but not necessarily.
Mr. Long. OK. Have you heard any complaints about the boxes
that FEMA is shipping arriving with missing masks? Sometimes
over half the box is filled with filler material. Have you been
approached about that?
Mr. Bowen. No. In fact, quite the opposite. We are having
hospitals--Baylor, for instance, in Dallas, got some masks from
FEMA, of ours, and they liked them so much they want to start
buying them. So we are actually hearing the opposite of that.
That is probably----
Mr. Long. Oh, no, no, no, I am not accusing you of shipping
out half-filled boxes.
Mr. Bowen. Yes.
Mr. Long. But the State of Missouri, that is what we are
receiving from FEMA.
Mr. Bowen. It probably----
Mr. Long. Boxes that have obviously been cracked open
somewhere else, masks removed----
Mr. Bowen. Are those Prestige Ameritech masks? Oh, you are
asking me, so you don't know, right?
Mr. Long. No. I have texted the governor here a minute ago,
but he didn't----
Mr. Bowen. Yes.
Mr. Long. It just came to me when you were talking about
what masks you make a while ago, so I am waiting for an answer
from the governor's chief of staff. If that is an ongoing
problem with other States, or if you have heard anything about
it, but we are just trying to get the bottom of these masks,
that FEMA ships out boxes and you open them up and there is a
bunch of filler material and half the masks or three-fourths
are gone.
Mr. Bowen. That doesn't make sense.
Mr. Long. No, it doesn't.
Mr. Bowen. Yes. We ship full cases to FEMA, and we are not
in the habit of putting fillers in our boxes.
Mr. Long. No, no, no, I am sure your company, don't get me
wrong.
Mr. Bowen. Oh, no, no, no, no, I understand that, but I am
just saying, if that is happening, it is probably from
somewhere else.
Mr. Long. Well, that is what we need to find out, where
that somewhere else is.
Mr. Bowen. Yes. Well, and remember I am only selling them a
million a month. They are getting lots, lots and lots and lots,
millions and millions from other people.
Mr. Long. We are thankful for anything we get in Missouri,
trust me, we tried for a long time to get a hold of them.
Mr. Bowen. I have a little bitty contract.
Mr. Long. One of the two largest hospitals in my district
ordered masks, and I am not even--I am sure they were N95s they
ordered. They paid eight times what was the going rate pre-
corona outbreak. They got their N95 masks in great shape;
everything was fine, the boxes were full, and they were
counterfeit.
So that is one of reasons for this hearing here today,
trying to sort out some of these things and figure out, like
you say, if people are stealing your website, it is obvious, I
guess, where some of the counterfeit masks at eight times the
going rate are coming from.
I got a little off-subject here. Let me ask my question
here before I get too far out there on a limb. But it is my
understanding that you were able to get connected with the
White House economic adviser, Peter Navarro, in March.
Mr. Bowen. I am not sure--yes, I guess it was March, yes.
Mr. Long. That is correct, OK.
Mr. Bowen. Yes.
Mr. Long. NBC News reported that after you connected with
Peter Navarro, that Dr. Bright wrote to his deputy asking him
to explore whether BARDA could divert money that was expressly
reserved for vaccines and other biodefense measures to buy
masks.
Mr. Bowen. OK.
Mr. Long. According to NBC News, this was an example of how
Trump and his top aides have played favorites in awarding
contracts and allocating scarce resources. Your company,
Prestige Ameritech's deal with FEMA is one of only two
identified in the history of the Federal contracting database
that explicitly says it was directed by the White House.
My question, what is your response to these allegations
from NBC? I am only asking since Dr. Bright's whistleblower
allegations accuse others at the Department of Health and Human
Services of cronyism.
Mr. Bowen. I am really glad you brought that up, because
NBC is--that article was only one article of two that were
critical about us, and both of those articles were written by
people who didn't talk to me and got the article wrong. If you
would like, I can tell you how that all came about.
Mr. Long. Certainly.
Mr. Bowen. OK. I was on either NPR or BBC, and one of Steve
Bannon's producers heard me on the show and asked me to be on
their show. And they called me, and I--one of their producer
guys named George called and said, hey, would you be on Steve
Bannon's show?
And I don't know a lot about Steve Bannon, but I know he is
a lot farther to the right than I am. And I said, well, in all
fairness, I need to tell you, I am not a Trump supporter. And
he said, I don't care.
So--but I just wanted to get that out of the--I said, I
don't want to be on this show if you think I am a Trump
supporter. And he said, no, I don't care.
So then the show went really well, and I was invited back.
And I enjoyed talking to Steve Bannon. It was fun. And Steve
got it, he got the cause, and he said, I am going to tell a
friend of mine, Dr. Hatfield and Dr. Navarro about you guys.
And I said, who is Dr. Navarro? And he told me, and I said
great, OK.
So then Doctor--somebody from Dr. Navarro's office called
me, and I went through the same spiel. I know you think I am a
nut, but that is just the way I am, I want to make sure
everybody knows everything. And so somebody from Dr. Navarro's
office called and asked me about my company and everything. I
said, yes, I make masks. I said, but, again, in all fairness, I
need to tell you, I am not a Trump supporter. In fact, I did an
article in the Dallas Morning News two years ago that was very
critical, and that is going to come out. And he said, I don't
care.
So--and then, to make matters--to beat a dead horse, when
Dr. Navarro called me, I did the same thing. I said, hey, just
FYI, this--you give me a contract, this article is going to
come out, and this might embarrass you, just to let you know.
And he laughed. Dr. Navarro laughed at me. And he said, send me
the article, and I did.
So I have told my friends recently, that article should
have been titled ``Trump administration gives mask contract to
Biden supporter.'' That is the real deal.
Mr. Long. OK.
Mr. Bowen. So it was not cronyism, sir.
Mr. Long. Do what?
Mr. Bowen. It was not cronyism at all. And let me tell you,
too, Peter Navarro was a gentleman, acted in good faith. He was
concerned about the mask supply, so was I, and that is what we
talked about.
Mr. Long. I think the team----
Mr. Bowen. No cronyism. And by the way, if you want to take
that FEMA contract away from me, please do. I can make a lot
more money selling those masks somewhere else. I got a pure
heart, sir. I really do.
Mr. Long. No, no, yes. But I think Trump's advisers and
close people, you see them at the press conference out there--
--
Mr. Bowen. Yes.
Mr. Long. Several of those people are not Trump supporters
either.
Mr. Bowen. Yes.
Mr. Long. But the President has picked them because they
are the best in the business, which I think that is good.
I yield back.
Mr. Bowen. Well, that was the farthest--farthest from
crony. I pretty much tried to talk myself out of that. That is
probably why Mr. Navarro said I was difficult to work with. I
don't know.
Ms. Eshoo. The gentleman's time has expired. A pleasure to
recognize the gentleman from New Mexico, Mr. Lujan, for his 5
minutes of questioning.
Mr. Lujan. Thank you, Madam Chair.
Mr. Bowen, thank you so much for being with us today, sir.
As you outlined in your testimony, you have been raising
the alarm about the national security risk from the loss of
domestic mask production for some time. Does the United States
need to change that and dramatically increase the manufacturing
of medical supplies?
Mr. Bowen. Well, there is a short-term issue and a long-
term issue. Right now, there is a lot of masks that are needed,
and there are a lot of people going into the business.
Unfortunately, a lot of them don't know what they are doing and
were making masks out of fabric and other things that don't
work.
What I call that is making a life jacket out of lead. You
know, I can make a life jacket out of lead and I can paint it
orange, but don't go in the pool. Some of these masks that are
being made are worthless. So--I am sorry. I got--I lost the
question.
Mr. Lujan. I think you answered the question, that, yes,
the United States needs to take this seriously, and to up
manufacturing, but we need to do it the right way.
Mr. Bowen. Yes. I don't think we need to up manufacturing
that much. I just think we need to have it be in the United
States so it can't get cut off, like a lot of the Chinese
supply was cut off.
Mr. Lujan. Appreciate that, sir.
On January 22nd, you emailed officials at HHS and offered
to reactivate four of your company's unused production lines
for N95 respirators, correct?
Mr. Bowen. Yes, sir.
Mr. Lujan. And what was the response to your offer?
Mr. Bowen. Well, Dr. Bright was kind of all over it. I
mean, he really thought this was an important thing. So he
said, I am going to forward you to Laura Wolf, she is in charge
of infrastructure. And my attitude was, it is a little bit
too--this is too little, too late, but we have got these four
machines, we could at least protect some people, maybe our
infrastructure.
So they asked me to get with her and tell her what we could
do. So I did, I sent a big long email that said, here is what
we can do. And then there wasn't a lot of response after that.
And again, I wasn't looking for a contract. I am just
trying to be helpful at this point. So--and again, I think that
the travesty here isn't what happened in January, in that time.
Laura Wolf is no more responsible than all these other
thousands of people that I told, hospitals and everybody I
told. So to look at her and go--or to look at them and go, hey,
they didn't listen, and you were right, well, I might not have
been right. They are all making decisions in a battlefield
situation. I am not going to be too hard on those folks.
I think that the real issue is that, I mean, look at the
HHS presentation from 13 years ago. They said, here it is, we
are going to have a problem.
And that day--that is why I say when Brenda Hayden came and
gave us that presentation, Brenda, you are preaching to the
choir, we can't believe this, this is so wonderful. And then
Brenda goes, but we are not allowed to fix it. I said, you have
got to be kidding.
So that is why I latched onto BARDA, because they were the
only people who believed it, and I kept thinking--and I will
tell you how bad it was and how the responsibility of this goes
far and wide, is all three of those directors believed it and
knew that it was going to happen, and they tried to work with
me.
Dr. Robinson got on a plane and went and talked to a
hospital group in Houston because I asked him to. And then
because of that, MD Anderson Cancer Center today has enough
masks, and they are the only hospital system in Texas--sorry--
in Houston who does because Dr. Robinson got on a plane.
Mr. Lujan. Mr. Bowen, just because my time is going to run
out here, sir. In that communication, it is my understanding
that you shared how many masks you could make. And what I was
led to believe was 1.7 million masks per week or 7 million per
month. Is that correct, sir?
Mr. Bowen. That is correct. If we ran 24/7, yes, sir.
Mr. Lujan. And the price you offered was 79 cents, I think
I heard you say earlier?
Mr. Bowen. Well, back then, there was no talk of price. I
just said these machines are available. And again, I wasn't
looking for a contract. I just said, this is here, remember
this, this is here, don't forget.
Mr. Lujan. Earlier in the testimony, though, I think you
had said the price was 79 cents for some other----
Mr. Bowen. Since then, we have priced them at 79 cents.
Mr. Lujan. I appreciate that, sir. And when the government
finally acted on the need for masks and entered into contracts
with less experienced manufacturers, they ended up paying as
much as $5.50 per mask. Is that correct?
Mr. Bowen. I just know what I read in the paper.
Mr. Lujan. I read that as well. It sounds like price-
gouging to me.
Look, Dr. Bright testified that there is still a shortage
of PPE. There should be no question to everyone in this hearing
that there is a shortage of PPE, including masks.
Now, instead of the Trump administration accepting
responsibility and ensuring critical PPE is manufactured at the
level needed and coordinating with States to distribute PPE
where it is needed, the administration left States bidding
against one another.
Jared Kushner, who was appointed by the President to be in
charge of medical supplies, said at a press conference, quote,
``The notion of the Federal stockpile is that it is supposed to
be our stockpile. It is not supposed to be States' stockpiles
that they then use.'' A day after Jared Kushner was on that
press conference, the website was changed to reflect his
remarks.
Madam Chair, I just want to submit into the record an
article from U.S. News & World Report, ``States Competing in
Global Jungle for PPE.''
Ms. Eshoo. So ordered.
[The information appears at the conclusion of the hearing.]
Mr. Lujan. Thank you, Madam Chair.
Ms. Eshoo. Does the gentleman yield back?
Mr. Lujan. I yield.
Ms. Eshoo. The gentleman yields back. A pleasure to
recognize the gentleman from Illinois, Dr. Bucshon, for his 5
minutes of questions.
Mr. Bucshon. Yes. Thank you, Madam Chairwoman.
Thank you for being here.
So it is just you and 3M that makes these types of masks in
the U.S. pretty much.
Mr. Bowen. No.
Mr. Bucshon. I mean prior--predating the pandemic.
Mr. Bowen. Predating the pandemic----
Mr. Bucshon. There is not much U.S. competition?
Mr. Bowen. Well----
Mr. Bucshon. Not much U.S.----
Mr. Bowen. Well, a formal----
Mr. Bucshon. On a large scale. That is what I am saying.
Mr. Bowen. Not on a large scale.
Mr. Bucshon. Yes, yes, yes.
Mr. Bowen. No, we are all small. The members of the Secure
Mask Supply Association that I started in 2014, there are four
of us and then a few others that are small, but we make
probably less than ten percent of the supply.
Mr. Bucshon. OK. I mean, this has been a longstanding
issue. I mean, your testimony has shown us that. Comments from
Members have shown us that. And honestly it is an issue that
should have been addressed probably in Congress. I mean, you
know, Congress can tell agencies what to do and how to act and,
you know, government contracting rules, agency rules and
regulations.
I mean, I have been at this, this is my tenth year in
Congress, and it has always amazed me about how not very
prescriptive we are in Congress. We give--it is more broad on
what we say. I mean, the recent stuff that we have done is an
example.
For the most part, it has turned out OK, but we do give
agencies a lot of leeway to set rules, regulations, and other
things. And it is clear you have interacted with these agencies
for years. And even though maybe we knew up here and talked
about it, that we had to fix this problem, it was really never
fixed. Unless Congress tells them to do it, they are probably
not going to.
You know, the other thing is the private sector
marketplace. I know you talked about that, how hospitals get
products from--you know, buy cheaper products that are not made
in the United States. For your products, say for an N95 mask,
the FDA has to approve those products to be used in the United
States?
Mr. Bowen. Yes, sir. Well, I think just now, I think that
has changed. I believe it is just NIOSH for N95s.
Mr. Bucshon. OK. But there is a Federal agency that has to
certify this is something we----
Mr. Bowen. Yes, sir.
Mr. Bucshon. Right. So, you know, we--so, I mean, we do
have some control over what, in certain respects, about the
quality of the masks that we import into the United States.
Clearly there has been, you know, some counterfeits, but
probably also some products brought from China and other places
that maybe don't go through. Do they go through the same
certification process that you do?
Mr. Bowen. Well, they are supposed to, but I know, for
instance, every once in a while a Chinese respirator--well, let
me say what NIOSH will do. They will take masks out of the
market.
Mr. Bucshon. Yes.
Mr. Bowen. They will go buy masks and test them.
Mr. Bucshon. Yes.
Mr. Bowen. And if they fail, you can lose your
registration.
Mr. Bucshon. Yes, OK. And they do that for the Chinese-made
masks, too, right?
Mr. Bowen. So the Chinese masks, a lot of those have
gotten--lost their registration.
Mr. Bucshon. OK. And for the Federal--for the national
stockpile, I mean, it seems to me that we are going to have to
really consider changing how we deal with that. I mean, you
know, you have a stockpile of something; you buy all of this
stuff, and then it updates, right? And then you buy it all
again.
Mr. Bowen. Right.
Mr. Bucshon. So what is the outdate on a--say just an N95
mask. How long are those certified to be used? It is sitting on
a shelf, you pull it off there.
Mr. Bowen. They are all different.
Mr. Bucshon. For how long?
Mr. Bowen. They are all different. Five, 10, 15 years. They
are all----
Mr. Bucshon. They are all different.
Mr. Bowen. They are all different. But I have never thought
that stockpiling was the way to go.
Mr. Bucshon. Right. So this mask here may be--might be--you
know, if it sat on a shelf in a closed box, it might say on
their ten years.
Mr. Bowen. It might be fine.
Mr. Bucshon. Or it might be fine, OK.
Mr. Bowen. Yes, yes. Or the elastic could rot and----
Mr. Bucshon. Which has happened by the way. I have had
people at hospitals tell me they have pulled masks off the
shelf and the elastic has popped when they tried to put it on.
Mr. Bowen. Yes. I don't think stockpiling is the----
Mr. Bucshon. So what do you think we should do? I mean,
should we----
Mr. Bowen. Well----
Mr. Bucshon. For example, in the stockpile, if they were
outdated, or start to outdate, should we be able to sell that
stuff before it outdates? I mean, what would be the length of
time before an outdate that you would feel comfortable selling
a product?
Mr. Bowen. I don't believe in stockpiling, sir, because of
all the problems that we have already identified.
Mr. Bucshon. OK.
Mr. Bowen. I think what we should do is come up with a new
kind of mask that can be made extremely fast. Talking about
hundreds of millions a week.
Mr. Bucshon. So some innovative stuff?
Mr. Bowen. Absolutely.
Mr. Bucshon. Yes, OK.
Mr. Bowen. And then ramp up. I presented a program or an
idea called Hypersurge to CDC several years ago, and that is
what I said. And they said it was the best presentation of the
meeting. Now, we never did it because I couldn't figure out a
way to make it profitable, to go and build a machine that is
not going to be used.
Mr. Bucshon. Right, right, right.
Mr. Bowen. I am not in that business.
Mr. Bucshon. Yes. So I get that because, like, I was a
heart surgeon before, and so we would have--we used to when I
first started 25 years ago, we would have a stockpile of heart
valves, of all sizes.
Mr. Bowen. Right.
Mr. Bucshon. The hospital bought them. They sat there. They
had outdates on them. And over the years, ultimately, we got a
point where they don't stockpile those anymore at the hospital
because things would outdate and they would have to get rid of
them. So now basically things rotate--you know, when you are
going to do a heart surgery case, you can get--the products
will come through, and you will be--it is consignment,
basically, right? You don't buy them anymore.
That's kind of what you are saying as a stockpile. You
don't stockpile this stuff, but you have a way of quickly
getting things----
Mr. Bowen. Well, and a stockpile will work in some
situations. For instance, the government does buy masks. The VA
and the DOD buys millions of masks.
Mr. Bucshon. Right.
Mr. Bowen. So that can rotate through. So they need a
coherent plan, and that is what I tried to present. I said, we
have got these four machines. Let's use one machine for your
peacetime use. We will rotate that stock for you.
Yes, that was the plan.
Mr. Bucshon. I am just saying, the U.S. Government could
help create a consistent marketplace for U.S.-made masks.
Mr. Bowen. Yes. OK.
Mr. Bucshon. We could be part of the solution.
Mr. Bowen. It can be done for healthcare workers. To do it
for the whole United States for something that happens every
hundred years to protect all of Americans is probably not
practical.
Mr. Bucshon. Understood.
Mr. Bowen. But protecting America's healthcare workers is
absolutely possible.
Mr. Bucshon. Fair enough.
All right. I yield back. Thank you.
Ms. Eshoo. The gentleman yields back. A pleasure to
recognize the gentleman from Oregon, Mr. Schrader, for his 5
minutes of questions.
Mr. Schrader. Hi, Mr. Bowen, welcome. We are doing a lot of
things these days that aren't real practical, but we are being
forced into them.
Mr. Bowen. It is surreal.
Mr. Schrader. Yes.
To some of the communications with Dr. Bright, one of the
references he made was to a Department of Homeland Security
request or communication with you back in mid-January to
procure some masks. Could you talk about that just a little
bit, what was the nature of that?
Mr. Bowen. Yes. What I would classify as some sort of a
purchasing agent kind of a person, not a high-ranking official,
called, and said they were looking for masks, I believe for
their screeners. And I said, I don't have any, we are sold out.
And then I just asked him, what do you think, is this real?
I said, give me your honest opinion. And he said, I think it is
going to be bad. And I said, yes, I do too.
So to pick up the phone and call Rick Bright--again, these
folks to me were brothers in arms. I called him for 15 years--
13 years. And every time something like this would happen, I
would pick up the phone and go, hey, is this it, is this the
big one, you know, can I help you? Yes.
Mr. Schrader. Well, it is interesting that while HHS was
not receiving this information in a productive manner, DHS--at
least some folks in DHS were very aware, kind of a situation.
Mr. Bowen. I don't know, but we never--we were never able
to sell the government masks. The government was never a
customer of ours until the H1N1 pandemic, and they bought masks
from us in emergency, and then never bought again. And
tragically----
Mr. Schrader. Well, I would like, just, if I may, I would
like to get at that.
Mr. Bowen. All right, go ahead.
Mr. Schrader. But before we do, on February 3rd, there was
communication with you and Dr. Wolf----
Mr. Bowen. Laura Wolf?
Mr. Schrader. Yes. And a comment was made, I think--and Dr.
Bright referred to this--that if we weren't responding now,
that our masks would forever be under foreign control. Do you
remember that comment?
Mr. Bowen. I don't know.
Mr. Schrader. OK.
Mr. Bowen. But I----
Mr. Schrader. I was curious what you meant by----
Mr. Bowen. I said that?
Mr. Schrader. Yes.
Mr. Bowen. Oh, yes, yes. What I meant was, if we--I am glad
you asked that question. What I meant was, if we don't fix the
U.S. mask supply now, while everybody is thinking about it,
while people are dying, we are going to do exactly what we did
after H1N1.
During H1N1, I am on the news just like now. And we
thought, it is over; we have finally been vindicated. We
couldn't believe it when everything went right back. And it is
worse. Things are worse now than they were before H1N1.
Mr. Schrader. So getting back to your earlier comments and
a bit of what Dr. Bucshon was talking about, you know, pretty
clear we need to make some of this stuff in America.
The question is--you know, I have a little tiny veterinary
practice--or had a very small veterinary practice, and we use
masks. The question--but I was always worried about the dollar,
and my job here is also to protect the taxpayer dollar. And,
you know, $5 a box, $1 a box, you got to think about it at
least a little bit.
So what is the right mix there? How do we protect the
taxpayer dollar and make sure we protect made-in-America so
that we can react to these----
Mr. Bowen. What I am going to say is going to make no
accounting sense. What I am going to say is that the dollar is
not real. It should be ignored. They are not making a profit.
Just because some country can sell a mask and lose money on it,
to us, does that mean we ought to buy that and think that it is
viable? It is not. It is not. We ought to buy everything that
has to do with a critical product, like a mask, in the United
States.
Masks cost less now. My masks cost less now than masks cost
30 years ago. You can buy two Class 2 medical devices, which
are called surgical masks, for less than a gumball. OK, the
fact that China can make them for two cents, or sell them for
two cents; let's ignore that. It is not real. And it is a
threat to national security.
Mr. Schrader. So last question, if I may, and you have
alluded to this again, you know, it would be nice to have a
stockpile, but a stockpile is not the total answer for what you
and Larry were just talking about.
What role does the Federal Government have in setting up
maybe a platform that businesses could use when times are
tough? In other words, it is not worth your while to set up
this platform, produce it for a couple of months, and then try
and shut this down, unemploy a ton of people.
Mr. Bowen. Absolutely.
Mr. Schrader. What role could the Federal Government have?
We face this with drugs. The chairwoman has been very adamant
and concerned about all our active ingredients are made in
China or India. That is not a healthy situation either,
especially right now.
Mr. Bowen. No.
Mr. Schrader. So what is the role, what is the right
public-private partnership with you guys to stand up a platform
that could being activated and we bear some of the costs and
you guys can tool right up?
Mr. Bowen. Start by tearing down the silos between the CDC
and VA and DOD and BARDA and HHS. Get all of those people in a
room. Because the VA and the DOD use millions and millions of
masks. So that it can rotate a stockpile. That can justify
having machines sitting here ready to be used.
It needs to be--there needs to be a coordinated plan
between all of these organizations. And then there needs to
be--again, the government needs--and the government can't tell
hospitals to buy American-made masks, but they can sure put
them on notice that if you don't, you are probably going to get
sued at some point.
You know, I have to laugh. I told my wife the other day, I
said I am probably going to spend the last ten years of my
career being a paid witness. Because I think these--I think all
these people who can't protect their employees are going to
say, hey, why did you do this to us? You know?
And let me say one more thing too. I have dealt with this
thing for so long, and it has been so illogical, and I have
tried to figure it out, and who is at fault, who is at fault,
and some people ask me that, who is to blame? And I got to the
point where it is human nature. It is all of us.
I couldn't convince doctors. I couldn't--listen to this. I
had three directors of BARDA said that, Mike, if you get
somebody to call me, I will verify that what you are saying is
true. I will tell them it was true.
Mr. Schrader, I couldn't get them to call. I couldn't get
hospitals to make that call. I don't think they wanted to hear
it. They are programmed to save money. They are not programmed
to say, I want to make sure my masks are going to be here. It
didn't compute. I was speaking Greek to everyone.
So to look at this story and look back and blame everybody,
I am not even going to do that. I am looking at this pandemic.
There is a silver lining. This silver lining is, it has told
everybody there is a big problem. And we can fix this problem
and never go through this again.
Mr. Schrader. Thank you so much.
Mr. Bowen. Thank you.
Ms. Eshoo. The gentleman yields back. A pleasure to
recognize the gentlewoman from Indiana, Mrs. Brooks.
Mrs. Brooks. Thank you, Madam Chairwoman.
And thank you, Mr. Bowen, for being here. It is so
interesting to hear. And I want to thank you actually for not
blaming and trying to educate all of us as to what you have
been telling America and government officials for a very, very
long time.
In fact, the chairwoman and I have been a part of--and I
entered into the record many--a few hearings ago, a group
called CSIS, strengthening America's public health security.
And the title of this big report that a bunch of professionals
came together, a bunch of medical professionals came together,
the title of the report is ``Ending the Cycle of Crisis and
Complacency in U.S. Global Health Security.'' It was led by
Julie Gerberding, who had been a health official. It was led by
Senator Kelly Ayotte, who had been in the U.S. Senate. It was
all focused on--and it came out in November of 2019. It came
out in November of 2019. And it had a lot of great
recommendations that I hope, once again, because I talked about
it before, in early 2020, we always go into the cycle of
dealing with something, then we become complacent, and we lose
focus once again.
And we have done it, you have said, since 9/11. President
George W. Bush had a focus on it, tried to bring attention to
the mask problem, and others. And then we lost it during the
Obama administration. And you wrote lots of letters. And we
didn't ramp up.
But I have to tell you that during all of that time
participating in that commission, I don't--we talked about
therapeutics, we talked about vaccines, we talked about
diagnostic testing. I don't recall anyone ever talking about
masks. OK? They didn't talk about PPE. And these were all
professionals who have been at this, sitting around the table.
And I am glad that Chairwoman Eshoo is agreeing with me. We
didn't have that discussion. And now we are all suffering. Our
medical professionals, really, and our law enforcement and
fire, who are truly on the front lines, are the ones now
suffering the consequences, and now we have this huge issue.
I want to talk briefly about the stockpile since you don't
believe the stockpile is the way to go. Most of America didn't
even know there was a stockpile until this all happened. Most
of America didn't know anything about all of these types of
things until this pandemic hit.
So we have to have some supply. I come from Indiana, a
manufacturing State. We have to have a supply chain. We have to
be able to ramp up production. BARDA is all about partnering
with the private sector. Many BARDA directors didn't get the
job done, based on what you said, not just Dr. Bright, but Dr.
Hatchett and Dr. Robinson, they couldn't get the job done.
So what do you--and we are going to welcome your comments
later on, as a manufacturer, and I represent a lot of
manufacturers. If we don't have a stockpile and if we don't
have a dramatic need for PPE, and let's, God forbid, hope we
don't, a year from now or two years from now, but we might be
going forward for a while, what is the magic formula about
ramping up production when we need it versus when we don't need
it?
Mr. Bowen. This is just my opinion. My opinion is to have a
small stockpile that can be rotated through America's hospital
system.
But as far as the general--the bulk of the masks, I think
we could come up with a different kind of mask that could be
made so fast that you wouldn't need to stockpile. Because the
problem isn't--the problem is, how do you get masks to the
right--how do you get masks to people, how do you get millions
of masks to people?
Well, you can do it two ways. You can either have them in a
stockpile where they could rot, or you learn how to make them
faster. And with a concerted effort, with a group like I was
talking about, where you get some people and some smart people
in the room, and, hey, make it lucrative, tell the American
mask industry, here is what we want to do, I want to--figure
out how to make a million masks a day on one machine.
Mrs. Brooks. But would that be a government contract, or
would that be turning on the spigot so that the private sector
can call those mask makers, the hospitals can call those mask
makers? Because that is what is happening right now.
Mr. Bowen. I think it could be both. I think the government
should use the VA and DOD's business as a carrot. DOD and VA
are buying millions and millions of dollars worth of masks. I
would love to have that business.
So what I am saying is, me or another American mask maker
or combination, gets that business and builds the machine or
whatever. You know, I can't think through the whole thing, but
there are ways to do that.
Mrs. Brooks. We could use your counsel. And while I have
just a few colleagues here, the chairwoman and I have a bill,
H.R. 6517, which is all about modernization of the stockpile
inventory, and it is about making sure that we can move out
expiring products, like expiring masks, before they expire, so
that they don't get shipped to States, which I do think is
happening, that some expired products are going to States.
But I would encourage everyone; we are trying to modernize
the stockpile, and improve the stockpile, and we welcome your
ideas and thoughts. And certainly wish that America had
listened more to you starting in 2007 when you said the whole
HHS information came to light. So thank you.
Mr. Bowen. My pleasure.
Ms. Eshoo. The gentlewoman yields back. The Chair now
recognizes the gentleman from California, Mr. Cardenas, for his
5 minutes of questions of Mr. Bowen.
Mr. Cardenas. Thank you very much, Mr. Bowen. Appreciate
your persistence.
I am going to label you as someone who cares. It sounds
like you care about employees.
Mr. Bowen. I care about a lot of things. I love my country.
Mr. Cardenas. Yes, I was going to get to that.
Mr. Bowen. Yes.
Mr. Cardenas. I was going to crescendo into how much you
love our country. And I think that you love people beyond our
country, because we are such an amazing example to the world
when we do things to the level of our capability. Do you agree
with that?
Mr. Bowen. I totally agree.
Mr. Cardenas. And on this issue, I think you know as well
as anybody, we are not doing our part the way we can show the
world how to do things right, how to do things for the right
reasons.
It sounds to me that you have 13 years of trying to get
many people, including the Federal Government, to understand
that something is wrong, but it is not going to take a genius,
nor is it going to take more money than we could put together
to do it. It just means that people need to listen, pay
attention, and then implement. Is that a----
Mr. Bowen. Yes. I always said it didn't take a lot of
money. It just takes some change. We have got to do things
differently.
Mr. Cardenas. I have never been accused of being a genius.
Are you a genius, sir?
Mr. Bowen. I am not a genius, and I am not stable,
sometimes.
Mr. Cardenas. You are normal?
Mr. Bowen. I am normal.
Mr. Cardenas. Yes, thank you. I figured that.
Mr. Bowen. I describe myself as a goober with a conscience.
I am just a normal guy.
Mr. Cardenas. There you go.
When you hear the term ``national security,'' the issue we
are talking about today, just specifically masks, does it have
something to do with national security? Eighty thousand people
have died, and not that every single one of them could have
been saved, but 80,000 people have died during this pandemic in
America.
I personally believe that number didn't have to be that
high had we done more things better, including getting PPEs, or
personal protective equipment, specifically masks. The right
kind, by the way.
Mr. Bowen. I agree with you.
Mr. Cardenas. So you said something earlier. I have been
listening and I really do appreciate you very much and your
willingness to come and speak to the American people. Because
you know you are speaking to Congress, but you are really
speaking to the American people. This is life. Thank God some
people are watching.
You said something about stockpiling and you mentioned a
couple times, like the VA, et cetera.
I used to own a little business. I wasn't a manufacturer
specifically, but I used to own a little business. I know what
it is like to care about your employees, to know that if you
had to shutter your doors, or shut down a part of your factory,
you know families are going to suffer, people you are close to,
people that you depended on. So I understand, I am getting that
from you, that you do care about a lot of things, including the
people that if you are going to put them to work, you don't
want to lay them off later for no good reason.
Mr. Bowen. Correct.
Mr. Cardenas. So the issue of stockpile, old-fashioned
stockpile, where we allow these kinds of things, for the rubber
bands to break or what have you, which that happens, what I
envisioned is--you may have alluded to and I may be wrong--a
rotation of some sort, a cooperation of some sorts, between a
big entity like the VA, to actually get a synergy of orders,
and then also rotate that stuff--legally and appropriately and
safely and properly--to other users before those items expire
so that we maximize not only production, but we minimize waste,
and we actually, get those products where they need to be when
they need to be there.
Mr. Bowen. If you got everyone involved, all of the big
three hospital distributors, like Medline and Owens & Minor and
Cardinal involved, and the government really would only have
to--I am thinking through this--but it wouldn't cost as much as
a government stockpile. If these people and us, all the people
in the mask industry, if we all carried more inventory and the
government subsidized just that part of it, they wouldn't have
to buy--I don't know. I am not an economist. But if we all work
together, we could do that.
Mr. Cardenas. And the thing that conservative taxpayers and
conservative elected officials don't like it when you talk
about subsidizing. But in reality, the example you just gave,
the brief example you just gave, in the long run, the taxpayers
would end up spending less, the government would end up
spending less, everybody would end up spending less, if we just
try to figure out how to fill that gap properly.
Mr. Bowen. Right.
Mr. Cardenas. That is what you are talking about, right?
Mr. Bowen. Right.
Mr. Cardenas. So what I would like to invite you to do, and
you may have done it already, is I would like to invite you to
call my office, Congressman Tony Cardenas, and I will work with
any of my colleagues so that we can introduce a bill to
actually enlist and require that activity from the Federal
Government of the United States, enlisting voluntarily, and
required by the government side, to the government to require
itself, to damn well do that once and for all.
And I believe that this would be an example about masks,
but we are going to be able to cross-pollinate that amazing,
cost-saving, life-saving example in other areas of
responsibility.
Mr. Bowen. The one thing that would be mandatory for that
to happen is for America's hospitals to be willing to pay a
little more for a mask, because nobody can match the prices,
yes.
Mr. Cardenas. I know some of my colleagues don't like the
word ``mandate,'' but we could mandate that in a way where they
welcome it.
Mr. Bowen. Yes.
Mr. Cardenas. And not with a stick but truly a carrot. But
like you said, they just have to understand how it would work
in their benefit.
Mr. Bowen. Yes, I don't know what the solution is, but I
think it is probably some sort of a government and private
industry partnership.
Mr. Cardenas. Yes. It is called a PPP.
Mr. Bowen. The medical industry is full of people who care.
You guys are people who care.
Ms. Eshoo. Right. The gentleman yields back.
Mr. Cardenas. I yield.
Ms. Eshoo. It is a very interesting line of questions.
I would just place something on the table here, the empty
table, and that is that it is one thing for a foreign country,
China, you know, to make sneakers and, you know, T-shirts and
whatever. But we are talking about commodities that truly are
part of our national security. And if anything has laid that
bare, it is this pandemic. So this is another category, and we
have to treat it as such.
The Chair is very pleased to recognize the gentleman from
Georgia, Mr. Carter, for his 5 minutes.
Mr. Carter. Thank you, Madam Chair.
Mr. Bowen, very quickly, I have been in and out, so I am
still a little confused. Just help me clear up, because I owe
my friend, the chairlady, two minutes, so I am going to give
those back to her.
But I am still confused about your current capabilities.
Mr. Bowen. OK.
Mr. Carter. You said you have four lines that are just
sitting dormant, sitting empty right now. Is that correct?
Mr. Bowen. We have four idle respirator manufacturing
lines, yes, sir.
Mr. Carter. And they are just--I mean, they are not being
used right now?
Mr. Bowen. Yes, but--go ahead, and finish your question.
Mr. Carter. Yes, they are not being used?
Mr. Bowen. Correct.
Mr. Carter. Correct?
So you have said you have already gotten machines for those
lines. You don't have to procure them. The only thing you are
going to have to do is to get staff in order to use those
lines.
Mr. Bowen. No. There is three things. We need to hire a
hundred people, we need to train a hundred people, we need to
get all the materials for that, and we need to get NIOSH
approval. We bought those systems from a defunct Vermont mask
company seven years ago.
Mr. Carter. OK.
Mr. Bowen. We really don't even know how to use those
machines. They are kind of a last resort. And if you will go
back and look at my email to Dr. Bright, I said, this would be
basically a pain to do, but they are here, and if we need this
for infrastructure, let's talk about it.
But what we have done in the meantime is we have gone from
making 75,000 respirators a month--think of that number,
75,000--to 2 million. And then in another 40 days, we will be
at 4 million, from 75,000. So that is thousands and thousands
of percent increase.
Mr. Carter. But you said you bought those. You bought them
for a purpose. You bought them to use them, right?
Mr. Bowen. No. Thank you for asking that question. No, they
came as part of an acquisition. We bought a defunct medical
company. Those machines came as part of the acquisition.
Mr. Carter. OK.
Mr. Bowen. And they are made in China. Again--go ahead.
Mr. Carter. But did you say earlier that your phone was
ringing off the hook, you got orders coming out of the yazoo
and----
Mr. Bowen. Yes, yes, yes, OK, but I can't go on a suicide
mission. I can't ramp up, and hire all these people for
something that I don't know how it is going to end, or how long
it is going to last. And we did this.
You have got to remember, we almost went out of business
doing this before. We ramped up, and we spent money and built a
bigger factory, hired 150 people, built more machines, and then
one day the business not only went away, it went smaller than
it was. And we had to raise a million dollars, we had to take
pay cuts, and we had to fire 150 people.
Mr. Carter. So what you are saying, and I am not trying to
put words in your mouth.
Mr. Bowen. I am saying I need a long-term contract.
Mr. Carter. You are saying you are not going to use them,
you are not going to fire them up unless you get a long-term
contract from the government?
Mr. Bowen. I am not going on a suicide mission. Absolutely.
Mr. Carter. So, that is yes, you are not going to use them
unless you get a long-term contract?
Mr. Bowen. Unless I get a customer who is going to use--
commit to use those machines so I don't have to fire a hundred
people.
Mr. Carter. So that means that you would have to have a
long-term contract from the government in order to do it?
Mr. Bowen. Yes.
Listen, we have gone from one shift to three, 80 people to
200. We are making four times the products we made. We are
making over a million masks a day. Don't you look at me and act
like I am sitting on my ass and not firing up four machines. It
is not like just turning on a switch. It is putting people's
lives that is going to--I am not going to--listen----
Mr. Carter. Sir, I understand. I am a businessman, too, and
I understand what it takes.
Mr. Bowen. Listen. Let me tell you this. I sat and watched
my business partner cry when he had to lay those people off. We
are not doing that again.
Mr. Carter. So in order--so it is going to have to be a
long-term contract from the government, though. That is my
point.
Mr. Bowen. From somebody.
Mr. Carter. And I get it, from somebody. But why----
Mr. Bowen. I can't hire a hundred people based on a maybe.
Mr. Carter. I am sorry?
Mr. Bowen. I can't hire a hundred people based on a maybe,
based on a when is this going to end, who knows.
Mr. Carter. None of us can, whether we are in the private
sector or the public sector, we can't do that. We all
understand that.
Mr. Bowen. OK. You don't--you are not risking your
livelihood and----
Mr. Carter. Sir, I risked my livelihood for 30 years as an
independent retail pharmacist. I never had--I had contracts
with nursing homes.
Mr. Bowen. Why don't you buy my--why don't you buy my
machines and hire a hundred people? I will tell you what, I
will give you my machines if you want to hire a hundred people.
Mr. Carter. But the point is that, you are here saying, I
am not going to do it unless I get a long-term contract from
the government. I am just trying to get clear----
Mr. Bowen. Wait, wait, wait, wait, wait, wait, wait. No,
no, no, no, no, no, no. Go back to the context. The context of
that was, in those emails, in, hey, here is four machines,
let's--they are here, but I can't turn them on unless it is a
long-term deal. I am not just going to flip them on and have
you flip them off and leave me hanging like everybody did last
time.
And let me tell you what happened last time. The government
sits around, doesn't buy American-made products, comes to me in
a pandemic, buys millions of masks in 2010. You know what they
did with those masks? They stored them for ten years. Then they
auctioned them to some knucklehead who put them on eBay and
sold them for ten times what they were worth.
So not only did--have I not seen the government in ten
years, I have got to compete with my own masks, and I have got
to have thousands of phone calls for me--to me from people who
bought that 10-year-old mask of mine on eBay for $10, ten times
the price, yelling at me. And I had nothing to do with it. It
is because the government waited and sold this stuff.
I have been hit from every side on this thing. We have bled
for this country. We have created jobs. We put our factory in
Texas when everybody else had already left the country.
So don't sit here and judge me for four machines that
aren't running, that I would have to hire and fire a hundred
people for. I am not going to do it.
Mr. Carter. Not unless you have a long-term government
contract?
Ms. Eshoo. The gentleman's time has expired.
Mr. Bowen. How many times do we have to say this?
Ms. Eshoo. The Chair recognizes the gentleman from
California, Dr. Ruiz, for his 5 minutes of questions.
Mr. Ruiz. Thank you, Mr. Bowen, for your testimony today,
and thank you for trying to sound the alarm on the issues of
mask shortage and reliance on foreign manufacturing for over a
decade now, before anyone had ever heard of COVID-19.
As you state in your written testimony, relying so heavily
on imported masks is a national security risk, and,
unfortunately, the last few months have shown us how vulnerable
it leaves us during a pandemic.
You, of course, already knew that and tried to do something
about it, and, unfortunately, those efforts were stifled.
If your warnings had been heeded, we would not be in this
situation now where doctors and nurses cannot find the personal
protective equipment that they need to protect themselves and
do their job safely.
We all have heard the stories--doctors reusing masks that
are meant for single use, nurses wearing garbage bags because
they are out of gowns. This is unacceptable. This is the United
States of America, and our frontline health workers don't even
have access to these basic supplies.
That is why I introduced the Commission on America's
Medical Security Act, which would direct the National Academies
of Sciences, Engineering, and Medicine to assess the United
States' dependence on foreign manufacturing for drugs and
medical devices. That bill was included in the CARES Act, which
was signed into law in March.
Of course, the ultimate goal is a system that doesn't put
our own access to critical supplies and equipment is at risk
because we are at the mercy of other countries during a
pandemic when they need those supplies for their own
populations. It is a health security risk that puts American
lives on the line, and, therefore, it is a national security
risk.
Mr. Bowen, when we get past this crisis and analyze the
mistakes that were made in order to not repeat them in the
future, how do we restructure a system so that we aren't caught
in another preventable mask or other PPE shortage in future
pandemics?
Mr. Bowen. I am not sure. I think we should put together a
group of people that includes some of you all and the mask
makers and the mask distributors, the VA and the DOD, and come
up with a plan. It is not rocket science. It is just logistics,
and the military is really good at logistics.
Mr. Ruiz. Great.
Mr. Bowen. And also I think too, just to be fair, again, I
want to be fair with this, we couldn't--this is an
extraordinary situation. I make masks for MD Anderson Cancer
Center and the Texas Health Resources hospitals in Fort Worth
and Cook Children's Hospital. Those are my three biggest
accounts. And they are using, my goodness; they are using so
many more masks. It is not just 10 percent, 20 percent. It is
hundreds of percent.
So could we have made sure everybody had masks? Probably
not. But it would have been a lot better than it is now.
Mr. Ruiz. Well, if we would have heeded the warnings
decades ago and created them and ramped up our ability to
produce them, then I believe that we could have.
There have been reports regarding the safety issues of some
of the masks that have been imported in the past week and also
reports about the FDA pulling approval for over 60
manufacturers in China for N95 masks after tests showed that
they did not meet quality standards.
N95 masks filter out 95 percent of particles, hence their
name, but some tests showed that many masks produced by Chinese
manufacturers were, according to one CDC official, grossly
under that number. One of the companies who had their approval
removed filtered out only 24 to 35 percent of particles.
As a doctor who was in the emergency department, I am an
emergency physician, during the H1N1, the prospect of this is
horrible. It leaves those in the front lines taking the highest
risk with a false sense of security and even higher
vulnerability. And while I acknowledge that the FDA eventually
pulled their approvals, it wasn't done before these masks were
already in circulation here in the U.S.
Can you comment on this development and outline steps we
can take to protect our healthcare workers against substandard
masks in the future?
Mr. Bowen. That is not an area of my expertise. I don't
know how masks get in the country. I don't know what foreign--I
don't know how that works, so I don't have a solution for that,
but it is definitely a problem.
Mr. Ruiz. OK. Let's say the President fully and
comprehensively used the Defense Production Act and worked with
multiple companies in multiple industries to massively produce
masks and all the ingredients needed and created a supply
chain, and also created a rapid response team of all the CEOs
from those different companies. Would you be willing to
participate in that rapid response team to handle a surge in
the future?
Mr. Bowen. No. I am open to any reasonable type of thing. I
am not sure if----
Mr. Ruiz. Great, thank you.
Mr. Bowen. The government doesn't do real well managing a
lot of different things, so I am not sure if that would help.
Mr. Ruiz. Well, I think that is why the CEOs, as a rapid
response adviser team, would be very helpful.
Thank you.
Mr. Bowen. All right.
Ms. Eshoo. The gentleman yields back. A pleasure to
recognize the gentlewoman from Michigan, Mrs. Dingell, for her
5 minutes of questions.
Mrs. Dingell. Thank you, Madam Chair. And I want to say,
too, I want to start out by thanking our Chairwoman Eshoo and
Representative Susan Brooks for their leadership in
understanding the stockpile and the need for the country to be
producing these. And I think we really need to be talking about
the medical supply chain.
I am also going to tell you, I am a car girl, I am a
manufacturing girl, and I think we need to be making a lot more
in America. I think that these times have changed us. I don't
think people understood supply chain when we used to talk about
it.
I also think there is going to be a much stronger customer
base for respirator--I used to call them ventilators, or
respirators, but the N95 masks that we are talking about. I
think that there is going to be a permanent need in this
country, and I think we have to talk about the stockpile as we
go forward.
It is not a new issue, Mr. Bowen, as you have, and my
colleagues have highlighted. And that is why we are all talking
about the bills that we have got in, and I have got a good,
strong, bipartisan bill with my colleague, Congresswoman Jackie
Walorski, the Medical Supplies for Pandemics Act, that would
reform the Strategic National Stockpile--I still think we need
it--to strengthen domestic production of PPE.
And I am also going to say that now you are just talking
about a need for frontline doctors and nurses, but as people
are going back to work there is even a broader need for PPE
equipment. We are reopening factories, and the supplier
community and the car manufacturers are putting stringent
production, new protocols into place, and they are going to
have a need as well.
So I think we are going to have to talk about what is
supply and demand in this country and how do we make sure that
there is enough. And it is not only in times of crisis. I think
there is going to be a market there. I mean, the fact of the
matter is, Ford Motor--you may not know that--is now producing
N95 masks in my district in Flat Rock, Michigan.
You were going to say something?
Mr. Bowen. General Motors was kind enough to send
consultants to us. They have worked with us for the last 30
days.
Mrs. Dingell. I know. So the companies are stepping up.
But I want to ask you a question. I mean, Ford has, without
any Federal Government order, has produced 23--I can't read
this number, but they have been producing a lot of these masks
so far, so there is a market out there.
But I want to ask you a question. Do you have any sense of
how many more N95 masks would be on the market had the Federal
Government has taken you up on your offer to reactivate N95
manufacturing lines in January?
Mr. Bowen. Well----
Mrs. Dingell. And can we be a little short because I have
got a lot of questions.
Mr. Bowen. Yes. Seven million a month.
Mrs. Dingell. OK. And the Medical Supplies for Pandemics
Act that Congresswoman Walorski and I have introduced would
authorize funding to increase supply chain elasticity, but
purchasing additional capacity for manufacturers like Prestige
Ameritech for emergencies, and this situation underscores the
need for future investment in the area.
But, Mr. Bowen, you talked about previously that you had
ramped up production of masks and hired over 150 new workers
during the 2009 H1N1 pandemic to meet the increased demand. But
you have since then described this decision as a mistake. Why?
I mean, you don't think you could keep the--I actually agree
with you.
Mr. Bowen. No, because people stopped buying my products
after the pandemic. I didn't need 150 people. We went--our
sales went down. And there was such a glut in the marketplace,
my biggest customer didn't order for seven months. So not only
did sales go down, some of my customers didn't order for a long
time.
Mrs. Dingell. But you kept the equipment, the capital
equipment that you had.
I guess I am trying to figure out, how do we keep
production in America. I had three hospital systems that spent
just a million dollars, just a million dollars, on the plane
from Chinese to the U.S. to get these N95 masks and paid
quadruple the price of what they normally pay to get the masks
here.
Mr. Bowen. Well, if they would pay 15 or 20 percent more
during peacetime, they wouldn't have to do that. Because what
they have done is, the hospitals have created this problem by
trying to save money and chasing these products to China.
Mrs. Dingell. Well, I think we have got to bring the supply
chain back to this country, period, so we don't have to chase
them, and we have got to figure out what----
Mr. Bowen. But, you know, what is funny, though, is I see
hospitals now, in the middle of this, saying, yes, we are going
to switch back to American, but only 25, 30 percent. They still
want to buy China products. So it is not going to all come
back, because people aren't going to pay for it.
Mrs. Dingell. Thank you, Madam Chair.
Ms. Eshoo. The gentlewoman yields back. And now I would
like to--there isn't anyone on the minority side, right? OK.
The gentlewoman from New Hampshire, Ms. Kuster, for her 5
minutes of questions is recognized.
Ms. Kuster. Thank you, Mr. Bowen. And thank you for being
with us, we appreciate it.
This here is a homemade mask, which is what people in my
State of New Hampshire have had to do because we couldn't get
the masks. And we tried in a bipartisan way. We have a Federal
delegation that is Democrat, we have a governor who is
Republican. We all scrambled behind the scenes. And eventually,
we were told, because we weren't a hot spot, we are a small
State, we are a rural State, but we have plenty of COVID-19,
and we couldn't get it.
And so luckily, eventually, our entrepreneurs, like
yourself, stepped up. You may know Dean Kamen. He took two
flights to China and came back with all the equipment, the
supplies, the masks.
And so we need to understand how we got here and why nobody
was listening to you about the production of masks here in
America.
I want to just quickly revisit your exchange with Mr.
Carter, because I don't think it is outrageous that you would
be looking for a contract with a price knowing that that you
would have a market. We do that in the Department of Defense
all the time. How many tank manufacturers do you expect to make
a tank not knowing whether the government was going to buy it?
Right?
Mr. Bowen. Yes.
Ms. Kuster. I mean that is where we are, right? We need
your product to protect our people, to protect the American
people.
And my colleague Mrs. Dingell is absolutely correct. Yes,
it is the frontline workers, and I every night am thinking of
sleepless nights of people going home who have been exposed all
day long and they are going home to their children because they
didn't have the equipment that they needed. We wouldn't send
our troops into harm's way and we are sending our healthcare
providers into harm's way.
So just walk me through, if you will, what is it when you
warned of the mask shortage, what did you think? You said the
U.S. mask supply is at imminent risk. Walk me through what you
were trying to convey.
Mr. Bowen. What I was trying to convey to Dr. Bright was
that China was in the process of cutting the mask supply and
that China supplies about half of the mask supply. The mask
supply was already tight. So imagine half of it going away.
Now, here is what I didn't say, Mexico makes the other
half. If Mexico gets in really big trouble, we might not get
that supply, too. Had China not been able to get their supply
or their disease under control and Mexico been in trouble, the
entire U.S. mask supply would have been cut off. We dodged a
bullet by just having part of it cut off.
Ms. Kuster. Are you familiar in the Department of Defense
with the made-in-America and why we do that?
Mr. Bowen. I sent Mr. Trump a letter in 2017. I sent it to
everybody in his staff. And it said, please--I can give you the
letter--it said, please, make the DOD and VA--or make the DOD
use the Berry amendment. Masks are covered under the Berry
amendment. We spent thousands and thousands of dollars with a
government type attorney who made a case that masks should be
under the Berry amendment because they are clothing and the
Berry amendment handles military clothing and they shot it
down. And then I didn't get any response from the Trump
administration.
But I also wrote the Obama administration 20 letters and
they sent me a form letter back. So this is everybody, this is
everybody. I am not throwing any administration under the bus.
This is everybody.
Ms. Kuster. You feel disrespected, though, in the process.
And you were trying to protect the American people.
Mr. Bowen. No, no, no, no. What is funny is I get really
mad about this, and I tend to pop off and I am sorry. I didn't
used to be like this. Let me say this----
Ms. Kuster. You are frustrated.
Mr. Bowen. I didn't use to swear. I swear now, I didn't use
to swear before.
Ms. Kuster. We are all frustrated. Let me tell you, I have
let lose a few words that my mother would be shocked by.
Because people are hurting, right? We can't protect ourselves.
What is your most fundamental--are you a parent?
Mr. Bowen. I have five children, four living. My oldest son
died of the same thing that Mr. Biden's son died of. And I have
16 grandchildren.
Ms. Kuster. And every night you go to bed, you would do
anything to protect them. And that is the position we are in;
we are trying to protect the American people. We are trying to
protect our own families. And I wish you had been listened to.
Mr. Bowen. Let me say this, I am get 500 to 1,000 emails a
day. I am getting emails from people, not businesses, I am
getting emails from moms, I am getting emails from old people;
please send me masks. And I----
Ms. Kuster. You make a product that can protect people.
Mr. Bowen. I can't help these--I can't help all these
people. And what is so frustrating, because I said this for
years, I have got every email I have ever sent all these
people. And I have said for years you can't, we can't wait
until the pandemic happens before we do something about it it
is and time to fix it. We had 13 freakin' years to fix it. And
that is the travesty.
But, again, the thing that I couldn't figure out is why
nobody hardly would listen. It was universal. It was like,
whew.
Ms. Kuster. Well, I will just close by saying this: Note to
self, don't eliminate the Office of Pandemic Preparedness.
So thank you for being here with us today.
And I yield back.
Mr. Bowen. My pleasure.
Ms. Eshoo. The gentlewoman yields back.
Well, this concludes our second panel. I want to thank you
again, Mr. Bowen, not only for coming here today, flying across
the country, all the complications that are a part of that, so
many flights canceled.
When I spoke to you on the phone and urged you to actually
come to Washington, you said, why? And I said, because I think
you are a patriot. You have been on this for more than a
decade. And I think you have more than proven that today, to
every single Member that is here.
Your story and your tenacity about a commodity that is a
part of our national security, I wish people had listened
to.But now it is our job to listen to you and to make sure that
your crusade can essentially come to an end. You shouldn't have
to spend another 10, 15 years knocking on doors.
So your testimony I think has really moved the needle. And
you should--I hope that you will go home feeling gratified. You
will be totally satisfied when we really get this done. But I
think that your testimony has been--you are a truth teller,
totally unvarnished and refreshing, I might say.
We listen to a lot of witnesses here and there are all
kinds of styles and that, but yours is a special form of truth-
telling, it is refreshing, and it is filled with the kind of
content for us to not only understand, but that we take it and
we run with it.
I started out the hearing today by saying I never thought
that I would Chair a hearing that is really so sad. And the
backdrop of all of this is 80,000 souls that have been lost,
that we are not meeting the needs of the American people in
this crisis.
When it comes to what you make we can't even keep up with
and make sure that doctors, nurses, healthcare workers have the
supplies, the critical supplies that they need. It is shameful
in our country.
So we are very grateful to you for coming.
Mr. Bowen. Thank you.
Ms. Eshoo. And we want you to stay healthy. We need you.
And Members will be able to submit; they all know that they
can submit questions. And pursuant to the committee rules, they
have ten business days to submit additional questions for the
record to be answered by the witness, in this case yourself.
And also again we ask you to respond promptly to any such
request.
So thank you again.
And I have just a little bit of housekeeping here. I
request unanimous consent to enter the following documents into
the record.
Mr. Griffith. Madam Chair, unless it is absolutely
required, I will waive that reading of the list, if that is all
right. And it is my understanding there are some documents that
we have had a hard time getting to you, and if we could ask
that they be placed in the record without objection, as well
with the understanding that you have to take a look at it to
make sure it is appropriate.
Ms. Eshoo. Exactly. I reserve the right for the majority to
review them, and having done so, then place them in the record.
And I appreciate the gentleman agreeing or waiving the
unanimous consent request.
Ms. Kuster. Madam Chair?
Ms. Eshoo. Yes. You are recognized.
Ms. Kuster. Could I just ask for the record that Mr.
Bowen's letter that he made reference to be entered into the
record?
Ms. Eshoo. And what letter is that?
Ms. Kuster. You referenced a letter that you had sent to
the administration about the making of masks.
Mr. Bowen. Yes. I can send the letters I sent to both the
Obama administration and the Trump administration.
Ms. Eshoo. If you can get that to us, Mr. Bowen, then both
sides can review. And with the approval, the agreement of both
sides, we can place them in the record.
Mr. Griffith. Yes, ma'am.
Mr. Bowen. Would you like the letters I sent to Secretary
Mattis and other people as well?
Ms. Eshoo. Whatever you want to give us, we will review. Be
happy to.
Mr. Griffith. And if I might, Madam Chair, I know it was
probably said in frustration, but as I indicated to you that I
had a number of companies that had gotten back into the
business. And one of those, Integrated Textile Solutions, says
they will take the machines if you really want to get rid of
them. Just letting you know.
Mr. Bowen. We will work something out.
Mr. Griffith. I will put you all together and y'all can
figure it out.
Mr. Bowen. We will work something out.
[The information appears at the conclusion of the hearing.]
Ms. Eshoo. On behalf of all of the Members, we want to
thank the committee staff on both sides. This is our new way of
operating. And as everyone makes the adjustments, you are doing
the hard work so that we can make the adjustments to make sure
that the directives of the Capitol physician's office has put
out.
And I can't thank you enough. I mean, you have been--I have
been watching you. I even said to Mike, you don't have gloves
on.
So thank you to all of you. I salute you.
And again, Mr. Bowen, thank you.
To the rest of the guests in the room, thank you.
Now, maybe some of us are going to go off and have
breakfast and lunch combined, something like that. I think we
kind of earned our keep today with 4-6 hours of well-spent time
on behalf of the people of our country.
So, with that, the Health Subcommittee is adjourned.
Mr. Bowen. Thank you for the invitation.
[Whereupon, at 4:13 p.m., the subcommittee was adjourned.]
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