[Joint House and Senate Hearing, 118 Congress]
[From the U.S. Government Publishing Office]
THE FEDERAL RESPONSE TO COVID-19
=======================================================================
JOINT HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
AND THE
SUBCOMMITTEE ON HEALTH
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED EIGHTEENTH CONGRESS
FIRST SESSION
__________
FEBRUARY 8, 2023
__________
Serial No. 118-7
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Published for the use of the Committee on Energy and Commerce
govinfo.gov/committee/house-energy
energycommerce.house.gov
________
U.S. GOVERNMENT PUBLISHING OFFICE
52-490 PDF WASHINGTON : 2024
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COMMITTEE ON ENERGY AND COMMERCE
CATHY McMORRIS RODGERS, Washington
Chair
MICHAEL C. BURGESS, Texas FRANK PALLONE, Jr., New Jersey
ROBERT E. LATTA, Ohio Ranking Member
BRETT GUTHRIE, Kentucky ANNA G. ESHOO, California
H. MORGAN GRIFFITH, Virginia DIANA DeGETTE, Colorado
GUS M. BILIRAKIS, Florida JAN SCHAKOWSKY, Illinois
BILL JOHNSON, Ohio DORIS O. MATSUI, California
LARRY BUCSHON, Indiana KATHY CASTOR, Florida
RICHARD HUDSON, North Carolina JOHN P. SARBANES, Maryland
TIM WALBERG, Michigan PAUL TONKO, New York
EARL L. ``BUDDY'' CARTER, Georgia YVETTE D. CLARKE, New York
JEFF DUNCAN, South Carolina TONY CARDENAS, California
GARY J. PALMER, Alabama RAUL RUIZ, California
NEAL P. DUNN, Florida SCOTT H. PETERS, California
JOHN R. CURTIS, Utah DEBBIE DINGELL, Michigan
DEBBBIE LESKO, Arizona MARC A. VEASEY, Texas
GREG PENCE, Indiana ANN M. KUSTER, New Hampshire
DAN CRENSHAW, Texas ROBIN L. KELLY, Illinois
JOHN JOYCE, Pennsylvania NANETTE DIAZ BARRAGAN, California
KELLY ARMSTRONG, North Dakota, Vice LISA BLUNT ROCHESTER, Delaware
Chair DARREN SOTO, Florida
RANDY K. WEBER, Sr., Texas ANGIE CRAIG, Minnesota
RICK W. ALLEN, Georgia KIM SCHRIER, Washington
TROY BALDERSON, Ohio LORI TRAHAN, Massachusetts
RUSS FULCHER, Idaho LIZZIE FLETCHER, Texas
AUGUST PFLUGER, Texas
DIANA HARSHBARGER, Tennessee
MARIANNETTE MILLER-MEEKS, Iowa
KAT CAMMACK, Florida
JAY OBERNOLTE, California
------
Professional Staff
NATE HODSON, Staff Director
SARAH BURKE, Deputy Staff Director
TIFFANY GUARASCIO, Minority Staff Director
Subcommittee on Oversight and Investigations
H. MORGAN GRIFFITH, Virginia
Chairman
MICHAEL C. BURGESS, Texas KATHY CASTOR, Florida
BRETT GUTHRIE, Kentucky Ranking Member
JEFF DUNCAN, South Carolina DIANA DeGETTE, Colorado
GARY J. PALMER, Alabama JAN SCHAKOWSKY, Illinois
DEBBIE LESKO, Arizona, Vice Chair PAUL TONKO, New York
DAN CRENSHAW, Texas RAUL RUIZ, California
KELLY ARMSTRONG, North Dakota SCOTT H. PETERS, California
KAT CAMMACK, Florida FRANK PALLONE, Jr., New Jersey (ex
CATHY McMORRIS RODGERS, Washington officio)
(ex officio)
Subcommittee on Health
BRETT GUTHRIE, Kentucky
Chairman
MICHAEL C. BURGESS, Texas ANNA G. ESHOO, California
ROBERT E. LATTA, Ohio Ranking Member
H. MORGAN GRIFFITH, Virginia JOHN P. SARBANES, Maryland
GUS M. BILIRAKIS, Florida TONY CARDENAS, California
BILL JOHNSON, Ohio RAUL RUIZ, California
LARRY BUCSHON, Indiana, Vice Chair DEBBIE DINGELL, Michigan
RICHARD HUDSON, North Carolina ANN M. KUSTER, New Hampshire
EARL L. ``BUDDY'' CARTER, Georgia ROBIN L. KELLY, Illinois
NEAL P. DUNN, Florida NANETTE DIAZ BARRAGAN, California
GREG PENCE, Indiana LISA BLUNT ROCHESTER, Delaware
DAN CRENSHAW, Texas ANGIE CRAIG, Minnesota
JOHN JOYCE, Pennsylvania KIM SCHRIER, Washington
DIANA HARSHBARGER, Tennessee LORI TRAHAN, Massachusetts
MARIANNETTE MILLER-MEEKS, Iowa FRANK PALLONE, Jr., New Jersey (ex
JAY OBERNOLTE, California officio)
CATHY McMORRIS RODGERS, Washington
(ex officio)
C O N T E N T S
----------
Page
Hon. H. Morgan Griffith, a Representative in Congress from the
Commonwealth of Virginia, opening statement.................... 2
Prepared statement........................................... 4
Hon. Kathy Castor, a Representative in Congress from the State of
Florida, opening statement..................................... 10
Prepared statement........................................... 12
Hon. Brett Guthrie, a Representative in Congress from the
Commonwealth of Kentucky, opening statement.................... 14
Prepared statement........................................... 16
Hon. Anna G. Eshoo, a Representative in Congress from the State
of California, opening statement............................... 20
Prepared statement........................................... 21
Hon. Cathy McMorris Rodgers, a Representative in Congress from
the State of Washington, opening statement..................... 23
Prepared statement........................................... 25
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 28
Prepared statement........................................... 30
Witnesses
Lawrence A. Tabak, D.D.S., Ph.D., Senior Official Performing the
Duties of Director, National Institutes of Health.............. 32
Prepared statement........................................... 35
Answers to submitted questions \1\
Rochelle P. Walensky, M.D., Director, Centers for Disease Control
and Prevention................................................. 47
Prepared statement........................................... 49
Answers to submitted questions \1\
Robert M. Califf, M.D., Commissioner, Food and Drug
Administration, Department of Health and Human Services........ 61
Prepared statement........................................... 63
Answers to submitted questions \1\
Submitted Material
Inclusion of the following was approved by unanimous consent.
Statement of Dawn O'Connell, Assistant Secretary for Preparedness
and Response, Department of Health and Human Services.......... 139
Report, ``Physical interventions to interrupt or reduce the
spread of respiratory viruses (Review),'' by Jefferson T, et
al., Cochrane Database of Systematic Reviews, Issue 1, January
30, 2023....................................................... 145
Article of May 9, 2022, ``The panel was supposed to improve
efficiency at the NIH. It hasn't even met for 7 years,'' by Lev
Facher, STAT News.............................................. 150
----------
\1\ Replies from the three witnesses and Dawn O'Connell, Assistant
Secretary for Preparedness and Response, Department of Health and Human
Services, have been retained in committee files and are available at
https://docs.house.gov/Committee/Calendar/ByEvent.aspx?EventID=115351.
Ms. O'Connell was invited to testify in person but was unable to
attend.
News release of December 22, 2022, ``New Report Confirms U.S.
Life Expectancy has Declined to Lowest Level Since 1996,''
National Center for Health Statistics, Centers for Disease
Control and Prevention......................................... 154
Article of February 1, 2023, ``Study: U.S Lags Behind Other
Wealthy Countries in Health Outcomes,'' by Elliott Davis, Jr.,
U.S. News and World Report..................................... 155
Article of January 30, 2023, ``It's Time for the Scientific
Community to Admit We Were Wrong About COVID and It Cost
Lives,'' by Kevin Bass, Newsweek............................... 158
Article of December 21, 2021, ``Data Failures Keep the CDC From
Seeing the Whole Picture on Covid,'' Bloomberg................. 166
Web page, Centers for Disease Control and Prevention, ``Contact
Tracing for COVID-19,'' August 11, 2022........................ 170
Web page, Centers for Disease Control and Prevention, ``Contact
Tracing for COVID-19,'' February 7, 2023....................... 171
Article of December 19, 2020, ``The inside story of how Trump's
denial, mismanagement and magical thinking led to the
pandemic's dark winter,'' by Yasmeen Abutaleb, et al.,
Washington Post................................................ 172
Article of May 11, 2022, ``GOP opposition leaves covid aid in
peril as White House warns of surge,'' by Tony Romm, Washington
Post........................................................... 188
Article of October 26, 2021, ``Trump's Focus as the Pandemic
Raged: What Would It Mean for Him?,'' by Michael D. Shear, et
al., The New York Times........................................ 192
Article of April 24, 2020, ``Trump's Suggestion That
Disinfectants Could Be Used to Treat Coronavirus Prompts
Aggressive Pushback,'' by Katie Rogers, et al., The New York
Times.......................................................... 201
Article of March 19, 2020 (updated September 4, 2021), ``Before
Virus Outbreak, a Cascade of Warnings Went Unheeded,'' by David
E. Sanger, et al., The New York Times.......................... 204
Article of January 25, 2023, ``Two new studies paint encouraging
picture of Covid-19 vaccine's performance,'' by Helen
Branswell, STAT................................................ 211
Article of February 2, 2023, ``Shuren: FDA needs new authorities
to prevent device shortages beyond public health emergencies,''
by Ferdous Al-Faruque, Regulatory News......................... 214
Article of September 11, 2020, ``Trump officials interfered with
CDC reports on Covid-19,'' by Dan Diamond, Politico............ 217
Article of June 4, 2021, ``Attacks on Fauci grow more intense,
personal and conspiratorial,'' by Natasha Korecki and Sarah
Owermohle, Politico............................................ 226
Article of May 6, 2021, ``Republican promote pandemic relief they
voted against,'' by Steve Peoples, AP News..................... 235
Report by Leavitt Partners, ``Overview of Recent Long-COVID
Studies,'' COVID Patient Recovery Alliance..................... 238
Report, ``SARS-CoV-2 and NIAID-supported Bat Coronavirus
Research, An Analysis: Evolutionary Distance of SARS-CoV-2 and
Bat Coronaviruses Studied Under the NIH-supported Research
Grant to EcoHealth Alliance,'' National Institute of Allergy
and Infectious Diseases, October 20, 2021...................... 248
THE FEDERAL RESPONSE TO COVID-19
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WEDNESDAY, FEBRUARY 8, 2023
House of Representatives,
Subcommittee on Oversight and Investigations,
joint with the
Subcommittee on Health,
Committee on Energy and Commerce,
Washington, DC.
The subcommittees met, pursuant to call, at 10:01 a.m., in
the John D. Dingell Room 2123, Rayburn House Office Building,
Hon. Morgan Griffith (chairman of the Subcommittee on Oversight
and Investigations) presiding.
Members present: Representatives Griffith, Guthrie
(Subcommittee on Health chairman), Burgess, Latta, Bilirakis,
Johnson, Bucshon, Hudson, Carter, Duncan, Palmer, Dunn, Lesko,
Pence, Crenshaw, Joyce, Harshbarger, Miller-Meeks, Cammack,
Obernolte, Rodgers (ex officio), Eshoo (Subcommittee on Health
ranking member), Castor (Subcommittee on Oversight and
Investigations ranking member), DeGette, Schakowsky, Sarbanes,
Tonko, Cardenas, Ruiz, Peters, Dingell, Kuster, Kelly,
Barragan, Blunt Rochester, Craig, Schrier, Trahan, and Pallone
(ex officio).
Staff present: Sean Brebbia, Chief Counsel, Oversight and
Investigations; Jolie Brochin, Clerk, Health; Lauren Eriksen,
Clerk, Oversight and Investigations; Grace Graham, Chief
Counsel, Health; Nate Hodson, Staff Director; Peter Kielty,
General Counsel; Emily King, Member Services Director; Chris
Krepich, Press Secretary; Molly Lolli, Counsel, Health; Michael
Taggart, Policy Director; Lydia Abma, Minority Policy Analyst;
Hannah Anton, Minority Staff Assistant; Jacquelyn Bolen,
Minority Health Counsel; Austin Flack, Minority Junior
Professional Staff Member; Waverly Gordon, Minority Deputy
Staff Director and General Counsel; Tiffany Guarascio, Minority
Staff Director; Stephen Holland, Minority Senior Health
Counsel; Liz Johns, Minority GAO Detailee; Mackenzie Kuhl,
Minority Digital Manager; Una Lee, Minority Chief Health
Counsel; Will McAuliffe, Minority Chief Counsel, Oversight and
Investigations; Elysa Montfort, Minority Press Secretary; Juan
Negrete, Minority Professional Staff Member; Harry Samuels,
Minority Oversight Counsel; Andrew Souvall, Minority Director
of Communications, Outreach, and Member Services; Caroline
Wood, Minority Research Analyst; and C.J. Young, Minority
Deputy Communications Director.
Mr. Griffith. This joint hearing of the Subcommittee on
Oversight and Investigations and the Subcommittee on Health
will now come to order.
I now recognize myself for 5 minutes for an opening
statement.
OPENING STATEMENT OF HON. H. MORGAN GRIFFITH, A REPRESENTATIVE
IN CONGRESS FROM THE COMMONWEALTH OF VIRGINIA
Good morning, and welcome to this joint Oversight and
Investigations and Health Subcommittee hearing examining the
Federal response to COVID-19.
Before we start I would like to extend my condolences to
Assistant Secretary O'Connell of the Administration for
Strategic Preparedness and Response, who was planning to
testify here today, but, unfortunately, her sister passed away.
To date, more than 1 million Americans have died from
COVID-19. And on top of the loss of life, the pandemic brought
our country to a standstill. It cost our economy around $15
trillion. That equates to more than 200,000 small businesses
permanently closed due to the pandemic.
Schools were closed for far too long, setting children
behind in learning and damaging their social, emotional, and,
in many cases, their physical well-being. The Nation is still
recovering from the pandemic's impact and the damage it caused.
Given these losses, it is appalling that the last time we had
the heads of the public health agencies before us was March of
2021, almost 2 years ago.
We held a hearing last week with the Governmental
Accountability Office and other experts in the field of
pandemic and biological outbreaks where we discussed how being
able to quickly identify the root cause of a disease outbreak
or biological incident is crucial for a list of reasons,
ranging from countermeasure development to identifying what
activities may have been responsible for the pathogen outbreak.
While the worst of the COVID-19 pandemic is likely behind
us, there are a host of areas that we need to examine,
including actions taken and not taken by the Federal
Government, as well as how we address future pandemic
preparedness. By all accounts, the risk of catastrophic
biological incidents and infectious disease pandemics is
increasing. So it is critical that we understand in detail the
Federal response.
Since the heads of these agencies have not appeared before
us in quite some time, we have a lot of questions about the
Federal Government's response to COVID-19. Further, many of the
questions we have are due to a lack of response to
congressional inquiries regarding COVID-19.
One of the major concerns that has gone unanswered by the
National Institute of Health is the lack of compliance and
oversight into grant awards to EcoHealth Alliance. There are a
myriad of compliance issues surrounding EcoHealth and their
sub-award grants to the Wuhan Institute of Virology,
specifically for coronavirus research. The NIH has been
reluctant to answer our inquiries on issues such as EcoHealth
withholding data, potentially double billing the Federal
Government, and missing laboratory notebooks and electronic
files that were supposed to be delivered to the NIH by
EcoHealth.
This process does not have to be confrontational.
Republican leaders have sent a similar letter to entities such
as Boston University about an experiment involving a hybrid
COVID virus that attracted press attention. Boston University
fully cooperated, sending a written response letter directly
addressing the questions, producing about 2,000 pages of
documents, and providing a briefing to bipartisan staff. In
contrast, the NIH has not provided a satisfactory or complete
response. This is not acceptable.
Let me be clear: It is not acceptable to stonewall any
Member of Congress with oversight authority, whether that
Member be a Democrat or be a Republican, whether that Member be
in the minority or in the majority. The people of America
entrust us to find the answers and to provide oversight of the
Federal Government.
Another one of the many issues that we hope to address
today is the Centers for Disease Control and Prevention and
their rationale for masking and the closure of reopening
schools. We now have the findings of a comprehensive review of
multiple randomized controlled trials that show ``no clear
reduction in respiratory viral infection with the use of
medical surgical masks'' or, in fact, with the use of N95
masks. The conclusion of these studies makes me wonder what
evidence there was to justify forcing masking on our children.
The members of these subcommittees also have questions
about pathogen research being funded and conducted by Federal
agencies. In the United States we have recently seen high-risk
research done to intentionally modify pathogens such as NIH
experiments to enhance monkeypox virulence.
As a final note, I hope that our witnesses are more
forthcoming and cooperative as we move forward. At the end of
the day, we need to work together. The committee's majority is
willing to work with you and our Democrat colleagues
constructively to deliver solutions and pave a path forward for
America. We want to work in common purpose for the national
good, but we must be partners. You and your agencies must be
transparent, responsive, and cooperative in order for us to be
able to work together.
I thank the witnesses for being here today and for being a
part of this important discussion.
[The prepared statement of Mr. Griffith follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Griffith. All right. The Chair recognizes the Oversight
and Investigation Subcommittee ranking member, Ms. Castor, for
5 minutes for her opening statement.
OPENING STATEMENT OF HON. KATHY CASTOR, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF FLORIDA
Ms. Castor. Well, thank you, Mr. Chairman, and thank you
all for being here today. Thank you to our witnesses. Thank you
for all that you do to help keep Americans healthy, safe, and
well.
I am sorry that Assistant Secretary for Preparedness and
Response Dawn O'Connell cannot be with us today to share her
expertise, and want to express my sympathies for the southern--
sudden death in her family, and her loss. I appreciate, though,
that she did submit testimony and has agreed to respond to
written questions.
While all Americans are relieved that we are emerging from
the worst pandemic in our lifetimes--over 1 million American
lives lost--examining the response to COVID-19 will help us
prepare for the next public health emergency.
But if we take ourselves back to those early days of the
pandemic, I remember very well the public was scared. They were
uncertain. But public health experts and government and across
the country mobilized to better understand the virus, to
develop vaccines and treatments, and try to provide us with the
answers in the face of great uncertainty. They worked to follow
the science and improve guidance as we learned new information
about the virus and how to contain it. And they were trying
their hardest to save lives in the face of a new threat.
The tone from the top, however, was very different in the
earliest, most critical days of the COVID-19 pandemic. Then-
President Trump downplayed the threat, saying it was one person
coming in from China, and we have it under control, and it is
going to go away. He improvised from the White House briefing
room about potential treatments completely unsupported by
science and sometimes dangerous: hydroxychloroquine, bleach,
ultraviolet light. He repeatedly undercut the hard work of
public health officials who were up against one of the greatest
threats to our country in modern times.
Despite this, the Republican majority now somehow claims
that the Biden administration is to blame for reduced
confidence in public health institutions. Over the past 2
years, Republicans have repeatedly chosen to cast blame on the
Biden administration and career public servants to deflect from
their leader's early failures to contain the pandemic. And some
have actively spread misinformation and tried to hide vital
public health data.
At last week's hearing, I stated that I was hopeful that we
could avoid in this committee the kind of partisan attacks on
public servants that we have seen taking root in other
committees across the House and, instead, focus constructively
on how to strengthen our public health infrastructure for the
future.
Unfortunately, just one day after last week's hearing, this
committee sent a letter to NIH requesting a huge number of
documents and transcribed interviews of career staffers, while
implying that the agency is hiding information about the
origins of COVID-19.
Democrats, however, remain focused on how to restore and
maintain trust in the world's top health institutions
represented here today, give them the tools and the resources
they need to keep Americans safe and ensure that the public has
the best information based on solid science to make decisions.
Combating the virus is an enormous challenge. It continues
to mutate, and our response and strategies must evolve with it.
But what will remain constant is my firm support for strong
public health institutions which have saved countless lives.
I am immensely grateful for the witnesses' leadership. I
look forward to hearing how you plan on incorporating the
lessons learned from COVID-19 to further strengthen your
agencies and these important missions for the future.
[The prepared statement of Ms. Castor follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Ms. Castor. I yield back my time.
Mr. Griffith. I thank the gentlelady, and I now recognize
the chairman of the Health Subcommittee and the cochairman of
today's joint committee, Mr. Guthrie, for 5 minutes for his
opening statement.
OPENING STATEMENT OF HON. BRETT GUTHRIE, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF KENTUCKY
Mr. Guthrie. Thank you. I welcome all of you guys here
today. Good to have you here before us. And my condolences, as
well, to Assistant Secretary O'Connell and her family.
A little over a week ago, President Biden said his
administration would end the COVID-19 public health emergency
on May the 11th. And I am glad the President formally announced
he would end the PHE and relinquish the emergency powers.
However, after over 2 years into the Biden presidency,
Congress and the American people have little to no visibility
into nor input on the administration's pandemic response. And
we are going to change that today.
Today is the first of many opportunities for both members
of this subcommittee and, by extension, our constituents to ask
important questions about decisions made by our Nation's
leading health--public health officials in response to the
COVID-19 pandemic. My hope is that this work leads to reforms
that make us better prepared for pandemics and other public
health security threats in the future.
To start, public trust in our public health institutions is
at a low. And this is driven by Federal Government's misguided
and inconsistent preparation for and response to the COVID-19
pandemic. This is heightened by confusing, sometimes
conflicting communication and guidance coming from our public
health agencies.
In the earliest days of the pandemic, the CDC stumbled
rolling out testing kits, the Food and Drug Administration took
too long to authorize diagnostics, and the Strategic National
Stockpile was ill-equipped with deficient and expired
equipment. Thankfully, Operation Warp Speed was able to cut
through some of this red tape in bureaucracy to facilitate the
rapid development of vaccines and therapies that helped prevent
serious illness and death from COVID-19 and put us on the road
towards normalcy.
The pandemic has also exposed how our public health
agencies failed at their core functions to be good stewards of
taxpayer dollars. The National Institutes of Health flouted
HHS-wide rules on conducting proper oversight of potential
pandemic pathogen research. After living through COVID-19, the
origins of which still largely remain unknown, it is absolutely
clear that we must require strict Federal oversight of these
risky research projects.
And of COVID-19 origin, NIH's refusal to acknowledge any
suggestion that the COVID-19 virus may have traveled from
nature to a lab to humans has--only continues to fuel the
controversy and questions around it. To discover the truth and
instill confidence back in our Federal research programs, why
not engage in a robust, honest, and transparent dialogue and
investigation?
Instead, Federal officials worked with social media
companies to censure those who offered a differing viewpoint,
further fueling public distrust in our public health
institutions.
Unfortunately, the Biden administration's one-size-fits-all
approach to the pandemic has only made our response even more
challenging between inconsistent CDC COVID-19 guidance
policies, testing challenges, the FDA rationing of key
therapeutics, to name a few.
Among these mistakes carry significant real-world
consequences. Kids and parents were left without--with limited
options for in-person instruction because the Nation's largest
teacher's union offered line-by-line edits on reopening
guidance. This robbed our kids of the benefits of in-person
instruction and has had devastating effects on kids struggling
with anxiety and depression at unprecedented levels.
As members of this committee, we also cannot permit mission
creep into our public health agencies. We must ensure our
Federal partners are focused on their core mission of
preventing, preparing for, and responding to public health
emergencies.
Luckily, we have a chance to address many of these systemic
issues that hindered our Federal response to the COVID-19
pandemic. I look forward to working with my colleagues on this
subcommittee, and I look forward to working with our witnesses
here today to consider appropriate reforms as we work to
reauthorize the Pandemics and All Hazard Preparedness Act, or
PAHPA, that will be led by our colleague, Mr. Hudson. Doing so
could make a difference between life and death of millions of
Americans.
[The prepared statement of Mr. Guthrie follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Guthrie. I thank you and I yield back.
Mr. Griffith. I thank the gentleman for yielding back. I
now recognize the ranking member of the Health Subcommittee,
Ms. Eshoo, for her 5-minute opening statement.
OPENING STATEMENT OF HON. ANNA G. ESHOO, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Ms. Eshoo. Thank you, Mr. Chairman, and good morning to the
witnesses. Thank you for being here today.
On March 11th, 2020, the World Health Organization declared
the coronavirus a pandemic. Now, 3 years later, we have the
benefit of hindsight, and we know we were unprepared. We lost 1
million precious souls in our country: grandparents, mothers,
fathers, siblings, and some of our colleagues.
Now we have to do everything possible to prepare our Nation
for new and emerging threats to public health. We have to learn
from the mistakes made, including the faulty coronavirus
testing kits that the CDC insisted on developing on their own,
which allowed infections to spread undetected; the bare
cupboards of the Strategic National Stockpile, leading to our
Nation's heroic healthcare workers wearing trash bags as
protection; a long legacy of racial health disparities and a
weak social safety net that allowed the virus to
disproportionately infect and kill Black, Hispanic, and
indigenous people; a chronically underfunded public health
system whose poor data undercut the government's response to
COVID; and confusing and opaque public health communications,
which bad actors took advantage of to spread misinformation and
discourage lifesaving vaccinations.
It is also clear where the Federal Government succeeded in
its response. Because of the work NIH was already doing when
the pandemic began, researchers were able to develop a safe,
highly effective vaccine for the new virus very quickly. COVID
vaccines have resulted in 120 million fewer infections, 18\1/2\
million fewer hospitalizations, and 3.2 million lives saved.
Nimble decision-making by the Federal Government and Congress
allowed more Americans to get health coverage, Medicare to
cover telehealth and at-home care, and the FDA to use emergency
authorizations and flexible clinical trial designs to provide
treatments and vaccines quickly.
Three years later, our Nation is finally recovering from
the pandemic. Now we have to incorporate the lessons we have
learned to strengthen our public health infrastructure before a
new threat is upon us. Our Nation's health and security depend
on this.
I look forward to the testimony from the three heads of the
agencies that are here today, and--that their testimony be
highly instructive to us on how we can improve our Federal
response going forward.
[The prepared statement of Ms. Eshoo follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Ms. Eshoo. And with that, Mr. Chairman, I yield back the
balance of my time.
Mr. Griffith. I thank you and now recognize the chair of
the full committee, Mrs. McMorris Rodgers, for her 5-minute
opening statement.
OPENING STATEMENT OF HON. CATHY McMORRIS RODGERS, A
REPRESENTATIVE IN CONGRESS FROM THE STATE OF WASHINGTON
Mrs. Rodgers. Thank you, Chair Griffith. The questions that
we are asking here today are the questions that we hear from
people in our communities every day. As the people's elected
representatives, we have a responsibility to conduct oversight.
President Biden's public health leaders are here today
because they have broken the American people's trust.
I will start with you, Dr. Tabak. I was once a huge
supporter of NIH. The overall lack of responsiveness, the
suppression of dissenting voices and the COVID origins
investigation, the frequent mixed messaging on health
precautions--the NIH is falling short of its goal of integrity
and accountability. For the past 2 years we have pressed for
answers about what kind of research you are funding with
taxpayer dollars and what sort of oversight you are doing to
ensure funds are not misspent. Your cooperation has been
abysmal.
Next, Director Walensky and the Centers for Disease Control
and Prevention. Your guidance was used by the Federal
Government to justify mandates that have more parents
questioning routine vaccination. Your guidance, influenced by
teachers unions, kept schools closed. Your guidance, using
unreliable studies, was used to justify mask mandates on our
kids. We know these weren't decisions based upon best science
and data from around the world. Now our children are paying the
price. Academically, they have been set back for years.
Emotionally, they are living--we are living through the most
severe youth mental health crisis we have seen. And physically,
cases of type 2 diabetes and obesity in children has surged.
Dr. Walensky, the CDC does not need more authority. It
needs robust oversight. It has always operated without a
congressional authorization, and it is going to change.
Dr. Califf, the FDA has failed to alleviate the concerns
about the vaccine. I will note that, before imposing
authoritarian vaccine mandates as President, candidate Biden
made statements about the vaccine that did lasting damage. But
top vaccine review officials Marion Gruber and Phil Krause left
FDA as the Biden administration was working to authorize
boosters, doses which many people have not--may not have
needed.
And beyond the vaccine, FDA inspections of foreign sites
are woefully lacking. Innovators can't get the guidance they
need to approve standards, and patients are the ones left
without the innovation or supply of products they need.
Finally, regarding Assistant Secretary Dawn O'Connell's
absence. I understand why she is not here today, and I extend
my deepest sympathies, condolences to her and her family.
However, the Administration for Strategic Preparedness and
Response is the top official in public health emergencies.
ASPR's job is to be prepared. So it is unacceptable that
another leader from the administration wasn't prepared to be
here today in the Assistant Secretary's place. There are no
excuses, especially given the enormous amounts of resources and
responsibilities we have allocated to ASPR over the years.
My message today to all the administration public health
officials is that this is going to be a long road. Trust is
broken a lot faster than it is built. And many will say that
the American people deserve an apology, but they deserve much
more. I think about every person who lost a loved one to COVID-
19, the people who died alone because of COVID-19 policies, the
frontline workers who sacrificed but were still forced out of
their jobs because of vaccine mandates, and the children
isolated and set back from school closures. Surely, we can all
agree that for them we cannot repeat the mistakes of the
pandemic response. They deserve full accountability and
transparency, nothing less.
That is the bare minimum of what we expect today so that we
can begin to heal, restore trust, and better prepare for the
future.
[The prepared statement of Mrs. Rodgers follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mrs. Rodgers. Thank you.
Mr. Griffith. I thank the gentlelady and now recognize the
ranking member of the full committee, Mr. Pallone, for his 5
minutes.
OPENING STATEMENT OF HON. FRANK PALLONE, Jr., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. Thank you, Chairman Griffith. Today we will
hear from the government officials leading both the ongoing
COVID-19 recovery and the efforts to bolster the Nation's
public health system for the long term, which is our best
defense against future pandemics. And this is no simple task.
When President Biden came into office, he inherited a year-
old pandemic from the Trump administration, during which public
health experts were routinely ignored and maligned,
hamstringing the government's ability to respond. Deaths were
soaring faster, and those involved in COVID-19 response were
frequently forced to correct President Trump's misinformation
about the virus, which distracted from the important goals for
distributing newly authorized vaccines.
It is unfortunate that a national emergency so quickly
turned into a partisan issue at a time when we most needed to
come together.
Now, over the last 2 years, the Democratic Congress and the
Biden administration invested in a nationwide vaccine campaign
and COVID test distribution that accelerated our recovery.
After facing new challenges from more aggressive COVID-19
variants, death rates and hospitalizations have once again
fallen across the Nation. However, we must continue to be
vigilant and monitor new variants, improve vaccination rates,
and ensure that an uptick in cases does not occur.
At the same time, we know that COVID-19 is not the last
pandemic we will face, and we need to be sure we are
incorporating the lessons learned from the pandemic into our
public health infrastructure. And today we will hear agency
plans to do just that.
Now, a strong public health response includes effective
communication and access to accurate, reliable information and
includes consistent investment in scientific research that
leads to development of safe and effective vaccines and
treatments. It includes establishing partnerships between the
Federal, State, and local governments and the private sector to
ensure a smooth response when a public health threat arises.
We must also address the racial and ethnic disparities that
affect our ability to mount an equitable response to a
pandemic. These inequalities predated COVID-19 but were
magnified during the pandemic. And it is unacceptable in this
day and age that the burden of death and disease continues to
fall disproportionately on people of color.
Unfortunately, later today we are on the floor of the House
taking up yet another partisan bill that seeks to roll back
COVID protections. This is the third bill from the GOP that
seeks to roll back COVID protections at a time when COVID
continues to spiral and variants are a real danger.
I will remind my colleagues there are 500 people still
dying every day from COVID. This is still with us.
And when I was at Rules earlier this week on this third
bill, there were some on the right--and that does not include
members of this committee, I am not talking about our
chairwoman, or Chairman Guthrie, or Dr. Burgess--but there were
some extremists on the right who continue to rail against
vaccines. It is very dangerous. I am not, you know, saying this
is true for most Republicans, but there are certainly some on
the right that give the impression that the vaccines are not
safe, that they are not effective, and that somehow people
shouldn't take them. And I just want to bring that up, because
it disturbs me greatly. I was very disturbed when I went to
Rules to hear that over and over again.
And I think that, again, I will remind my colleagues that
the bill we are taking up today that says that global
travelers, foreigners that come to the United States, don't
need vaccines--well, that decision, the decisions about the
public health emergency, about vaccine mandates, those should
be made by the people in front of us at this table. Those
decisions should be made by the public health experts who have
the science, and not by Congress. We don't have the expertise,
in my opinion, to make those decisions, which is why I continue
to oppose these rollbacks of our efforts to deal with the COVID
crisis.
And when Republicans put politics over science, it
seriously undermines our ability to combat this pandemic and
the hard work that these public agencies do every day. So I
hope that we can get back to the business of regular order, of
the committee taking on the Nation's challenges. None of those
three bills came through this committee. None of them had
regular order.
But we have a lot to do this year, and we have to
reauthorize the Pandemic and the All Hazards Preparedness Act,
which is set to expire in September. PAHPA has been a
bipartisan effort in the past, and I hope that we can be guided
by that precedent, so that we can make sure that our Nation is
in the strongest position to address a future crisis.
[The prepared statement of Mr. Pallone follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Pallone. And with that, Mr. Chairman, I yield back.
Mr. Griffith. I thank the gentleman. We now conclude with
Member opening statements.
The Chair would like to remind Members that, pursuant to
committee rules, all Members' opening statements will be made a
part of the record.
We want to thank our witnesses for being here today and
taking the time to testify before the subcommittees, these
subcommittees.
Each witness will have the opportunity to give an opening
statement, followed by a round of questions from Members. Our
witnesses today are Dr. Larry Tabak, the senior official
performing the duties of the Director of the National
Institutes of Health; the Honorable Robert Califf, Commissioner
of Food and Drugs, U.S. Food and Drug Administration; and Dr.
Rochelle Walensky, Director of Centers for the Disease Control
and Prevention.
We appreciate all of you being here today, and now we will
swear you in. If each of you could stand.
As you know, the testimony that you are about to give is
subject to Title 18, Section 1001 of the United States Code.
When holding an investigative hearing, this committee has the
practice of taking testimony under oath. Do any of you have an
objection to testifying under oath?
Let the record reflect no one objected.
Further, you are also advised, under the Rules of the House
and the rules of this committee, that you are entitled to be
advised by legal counsel. Do you desire to be advised by
counsel during your testimony today?
Let the record reflect that no one requested legal counsel.
In that case, if the witnesses already--have already stood,
if you will raise your right hand, I will swear you in.
[Witnesses sworn.]
Mr. Griffith. Thank you very much. You all may be seated.
I now recognize Dr. Tabak for 5 minutes to give an opening
statement.
Dr. Tabak. Our clock is not resetting.
Mr. Griffith. The clock isn't--he is right. We need more
than 23 seconds for him.
[Laughter.]
Mr. Griffith. I appreciate that. And all of you know the
code of green, yellow, and red. Thank you.
Go ahead.
STATEMENTS OF LAWRENCE A. TABAK, D.D.S., Ph.D., SENIOR OFFICIAL
PERFORMING THE DUTIES OF THE DIRECTOR, NATIONAL INSTITUTES OF
HEALTH; ROCHELLE P. WALENSKY, M.D., M.P.H., DIRECTOR, CENTERS
FOR DISEASE CONTROL AND PREVENTION; AND ROBERT CALIFF, M.D.,
COMMISSIONER OF FOOD AND DRUGS, FOOD AND DRUG ADMINISTRATION
STATEMENT OF LAWRENCE A. TABAK, D.D.S., Ph.D.
Dr. Tabak. Thank you, Chairs Rodgers, Griffith, and
Guthrie, and Ranking Members Pallone, Castor, and Eshoo, and
distinguished committee members. I am honored to be here today
to discuss NIH's role in responding to COVID-19 and other
public health threats.
Biomedical research supported by NIH enabled the rapid
development of lifesaving vaccines, diagnostics, and treatments
for COVID-19. While we take pride in these achievements, our
work must continue. We are leveraging what we have learned from
this pandemic to prepare for future threats.
Many of you will recall that we had shots in arms in less
than 1 year, a record time for vaccine development. But I
remind you that decades of research by thousands of scientists
is what enabled us to rapidly develop COVID-19 vaccines in
2020. Prior to the pandemic, NIH-supported scientists spent
years studying different coronavirus proteins to define
potential therapeutic targets. Researchers learned how to
stabilize a key surface protein found on coronavirus, the spike
protein, so that it would optimally stimulate our immune
system, and this forms the basis of the COVID-19 vaccines.
Structure-based vaccine design, alongside novel vaccine
platforms such as mRNA, are game changers for vaccine
development. In fact, these same tools have us on the cusp of
safe and effective RSV vaccines for key populations.
NIH is playing an important role in the administration's
national biodefense strategy. For example, we are developing
next-generation COVID-19 vaccines, including a nasal spray or
mucosal vaccine that could do a better job of preventing
infection and transmission of SARS-CoV-2, as well as
pancoronavirus vaccines designed to provide broad protective
immunity against emerging SARS-CoV-2 variants, as well as other
coronaviruses with pandemic potential.
We are also working to shorten the timeline between a newly
emerging pathogen and development of lifesaving products by
studying prototype viruses within other viral families that
have the potential to cause significant disease.
NIH has also played a significant role in speeding the
development, scaling up, and delivery of COVID-19 diagnostic
tests. In April 2020 we launched the Rapid Acceleration of
Diagnostics, or RADx, initiative as a call for scientists and
engineers across the Nation to bring their most innovative
ideas to the table. RADx has helped produce over 5.8 billion
COVID-19 tests and test products. Thanks in part to NIH's work,
the 2020 refrain of ``Where can I get a test?'' is no longer
heard. RADx efforts continue with a new focus on developing
more accessible tests--for example, for people who are blind or
have low vision.
NIH's work on COVID-19 is far from over. While most people
recover quickly from COVID-19, some people experience long
COVID, with ongoing or new symptoms beyond the acute phase of
infection.
NIH began their Researching COVID to Enhance Recovery, or
RECOVER, Initiative, to better understand Long COVID, and to
identify effective treatments and potential ways for preventing
it. This program brings together interdisciplinary researchers
and patients. Advice from patients has guided the initiative
goals and protocols. RECOVER is following a large cohort of
children and adults at various stages of recovery from SARS-
CoV-2 infection over time to gather data that will help us fill
knowledge gaps such as understanding what makes some people,
but not others, vulnerable to long COVID.
The program will also launch clinical trials in the coming
months to evaluate whether certain interventions help improve
outcomes for people with various Long COVID symptoms. The
information gained from this initiative will help those whose
lives have been upended by the lingering effects of COVID-19.
To close, the more we know, the better positioned we will
be to respond to the next infectious threat. NIH's response to
the COVID-19 pandemic shows that long-term investment in basic
and applied biomedical research pays off.
Thank you for your time, and I welcome your questions.
[The prepared statement of Dr. Tabak follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Griffith. I thank the gentleman. I now recognize Dr.
Walensky for her 5-minute opening statement.
STATEMENT OF ROCHELLE P. WALENSKY, M.D., M.P.H.
Dr. Walensky. Chairs Rodgers, Griffith, and Guthrie,
Ranking Members Pallone, Castor, and Eshoo, and distinguished
members of the committee, it is an honor to be with you today.
Today our Nation is in a much different position than we
were at the start of the pandemic. Just 3 years ago, we were
recording the first COVID-19 cases that sadly resulted in as
many as 15 to 20,000 deaths per week. We were limited in
treatments, and vaccines were not yet available.
Two years ago, we began the largest vaccination program in
the history of this country, and along the way we have learned
how to adapt to and manage an evolving virus. Thanks to 670
million vaccines administered in the United States and the work
of those at CDC and thousands of Federal, State, local, and
private-sector partners, and because of the more than 100
million infections Americans have endured and survived, we have
built a wall of immunity and expanded the tools available to
decrease the risk of severe disease and death from COVID-19.
This past week, hospital admissions and deaths are down,
both nearly 9 percent, from the previous week. Though we have
made remarkable progress, we also had nearly 3,500 deaths from
COVID-19 in the last week. These are our family members, our
neighbors, and friends, and colleagues. Their deaths are tragic
and make it clear that we have more work ahead.
Entering the fourth year of our activated response to
COVID-19, we are moving faster than ever to deliver information
to the public. Just 3 months after the bivalent vaccine was
recommended, CDC scientists published data on vaccine
effectiveness against symptomatic infection, and 2 weeks later
followed up with data on how well these vaccines work to
prevent severe disease and hospitalization.
Only 1 month after we identified the latest subvariant, XBB
1.5, through our genomic surveillance, CDC published data to
demonstrate that the bivalent vaccine was just as effective as
it was against prior Omicron variants. These data continue to
build on strong evidence that the best way to prevent severe
disease and death from COVID-19 is to be up to date with your
vaccines, including the bivalent vaccine.
Our increased speed is the result of an intentional and
proactive effort to address both the challenges and
opportunities at CDC. This is the work of CDC Moving Forward,
an initiative I launched after an extensive agency review with
internal and external input. We are focused on six key areas of
improvement: sharing scientific findings and data faster;
enhancing laboratory scientific--science and quality;
translating science into easy-to-understand policy;
prioritizing communications; developing a workforce prepared
for future emergencies; and promoting results-based
partnerships.
Two weeks ago, I announced a reorganization to reduce
bureaucracy, break down silos, promote public health
capabilities, and increase accountability. This strengthens the
foundation of the agency to tackle our focus areas. But we know
that moving boxes around alone will not modernize CDC. We are
equally focused on how we do our work, on our systems and
processes internally.
For example, we reduced internal scientific review times by
50 percent and are publishing our science and data faster. We
were the first in the world to produce and share data showing
real-world performance of the JYNNEOS vaccine against mpox. We
are investing in accessibility and communications, fostering
clearer public health communications by rebooting the front
door to CDC, streamlining content to make it easier for
American people to find what they need. And we have established
a CDC Ready Responder Program to better prepare CDC's workforce
to engage at a moment's notice to future health threats, no
matter where they work at CDC, and to sustain that engagement
throughout a response.
We are committed to this work and more. But to maximize our
potential and to fully protect the Nation's health, we also
need critically important help from you in Congress.
Workforce authorities, such as strengthening student loan
reimbursement authority, expanding danger pay to appropriately
compensate our staff when put in harm's way, and providing
flexibility to quickly move staff to respond to a threat would
provide the opportunity to fully turn CDC into a response
agency.
We need data authorities so that we can access better
quality, standardized, and timely data so individuals and
families can make informed decisions about their health and
policymakers can better target resources and respond to
threats.
CDC must be the most advanced and capable agency in the
world when it comes to disease detection, tracking, and
forecasting. Data authority coupled with investments in our
data modernization initiative will make that possible.
I am committed to working with you to find common ground to
support public health and to make strides toward achieving
health security for all Americans. Thank you, and I look
forward to your questions.
[The prepared statement of Dr. Walensky follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Griffith. I thank you and now recognize Dr. Califf for
5 minutes for his opening statement.
STATEMENT OF ROBERT CALIFF, M.D.
Dr. Califf. Good morning, Chairs Rodgers, Griffith, and
Guthrie, Ranking Members Pallone, Castor, and Eshoo, and
members of the subcommittees. Thank you for the opportunity to
be here today to update the American people on our COVID-19
response. FDA appreciates your partnership in ensuring our
country overcomes this pandemic and in preparing for future
threats.
This pandemic underscores the importance of a swift and
agile response coordinated across all levels of government and
in collaboration with the private sector. While the pandemic
has caused great loss across our Nation, through extensive
communication, dexterity, and innovation, we have been able to
mitigate the impact of the pandemic and prevent innumerable
illnesses and deaths.
Most unfortunately, the proven effectiveness of authorized
and approved vaccines and therapies have been undercut by a
constant flow of misinformation, causing many Americans to
forgo lifesaving treatments, leading them to many unnecessary
deaths and hospitalizations. Nevertheless, FDA employees have
poured their efforts into COVID-19 response to protect the
American people. I am grateful for their tremendous work, and
to Congress for your support of these efforts.
I want to provide a brief update on FDA's efforts related
to COVID-19 medical products.
First, vaccines. Currently, there are three authorized
monovalent vaccines, two approved vaccines, and two bivalent
vaccines that meet FDA's expectations for safety and
effectiveness. The current vaccines reduce the risk of
contracting symptomatic infection and remain highly effective
at preventing serious clinical outcomes associated with SARS-
CoV-2 infection, including hospitalization and death. Staying
up to date on COVID-19 vaccination is the best thing Americans
can do right now to protect themselves and their families from
the risk of becoming seriously ill or dying from COVID-19.
Second, diagnostic tests. FDA remains focused on speeding
the process to get appropriately accurate and reliable tests in
the hands of all Americans who want one. The agency prioritized
at-home tests since the beginning of the pandemic, authorizing
30 over-the-counter at-home tests, resulting in hundreds of
millions of additional tests available monthly to American
consumers. Importantly, the agency has also detected numerous
and accurate tests that would have done substantial harm if
allowed to have unfettered access to the market.
FDA also continues to issue EUAs as appropriate for other
types of devices and facilitates the availability of critical
devices and supplies. Today we have issued EUAs or provided
traditional marketing authorizations to over 2,800 medical
devices for COVID-19, which is 15 times more EUAs than all
other previous emergencies combined.
Third, we continue to expand the country's arsenal of
COVID-19 therapies and have facilitated the development and
availability of three approved drugs to treat COVID-19, and
EUAs for 14 therapies.
It is also important to note our critical supply chain
work, which has protected consumers by preventing medical
products that do not meet import requirements from entering the
country. This includes continuously surveilling the medical
product and food supply chains for potential shortages,
disruptions, and contaminated or fraudulent products, with
focused examinations on COVID-19 relief supplies.
The agency remains committed to continuing the use of every
tool available to us to continue to mitigate the threat of this
virus and others that we have simultaneously worked to
counteract, such as mpox, RSV, and pandemic influenza. Many of
these tools are thanks to the work of Congress and your
understanding of the importance of preparation and addressing
the needs of our supply chain before an emergency strikes.
FDA employees are anything but complacent, and they will
continue to work to make sure that we are even more equipped to
address any future threats. Preparing for future emergencies
depends on using the many strategies that led to a successful
response, as well as the establishment and refinement of
authorities and flexibilities that allow the agency to identify
and mitigate risks while promoting innovation outside the
public health emergency.
It is essential that we improve our system for evidence
generation. That is, doing the right clinical trials and having
access to the data that Dr. Walensky has brought up. For
example, the COVID-19 pandemic also underscored the importance
of both diagnostic test access and test accuracy, and the
critical need for a modernized regulatory framework that
applies to all in vitro diagnostics. After years of
collaborative work, including with leaders of this committee,
we believe the VALID Act would achieve this goal, and is
appropriately balanced. Modernized authorities would enable us
to act faster, prevent problems, and allow for greater insight
into FDA's regulated products for greater safety.
We look forward to continuing working with you to ensure a
continuation of our COVID-19 response success and future
readiness. Thank you, and I look forward to your questions.
[The prepared statement of Dr. Califf follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Griffith. I thank the gentleman. We now have concluded
our testimony. I appreciate all the witnesses giving their
testimony. We will move into questions and answers, and I will
recognize myself for the first 5 minutes of questions.
Dr. Tabak, I, along with now-Chairs Rodgers and Guthrie,
have sent the NIH 14 letters requesting information. Those
letters ranged in date from March 18, 2021, to November 30th,
2022, and most have gone completely unanswered. We received
responses from other agencies, such as the CDC, to our letters.
It appears there was a standing policy at the NIH to
disregard letters from the minority members of this committee.
Is that true, yes or no?
Dr. Tabak. No.
Mr. Griffith. So it is just incompetence that caused 14
letters to go basically unanswered. I will take that as a
given.
We sent you a letter on February 2nd last week requesting
documents and information from the NIH related to the COVID
origins and the EcoHealth Alliance grant to support our
legislative efforts on pandemic preparedness and NIH grant
management. NIH sent us over 580 pages of documents last night
after the close of business and shortly before the President's
State of the Union address that consisted mostly of repeat
documents already given out or made public. That is not true
cooperation.
So I ask you, is the NIH going to fully cooperate with our
requests?
Dr. Tabak. We will continue to cooperate fully.
Mr. Griffith. You will cooperate on this request. Thank
you.
We sent the NIH a letter on November 30th, 2022, asking you
not to destroy evidence related to COVID. Last week we sent
another letter asking that you ``take all reasonable steps to
prevent the destruction or alteration, whether intentionally or
negligently, of all documents, communications, and other
information, including electronic information and metadata that
are or may be responsive to this congressional inquiry.''
Will you vow to follow this request and not destroy these
vital records? Yes or no.
Dr. Tabak. Yes.
Mr. Griffith. Thank you. Even though the NIH suspended
EcoHealth's grants in July of 2020, before our COVID-19
inquiries began over grant noncompliance concerns, and later
that it was found that EcoHealth did not follow important grant
terms, the NIH subsequently gave a new grant to EcoHealth in
September of 2022.
Why would you allow a company who breached their contract
with the NIH and failed to comply with some important reporting
requirements to get more of the American taxpayer dollars?
Dr. Tabak. We follow process. They were put under
advisement of these deficiencies. They have been working with
us to correct them, and that is why we proceeded.
Mr. Griffith. But they can't correct the information that
they didn't require their partners at the Wuhan lab to give
them to give you 3 years later. So we don't have the
information that we learned last week was important in
determining both the origins and how to treat those origins at
an early date. They failed in a major respect. How can that
possibly now comply with your processes?
Dr. Tabak. And we have corrected with them their
administrative shortfalls, and continue to work with them.
We are unable to disbar an organization that----
Mr. Griffith. So do you want authority from Congress to be
able to disbar an organization that breaches their contract and
fails to get us information from a subcontractor that may have
had vital information in helping us to respond to the COVID-19
outbreak?
Dr. Tabak. The shortcomings of the Wuhan Institute of
Virology have been noted in the GAO report, as you know.
Mr. Griffith. I know.
Dr. Tabak. And they recommend that disbarment be
considered. And this is something that, you know, we will, of
course----
Mr. Griffith. Do you need new authority from us to disbar?
Dr. Tabak. We do not disbar. That--the disbarment official
sits in HHS.
Mr. Griffith. All right. Should we add financial penalties
to NIH contractors to ensure stricter compliance if they fail
to meet their contractual obligations into--and to fail to give
you vital records? Do they need a financial incentive that is a
negative incentive?
Dr. Tabak. We can put such incentives, if you will, or
disincentives in our terms of condition.
Mr. Griffith. You can or cannot?
Dr. Tabak. We can.
Mr. Griffith. You can? I suggest you do so.
Should we add financial penalties to the NIH if they fail
to do oversight on important research being done with the
American taxpayer dollars?
Dr. Tabak. I can't speak to that.
Mr. Griffith. All right. Dr. Tabak, from 2015 to 2019
EcoHealth Alliance gave multiple--NIH grantee for coronavirus
research--gave multiple subaward transactions to the Wuhan
Institute of Virology. EcoHealth has serious deficiencies, as
we have discussed. The Office of the Inspector General even
confirmed this in a recent report.
How do you allow that to happen without consequences?
Dr. Tabak. The consequences were the initial suspension,
reinstatement, suspension of the grant. And we have worked with
the primary grantee, EcoHealth Alliance, to get them back into
proper order.
Mr. Griffith. It does not seem sufficient to this Member.
I yield back to myself and now recognize the gentlelady,
Ms. Castor, ranking member of this subcommittee, for her 5
minutes.
Ms. Castor. Thank you, Mr. Chairman.
The witnesses here today represent the most important
scientific institutions in our fight against the COVID-19
pandemic and other diseases, and I greatly appreciate your work
and the work of countless health professionals, everything that
you have done in facing down this virus and your work to save
lives.
Unfortunately, President Trump's early minimization of
COVID-19, followed by numerous instances of pushing
misinformation, eroded public confidence in these vital public
health and health institutions at a time that we relied on them
the most.
This wasn't limited to the White House, however. In
Florida, Governor DeSantis and his surgeon general have peddled
conspiracy-driven propaganda that runs counter to the consensus
of every major scientific and health organization. The Governor
has actively discouraged public health protocols and vaccines.
He has hidden data. He has withheld aid. He has put dangerous
policies in place that have cost lives and have put Florida
children and families at risk.
So you have an enormous job to combat this misinformation
and rebuild the public trust. So I would like to hear what you
all are doing to ensure that we are operating on proper
science, and that the public has trust in your institutions.
Dr. Tabak, I will start with you.
Dr. Tabak. One of the programs that we have established is
known as CEAL. It is a community engagement alliance where we
do localized approach, partnering with faith and community
leaders, particularly in underserved communities, to address
all questions about COVID vaccines, therapeutics, et cetera.
In the RECOVER trial, we are engaging patients and
communities broadly, again, trying to build--work with them
through trusted community voices.
Ms. Castor. Dr. Walensky, I will ask you the same question,
but I know you have undergone a very extensive review. It has
been called ``unflinching'' in your examination of past
mistakes by the CDC and how you improve going forward. You have
done some reorganization. So how are you working on building
public trust in the agency's mission?
Dr. Walensky. Thank you. Yes. Obviously, much of--some of
the challenges, or challenges this administration inherited,
they have been longstanding challenges at the CDC, and we have
taken this opportunity to learn from what we--the challenges of
the COVID-19 pandemic. That includes sharing our scientific
data faster, enhancing our laboratory quality, translating that
science into clear, concise communications.
I do want to highlight the real importance of mis- and
disinformation and how it has undermined our vaccine efforts.
It is the case that we anticipate vaccine rates have gone--
well, we have seen vaccine rates of incoming children into
kindergarten have gone down from 94 percent to 93 percent just
in this last year. That is a quarter of a million children not
coming to kindergarten with being up-to-date in their vaccines.
We are doing a lot of work at CDC, but this is not something
that CDC can do alone. It is going to take all of our agencies.
It is going to take all of the government, and every single one
of us has a role in mis- and disinformation.
Ms. Castor. I have seen it in Florida. The vaccination
rates for children are down, and I know it is a direct result
of a lot of this, the scare tactics and misinformation.
Dr. Califf, I am going to ask you to respond for the
record, because I would like to ask Dr. Walensky about the
CDC's data modernization initiative.
So we are--it is so important that we aim to get--to
empower the agency to get better, faster, more actionable
insights on public health data. But I heard from folks back in
Florida and all across the country it was so outdated. We have
given the CDC funds to modernize it. I know that is just a drop
in the bucket. So how--what are you doing to ensure that the
public has the most accurate data that is up to date?
Dr. Walensky. So just to give you a scope of the problem,
it took us 6 months to get data use agreements for--to receive
data during COVID-19, and it was over 100 data use agreements.
So we are working through our data modernization efforts to
have a singular highway through which data passes so that data
from your districts can come to CDC, and then we can give it
back to your districts----
Ms. Castor. And not by fax machine.
Dr. Walensky. No, not by fax machine. And, in fact, in
those districts where we have seen--where we have stopped using
the fax machines, there are data to suggest we saved 140
million person hours, so that we know that these highways will
work.
And then we can receive those data from your districts, and
we can give those data back to you so you can see what is
happening in your districts and the districts around you, what
threats might be at your front door.
Ms. Castor. So we save lives and save money at the same
time. It sounds good. Thank you so much.
I yield back.
Dr. Walensky. Thank you.
Mr. Griffith. The gentlelady yields back. I now recognize
the chairman of the Health Subcommittee, Mr. Guthrie.
Mr. Guthrie. Thank you very much. I appreciate it.
And responding to what our ranking member said, we
obviously have to listen to experts, because we are not
experts. But we don't have to give away our right to oversight.
We are responsible for oversight of what is going on at the
agencies. That is in our purview. I know we didn't have
hearings when they were in the majority, but we are now.
And quite honestly, Dr. Walensky and Dr. Califf, you all
have reached out to me, so I think you all appreciate our role
in oversight, and that is noted and appreciated.
And so--and the reason is this, and as an example we are
going to talk about school closure. I think we talked of that
before.
In summer of 2020, the Kentucky schools were getting ready
to start back again. This is before you guys were in office, I
understand that. And then the Governor delayed, said--told
schools they couldn't open. Then he went to a point and said,
``OK, I am going to suggest you don't open, or ask you not to
open, but not force it.''
We had school systems say, ``We have been spending the
summer getting ready. We are going to get open, we are going to
stay ready.'' So they met in the fall of 2020, a handful of
school systems in my district. One superintendent didn't want
to meet, but the nonexperts who are elected school board
members voted down, and they met. And the kids were better off
for what--the decisions that the nonexperts made.
And the Governor even pointed out our school system, some
of my superintendents by name, for--``You all are going to
cause problems, you are opening your school system.'' Well, it
didn't take too long to understand--not that there weren't any
cases in our school system, but none traced to the school
system. And we learned pretty quick the kids weren't super-
spreaders like they are with the flu. And not a single person
from Frankfort went to one of our schools that were open every
day and said, ``Is there some--what are you guys doing to make
it work?''
And so then you fast forward to, you know, 2021, and then
the guidance, Dr. Walensky, coming out from CDC. That was
highly reported, heavily reported that teachers union were
involved in a line-by-line edit of the guidance. And it would
have been helpful if one of my superintendents would have had
the opportunity to apply.
So it gets not just to that situation, but also you're the
experts. But how do we--how is it transparent? How do we know?
How can we have confidence in guidance, when we have school
systems meeting, and meeting effectively, but then guidance
came out that a lot of people used to keep the--I know you
didn't order the school systems to close, but they used your
guidance to do so.
Dr. Walensky. Yes, I appreciate the opportunity to speak to
this.
So I came in on January 20th, and it was my--among my
highest priorities to get our schools open. And it
demonstrated--the work that we did was demonstrated to be
successful. So when I came in, 46 percent of schools were open.
By the end of May we had 63 percent of schools fully open. And
by September we had 94 percent of schools fully open.
Among the first guidances that I released, I think within 3
weeks of my arrival, was how to get our schools open. That is
the guidance to which you are referring. And I would just like
to speak to how we put that guidance together. We take subject
matter experts, we have our scientists review the data, review
the science----
Mr. Guthrie. Did the teachers union have specific--I have
just got so much time, I am sorry--but did the teachers union
have specific access to it----
Dr. Walensky. So----
Mr. Guthrie [continuing]. That others didn't?
Dr. Walensky. In a penultimate version, what we do is we
look at our key stakeholders. We reached out to over 50 key
stakeholder groups. That included parents, that included
superintendents, that included teachers, because we really need
to make sure that those stakeholders can actually implement on
the guidance that we put forward.
There was a key piece missing in that penultimate version,
and that is what do you do for teachers who are
immunosuppressed, those teachers who are getting breast cancer
treatment, teachers who have had a heart transplant. That piece
had been missing. It was the reason that we requested that
feedback, is so that we can say, ``What is missing to
implement?'' And it was that piece that was changed after those
discussions.
Mr. Guthrie. So are you going to do things differently, or
do you feel like----
Dr. Walensky. So we are strengthening our processes as to
how we standardize and do that outreach, but I think that
outreach is--continues to be critically important. We need to
know how the end users will receive our guidance to understand
what is implementable for the----
Mr. Guthrie. We want to make sure that everybody has access
from all parties----
Dr. Walensky. And we did speak to superintendents and
parents. We spoke to over 50 groups.
Mr. Guthrie. Thank you.
And Dr. Califf, I understand that FDA has--that people have
said it has really good guidance practices. Can you speak to
that, to your guidance practice, when you get input from folks
moving forward?
Dr. Califf. As I think you know, there is a draft guidance
that is put out, and then comments are achieved from the
public, really, at that point. But during the course of
drafting guidances we may have discussions with interested
parties. Many of our guidance, as you know, deal with the
medical products industry, for example. And we do talk with
people, because we can't--you know, can't do these things in a
vacuum.
Mr. Guthrie. OK, thank you.
And Dr. Walensky, I only have about a half a minute, so I
am going to try to get my question quick. But we talked a
little bit about mission creep.
When CDC is the pandemic preparedness and response, and--
CDC, over 100 years since we have had our big--last big
nationalwide pandemic, and just the response to--is CDC
prepared for a--it wasn't prepared, it did appear, at the very
beginning. Is it prepared now for another----
Dr. Walensky. A lot of what we are doing in CDC moving
forward is strengthening our piece or component that is a
response-based agency. We have a new CDC responder--Ready
Responder Program.
What we could really use from Congress is the workforce
authorities to be able to do that, workforce authorities that
are similar to other response agencies like FEMA, work for--
danger pay, overtime pay, loan repayment, tax-free loan
repayment. So those workforce authorities would be really
helpful for us to be even more ready to respond.
Mr. Guthrie. I am sorry, 5 minutes goes fast. I yield back.
Mr. Griffith. I thank the gentleman for yielding back and
now recognize Ms. Eshoo, the head of the--or the ranking member
of the Health Subcommittee.
Ms. Eshoo, you are recognized for 5 minutes.
Ms. Eshoo. Thank you, Mr. Chairman. Just to comment about
the last exchange, in my view something was left out of it: the
American Rescue Plan.
In March of 2021, the Congress passed, the President signed
into law billions and billions of dollars for vaccines for all
of the things that would protect the American people, and that
cannot be overlooked. It is an important discussion about
schools, and understanding how guidances work, and who the
agencies meet and talk to to come up with the best policies
going forward. It is all important in a hearing. But I--this
cannot be overlooked. I don't know what would have happened to
the people of our country without that rescue plan. And it
wasn't unanimous. But it got done.
Dr. Tabak, I would like to ask you about--speaking of
money--the Congress appropriated $1 billion to NIH to study
long COVID. Patients have been waiting--and they have been more
than patient--since December of 2019. And I think the effort is
called RECOVER, and it is to research, you know, potential
treatments. Where is that? How close are you to coming out with
what is needed for those that have been waiting a long time?
Dr. Tabak. We have put together a national cohort of
patients at different stages of infection with COVID-19, and
those who have already reported that they suffer from long
COVID.
Ms. Eshoo. I am familiar with that.
Dr. Tabak. And----
Ms. Eshoo. I want to know how close you are to----
Dr. Tabak. Well, we are within the next----
Ms. Eshoo [continuing]. The mission----
Dr. Tabak [continuing]. Few months to launch the first
interventional trials.
The reason it has taken the time it has is because we
wanted to build a large enough cohort of patients so that we
would actually get actionable answers.
Ms. Eshoo. So it took from 2019 to now to get the cohort?
Dr. Tabak. Indeed, it has, because----
Ms. Eshoo. And how many are in it?
Dr. Tabak. I am sorry?
Ms. Eshoo. How many are participating in it?
Dr. Tabak. I would have to get back to you the specific
numbers, but please appreciate that, as the virus evolved, so
too has long COVID. The----
Ms. Eshoo. Well, exactly. That is why I am asking.
Dr. Tabak. And that is why we need to continue to build a
cohort that is representative of the disease, so that the
answers that we get with our interventional trials will have
some actionable----
Ms. Eshoo. OK. Well, if you have anything else that you can
add to that, I would appreciate learning it, getting it from
you.
To both the CDC and the FDA, I think the public and
certainly Members of Congress became all too familiar with
advisory committees during--and that impacts your work. But I
think that it also added to the confusion of the American
people.
Advisory is exactly that, it is advisory. And I have to say
that I found it troubling. It seemed to me that there was a
lack of balance between the ultimate decision maker and an
advisory committee, an advisory committee.
So can you--well, first of all, do you think that there
should be some streamlining of these advisory committees, and
really make them more practical?
Dr. Califf.
Dr. Califf. Thank you for that question. I actually chaired
an FDA advisory committee for----
Ms. Eshoo. There you go.
Dr. Califf [continuing]. Some period of time back in the
good old days.
I think advisory--it is like democracy. It is messy. And I
think advisory committees are critical. The FDA full-time staff
need to interact with outside experts in a structured manner.
But you're right, they are advisory, They are not decision-
making. Our regulatory decisions are made by full-time civil
servants who don't have a conflict of interest financially and
whose mission is preserving and protecting public health.
We are looking across the FDA right now at what we can do.
Streamline is one word, I would say, to optimize the use of
advisory committees. They're so important, whether it is food,
tobacco, or rare diseases, for example. We need to have that
kind of input. So it is critical. We need to make it better.
Ms. Eshoo. Dr. Walensky?
Dr. Walensky. Yes, I don't have much to add to that, except
to say that there is incredible value in the independent expert
opinion of nongovernmental officials who are very well-
recognized across the country in their field of vaccine that we
have on our Advisory Committee on Immunization Practices.
I agree they are messy. They have been challenging during--
--
Ms. Eshoo. So are you looking to change anything?
Dr. Walensky. We are reviewing the advisory committee
processes, yes. However, you know, I do think that there is an
important component of our Advisory Committee on Immunization
Practices that has been steadfast through all the vaccines.
Certainly, it has been in the spotlight during COVID-19
vaccines, but there are many pediatric vaccines that have been
reviewed carefully through this committee.
Mr. Griffith. The gentlelady yields back. I now recognize
the chairman of the full committee, Cathy McMorris Rodgers, for
her 5 minutes of questions. Thank you.
Mrs. Rodgers. Thank you, Mr. Chairman. I want to start with
Dr. Walensky.
Dr. Walensky, there is serious distress today with our
public health agencies. I recently saw one poll that nearly 40
percent of the public does not trust our public health agencies
to handle the next public health emergency. And I don't blame
them. While I appreciate that we were dealing with an evolving
virus, there were also a lot of mistakes, too many mistakes
with communication and decision making from the CDC.
And one relates to mask mandates. You know, there has been
several studies that have looked at the effectiveness of masks
to prevent the COVID spread. And there was one just recently
that came to several important conclusions. First, there is--
there was a notable lack of reliable studies on the efficacy of
face masks. And second, there remains much uncertainty about
the impact and the effect of face masks.
While acknowledging the limited data pool, it found no
clear sign of a reduction in transmission when using either
medical or surgical mask. Yet today CDC still recommends masks
in schools for all ages, even though the emotional, mental,
physical, and educational toll masking has had on our kids is
widely recognized. In fact, the CDC is currently the only
national or international public health agency that recommends
masking 2-year-old children.
I would like you to explain in detail the process and the
timeline by which evidence such as this is used by the CDC to
update, modify, or necessarily withdraw current guidance.
Dr. Walensky. Great. Thank you for the opportunity to
clarify on those points.
So I believe you're referring to the Cochrane Review study.
This is an important study.
Mrs. Rodgers. Yes.
Dr. Walensky. But the Cochrane Review only includes
randomized clinical trials. And as you can imagine, many of the
randomized clinical trials that were included in that were for
other respiratory viruses, not COVID-19. Some of them were for
COVID-19, just to be clear. But it is very different for COVID-
19, because you have a pre--a virus that--different from flu,
potentially different from SARS or MERS, transmits before you
actually have symptoms.
Mrs. Rodgers. So----
Dr. Walensky. It is also the case that the--one of the
limitations in that study was clearly stated that people were
not actually engaged in the intervention. So you actually have
to wear the mask for it to work.
Mrs. Rodgers. OK, OK.
Dr. Walensky. So there are lots of studies now----
Mrs. Rodgers. Dr. Walensky?
Dr. Walensky [continuing]. In Georgia----
Mrs. Rodgers. Dr. Walensky, why are we masking our kids
today?
Dr. Walensky. You know, thank you. Also, so our guidance
for school-based masking is related to our COVID-19 community
levels. And fortunately, we are in a place now in this country
where most of our country is in green or yellow, has low or
moderate transmission COVID-19 community levels. And in those
situations we actually don't recommend masking. We recommend it
for high COVID-19 community levels.
Mrs. Rodgers. So what is your timeline for updating,
reevaluating these guidance?
Dr. Walensky. You know, our masking guidance doesn't really
change with time. What it changes with is disease. So when
there is a lot of disease in a community, we recommend that
those communities and those schools mask. When there is less
disease in the community, we recommend that those masks come
off.
Mrs. Rodgers. So--OK. So it is just going to continue. That
is----
Dr. Walensky. We will continue to recommend that, when
there is high amounts of hospitalization, severe disease, and
disease in the community----
Mrs. Rodgers. Despite the emotional, mental, physical,
educational toll that we know masks are having on our kids.
Dr. Walensky. As you and I have spoken about----
Mrs. Rodgers. Yes.
Dr. Walensky [continuing]. Yes, indeed, it is important
that we recognize that our kids need to be in school.
Mrs. Rodgers. OK, yes.
Dr. Walensky. We know that when masks don't--when masking
doesn't happen in high COVID-19 community levels, those do----
Mrs. Rodgers. OK, thank you. We will continue this
conversation.
Dr. Tabak, just this last weekend New York Times published
an article about the astonishing, horrible learning loss
resulting from government recommendations that led to lockdowns
and virtual schooling. NIH has a budget over $40 billion. Has
NIH initiated any studies looking at learning loss or the
impact of shutdowns on childhood development?
Dr. Tabak. Yes, we have, both through the National
Institute of Mental Health and the National Child Health and
Development.
Mrs. Rodgers. I would--I am anxious to see those studies,
the reports. So I just would ask you to give me that list, and
where the funding was provided, and a summary of the studies.
That would be great.
And in my final minute here, Dr. Califf, you know, I
continue to hear concerns about the FDA having virtual
meetings, and especially for innovators and others that have
some amazing breakthroughs being told by the FDA that you can
only meet through Zoom, or not even through Zoom. I had one--
yes, can't even meet through Zoom, you have to be--have written
correspondence. You know, it slows down approvals for
everything from flu tests to novel vaccines.
So I would just like to ask, when is everybody going to be
back to work? Or what percentage of employees are back to work
5 days a week? What percentage of meetings are via Zoom?
Dr. Califf. One hundred percent of our employees have been
at work every day since the beginning of the pandemic, and will
continue to do so. In fact, working----
Mrs. Rodgers. In the office?
Dr. Califf [continuing]. Nights and weekends.
Mrs. Rodgers. In the office?
Dr. Califf. Many of our employees aren't in the office to
begin with. We have inspectors, we have people reviewing data.
We have 200 locations around the country.
I would also add we have now added back in-person meetings.
They are being scheduled. Interestingly, when I have said,
``Would you like all in-person meetings,'' the industry, by and
large, has said, ``We would sort of like both,'' because the
ability to have a meeting on the spot via Zoom, it is a period
of trying to get a bunch of people to Silver Spring and stay in
a hotel----
Mrs. Rodgers. Well, my time has expired.
And I suspect sometimes it makes sense to do it via Zoom.
It was most concerning to me when it was--the response was it
requires written communication as the only way. We all know
that that is going to cause all kinds of delays.
So bottom line, bottom line, we need all of you to be
responsive. We need you to be accessible. And we do look
forward to greater communication between all of your agencies
and Congress. We are the elected representatives of the people.
Thank you for being here today.
Mr. Griffith. The gentlelady yields back. I now recognize
the gentleman, the ranking member of the committee, Mr.
Pallone, for his 5 minutes.
Mr. Pallone. Thank you, Mr. Chairman.
As we know, the President has announced that he plans on
unwinding the current COVID-19 public health emergency by May
11th. And this is possible because of the work that this
administration was able to do to control this disease. This
administration orchestrated the largest free vaccination
campaign in U.S. history, delivered hundreds of millions of
dollars--well, hundreds of millions of tests to the public, and
provided guidance to schools and offices to open safely.
And in no small part because of these successes, my
Republican colleagues have declared that the pandemic is fully
over, and that the administration should suspend the public
health emergency immediately. This, of course, was the first of
the three bills that I mentioned in my opening statement that
seek to roll back, in my opinion, COVID protections. And I have
been very critical that such an abrupt end to the emergency
would seriously undermine the progress that we have made. It
would also ignore the sad fact that an average of nearly 500
people are still dying every day from COVID-19.
The decision to base--to end the emergency should be based
on science. It should be with the agencies that have the
expertise. And again, the President has said he plans to do
this, which means that that could change if the COVID situation
got worse with more variants, whatever.
So the Republicans have also claimed that the
administration does not have a plan for winding down the public
health emergency. And I would like to give our witnesses an
opportunity to respond to that. I am interested in hearing how
we can continue to protect the health and well-being of
Americans and minimize disruption. So let me ask each of you
quickly, because I have two sets of questions: How are you
planning for the next phase of the Federal response to this
pandemic, and what should Congress do to help facilitate a
smooth transition?
Dr. Tabak, I guess 30 seconds or so.
Dr. Tabak. Specific effects on us are modest. We will have
to work with our grant community for the slight changes that
they will have to address when the PHE is over.
Mr. Pallone. And Dr. Califf?
Dr. Califf. Our effects are also a little modest, because
our EUAs are independent of the public health emergency. So we
can keep them going as long as we need to.
We have been preparing the industry since day one to be
ready for the transition. We will put a Federal Register notice
out about exactly how to make the transition as these products
go to routine use and are no longer used on an emergency basis.
Mr. Pallone. And Dr. Walensky?
Dr. Walensky. I would like to be clear that we plan to
address this emergency and work towards the safety and security
of all Americans 24/7, regardless of whether there is a public
health emergency in place.
It is the case that when the public health emergency comes
down, we lose some of our ability to see the data. We will lose
testing data that we have as part of the public health
emergency. We will lose other data, as well. And we are
actively working right now to set up data use agreements so
that we will have the data that we need in the absence of those
authorities so that we can see the data and be able to present
them back to the American people.
Finally, we do not in this country have a vaccines-for-
adults program. We don't have a vaccine program for the
uninsured adult, as we do for children. And so it would be
really helpful. And we are working now to see how we can ensure
that uninsured adults will get vaccinated.
Mr. Pallone. And as I said, winding down the public health
emergency has to be grounded in science. And I think that
public experts like yourselves are in the best position to make
that decision.
But as we look towards the future, can you just briefly
discuss how important it is that these decisions are made based
on data trends and up-to-date information, and not ideology or
politics?
Thirty seconds each, Dr. Tabak.
Dr. Tabak. We believe in data. The data is very important
to review, and the public health experts need to weigh in once
they are able to review those data.
Mr. Pallone. Dr. Califf?
Dr. Califf. We have a saying at FDA: ``In God we trust, all
others must bring data.'' And I have lived my whole life as a
cardiologist, basing my practice on evidence. We need to have
the evidence to make good decisions.
I think, Dr. Walensky's statements about the need for the
CDC to get accurate, up-to-date data quickly is absolutely
critical to the future.
Mr. Pallone. And Dr. Walensky?
Dr. Walensky. My job is to provide the best public health
science for decision making. I do that by being informed, and I
can only be informed if I can see the data.
And so I would like to be informed, so that we can make
those decisions and then give them back to you so that you can
make the decisions at the local level.
Mr. Pallone. Thank you. And you know, I stress I know
that--I am not arguing that there doesn't need to be oversight
of what you do, which is, of course, the purpose of this
hearing today. That is a very important function that we serve
as elected officials and Members of Congress. But I do think
that, ultimately, these decisions about when to start or end
the public health emergency have to be made by the agencies and
the experts. That is what the statute says. And I don't want to
substitute your expertise for ours, because I don't think we
have the same level of information that you have, or expertise.
So thank you, Mr. Chairman.
Mr. Griffith. I thank the gentleman, who yields back. And
we like information, too.
I will say at this point we have--the chairs of--sub chairs
and chairs have gone over a little bit, but we have a 2:00 drop
dead. So I am going to try to be aggressive with the gavel. It
is nothing personal, I am just going to try to move this along.
I recognize Dr. Burgess for his 5 minutes of questions.
Mr. Burgess. Thank you, Mr. Chairman. I appreciate your
aggression.
Dr. Walensky, just a quick followup from something
Chairwoman McRogers--McMorris Rodgers said. You maintained that
mask--your guidance is your guidance. But I presume, if there
is new data that comes forward, you will reevaluate your
guidance. Is that not correct?
Dr. Walensky. Of course.
Mr. Burgess. OK.
Dr. Walensky. We are already reevaluating in real time.
Mr. Burgess. And just a general statement. Look, the
country has been through hell with this. Our doctors and nurses
on the front lines have been through hell. You all in public
health have been through hell, and policymakers have been
through hell.
There is a piece making the rounds currently, a Newsweek
op-ed piece written by a doctor--or medical student, more
correctly, Kevin Bass. And he observes, ``It's clear to me that
for public trust to be restored in science, scientists should
publicly discuss what went right and what went wrong during the
pandemic, and where we could have done better. It's OK to be
wrong and admit where one was wrong and what one learned.
That's a central part of the way science works.''
So it is with that backdrop--and I appreciate so much
doctor-to-be Kevin Bass making that observation and sharing it
with us. Look, no one--you and your predecessors, when this was
visited upon us, you didn't know what was to come, and it made
things very, very difficult. And sometimes I think it is OK
just to have the humility that we didn't anticipate that there
would be that 2-week lag. And when Dr. Fauci came and talked to
us in this room about how--what a good job they had done with
SARS-1, nobody knew at that point about that 2-week lag that
might occur from exposure, now you are infective, and now you
are symptomatic and should be isolated.
Dr. Tabak, I do have a couple of questions. You know, we
got the big OIG report the other day, and it generated a lot of
interest. Some questions have come up from that.
Let me just ask you, roughly, how many awards does the
National Institutes of Health issue every year?
Dr. Tabak. About 55,000.
Mr. Burgess. So that is a lot. In the report, in the OIG
report, you know, they, obviously, discuss--there were some
potential risks associated with research being performed under
EcoHealth awards, NIH did not effectively monitor or take
timely action to address EcoHealth's compliance with some
requirements. These costs included salaries exceeding the NIH
salary cap, employee bonuses, travel costs, tuition costs,
indirect costs. This audit covered all three NIH awards to
EcoHealth between 2014 and 2021 and found $89,171 in
inallowable costs.
That is in one grant. And you just said how many grants do
you administer?
Dr. Tabak. We--about 55,000 a year.
Mr. Burgess. So 89,000 multiplied by 55,000 is a lot. Are
you taking steps to tighten this process up, so we don't have
55,000 OIG reports down the road?
Dr. Tabak. So certainly, this is an outlier, and the----
Mr. Burgess. Well, Mr.--Dr. Tabak, with all due respect, we
are not sure, because we didn't know about the outlier status
of the current OIG report.
Dr. Tabak. I take your point. We accepted all of the OIG's
recommendations, and we are working to address each of them. We
now have modified our systems to prevent some of these missteps
from occurring in the future.
Mr. Burgess. So you will get back to us with your plan.
Dr. Tabak. I am happy to do that, yes.
Mr. Burgess. Let me just ask you, too, because you made the
offhand comment that disbarment resides with an official at
HHS.
Dr. Tabak. That is correct.
Mr. Burgess. Who is that official?
Dr. Tabak. I don't know the name of the person----
Mr. Burgess. Will you----
Dr. Tabak [continuing]. But there is an----
Mr. Burgess. Will you get it for us?
Dr. Tabak. [continuing]. A disbarment office.
Mr. Burgess. Will you get that? Because I am----
Dr. Tabak. Of course.
Mr. Burgess [continuing]. Interested in speaking with that
individual.
So let me ask you a question. This committee back in 2006--
I know it was a long time ago--the NIH Reform Act established
the Scientific Management Review Board, an oversight board
meant to make NIH more efficient. The--this board has not
convened since 2015, according to recently published
information in a healthcare publication, and the members of the
board don't know why they haven't met. Can you enlighten us as
to why that board is no longer meeting?
Dr. Tabak. The board no longer meets because we found that
board to be completely redundant to the advisory committee to
the Director in every aspect.
Mr. Burgess. So that is good, and I will stipulate that.
However, the annual cost of the board, $488,000 a year, 2 full-
time employees at a cost of over $320,000. Without convening
the board, I am concerned that the NIH may have diverted these
funds to other activities.
Dr. Tabak. The--well----
Mr. Burgess. It still appears on your books.
Dr. Tabak. OK, I will check into that and get back to you,
sir.
Mr. Burgess. Thank you.
Mr. Chairman, I have got a lot of questions that I am going
to submit for the record. Clearly, there is a lot of pent-up
demand because of the 3 years of the pandemic and this really
being the first oversight hearing we have had in person in a
long time. So thank you, Mr. Chairman, and I will yield back.
Mr. Griffith. I thank the gentleman. I will now recognize
the gentlelady from Colorado, Ms. DeGette.
Ms. DeGette. Thank you so much, Mr. Chairman, and welcome
to all of our witnesses.
I have been on this committee long enough to remember all
of our previous efforts in addressing what we saw as looming
pandemics. And each time we thought that we had put things
together within your various agencies to make that happen.
I remember back when I was the chair of Oversight, we had a
hearing in December right before the pandemic hit, the December
before it hit, and Dr. Fauci was here and some of his
colleagues, and I said, ``What is the one thing that keeps you
up at night?'' And they said the fear of a--some kind of a
virus pandemic. And lo, it came to be.
So, you know, we--it is easy to sit here and blame the
three of you. But in truth, our agencies are in need of
continual updating and expansion and resiliency to deal with
both evolving types of viruses but also to deal with ways we
can receive and disseminate information and ways we can
structure our agencies. So I want to thank you all for what you
are doing in--with your rearview mirror to try to improve the
way we do this in the future.
And I want to once again tell my colleagues on the other
side of the aisle that this is really what we should be doing
in a bipartisan way. It is all well and good to blame this
administration for what started under a Republican
administration. It would be easy for me to blame President
Trump, but I don't think that that blame game is what is going
to help us when the next virus emerges.
Having said that, and in this effort, I led a delegation
last summer to the CDC in Atlanta, where I was joined by
Ranking Member Castor, Dr. Ruiz, Mr. Peters, and Dr. Bucshon.
Dr. Walensky, we met with you and your staff, and we learned
about your attempts to modernize through institutional reforms.
Now, since then, I have been really pleased to see that the
CDC has issued plans to improve accountability, collaboration,
communication, and timeliness both within the organization and
to the American public. Part of those efforts--and you have
talked about it--are creating a new governance model through an
executive board that relates directly to the CDC Director, and
you have talked also this morning about making sure that you
could get access to timely, high-quality data and strengthening
workforce capacity to respond to these needs.
I am wondering if you could just talk very briefly about
what congressional authority you might need to do that as we
start thinking about developing legislation.
Dr. Walensky. Thank you, Congressman. It was a pleasure to
host you, and would welcome anyone else who wants to pay us a
visit down to Atlanta.
It is the case that workforce has been one of the
challenges. It is one of the things--one of the lessons that we
learned. A study from the de Beaumont Foundation demonstrated
that our public health workforce across this country is 60,000
in deficit. That means we have a lot of work to do, not only at
the CDC but across the country, to develop a public health
workforce that is as diverse as the communities we serve and
that is upskilled in our resources and data.
So among the things----
Ms. DeGette. So--I don't mean to interrupt you, but I have
a question for Dr. Califf, too.
Dr. Walensky. OK.
Ms. DeGette. What congressional authorities do you need to
achieve that?
And also the information----
Dr. Walensky. Workforce authorities would be incredibly
helpful: overtime, danger pay, overtime pay. So pay so when we
send somebody to Mubende, Uganda, in an Ebola outbreak, that we
are able to pay them danger pay. Those things would help,
workforce authorities.
Data authorities would be incredibly helpful, so that we
don't have to sign 100 data use agreements with individual
jurisdictions before we receive the data. That takes months in
happening.
And then finally, a vaccines-for-adults program, which
would be able to provide vaccines for uninsured adults.
Ms. DeGette. Right.
Dr. Walensky. We have one for children.
Ms. DeGette. We look forward to working with you.
Dr. Walensky. Thank you.
Ms. DeGette. Dr. Califf, I was--Dr. Bucshon and I were very
happy to hear you talk about our VALID Act, which ensures the
reliability of testing and diagnostic tools for diseases and
infections, including COVID-19. I am wondering if you can talk
why you think it is important to authorize FDA to regulate
laboratory-developed tests, why it is so urgent, and what we
can do.
Dr. Califf. Well, there is a lot of what we do that I think
of as the Goldilocks problem. We want to spur innovation. We
need our academic medical centers, for example, to develop new
tests as new viruses come along. You can't figure out what is
going on with a pandemic if you can't make the diagnosis with a
test.
On the other hand, the quality that is needed in these
tests is very important, because if you get the wrong answer
and you get the wrong treatment, that is a tragedy.
And so we need a framework for regulating laboratory tests
that enables and spurs innovation, but also protects the public
from tests that are bad. And as I have already mentioned, in
areas like molecular testing, over half the tests that we saw,
once the gates were open to allow them out, turned out to have
major problems.
Ms. DeGette. And there is no regulation right now, right?
Dr. Califf. Well, we have the authority to regulate, but
for decades now there has been enforcement discretion to
basically allow people to pretty much act freely. So we want to
really fix that so that, again, people can innovate but there
is a framework to do it. But then, when there is a problem, we
have the authority to bring it under control.
Ms. DeGette. Thank you.
Thank you, Mr. Chairman. I yield back.
Mr. Griffith. The gentlelady yields back. Now I recognize
the gentleman from Ohio, Mr. Latta, for his 5 minutes of
questioning.
Mr. Latta. Well, I want to first thank the chairs of the
Oversight and the Health subcommittees and the rankers for both
of these subcommittees for holding today's hearing. This is
very, very important, the answers that the American people want
to have answered today. So I thank you for it. I also thank our
witnesses for being with us today.
Dr. Walensky, Dr. Fauci said that natural immunity was one
of the best forms of protection against viruses. Knowing this,
and that the vaccines do not stop the spread of COVID-19, do
you plan to continue to provide CMS input on the vaccine
mandate, especially given that this isn't connected to the
public health emergency expiring on May the 11th?
Dr. Walensky. CDC provides public health data, scientific
data to the best of our ability. We have put out a scientific
review on the importance and value of infection-induced
immunity. But we continue to see in all of our data that, if
you have--that vaccines are the best and safest way to protect
yourself against severe disease and death.
Certainly, if you have previously had an infection that
adds and bolsters your immunity. But we continue to see data
that demonstrates that vaccines are the safest way to protect
yourself against severe disease and death, and we will offer
that information to the administration as those decisions are
made.
Mr. Latta. Let me follow up. How does the administration
intend to fix our depleted healthcare workforce?
And, you know, I am sure that you are out all the time in
the communities. And across the 5th Congressional District in
Ohio, I visit our hospitals and all of our areas that we have
so many people out there that really strained during COVID, and
saw, you know, from doctors, nurses, respiratory therapists,
and you go down the entire line. And, you know, in one of my
recent visits to one of our hospitals, they need about 5 to 600
people back into that hospital because, again, they can't
service and serve these patients across the region unless they
are there.
So how are we going to get our depleted healthcare
workforce back because of everything that has happened with
COVID?
Dr. Walensky. Yes, I appreciate the opportunity, because
one of the big challenges, especially in our public health
workforce, is our inability to have longstanding funding to
support that workforce. And because of the lack of that
longstanding funding, those are not jobs that people are
generally applying for when there is not long-term funding,
sustainable funding for them.
Through the American Rescue Plan, we did put out $3.2
billion to over 100 districts, jurisdictions, States, locals,
cities so that they could work on and develop their workforce--
again, having the workforce as diverse as the communities that
they serve, but also upskilling the current workforce.
We also have a new public health AmeriCorps plan, where we
are training up to 3,000 public health providers through the
Public Health America Corps plan over a 5-year plan.
Mr. Latta. You know, let me follow up on that real quick,
because, again, you know, a lot of people say they don't want
to be in a certain area. Maybe they don't like rural areas,
they want to be in a more urban area. But how are you going to
get the people back?
Because again, when I look at my area--because I go from
urban to suburban to very rural, but we have to get people back
in our rural areas for--to be able to be out there. Because I
know, again, the folks that are in these more rural communities
are really putting in the hours, and they are burning out.
Dr. Walensky. That is exactly right. And in fact, that is
the import of the sustainable funding in those areas. People
often want to go back to the communities in which they were
raised, but there aren't necessarily sustainable funding in
those communities for those efforts. And that is a lot of the
work that we are doing right now. Thank you.
Mr. Latta. Let me follow up. You suggested several times in
the past that fully vaccinated people don't carry or transmit
COVID-19. Unvaccinated Americans were demonized, shadow-banned,
and fired from their professions due to this poor guidance.
How does the CDC intend to build America's trust back now?
Dr. Walensky. Oh, thank you for this question. So it is
true that, over time, we have seen the evolution of our vaccine
recommendations, and that is because we have learned a lot
about this vaccine. We have also seen an evolution of the virus
itself.
So when we first had the vaccine that was first launched in
December of 2021--December 2020, sorry--we had the wild-type
strain. The vaccine worked very well at preventing severe
disease, death, and also transmission for both the wild type
and with Alpha. What happened with Delta is that the vaccines
still continued to work against severe disease and death, but
less so--still some, but less so--against transmission. That
has also been the case with Omicron and its subvariants: very
effective against severe disease and death, less effective,
though, still somewhat effective, against transmission.
Among our efforts in our CDC Moving Forward initiative is
to improve and strengthen our communications to the American
people. It is the case that, prior to this pandemic, most
people who came to the CDC website were public health
officials, academics. It is now the case that Americans are
coming to our CDC website. I inherited over 200,000 webpages on
our CDC website. We are doing a lot of work now to--in a
project called Clean Slate to update our website to make it
accessible for everyday Americans to come to our website. Thank
you.
Mr. Latta. Well, and again, I just want to thank the chairs
for today's subcommittee hearing. But I think we just said, you
know, it is--communicating back to the American people is
absolutely essential, because this trust has got to get gained
back.
And Mr. Chairman, with that I yield back----
Mr. Griffith. I appreciate the gentleman yielding back. I
now recognize the gentlelady of Illinois, Ms. Schakowsky, for
her 5 minutes.
Ms. Schakowsky. I just really want to thank our witnesses,
not only just for being here today, for the--to answer all of
these questions, but for 3 years of an unprecedented challenge,
working every day to try and protect the American people. So
thank you for that.
I wanted to talk a little bit more about just information
and the effect that it really had. Over a million Americans
died from COVID. I am just wondering if there is even any
estimate of what--if there had been the acceptance of the--and
the opportunity to be able to use the vaccines, if there is any
estimate of how many lives we might have saved. Dr. Walensky,
is there anything like that?
Dr. Walensky. You know, I am not familiar. I wouldn't be
surprised if folks who--at Yale, who have done some of these
estimates that you previously heard about in terms of the lives
saved, the millions of lives that have been saved, would be
embarking on that. But I am not familiar with that. I would
have to get back to you.
Ms. Schakowsky. Well, let's just--can you talk a little bit
more about what the consequences--did anybody else want to
answer that?
Dr. Califf. Yes.
Ms. Schakowsky. Oh, go ahead.
Dr. Califf. I mean, if I may. It is pretty unusual for a
person who is up to date on vaccination and had access to the
powerful antiviral drugs that we have to die from COVID. It is
a rare exception when that happens.
So, in fact, there is a great study that just came out last
week about doctors. We were losing hundreds of doctors until
the vaccine came out. It has a beautiful graph in it that shows
that, once the vaccination--because doctors almost all got
vaccinated right away and have stayed up to date--we now have a
lower-than-expected mortality rate in doctors because of this
intervention. So you can pretty much extrapolate that--
remember, the number to be relatively precise--it is hard to be
completely precise--80 percent lower chance of being dead.
Now, I am a cardiologist, so I am used to thinking about
life and death. And most people can pretty simply think about
this. Something that reduces your risk of being dead by 80
percent, that is important. And you can then back extrapolate.
We can't put exact numbers on it, but it is rare for someone to
die from COVID if they are up to date on vaccination and have
had access to the antivirals.
Ms. Schakowsky. Well, thank you so much.
You know, 209,000 nursing home residents have died because
of COVID. And I just wanted to talk to you about what we can do
to address this particular population to make sure that we can
keep them safer.
I don't know, any--Dr. Walensky or whoever.
Dr. Walensky. Yes, I very much appreciate your work and
advocacy for this population, because it is, in fact, this
population that, in this moment, is most vulnerable. We are
seeing deaths more in elderly population right now, those who
are not vaccinated.
Right now we have about 51 percent of our residents living
in nursing homes who have received the bivalent vaccine. But in
my mind, that is not enough. And our team is working really
hard. We have engaged with our long-term care facility
pharmacies to see--make sure that we get vaccine into those
pharmacies.
One of the challenges also was the multidose. So we are
working with those pharmacies to get single-dose vials so that
they can actually use those single-dose vials.
We are also working within the States to have home health
aides and EMTs go to those long-term care facilities, where
they may not have medical care on site, so that those people
can actually visit them and provide vaccine.
And then we have actually waived the data needing to come
in to facilitate it even further.
So we have had an--enormous amounts of efforts for exactly
the reasons that you note. Thank you for that.
Ms. Schakowsky. So I want--not just about COVID, but what
has CDC learned about best practices to address infections, et
cetera, that are in nursing homes? This is a real problem.
Dr. Walensky. Right. Well, in fact, we have a whole unit
that works on infection control prevention and that has been
specific to nursing homes. We have data that come in weekly
from our 15,000 nursing homes through our National Health
Survey network. So a lot of work happening within the nursing
homes because of this particularly vulnerable community, not
just that we see in COVID-19 but as we saw with influenza, as
we see with RSV, again, prone and vulnerable to numerous
infections and other threats.
Ms. Schakowsky. Thank you. And I see my time is almost up.
I will yield back, thank you.
Mr. Griffith. I thank the gentlelady, and now I recognize
the gentleman from Florida, Mr. Bilirakis.
Mr. Bilirakis. Thank you. I appreciate it. Thanks very
much.
OK, Dr. Walensky, I have a question for you regarding the
cruise industry. Throughout the pandemic I expressed
significant concerns, and actually led multiple letters, about
the COVID-19 restrictions for cruise ships and the Level 4
travel advisory that unfairly targeted the industry. These
restrictions were not backed by facts or science, but rather an
executive branch overreach, and they did nothing to actually
mitigate public health concerns. They unfairly punished
Floridians and others throughout the country, businesses who
rely on the cruise industry for their livelihood, by creating a
baseless no-sail order that cost local economies billions of
dollars.
Dr. Walensky, do you know how long the cruise industry was
prohibited from operating as a result of the CDC orders?
Dr. Walensky. I know we worked closely and hard to try and
open the cruise industry as soon as possible, for all of the
reasons that you note.
We also know that, during the COVID-19--initially came to
our shores, literally, through cruises. And so we worked
closely to make sure that those cruises would be safe, that we
could implement mitigation strategies with the cruise liners so
that they could be both safe and operational as soon as
possible.
But I would have to go back. I don't know off the top of my
head, but I would be happy to get you the information as to how
long they were closed, and the timeline there.
Mr. Bilirakis. Does 16 months sound about right?
Dr. Walensky. It may be. I would have to go back.
Mr. Bilirakis. OK. The no-sail order remained in effect, in
my opinion, far too long. What do you say to the people of my
State who lost their livelihoods due to your agency's inability
to make nimble and timely fact- and science-based decisions?
And how will you commit to changing your agency's approach
to the way it handles the travel and tourism sector? Because it
is so vital to my particular State and, of course, other
Members. We have hidden treasures throughout the world, but the
cruise industry is very important to our economy.
Dr. Walensky. The cruise industry and many other industries
have suffered gravely from the last 3 years. And so, you know,
what I can tell you is that we at CDC are working to put the
science of public health forward so that we can work with--
across the agencies to create policies that--where health is
one piece of the puzzle.
And so, you know, that is our job at CDC.
Mr. Bilirakis. Thank you.
Dr. Califf, according to recent GAO reports, they
reiterated longstanding concerns about the FDA's ability to
oversee the global pharmaceutical supply chain, an issue that
has been on their high-risk list since 2009. GAO found that the
FDA needs to increase monitoring of medical products
manufactured overseas and improve planning for drug shortages.
GAO reported that the FDA had vacancies among each of the
groups of investigators who conduct foreign inspections. For
example, within its foreign offices in China and India, about
one-third of its drug investigator positions were vacant.
Inexcusable, as far as I am concerned. This is a serious issue.
Dr. Califf, how much progress have you made in filling
these vitally important vacancies?
Dr. Califf. I appreciate your bringing this up. I couldn't
agree with you more that there is a lot of work to do on the
supply chains.
I would also point out it is not just an FDA issue. It is
really an interaction of FDA and industry and other parts of
government, in addition.
We are, thanks to the omnibus bill now, we have additional
hiring authority in these areas to bring on more people. And we
are hard at work in doing it. Our numbers of inspections are
growing daily now, and we are catching up to what was lost
during the pandemic.
And particularly in China, as you know, this has been a big
issue because of lack of access to entry into China until very
recently. So we are glad to provide you with the numbers, and
also we will have a lot to discuss about how to make this
better.
It is a global supply chain. It is fragile. The only
industry where we are not seeing supply chain problems is
tobacco, as far as I know, which is not exactly the way I would
like to see it.
Mr. Bilirakis. Yes. I would like to see also if you can
provide me this information, or even give me a rough estimate
now as to how many jobs have been filled since the legislation
was passed and how many remain--I mean, particularly, you know,
with the--with--overseas, China and India.
Dr. Califf. Well, we will get back to you with the details.
Mr. Bilirakis. Please.
Dr. Califf. I am happy to follow along with you.
I have done a lot of work in China and India myself in my
previous life in academia and industry, and we have got to be
there, because that is where a lot of our supplies are coming
from now, whether we like it or not. And I hope we can also fix
that, and bring more of it back to the U.S.
Mr. Bilirakis. Thank you very much. I yield back, Mr.----
Mr. Griffith. The gentleman yields back. I now recognize
the gentleman from California, Mr. Cardenas.
Mr. Cardenas. Thank you, Mr. Chairman. And also thank you
to the ranking member for having this important hearing.
The COVID-19 pandemic has taken a devastating toll and
highlighted the ugly reality of health disparities in our
country. It is our responsibility to learn from these lessons
that COVID-19 forced us to confront. Otherwise, people are
going to suffer systemic disparities over and over again. And
this lens extends to our research infrastructure, as well.
Dr. Tabak, you note in your testimony that the impacts of
the pandemic have not been felt equally across American
communities, with Black and Latino and other underserved
communities, as well as care practitioners and others on the
front lines bearing the brunt of both the physical and mental
health impacts of COVID-19.
How have these lessons about health inequity informed the
approach to our research infrastructure, and how are you
ensuring our clinical trials include people from traditionally
underrepresented communities and those with traditionally
under-represented lived experiences, as we look at the long-
term physical and mental health impacts of COVID-19?
Dr. Tabak. What we have learned is we have to proceed at
the speed of trust in order to engage people from what are very
often marginalized communities. We have to reach out, often
through trusted advisors, community leaders, to build the basis
of why the research that we are proposing to conduct is
important.
We are also working very hard to recruit a much more
diverse workforce. When somebody looks like you, it is easier
to engage in what are very important and serious discussions.
We--during the COVID response we have had specific
programs. For example, the RADx underserved populations
program, where we reached out to communities to understand why
there wasn't an uptake in some of the over-the-counter testing
procedures.
And so we are using a broad range of approaches. Within
NIH, of course, all of our research is being informed by these
lessons, certainly, not just that restricted to COVID.
Mr. Cardenas. Thank you, thank you. I also want to pivot to
discuss future management and communications during a public
health emergency.
So, Dr. Walensky, it is great to see you again, and thank
you so much for all the wonderful work that you do, and also
being one of the facing-forward individuals that Americans hear
from. So thank you for all the wonderful work you have been
doing.
You talk a bit in your testimony about the importance of
translating science into practical, easy-to-understand policy.
You came to my office, and I actually understood what you were
explaining to me. So thank you. I am not a doctor, like some of
my colleagues are.
In districts like mine, where the majority of households
report speaking Spanish at home as their primary shared
language, it is absolutely critical to make sure we have health
resources in Spanish and other languages in our great country.
How are you looking to improve health messaging across many
languages, and what challenges have you seen in your attempts
to combat COVID and misinformation in non-English languages?
We have a big problem in the Spanish-speaking community
when it comes to what people see on the internet and the
misinformation and disinformation.
Dr. Walensky. Yes, thank you for that question. It has been
critically important for us to bridge the equity divide that we
have seen in this country through COVID-19.
So much of what we have done are--many of our guidances are
not just available in Spanish but in dozens of languages,
actually. And it is critically important. But yet we still have
people who may not be able to access those guidances, either a
digital divide, a literacy divide, many other reasons. And even
in--yes, many other reasons.
So, you know, much of our work has been in how we reach
people. Is it through community health workers? Is it through
community-based organizations? Much of our divide we have seen
has been in the rural/urban divide. So what we really--46
million rural Americans who were--you know, have half the
vaccination rates in their pediatric populations. So we really
need to reach people where they are.
The mis- and disinformation often reaches them faster. And
that is really critically important to emphasize. We all have a
role, because we at CDC will do a lot of work to try and tackle
that. But it may not be the government official that they want
to hear from. It may be an academic society, it may be an
academic official, it may be, you know, somebody in their local
pharmacy, it may be their local pediatrician.
So we have much work to do in the mis- and disinformation.
And I would urge, again, all of us have a role in addressing
mis- and disinformation. Thank you.
Mr. Cardenas. Thank you, Mr. Chairman. My time having
expired, I yield back.
Thank you, Doctor.
Mr. Griffith. The gentleman yields back. I now recognize
the gentleman from Ohio, Mr. Johnson.
Mr. Johnson. Thank you, Mr. Chairman, and thanks to our
panelists for being with us today.
Dr. Walensky, thank you especially for being here. You got
a tough job. CDC has got a tough job. And public trust and
confidence in what the organization does is so vitally
important. And I know you know that.
In the American Rescue Plan, passed almost unilaterally by
our Democrat colleagues, it included a staggering $47.8 billion
of new spending for ``activities to detect, diagnose, trace,
and monitor SARS-CoV-2 and COVID-19 infections and related
strategies to mitigate the spread of COVID-19.''
In addition, that law provided CDC 1 billion for ``vaccine
confidence'' activities. Would you say the 1 billion for
vaccine confidence activities was successful in building
confidence in the vaccines?
Dr. Walensky. Thank you for that question. I think that
what we don't know is what would have happened in the absence
of those resources.
Mr. Johnson. No, but do you think it helped in instilling
confidence?
Dr. Walensky. I absolutely know that we have been using
those resources----
Mr. Johnson. No, but did you----
Dr. Walensky [continuing]. To reach----
Mr. Johnson. Did it improve the confidence level of the
public? That is what I am asking you, yes or no.
Dr. Walensky. Compared to where it otherwise would have
been in the absence of it, yes.
Mr. Johnson. OK, all right.
Dr. Walensky. But we also have a----
Mr. Johnson. Well, I am not sure that we got our money's
worth, because in my district people tell me not only are they
losing confidence in the COVID vaccines, but now other more
proven vaccines, as well. We are going backwards.
A recent study showed that, from 2019 to 2022, the
percentage of American parents who opposed requiring the
measles/mumps/rubella vaccines for school jumped from 23
percent to 35 percent. This is dangerous, and it is because
people do not know who to trust. There is a crisis of
confidence in our public health authorities, including the CDC
after a series of major missteps in the last couple of years.
This is exactly why we need to have this hearing today.
So, Dr. Walensky, continuing on, do you know how much
funding the American Rescue Plan gave CDC to conduct or to
support contact tracing activities?
Dr. Walensky. I would have to get back with you to have
that specific number.
Mr. Johnson. Please. Do you know how much money from the
recent omnibus does the CDC plan to spend on contact-tracing
activities?
Dr. Walensky. I would have to get back with you on that
specific number. We are no longer endorsing contact tracing----
Mr. Johnson. Do you know----
Dr. Walensky [continuing]. Specifically for COVID-19.
Mr. Johnson. OK. Do you know how much was provided for
staffing?
Dr. Walensky. Again, I won't be able to give you specific
numbers on any of these, but I would be happy to work with your
staff to do so.
Mr. Johnson. OK, I would appreciate it if you would get
back to me on that.
Then is it fair to say that the CDC has, through grants,
technical assistance, and research, spent billions of dollars
over the course of the COVID-19 pandemic on supporting contact-
tracing activities?
Dr. Walensky. Again, I don't know the specific number off
the top of my head, but I would--what I would say is it is
contact tracing, mitigation, testing, outreach----
Mr. Johnson. It has been allocated, though, right? Contact
tracing. Billions has been allocated and approved to the CDC
for that purpose.
Dr. Walensky. I would need to get back to you specifically
on the----
Mr. Johnson. What is your----
Dr. Walensky [continuing]. Line items----
Mr. Johnson. What is your contact tracing staff doing now?
Dr. Walensky. Well, I am not sure that we have contact
tracing-specific staff at the CDC.
Mr. Johnson. That answers my next question.
Dr. Walensky. Well, I do want to say, though, that we had
25 people--2,500 people deployed who had--into our response who
had full-time previous jobs.
Mr. Johnson. OK. Well, you kind of answered my next
question.
I ask this because I was surprised to find out that, as of
last Friday, the CDC's contact tracing website hasn't been
updated since February of 2022 during the Omicron surge. The
CDC has not changed or updated its guidance in a year. Adding
insult to injury, there is a notice on the contact tracing
webpage stating that ``CDC is reviewing this page to align with
updated guidance.'' This notice has been on the website since
August 11th, 2022. This means the CDC's contact tracing
guidance has been undergoing alignment for 181 days.
And Mr. Chairman, I would ask unanimous consent to put
these website documents into the record.
So when we talk about CDC losing its credibility, it is
things like this. CDC and its supporters argued as recently as
December 2022 that it needed billions of dollars for, among
other activities, contact tracing. But the CDC can't even be
bothered to update its public-facing guidance in a timely
fashion. Public confidence and public trust is important, Dr.
Walensky.
Thank you, and I yield back, Mr. Chairman.
Mr. Griffith. Thank you. The gentleman yields back. The
Chair now recognizes Dr. Ruiz for 5 minutes for questions.
Mr. Ruiz. Thank you. Thank you all to the witnesses who are
here and for your heroic work and for your service to our
country during this public health emergency. I appreciate that
you are taking the lessons learned through this unprecedented
experience and are applying them to future pandemic responses.
Lessons learned means things that--we must take a look at
the things that we did well, and then the things that need
improvement. And we need to be honest in the scope and the
proportionality of those good works and the things that need
improvement, as well. For example, let me remind everybody that
we have lost 1 million people and 1 million of our citizens,
residents, mostly our most vulnerable individuals. But at the
same time, we saved 3.2-plus million lives with the efforts
that were done.
We must look at why our Nation had the highest death rates
than any other nation and tackle those difficult questions in
order to prevent that from happening.
One thing for sure is that this pandemic shined a spotlight
on what we already know, which is that there are glaring
disparities in access to healthcare based on where a person
lives, the color of their skin, ZIP Code, or how much money
they make.
And so, for those who live perhaps in safer areas with the
resources to stay safer, you know, the issue of the pandemic
may not have been a high risk for them, and they are mostly
concerned of the enormous, enormous inconvenience that this
pandemic, unfortunately, gave to everybody. But if you are
living in a very concentrated household with people who are
sick and don't have access to healthcare, that--and you know
that the risk is much higher in your community, then the
precautions that the CDC and other experts are saying is
lifesaving.
And so that is why this is so important, because we must
understand in the public health world, as a physician, you must
ask the question: Who are the most vulnerable, the most likely
to die, and how are you going to prevent them from dying?
But it seems like our approach here is very malaligned, and
we need to really understand this issue.
In my district, for example, the Coachella Valley
Volunteers in Medicine and the Desert Health Care District in
Southern California worked to address these issues, to run
testing sites and vaccine clinics in the least-served areas of
the community, the hardest hit, hardest to reach, for the
homeless under the bridges, for the farm workers in the
workplaces, for the most vulnerable uninsured at their
churches. We took care to the people, and it helped.
Together with my office, and even myself rolling up my
sleeve, inoculating, conducting the testing in Spanish and
English, we met people where they were, reducing barriers that
people often face in getting the care that they need, like a
lack of transportation, the ability to take time off of work.
And I applaud the Biden administration for implementing
programs to help level the playing field through the HRSA and
the CDC programs that distributed vaccines directly to our
community health centers and the retail pharmacies who serve as
the very communities that traditionally have lower access to
care. And this was a response because of Governors who did not
follow the equity rule, did not believe in this approach, and
did not allow the monies to go to the hardest-to-reach areas.
As a member of this committee, and as the ranking member of
the Select Committee on the Coronavirus Pandemic, I truly want
to understand what we have learned about best practices in
addressing inequities, and how the agencies here today are
applying those lessons to close the gap in our pandemic
response and ensure equal access to care for all.
Dr. Walensky, what did the CDC learn about the tools needed
to address health disparities in the COVID-19 response?
And how is CDC incorporating these lessons into its
strategic reorganization to make equity a strategic part of our
effort in future healthcare pandemics?
Dr. Walensky. Thank you, Dr. Ruiz. You note what we learned
in COVID-19, but what we have known in infectious diseases all
along, which is infectious diseases go to the most vulnerable.
That is how they work, and that is how they--that is--it
happens in HIV, it happens in hepatitis C, it happened in
COVID-19, it happens in influenza.
We knew that that was going to be the case, and we
immediately put out resources, once we had them, in order to
address exactly, as you did--go to the community-based
organizations, go to those trusted messengers, make sure you
have crossed the divides where people might not be reached,
because we know that it is going to be the elderly, the
vulnerable, those in multigenerational households, those who,
when you say you should isolate, actually don't have any place
to isolate to, right?
And so that was the work of CDC. We have developed--8 weeks
after I came into office I declared racism a serious public
health threat. We developed an Office of Equity. That equity
office now in our reorganization announced 2 weeks ago will be
reporting immediately into the immediate office of the
Director. And we are looking forward to continuing those
efforts to address equity issues. Thank you.
Mr. Griffith. The gentleman yields back. I now recognize
gentleman from Indiana, Mr. Bucshon--Dr. Bucshon.
Mr. Bucshon. Thank you, Mr. Chairman. I want to start by
saying to all of our witnesses that I appreciate you being
here, and I know your jobs are very difficult.
The last 3 years have proven a rough time to work on public
health issues. And while I believe most public health officials
work in good faith, including you all, I also believe that you
and your predecessors have at various times been pressured by
your respective White Houses to take certain actions or make
certain statements in order to achieve political objectives.
Again, previous, current. And I just want to say that I cannot
understate my disapproval for such behavior.
It is so important that our public health agencies be
places of science and transparency. And if they are not, the
American people find out, trust is destroyed. And when that--
and then what reason do citizens have to listen to further
advice? So we all need to work together to reestablish the
trust in our public health agencies.
Dr. Walensky, I would like to discuss one aspect as it
relates to vaccine mandates. I want to make it clear I support
vaccination. I am personally vaccinated, as is my family. That
said, I strongly believe that any medical decision, medical
therapy is the decision of an individual and not of the Federal
Government.
Beginning in 2021, vaccine mandates were imposed across the
country. And as a result of these mandates, unvaccinated people
were fired from jobs, excluded from higher education, even
denied organ transplants and punished by judges in probate
hearings and child custody cases. And finally, many were kicked
out of our military.
The prevailing argument for the mandate was this: The more
people that got vaccinated, the less the virus would spread. It
is my understanding that, from the start, the vaccine
manufacturers provided evidence that vaccines were safe and
effective at reducing the severity of infections. But from the
start they did not provide evidence that COVID-19 vaccines
provide sterilizing immunity, preventing transmission of the
virus. Is that correct, Dr. Walensky?
Dr. Walensky. Yes, let's just--so the clinical trials
actually were not--did not have an endpoint on transmission.
But ultimately, through both the wild type and the Alpha
variant, there were data that were released in the New England
Journal that demonstrated that they did prevent for
transmission for the wild type and the Alpha variant.
Mr. Bucshon. Yes, and you said that earlier in the hearing.
The question is what--when did that happen? What was the date
that that happened, do you know?
Dr. Walensky. I couldn't give you the date of the New
England Journal piece, but I could tell you that, by the time
we saw Delta at the end of July of 2022, we knew that
transmission----
Mr. Bucshon. OK, because in 2021, March of 2021, you said
vaccinated people do not carry the virus and don't get sick.
That was based on previous information. That is what you are
saying.
Dr. Walensky. That was based----
Mr. Bucshon. It was an evolving situation.
Dr. Walensky. That was based on the wild type and the
Alpha, yes.
Mr. Bucshon. OK, so that clarifies why the CDC said what
they said at that time, I guess.
And so I would like to really know specifically when the
CDC knew that vaccines did not prevent transmission, how early
in the process. And the reason this is important--and I know
you said that you don't know the exact dates of the article and
all that. But, you know, the CDC continued to support vaccine
mandates throughout all this, and still do, even though we have
knowledge now that, although they are very effective--again, I
have been vaccinated, I wish everyone would get vaccinated--
that they don't prevent transmission, at least the current
variants. So why mandates?
And, Doctor, you know--and the FDA can answer that
question, too.
Dr. Walensky. Yes, so maybe--I do want to correct. It was
July of 2021, not July of 2022. But it was after the New
England Journal piece that you are speaking about.
Mr. Bucshon. OK.
Dr. Walensky. I do appreciate your actually emphasizing the
importance of vaccines, and how they prevent severe disease and
death.
Mr. Bucshon. Understood. So I have a limited amount of
time. So on the last question, you know, with that information,
why does currently we still recommend mandates?
Dr. Walensky. You know, my job at the CDC is to provide the
scientific data that demonstrates the safety, efficacy of these
vaccines in preventing severe disease----
Mr. Bucshon. OK, fair enough. And I saw--it is basically--
--
Dr. Walensky [continuing]. Larger policy puzzle.
Mr. Bucshon. It is basically policy driven, probably, from
the White House.
And, you know, the White House says their executive order
requiring COVID-19 vaccination for travelers to the U.S. is
based on CDC's advice. But what--you are telling me that you
have given them advice, and they are quoting you and saying
that they are maintaining this vaccine for people to come in,
even though we have just now discussed the fact that we know
that it doesn't prevent transmission. It will prevent the
individual from getting really sick, but there is no--there
is--it doesn't prevent the risk of someone coming into the
country and spreading it to other people.
Dr. Walensky. As well. So it does prevent severe disease
and death. It doesn't prevent transmission as well as it did
for prior variants, but it does still prevent some.
I would like to offer----
Mr. Bucshon. So I just--I am out of time. But we need to
lift this mandate on travelers that has a big impact on our
tourism industry, and most other countries are doing it.
I will yield back.
Mr. Griffith. The gentleman yields back. Now I recognize
the gentlelady from Michigan, Mrs. Dingell.
Mrs. Dingell. Thank you, Mr. Chairman, and I want to thank
all of our panelists for all of the work that you have been
doing under not the easiest of circumstances, and I have a lot
of questions, so I need to get to them, but I need to say that
we are going backwards on vaccines, and we are building--we
are--I hope our hearings do not contribute to the lack of
public trust.
I look at measles, which has been in my community because
people are afraid to get it. And I say this as someone who got
Guillain-Barre from the swine flu shot and was more afraid of
anybody in the Congress of the COVID flu shot. But I did my
research, I got it, I didn't die, and I got every other one. So
we need to make sure that we understand vaccinations save lives
and all kinds of things as we are doing these hearings. We can
ask questions, but let's not contribute to the lack of trust in
the community.
But since the outbreak of the pandemic, we have encountered
new challenges with emerging variants and other diseases. Just
this past fall we saw triple--with an increase in COVID-19
cases, an earlier-than-unusual flu season, and RSV, which hit
children and seniors especially hard.
In the midst of this latest challenge, we heard from
parents across the country struggling to find common, over-the-
counter pain relievers such as Tylenol and Advil for their
kids, as well as the antibiotic amoxicillin that is used to
treat all kinds of infections. You know, when you are sick and
you need it, you get scared when you can't find it.
So, Dr. Califf, we know FDA can't wave a magic wand and
immediately start producing more drugs when there are supply
chain issues. But what can the agency do in a situation like
this? What has the agency done to address these shortages?
And because we are going to be short on time, what
authorities or resources would it be helpful for the FDA to
have to better anticipate and deal with these increases in
demand and shortages?
Dr. Califf. Well, as you know, the industry is increasingly
developing digitized supply chains. Each company has great
detail about its own supply chain, but there is no central hub.
And right now our authorities across drugs, devices, biologics
are somewhat different. None of them are as complete as they
need to be.
Particularly, we need to--for the companies to notify us
when they see a shortage coming, whether it is because of a
manufacturing problem, which currently exists for the most
part, or because there is a great increase in demand that they
are forecasting that will outstrip their ability to manufacture
the product.
Ultimately, I would like us to envision 10 years from now a
digitized supply chain that could undergo stress testing like
we do for banks and the financial sector now.
Mrs. Dingell. So for the record, could you tell us later
for--in writing--if there is something Congress needs to be
doing to give you more support, so we don't have----
Dr. Califf. Yes, we will give you a list.
Mrs. Dingell. Thank you.
Dr. Califf. There is a--it gets into details, because----
Mrs. Dingell. I want details.
Dr. Califf [continuing]. It is like a puzzle.
Mrs. Dingell. But we will do it--I think all of us would
like to see that.
I would like to now turn to another over-the-counter drug
issue. When the pandemic was declared, we saw an increase in
demand for another commonly used drug: hand sanitizers.
Individuals and hospitals alike were having trouble finding it,
and through an enforcement discretion policy the FDA leaned on
the ingenuity of small business owners like local distilleries
to start producing product. Other producers, both in and
outside of the country, also increased their supply.
However, we saw some producers were importing hand
sanitizers that had been contaminated with benzene and
methanol, known carcinogens, and microbiologics that can infect
and cause illness. FDA put out statements alerting consumers
and asking manufacturers to recall their products, but FDA
could not order any manufacturers to take their products off
the shelves.
Although it may be shocking to many Americans--as it was to
me because, unfortunately, I bought one of those hand
sanitizers--FDA does not have the authority to recall most
drugs, even when they are contaminated with these harmful
chemicals.
Dr. Califf, can you explain how having the authority to
actually order a recall would be helpful in times when a
product is putting consumers at risk?
Dr. Califf. Of course, most companies want their products
to be good, so they will recall them on their own. But we run
into companies that don't do it and put people at risk. If we
can't order it to happen--all we are trying to do is then
inform the public about something that can be lethal or cause
serious illness.
So we really need to have the authority to do it. We
wouldn't use it unless we couldn't work it out with the
company.
Mrs. Dingell. Some in the past have suggested that, instead
of ordering a recall when a sponsor fails to comply with a
voluntary recall, FDA can simply revoke a product's approval or
declare the products misbranded. Are these options acceptable
substitutes for recall authority? Why or why not?
Dr. Califf. Absolutely not. Remember that, in a recall, you
have got to go to the shelf and take what has already been
there and notify people in their homes. It is not enough to
say, ``Don't sell any more.'' A lot of it is going to be out
there in commerce.
We have a situation going on outside the U.S. right now in
diethylene glycol in Tylenol and ibuprofen, which is one reason
we can't just import it. We have got to have control of the
situation.
Mrs. Dingell. Thank you.
I yield back, Mr. Chairman, but we have got some good areas
to work on together.
Mr. Griffith. Thank you very much. The gentlelady yields
back. I now recognize the gentleman from Georgia, Mr. Carter,
for 5 minutes.
Mr. Carter. Thank you, Mr. Chairman, and thank you for this
hearing, Mr. Chairman. We have--we are committed to a
government that is accountable, and we need to be accountable,
and so do the agencies, especially the agencies, and especially
when we are talking about the government's response to COVID-19
pandemic. The American people deserve--they deserve this
information. They deserve answers and accountability, because
there have been clear failures by this administration over the
past 2 years.
We still got existing vaccine and mask mandates that are--
and we have experienced diverting funds away from frontline
healthcare workers to COVID campaigns. It is no wonder why the
American people have lost their trust in our public health
institutions.
I am no different from any other Member of Congress up
here. I have a lot of pride in my State. I am very proud that
the CDC is in my State. But I am very concerned about the
public perception right now of the CDC, especially after what
we have been through. That is of concern to me as a native
Georgian, and as a representative from the State of Georgia.
So, Dr. Walensky, I hope that you will help me with this,
but I want to start with Dr. Tabak, because there is something
that is very important to me, as a healthcare professional, and
that is gain-of-function research.
I want to ask you. In the fiscal year 2023 omnibus, section
2315, there was a provision included that would ban the funding
of HHS dollars towards certain types of research involving
pathogens of pandemic potential or biological agents or toxins
that are at risk to be a severe threat to public health and
safety, effective immediately. This ban is in effect until the
agency conducts certain review and oversight of protocol, and
it can't be lifted. It cannot be lifted without the appropriate
notice to Congress.
My interpretation of this provision is that it is a ban of
gain-of-function research. And we may have a different
definition of gain-of-function research, but I want to ask you:
Can you please speak to how NIH is implementing this provision?
Dr. Tabak. So we do need to have a short conversation about
gain-of-function research. That is a generic term, and it gets
us in all sorts of trouble.
The type of research that you and everybody is concerned
about is a very narrow portion of that, where you take, for
example, a virus and attempt to make it more transmissible. You
attempt to make it more pathogenic.
Mr. Carter. OK, I will accept that, and I appreciate that
answer. That is what this was intended for----
Dr. Tabak. And we----
Mr. Carter [continuing]. In the omnibus.
Dr. Tabak. And----
Mr. Carter. And that--and my question is, are you
implementing this?
Dr. Tabak. And we currently are not funding that type of
research. We have nothing in that category. The NSABB, which is
an advisory committee to the USG, just provided a set of draft
recommendations which will presumably tighten our approach to
this type of research. Once the report is finalized, which we
expect will occur very shortly, I will send a memorandum to the
Secretary of HHS, and he, in turn, I presume, will reach out to
the NSC and to the OSTP----
Mr. Carter. So what----
Dr. Tabak [continuing]. To convene a governmentwide effort
to update the framework with which we work in these----
Mr. Carter. I want more. I want to hear more than just the
effort. This has to be done.
So what you are telling me is that it has been done, and
has been done immediately.
Dr. Tabak. The----
Mr. Carter. And I will accept your limited definition of
gain-of-function research.
Dr. Tabak. That is the definition.
Mr. Carter. OK. Then it goes on to say that--in the 2023
omnibus--that we banned the funding of pandemic potential
research in foreign countries of concern, and we defined
``foreign countries of concern'' as China, North Korea, Russia,
and Iran. Can you tell me, has that been done?
Dr. Tabak. There is no funding of EPP research in any
foreign country today that is sponsored by NIH.
Mr. Carter. Has there been in the past?
Dr. Tabak. No.
Mr. Carter. There has not been in the past?
Dr. Tabak. There has not been in the past, funded by NIH,
related to the SARS-CoV-2 virus. Many years ago there was EPP
research conducted in the Netherlands, and that was an
influenza.
Mr. Carter. OK, let me ask you one other thing. This
legislation also mandates that all funding for the research be
stopped no later than 60 days after the bill is enacted, and
that is the end of the month. Can you commit that your agency
will fully comply with the law, fully comply with the law and
completely defund any relevant grants at this time?
Dr. Tabak. We have no current grants funded, so there is
nothing to defund.
Mr. Carter. OK. So I just want to make sure I am clear. You
are not funding anything with your limited definition of gain-
of-function research, nor have you in the past. Yes or no?
Dr. Tabak. In the past there was funding, an influenza
research. But currently there is no such research funded.
Mr. Carter. And there will not be in the future.
Dr. Tabak. We are--we have no plans that I am aware of.
Mr. Carter. Thank you, and I yield back.
Mr. Griffith. The gentleman yields back. I now recognize
the gentlelady of New Hampshire, Ms. Kuster.
Ms. Kuster. Thank you so much, Mr. Chairman, and thank you
to our witnesses. This is a challenging time over the last 3
years, and I admire your patience.
I can't help but think honestly, if the former President
had just taken the vaccine on television in January when he
apparently took it in private, a million--you know, thousands
of lives could have been saved. So I am grateful for all that
you do.
It has been 3 years since COVID-19 flipped our lives upside
down and changed our world. And I want to acknowledge what the
Federal Government has accomplished to save lives and keep our
economies safe, as well as identify areas for improvement.
And I thank Mr. Bucshon for his comments that, under
several administrations, you have been challenged. And I think
we can work together, going forward.
So I want to focus on two specific issues: first, the need
to improve collection of real-time data to help us assess
pandemic threats; and second, the need to facilitate data
sharing to enhance our responsiveness to pandemics and other
public health challenges.
At the start of the pandemic, the U.S. did not have an
efficient system for collecting real-time data. This made it
difficult for public health officials to understand how to
respond to the pandemic. Recognizing this challenge, this
Congress invested billions of dollars to build, update, and
modernize data systems that served as the backbone of our
pandemic response efforts.
The American Rescue Plan provided billions of dollars in
funding to support a whole range of COVID-19 vaccine activities
that we have discussed today, including improvements to
information technology to enhance the quality and availability
of real-time data at the Federal, State, and local level.
This funding was vital, but we need a common framework that
guides us through these investments. Last Congress I worked on
bipartisan legislation to provide such a framework through
immunization infrastructure modernization. Dr. Walensky, why is
safe and secure collecting and reporting of public health data
so important, even beyond COVID?
And what has hindered State and local health departments
from bringing their systems into the 21st century?
Dr. Walensky. Yes, I appreciate all of your efforts here,
especially in immunization.
What I can tell you is, through our data modernization
efforts, we are standardizing how data are collected, and we
are creating similar highways so that data from jurisdictions
from your districts can come in to CDC, and then we can deliver
them back to you in real time. You can see what is happening
around you.
Some of the limitations that we have--maybe I will just say
those efforts have been successful. And prior to the pandemic
we had 187 healthcare facilities that could give us real-time
data. We now have 22,000. We are not where we need to be. But
because of those efforts at the beginning of the mpox outbreak,
we had 22--28 States that could actually give us data
electronically, and we were getting them in real time. Oregon
Health Community Center has saved 140,000 person hours because
they are no longer submitting test data by fax. So those data
modernization efforts are paying off.
We need congressional help in our data authorities. It took
us 6 months to get data use agreements in the beginning of
COVID-19. It took us 3 months to get data use agreements in the
beginning of the mpox outbreak so we could see how
immunizations were rolling out in communities.
Those immunization efforts specifically help us see where
we need to do further outreach, are vaccines reaching where the
disease is, where do we need to do further outreach. And
important, those immunization data provide us opportunities to
provide you back the information that you want, which is do
these vaccines work?
It is because of those immunization data that we were able
to be the first in the world to provide vaccine performance on
the JYNNEOS vaccine. Thank you.
Ms. Kuster. Great. So the second problem, once you have the
data, is data sharing. We need a clear need for efficient data
sharing between all sectors--the public, public health leaders,
government--to ensure that healthcare resources are directed to
those communities most in need.
Recognizing there are barriers to complete integration,
what can Congress do to help facilitate better data exchange
needed to respond appropriately to a--the next pandemic?
Dr. Walensky. So that would specifically be the data
authorities. So data authorities and immunizations data
authorities--to this day I can't tell you who is immunized in
the hospital. And we are going to lose our capacity to look at
laboratory testing and COVID-19 at the end of the public health
emergency.
So it is those data authorities, the sharing of data from
local districts to the States to CDC so that we can fluently
share it back to you so you know what pathogens may be knocking
on your front door.
Ms. Kuster. Terrific, thank you. I look forward to working
with--on a bipartisan basis to get that passed. Thank you.
Dr. Walensky. Thank you so much.
Ms. Kuster. I yield back.
Mr. Griffith. I thank the gentlelady and now recognize Mr.
Duncan of South Carolina for his 5 minutes of questioning.
Mr. Duncan. Thank you, Mr. Chairman. This has been an
interesting hearing.
I, first off, want to thank you all for all the efforts
that you put forth during the global pandemic crisis.
Dr. Tabak, you may want to talk to staff and amend your
definitive answer on gain-of-function grants or subgrants that
flowed through NIH. I think that would be important.
Dr. Walensky, you are a medical doctor. So, outside of
residency, did you ever serve in a hospital as a hospitalist, a
clinical practitioner, or anything like that?
Dr. Walensky. I was the chief of infectious diseases at
Massachusetts General Hospital for the 4 years prior to the--3
years prior to the pandemic, and clinically practiced for 25.
Mr. Duncan. Thank you. Oftimes doctors prescribe off-label
pharmaceuticals and treatments. Is that correct?
Dr. Walensky. Yes.
Mr. Duncan. Did you ever have an instance where the CDC
directed you, as a doctor, getting between you and the patient,
what you could prescribe off label?
Dr. Walensky. Certainly, as you make clinical decisions,
you look at guidance. But at an individual level, those
guidances are intended at----
Mr. Duncan. Guidance, but not directives, right?
Dr. Walensky. I am sorry?
Mr. Duncan. Guidance, but not directives.
Dr. Walensky. No. Guidance, but not directives.
Mr. Duncan. Right. So I am concerned that, during the COVID
pandemic, that the CDC, through various sources--and it could
have been HHS funding through CMS--got between the doctor and
the patient by telling doctors that you could not prescribe
off-level--off-label treatments for their patients.
The doctor is educated. He has clinical experience and
should be able to treat that patient however they see fit, if
they think that is the best. I don't care if it is a knee
replacement or if it is COVID-19 treatments. That is the
doctor's decision. Would you not agree with that?
Dr. Walensky. I would challenge a premise that we at CDC
have guidance on how--and definitive guidance on how--prescribe
drugs or--drugs are prescribed.
Mr. Duncan. Well, let----
Dr. Walensky. What I would say is that, in CDC, we have
clinical recommendations for----
Mr. Duncan. In the essence of time, let me just say that we
witnessed--I talked to a lot of doctors--that they were told by
the administrators of the hospital--because it was pushed down
from Washington, DC--that you couldn't prescribe certain off-
label therapeutics if--even if the doctor felt like that was
how they wanted to treat that patient.
Dr. Walensky. We could have a further discussion about
that, but I don't believe that was related to CDC guidance.
Mr. Duncan. Then why were the doctors being told that by
their administrators?
Dr. Walensky. Well, so we are the public health agency, not
the prescribing agency.
Mr. Duncan. Is that an HHS issue? Was it a CMS issue?
Dr. Walensky. I would have to defer. I don't know. I don't
know who would--but it is not CDC guidance.
Mr. Duncan. There were treatments, therapeutics, that were
working around the globe that doctors wanted to prescribe to
patients in the United States.
Dr. Walensky. There are----
Mr. Duncan. Would you also agree that people following the
guidelines of CDC that treated patients with Remdesivir or
whatever that died, would you agree that patients died based on
those treatments?
Dr. Walensky. There are COVID-19 treatment guidelines.
Those are--guidelines come out of the NIH, and I would like to
pass it to Dr. Tabak, if that is OK.
Dr. Tabak. So the treatment guidelines that Dr. Walensky
refers to are a compilation from NIH as well as outside experts
across the country.
Mr. Duncan. I get guidance, sir, and I appreciate guidance.
What I have been told is doctors were told they could not use
certain therapeutics that they thought might be in the best
interest of treating that patient and saving a life. Patients
died based on the treatments that were pushed down from
Washington, like Remdesivir. Patients died in this world, and
doctors make better decisions than when government gets in
between that doctor-and-patient relationship.
I would love to have a further followup, but I agreed to
yield some time to Dr. Burgess, and I yield as much time as I
have left.
Mr. Griffith. The gentleman yields. Dr. Burgess?
Mr. Burgess. I thank the gentleman for yielding.
Dr. Walensky, I just had a followup question. Thank you for
hosting me last October when I came down to CDC. And as you
remember, one of the things that I had been terribly concerned
about is the excess mortality, the fact that life expectancy--
according to your website, life expectancy in the United States
has declined to its lowest level since 1996.
Granted, the COVID deaths, granted the fentanyl deaths,
methamphetamine, diseases of despair. But I am not sure that we
are not missing something, and I want us to be very thorough in
looking at the data. And that is where I ask your help, because
CDC is the data repository in the country.
Is there something 5 years from now we are going to look
back and say, ``I can't believe we missed that''? So that is my
concern, that there is something hidden within all of this in
the excess mortality that we should be--where our focus should
be now.
Dr. Walensky. Yes, thank you for that question.
So we have different ways of looking at deaths. We have
aggregate data that come from the Department of Health. We have
line-level data also that lag a little bit, and then we have
the death certificate data, where we have the most definitive
information that we are going to get based on how that death
certificate is filled out.
Those death certificates are filled out with an underlying
cause and contributing causes. And we look at that for COVID-19
and other related deaths. It is the case that there is--COVID
is an underlying cause, but then many other causes, as you
know, opioid-related causes and then lack of access to medical
care. At emergency departments, ICUs, people had surgeries
deferred.
Mr. Burgess. Yes.
Dr. Walensky. So that is a lot of what we are looking at
right now.
Mr. Burgess. I am going to need to yield back, but I am
going to submit a question that I would like a response in
writing.
Thank you, Mr. Chairman.
Thank you, Jeff.
Mr. Griffith. The gentleman yields back to the gentleman.
The gentleman yields back to the chair. The Chair recognizes
the gentlelady from Delaware, Ms. Blunt Rochester, for her 5
minutes.
Ms. Blunt Rochester. Thank you, Mr. Chairman, for the
recognition, and I want to thank the witnesses.
I want to thank you not only for your work, but your work
during one of the most challenging times in the history of our
planet. As I sit here, I was thinking about the physical, the
mental, the economic toll that it has taken on all of us, and
the fact that there was so much that we did not know. And so I
just want to commend you, because I know you are sitting here
and, you know, getting some very tough questions, but it was
also something that we collectively went through and are still
going through.
I have a family member who died 2 months ago from COVID, so
I want us to remember this was unusual and that, even as we ask
our questions, that we remember we are still in this together.
I am glad that you brought up workforce needs, data
authority, supply chains. These are all things that have
impacted every single piece of this, including research and
development and innovation.
I know in its 76 years the CDC has never faced a public
health emergency of this magnitude. So it is not surprising
that there were a lot of lessons learned for all of us. And one
of the things that we learned is that the CDC lacked critical
data when COVID-19 emerged, resulting in an incomplete national
picture of this global threat.
I am glad there were a lot of questions already asked on
data authority, but, Dr. Walensky, what kinds of questions
would data authority allow the CDC to answer?
Dr. Walensky. I----
Ms. Blunt Rochester. Can you give us a few examples also of
how data authority could have helped in Federal decision
making?
Dr. Walensky. Sure. What fraction of people in the hospital
are vaccinated? What is--now, with--we have these authorities
through the public health emergency. But what is going to be
our percent positivity for testing? In impacts before we had
all of our data use agreements signed is who is getting
vaccinated. So those are key things as we have--we are in the
position to make important decisions. We are making those
decisions without the benefit of data that exist, and it makes
it harder to make them. Thank you.
Ms. Blunt Rochester. I know, for me, one of the biggest
things that I learned was that there were just basic things
like collecting data on race and ethnicity that were not clear,
and it ended up being one of the strongest indicators for death
and contraction.
Can you tell us how--what steps were taken to bridge the
gaps in data like race and ethnicity, or what more should be
done?
Dr. Walensky. Right. So we are working through our data use
agreements with each of our individual jurisdictions to be able
to receive those data.
Oftentimes, those data are not fully completed. And so that
gives us a limited view, as well. But if, through our data
monetization efforts, we can then standardize the data that are
collected and link them, then we--they would immediately
populate.
Ms. Blunt Rochester. Yes, thank you.
One of the issues that I hope is not lost or forgotten is
the issue of long COVID. And I am glad that that has also been
one of the topics of discussion here. I know individuals that
are still concerned, struggling. We have healthcare providers
that don't really know what to do.
And Dr. Tabak, what guidance do you have for healthcare
providers trying to understand and treat patients with long
COVID now?
Dr. Tabak. At the moment there are no treatments that we
know are effective against all forms of long COVID. What
clinicians are doing is they are treating symptoms based upon
their similarity in other diseases and conditions.
We hope to launch the first interventional trials using our
recovered cohort within the next few months and hopefully get
more definitive answers than that one.
Ms. Blunt Rochester. I can say I am pleased that I have
been working with stakeholders in this space, because I, again,
don't want us to forget it. This also, in addition to our
health impacts, it has impacts on our economy and jobs and
people being able to go to work.
I ask unanimous consent to enter into the record a
collection of published medical research and scientific
literature from the COVID Patient Recovery Alliance. I have
been--I ask for permission to enter into the record.
Mr. Griffith. Without objection.
[The information appears at the conclusion of the hearing.]
Ms. Blunt Rochester. Thank you. Thank you, Mr. Chairman.
I have been working with these stakeholders, and again, as
I said, I want to make sure that we don't forget those
individuals and that we continue to have a focus there.
We will have a lot more questions to enter into the record.
But again, thank you so, so much for your efforts. Again, we
are still all in this together.
I yield back.
Mr. Griffith. The gentlelady yields back. I now recognize
the gentleman from Florida, Dr. Dunn.
Mr. Dunn. Thank you very much, Mr. Chairman.
So 3 years have now passed since this onset of this
pandemic, and I think there's a lot of lessons that we can
learn. Some things our government did very well, and I think we
made some bad calls too. Operation Warp Speed was a resounding
success at developing vaccines and a great example of what
happens when we cut red tape.
I am concerned, however, that some policies were not
grounded very well. Specifically, I am concerned about the
mandates and the lockdowns. You know, when I was in med school,
we were taught that mandates caused the public to distrust
public health authorities. They undermined the public's
confidence in our advice. And that was reconfirmed in a very
large study out of Oxford International, a study of 29
countries in 2021. So mandates, I think, were
counterproductive.
The lockdowns. Lockdowns of economy are a new and strange
concept. We never had that. That was never in the playbook for
epidemiology in med school. I am reading now economists who
estimate $100 trillion damage to the free world's economy from
these lockdowns. Our great grandchildren will be paying for
this.
Dr. Walensky, whatever comes in the future, whatever the
next pathogen is, we can never do this again. Do you agree with
me?
Dr. Walensky. I agree that we should do everything in our
power not to have it happen. But I will tell you that I was a
practicing clinician in March of 2020, and we had a morgue
sitting outside the hospital. And so, when you can't take care
of a motor vehicle accident and you can't take care of a brain
tumor, extraordinary measures are necessary.
I would very much like to never be back----
Mr. Dunn. Yes, but the lockdowns didn't help. So, I mean,
what happened----
Dr. Walensky. Well----
Mr. Dunn. It was an if/then, but that is not like you got
any gain out of it.
Dr. Walensky. I do think when there are lockdowns, there
was further need--there is decreased need for things like motor
vehicle accident care. So I do----
Mr. Dunn. You locked down our whole economy.
Let me move on with the time here. So another concern I
have is our failure in diagnostics. We have known for over 10
years that the principal source of immunity--the principal
mediator of immunity to coronaviruses are in T cells, not B
cells. However, to this day we lack coverage for any cellular
immunity testing in this country. That is the T cell testing
that you see.
NIH and CDC have ignored this kind of testing, despite the
fact that we know this. This is the way the coronaviruses are
principally--to the degree that we have long-lasting immunity
from any coronavirus, it is mediated in the T cells. Still no
coverage.
You know, it is--the other thing you get with T cell
testing is you can--it is a test for natural immunity. So we
test whether or not somebody has been infected. Imagine how
helpful it would be to know who has some level of immunity, to
know how many people were infected with this virus. We could
still do population studies with this testing.
You know, Dr. Tabak, would you commit to the NIH studying
some T cell immunity?
Dr. Tabak. So, in fact, we are having conversations now
through our active consortium, which is a public-private
partnership, Federal agencies, and industry to do just that, to
look at T cell readout. And so----
Mr. Dunn. Please do, please do.
Dr. Tabak [continuing]. We are working towards that goal.
Mr. Dunn. You know, Singapore studied SARS-CoV-1 and T cell
immunity, literally, 6, 7 years ago. I mean, that is a long
time ago. We have known about this for quite a while.
I am also concerned, actually, about the shortage of
studies on therapeutics for early outpatient treatment. I mean,
we had a guidance nationally that basically said, ``If you test
positive, go home, quarantine, wait until your lips turn blue,
and then go to the hospital, and maybe we can save you.'' That
was it.
I mean, there were a lot of broad spectrum antivirals out
there of potential use. Specifically, I am thinking about in
Japan. This is not approved in America, but it has been
approved in Japan. In fact, it is a generic drug in Japan, and
it is Favipiravir. And we did--we just ignored it, we sailed
right past Favipiravir, never mentioned it, and we instead
approved, Dr. Califf, we approved Molnupiravir. Molnupiravir is
a another RNA polymerase inhibitor, but it inhibits human RNA
polymerase as well as viral. Favipiravir is specific for viral.
Can you tell me something about why we didn't take a look
at Favipiravir?
Dr. Califf. Of course, the FDA will look at anyone who
brings this data and seeks approval. So I will have to go back
on the specifics of this.
But Molnupiravir, as I know you know, had randomized
clinical trials that it brought----
Mr. Dunn. So did Favipiravir. It had--Favipiravir, when I
looked in 2021, had 96 trials.
Dr. Califf. Well, we also have to look at the quality of
the trial. So I will have to get back with you.
Mr. Dunn. Japanese trials are pretty high-quality medicine.
You know, I think--my time is expired, so I will have to--I
have to yield here. But I think there is some real
disappointments in targeting and choice of therapeutics and
diagnostics.
With that, Mr. Chair, I yield back.
Mr. Griffith. The gentleman yields back. I now recognize
the gentlelady from Illinois, Ms. Kelly.
Ms. Kelly. Thank you, Mr. Chair, and I want to thank the
chairs and ranking members for your insights on the challenges
and successes we have had--faced in strengthening our response
to the COVID-19 pandemic.
And excuse my voice.
And I want to thank the witnesses for all the work that you
do.
Vaccinations have proven to be a powerful tool. The Biden
administration's decision to make vaccinations free was a
pivotal step in our continuing journey toward health equity and
response to reluctance in communities of color to get
vaccination.
The evolution of COVID-19 messaging created opportunities
to address challenges and create strategy around increasing
confidence in public health messaging for Black and Brown
communities, including continued efforts to increase
vaccination rates and booster compliance. Still, bivalent
booster rates continue to lag, with 19.4 percent of Black
communities, 12.7 percent of Latino communities receiving
updated boosters, as compared with almost 30 percent of White
communities.
Dr. Walensky, considering the pending PAHPA
reauthorization, are there key learnings from COVID-19 that
will help to increase Black and Brown awareness and uptake of
public health strategies during the ongoing pandemic and other
future public health emergencies? Because there will be others.
Dr. Walensky. Yes, there will be others. Thank you for that
question.
Among the key points of our CDC Moving Forward is creating
partnerships, results-based partnerships. And part of those
partnerships is working with community-based organizations,
recognizing that people know how their communities will react,
and people know their questions that they would like answered.
We do have programs like Vaccinate with Confidence, race
and ethnicity, access to community health, Let's Rise,
promoting vaccine confidence. So all of these things are
working within communities, from people--from--with people from
those communities to understand what it is--what are their
questions, the local questions that they have related to
vaccine confidence.
It is a concern not only for COVID-19, but also for other
routine pediatric vaccinations as well.
Ms. Kelly. So I know COVID is not over, but it is waning.
So do you see that continuing, or we just did that during
COVID?
Dr. Walensky. Those efforts are continuing, not only for--
through the bivalent boosting, but we always have a vaccine
campaign for flu vaccines every year.
And then we really do have work to do in our pediatric
vaccines, as has been noted. We lost pediatric vaccination
rates this year, down from 95 percent 2 years ago, 94 percent
in the last year, 93 percent this year. A quarter of a million
less children entering kindergarten with their routine
vaccinations being up to date.
Ms. Kelly. Thank you.
How do you say your name?
Dr. Tabak. ``Tayback.''
Ms. Kelly. ``Tayback.'' I want to be correct.
Dr. Tabak, can you elaborate on how initiatives such as
NIH's CEAL, Community Engagement Alliance, against COVID-19
disparities increased clinical trial diversity for COVID-19
vaccines and treatments?
Dr. Tabak. Yes, I am pleased to do that. What we did was we
partnered with local organizations within the community, faith-
based organizations and other community leaders, people who are
trusted, and met with them to explain things, basic questions
about COVID, about therapeutics, about vaccines, and,
importantly, why it is important to participate in clinical
trials.
We wanted our trials to represent the Nation. And that, of
course, gives better comfort to people that a particular
intervention may work, if they know that somebody who looks
like them was part of the trial.
We are building this into everything that we are doing now
at NIH. We are not stopping just with the COVID response,
because, obviously, the same tenet holds true for all clinical
research. And so we are working hard to extend that.
Ms. Kelly. I am glad to hear that, because I was going to
ask how can the successes of these efforts be replicated to
ensure racial and ethnic diversity in clinical trials more
broadly. So I am glad you are continuing.
Dr. Tabak. Thank you.
Ms. Kelly. I just want to say thank you again. This is very
important to me, and I look forward to partnering in a
bipartisan way with my colleagues to ensure clinical trial
diversity.
Thank you. I yield back.
Mr. Griffith. The gentlelady yields back. I now recognize
the gentlelady from Arizona, Mrs. Lesko, for her 5 minutes of
questioning.
Mrs. Lesko. Thank you, Mr. Chair. My first question is for
Mr. Tabak.
You told Congressman Carter that NIH did not fund ePPP
research in foreign countries, except for an influenza
experiment in the Netherlands. Was that experiment funded by a
direct grant or a subgrant?
Dr. Tabak. The experiment in the Netherlands, I believe,
was a subaward, but I would have to check to confirm that. And
that was done in the--I think it was in the early 2000s. It has
been a while.
Mrs. Lesko. OK. And how, then, did the NIH know about the
experiment, if it was a subgrant?
Dr. Tabak. It was approved under the then-DIRK/P3CO
framework, and we use the normal monitoring procedures for
that, yes.
Mrs. Lesko. In the case of EcoHealth and the Wuhan lab, the
NIH was unable to get the records of a humanized mice
experiment because the Wuhan lab, the subgrantee, refused to
provide this to EcoHealth.
Given the failure of an NIH grantee to get lab records,
there could be other cases where NIH can't get the lab records.
Isn't that right?
Dr. Tabak. It is possible. As you know, that subaward has
now been terminated. They are no longer funded by NIH to do
anything.
Mrs. Lesko. So how can you state--how can the NIH know for
sure that it hasn't funded ePPP, when NIH can't be sure it can
get the lab records of experiments funded by NIH?
Dr. Tabak. As a result of them failing to provide us with
the adequate documentation, they no longer have any funding
from NIH.
The NIH funding, we approve what they are to do from their
progress reports and from their publications they have done
what they said they would do. The work was commensurate with
the modest sums of money that we provided to them. I don't know
what other work they are conducting.
Mrs. Lesko. Yes, I guess what I am saying is that, if you--
if we couldn't get the reports accurately, how can you
definitively say that there was no funding of this?
And so, anyway, I have another question for you. As the
vice chair of the Oversight and Investigation Subcommittee and
a member of the Select Committee on the Coronavirus Pandemic, I
can't stress how inexplicable the failure I believe any of NIH
oversight on the EcoHealth Alliance grant is to me.
In 2019, EcoHealth Alliance failed to submit a required
annual report on the research it was conducting related to the
emergency of the bat coronavirus. The 2019 progress report was
due by September 2019. The COVID-19 pandemic began late 2019.
Despite a bat coronavirus pandemic emerging in the city where
NIH-funded bat coronavirus research was taking place, NIH
failed to even ask for the missing progress report until 2021,
and it was still not actually submitted until months later,
more than 2 years after the due date.
Given these circumstances, how did the agency fail to
notice that the annual report on research done by EcoHealth and
the WIV was overdue for 2 years?
Dr. Tabak. The most important point to appreciate here is
that the viruses that were under study in that subproject bear
no relationship to SARS-CoV-2. They are genetically distinct.
They are absolutely unrelated to SARS-CoV-2. That is the most
important thing to understand.
As far as the administrative oversight----
Mrs. Lesko. And how do you know that for sure, sir?
Dr. Tabak. By looking at the phylogeny of--by looking at
the genetic sequence. It would be equivalent to saying that a
human is equivalent to a cow. That is how distant the sequences
of the viruses that they were using in this work were to the
actual SARS-CoV-2.
Now, the administrative overlap, the administrative issues,
we concur with that. We concurred with the oversight report. We
have taken steps to redress those administrative issues.
Mrs. Lesko. Thank you.
I have only 13 seconds left, so I will yield back.
Mr. Griffith. I thank the gentlelady and now recognize the
gentlelady from Washington, Dr. Schrier.
Ms. Schrier. Thank you. Thank you, Chairman Griffith. And
thank you to the witnesses for being here today. I appreciate
all the work you have done over the past few years, with a
rapidly changing pandemic and tricky messaging.
We have learned a lot in these past few years, and I just
want to make sure that we remember these lessons when the next
public health challenge comes along. Today there is a lot to
talk about, but I would like to focus on testing and on
therapeutics.
So, Dr. Califf, in your testimony you say that the FDA is
committed to continuing to use every tool in our toolbox to
fight this pandemic, and I absolutely agree. As a pediatrician,
I have been advocating now--we are talking years--for the use
of rapid tests and masks and a multilayered approach to keep
our kids and families safe and to keep our children in school,
in classrooms.
And I also just want to acknowledge, Dr. Walensky, thank
you for you also having that as your north star: How can we get
our children into classrooms and keep them and their teachers
there safely?
In fact, we did one of the first pilots in the country on
using rapid tests to get kids into school.
The FDA has authorized over 30 over-the-counter tests, and
I use them before I travel home to make sure I am not bringing
unwanted COVID back to my family. People use them around the
holidays to protect their families. And we have really come to
rely on these rapid tests.
Are any of the ones that we are using today fully
authorized, or do--are they all under emergency use
authorization?
Dr. Califf. I believe all of the rapid tests that we have
today are under EUA. But they will not go away, because we will
have a bridging program, and they will still be available.
Ms. Schrier. That is fantastic. You anticipated my next----
Dr. Califf. I will have to check to be sure it is 100
percent.
Ms. Schrier. OK. I wanted to make sure that that would
happen, because they are really indispensable.
I will hop to my other topic. Mr. Tabak--or Dr. Tabak,
excuse me--the RADx program has been incredible. These public-
private partnerships, getting accelerated treatments has been
incredible.
I was wondering if you could talk about how we are going to
use this and stay nimble with future threats, but just kind of
a briefer answer, because I have more for you.
Dr. Tabak. Well, from the lessons learned, we know that if
we could create centers that are ready to take very rapidly the
problem, find a solution, and then scale it up, that we could
make a big difference in any future pandemic.
Ms. Schrier. That public-private partnership has really
been incredible. And I appreciate the work in all of these
institutions: CDC, ASPR, BARDA.
I--we have already seen with COVID that, as the virus has
changed, some of our therapeutics are no longer useful, like
some of the monoclonal antibodies. And we know from our
experience with TB and with HIV that we may get to the point
where what we need are drug cocktails, essentially. You don't
just use one therapeutic, in order to evade all of the
mutations and changes in a virus and them getting around
therapeutics. We may need to use several at once.
There is not a lot of incentive for drug companies to do
that testing. And I was wondering if you could talk about what
is happening at the NIH to speed drug cocktails.
Dr. Tabak. In the active program, which is a public-private
partnership consortium between government agencies and
industry, we have, in fact, used that as an incubator for these
types of mix-and-match, if you will, types of approaches. And
we have been very pleased for a number of our industry
colleagues who have come forward and have been willing, you
know, to engage in this sort of conversation. So I think that
is the direction that we will have to proceed in the future.
Ms. Schrier. That is fantastic. And frankly, they will have
more of a guarantee of a long market life if they figure out
how to make theirs more effective in a cocktail.
Last question, Dr. Califf, I know there has been a lot of
discussion about whether vaccines are still useful even if they
are not perfect at preventing the disease or perfect at
preventing transmission. I just wanted to give you an
opportunity to set the record straight on your perception of
the importance of vaccines.
Dr. Califf. First of all, let me just speak to the
transmission issue, which has been discussed very much today.
It is true that the vaccines are not sterilizing. And Dr.
Bucshon, I think, was careful in using that word.
What we have, though, is a modest prevention, like a 50
percent prevention of the risk of getting infected if you're up
to date on your vaccination. And that is very important for
frontline workers of all types to stay healthy, for children
not to infect their grandparents who may be at risk.
But the most important thing, I think, is if you're up to
date--you've gotten your bivalent now, which is what that
means--your risk of dying if you get infected is reduced by 80
percent. And if you get an antiviral that is recommended by the
FDA, if you get infected and you're high risk, you have another
80 percent reduction. Now, you have to do contingent
probability, so what that means is your risk of dying is very
low if you get both.
So, you know, I am a cardiologist, so I am used to life and
death. This is like the most important thing one can do today
to keep from dying that is very remediable, free. There are
side effects to vaccines. We all know that. But they are far
overwhelmed by the benefits that occur.
Ms. Schrier. Thank you. As a pediatrician, I fully concur
with the importance of vaccines.
I yield back.
Mr. Griffith. The gentlelady yields back. Now I recognize
the gentleman from Pennsylvania, Dr. Joyce.
Mr. Joyce. Thank you, Mr. Chairman. I would like to address
the CMS vaccine mandates, because I think we recognize that it
has caused a cascade of problems, including workforce shortages
throughout the United States on all levels.
OSHA also released a mandate November 5th, which has been
held up in the courts and then subsequently withdrawn. Dr.
Walensky, was the CDC consulted in issuing these mandates?
Dr. Walensky. The CDC provides information regarding the
safety and effectiveness of vaccines and has provided the
information that says that those vaccines are very safe, very
effective in preventing severe disease and death, as Dr. Califf
just said, as well as preventing some symptomatic disease--not
as good as severe disease and death, but about 50 percent
protection against symptomatic disease, even during the Delta
and Omicron era.
Mr. Joyce. Did OSHA specifically reach out to you or your
teams before issuing these mandates?
Dr. Walensky. We provide our recommendation--or our
scientific guidance within an interagency process that works
across different agencies.
Mr. Joyce. Dr. Walensky, we are both Johns Hopkins-trained
physicians. We are both parents.
Head Start has a vaccination mandate that is in place. Did
the CDC provide data about COVID-19 risk to Head Start-aged
populations?
Dr. Walensky. I--CDC continues to provide recommendations
and information, science-based information, on the vaccine
safety and effectiveness in children and in adults.
Mr. Joyce. In earlier testimony you stated that the vaccine
mandates with COVID-19 have resulted in decreased routine
pediatric immunizations. Is this is not correct?
Dr. Walensky. I am not--I would have to go back to the
record. I am not sure I stated it exactly in that way.
Mr. Joyce. Do you feel that, with the potential of
decreased routine childhood immunizations to measles, to mumps,
to rubella, do you feel the continuation of the Head Start
vaccine mandates will put at risk these children, or actually
have their parents consider whether or not they should continue
in these Head Start programs?
Dr. Walensky. What I can tell you is that vaccines save
lives. That is true in our routine vaccination for pediatrics.
It is true in COVID-19. It is true in influenza. And I think we
should do everything that we can to promote vaccination,
because it saves lives for all of these different infectious
threats.
Mr. Joyce. I feel that we are subjecting certain
populations to more risks than when we recognize that parents
are not immunizing their children with vaccine mandates, which
we recognize are not necessarily effective, particularly in
pediatric populations.
I would like to pivot and talk about the end of the COVID
public health emergency. Unwinding the public health emergency
will eventually reset the health system back to what was in
place before the pandemic, with some exceptions, unfortunately.
And it really is unfortunate. I do not feel that we will
restore in our public health agencies the credence that is so
necessary at any time soon.
Dr. Califf, as a followup from my September 2022 letter
with explicit steps, what explicit steps is the FDA taking or
will the FDA take to continue to move forward on COVID-19
therapeutics, specifically therapeutics that so many patients
continue to need, patients who are immunocompromised, from--
whether that is from underlying disease, or patients who are
immunocompromised because they are in the middle of a cancer
therapy, patients who are exposed to many different types of
infectious disease but particularly to COVID-19?
Dr. Califf. Well, let's talk about the technical aspects
first. And I appreciate the question, because millions of
immunocompromised people, as you know, in the United States,
they deserve special protection.
We have now the ability to make therapeutic antibodies, as
you well know, in addition. The first step is get vaccinated,
be up to date on your vaccination, make sure, if you get
infected, that you get a potent antiviral. Those are available,
they are effective in immunocompromised patients, as well as
other people.
Mr. Joyce. My time is limited. Please allow me to
interrupt. So the therapeutic antibodies, are they effective
against the current strains that we see with COVID-19?
Dr. Califf. None of the ones currently available are
effective against----
Mr. Joyce. So we are talking about what is going to be
available. If we recognize that the immunotherapies are not for
you, are not effective against the current strains, what do we
have to offer these patients?
Dr. Califf. Oh, I think the way to think about this now is
that the technology has gotten so advanced, there is like a
library of therapeutic antibodies. Don't be surprised if you
see some that were old and didn't work against old strains now,
with the new variants, actually becoming active against them.
So those are constantly being tested.
But we also need to work with the industry to figure out a
way to make it worth their while to continue to work in this
field, because what they are looking at is they make a
therapeutic antibody, 3 months later there is a new variant and
there is no longer a market for it.
One of the real keys to Operation Warp Speed and to what
came after was the government infusing money that took the risk
away for the industry, for being active to use all their
capabilities. So we do have work to do there, but----
Mr. Joyce. I think----
Dr. Califf [continuing]. The technology is----
Mr. Joyce. I think my time has expired. I think we have a
lot of work to continue to do.
And thank you, Mr. Chairman. I yield back.
Mr. Griffith. The gentleman yields back. I now recognize
the gentlelady from Massachusetts, Mrs. Trahan.
Mrs. Trahan. Thank you. Thank you to our chairs and our
ranking members for holding a hearing on the Federal response
to COVID-19.
I want to thank our witnesses today for, you know, your
testimony, for your patience, certainly for your leadership as
we navigated the most deadly pandemic of our generation.
The U.S. has made tremendous progress in our fight against
COVID-19. As many of my colleagues have already said today, the
Biden administration stood up the largest free vaccination
program in U.S. history, delivered hundreds of millions of free
at-home tests to households, and passed the historic American
Rescue Plan, which put money in the pockets of financially
strained Americans and enabled schools to reopen safely for our
kids.
COVID has required an all-of-government response that
tested the Federal Government's public health system capacity,
including testing and vaccine development, supply chain
capabilities, treatment and medical responses, and workforce
readiness.
It is critically important now more than ever to take our
lessons learned from COVID to better equip our preparedness and
response systems so that we are never caught flat-footed again.
For this reason, I will be introducing a bill in the coming
weeks that funds a Disease X Medical Countermeasures program at
BARDA for unknown viral threats with pandemic potential.
Current funding constraints at BARDA only allow the agency to
go so far. With much of BARDA's MCM development work focused on
a defined list of chemical, biological, radiological, and
nuclear threat agents as well as influenza, we may not be
prepared to develop and manufacture at scale future drugs and
vaccines against unknown viral threats that can lead to a
devastating pandemic.
The Disease X Act will help BARDA to fully focus on their
full list of priorities, including increased focus on emerging
infectious diseases. That said, BARDA played a critical role in
our response to COVID. With a decade of investments and
platform technologies under flexible agreements, BARDA was able
to pivot to develop COVID-19 MCMs at a rapid pace.
Dr. Califf, as you know, Congress passed many provisions
from the Prevent Pandemics Act as part of the 2023 omnibus
funding bill that was just signed into law. One of these
provisions creates a platform technology designation program at
FDA to support the development and review of new treatments and
countermeasures that use adaptable technologies that can be
used in more than one drug or biological product for novel
public health threats. We saw how powerful the mRNA platform
was for the COVID-19 vaccine, and now other applications of
this platform are being explored.
So, Dr. Califf, how will this new regulatory designation
for platform technologies potentially lead to faster
development of vaccines and therapeutics for currently unknown
emerging infectious diseases in the future?
And how does FDA plan to implement this new designation?
Dr. Califf. Well, you know, mRNA is the example, as Dr.
Tabak already stated. When you've got a platform that can be
used for multiple different therapeutics, it's a wonderful
thing. But it doesn't happen overnight. So if you wait until
you're in a crisis, you can't then develop the platform. This
happens over years to decades. So working with our partners at
NIH, BARDA, ARPA-H, I wouldn't be surprised if it has a
critical role to play here.
We want this to happen so that, when there is a need, the
platform is available and multiple therapeutics can be
developed.
Mrs. Trahan. Thank you. And as mentioned previously,
provisions from the Prevent Pandemics Act were recently signed
into law. While I am pleased many of these provisions have been
enacted, this cannot be the end of our work to strengthen our
preparedness and our response infrastructure.
So, Dr. Walensky, what are some of the capabilities to
detect and monitor emerging infectious diseases at CDC included
in the Prevent Pandemics Act, and what additional authorities
and resources are needed to prevent and respond to future
pandemics?
Dr. Walensky. Thank you. Yes, so through PREVENT we were
able to receive OTA, other transaction authority, but we were
unable to receive the data authorities that we need, the
workforce authorities that we need.
From a workforce standpoint, our ability to rapidly respond
if we are going to be a response-based agency, which we are
working--we are, and--but we have never had to at this size,
scale, and scope. If we are going to be able to be--to respond
to this size, scale, and scope, as was required over these last
3 years, we need to have the authorities that other response-
based agencies do: workforce hiring authorities, danger pay,
overtime, as well as our data authorities.
It took us 6 months to receive data use agreements from 100
different jurisdictions early in the pandemic in order to be
able to see the data. Similarly, through the mpox challenges
over the summer, we had the same challenges in not having to be
able to see the data. If you can't see the data, you can't act
on the data. And that is true at CDC, but also back at the
local level. We would like to give those data back to the local
level so they can respond as well. Thank you.
Mrs. Trahan. Great. Thank you so much.
I yield.
Mr. Griffith. The gentlelady yields back. I now recognize
the gentlelady from Tennessee.
Mrs. Harshbarger. Hey.
Mr. Griffith. Mrs. Harshbarger.
Mrs. Harshbarger. Thank you, Mr. Chairman. Thank you, Mr.
Chairman. Thank you to the witnesses for being here today.
I want to talk to you, Dr. Walensky. According to Twitter
files reported by David Zweig on December 23rd, the Biden
administration was working with Twitter to flag anything that
conflicted or differed from CDC guidance as misinformation. Dr.
Walensky, were you or your staff in meetings, phone calls, or
virtual meetings with the Biden White House administration
officials and Twitter? And that is a yes-or-no.
Dr. Walensky. Thank you for the question. There is pending
litigation on that, so I am not going to get into the specifics
on that today. Thank you.
Mrs. Harshbarger. Oh. What about Facebook and Instagram?
Dr. Walensky. Similar.
Mrs. Harshbarger. Giving--given reporting the CDC was
consulted frequently, and at times daily, and on giving
recommendations on what content to flag as fake or misleading
on Twitter, Facebook, and Instagram, how many staff did you
have dedicated to working with technology companies?
Dr. Walensky. Again, there is pending litigation on that,
so I am not free to comment right now.
Mrs. Harshbarger. Was there any centralized guidance from
you about what staff should relay as fake or misleading?
Dr. Walensky. Pending litigation, regrets.
Mrs. Harshbarger. Well, Dr. Walensky, when there are
numerous examples of individuals being flagged as misleading
for referencing peer-reviewed studies, posting CDC's own data,
or their own opinions as experts being called into question
merely because it differs from your scientific perspective,
that is just unacceptable.
And let me ask you, Dr. Califf. Let me go back to a
question. Will the FDA commit to provide transparency for the
raw data used to make key decisions during the course of the
pandemic on vaccines and treatments?
And specifically, will the FDA commit to releasing all data
on complications in phase four monitoring to allow for outside
analysis, yes or no?
Dr. Califf. We are committed to transparency on the
information that we are collecting in our vaccine follow-up.
Mrs. Harshbarger. OK. All data?
And I am asking you that because there was a FOIA request
for Pfizer COVID-19 vaccine safety data. And from what we read,
it said that it would take the FDA 75 years at 500 pages a year
to get that 329,000 pages of data that the FOIA request asks
for.
Dr. Califf. Well, I will have to get back to you on that
specific number. I am not familiar with the exact number. But
we will do everything we can to make sure people are informed
about vaccine safety.
Mrs. Harshbarger. Yes, that would be very pertinent, since
these vaccines are going out to the public, these boosters are
going out to the public. And I don't understand. It said in the
article there were 10 employees that were requested to review
that data or FOIA request.
And how many employees did the FDA employ, how many do you
have, do you know?
Dr. Califf. We have 18,000 employees in total.
Mrs. Harshbarger. Eighteen thousand employees, but there's
10 that are put on FOIA requests. And at that rate, at 329,000
pages and the FDA saying that they could only do 500 pages a
day, it would take 75 years. But if you would, get back with me
on that.
And I have some other questions about CPG guidances and how
they are construed as law, but I will put that in writing for
you.
Let me see. I have got a little bit of time left, and I
have another question, if I can go--if I can find it. And it is
about another recent health concern.
On October 31st, 2022, the Republican leadership of this
committee sent a letter to the NIH raising concerns and
questions about a monkey pox, or an mpox, viral enhancement
experiment being conducted at the NIAID. This experiment
involves transferring the more lethal version of the mpox
virus, which has about a 10 percent mortality rate in
unvaccinated people, with the less lethal but more
transmissible mpox virus circulating in the U.S.
Now, the less transmissible mpox virus has a mortality rate
of less than 1 percent, and the more lethal virus is classified
as a Federal select agent. It appears that the project is
reasonably anticipated to yield a lab-generated mpox virus that
is 1,000 times more lethal in mice than mpox virus currently
circulating in humans.
The NIH has refused to respond to the committee's letter.
And as Chairman Griffith mentioned, in stark contrast the
committee asked very similar questions to Boston University
about its recent experience involving SARS-CoV-2, and the folks
at Boston University were very forthcoming. And because they
told us exactly what they were doing and why they were doing
it, we are confident they are acting appropriately.
And I will have followup questions for you, Mr. Tabak,
about, since you haven't responded, why haven't you responded,
and what are you hiding? Did you fail to select --to follow
select agent regulations?
And did the NIH fail to follow its own guidelines and
policies like it did with the EcoHealth grant?
Dr. Tabak. The experiments that you are referencing were--
did follow all the select agent guidelines. It was conducted in
our intramural program. It was approved back in 2015. What they
did was they replaced genes in the more virulent----
Mrs. Harshbarger. Well, you can--I know my time is up, and
I know we are on a schedule, but if you would, follow up in
writing with me.
And I do have some other questions for Dr. Walensky about
that----
Mr. Griffith. I think we are still waiting to find out what
level lab that is in too. But OK----
Mrs. Harshbarger. Yes.
Mr. Griffith. We will get that in writing later. I now
recognize----
Mrs. Harshbarger. Thank you.
Mr. Griffith [continuing]. Representative Tonko of New York
for his 5 minutes.
Mr. Tonko. Thank you, Mr. Chair. The allegation that NIH-
funded research in China led to the release of COVID-19 from a
lab has been routinely debunked.
I ask unanimous consent to submit a document for the record
published by NIH demonstrating that SARS-CoV-2 and the types of
viruses studied with NIH funding are too genetically distant to
be directly related.
We all share interest in biosecurity, but we should make
decisions, obviously, based on facts.
Mr. Griffith. I am happy to recognize--or to admit that
without objection. I would just note that, with a huge hole in
the data, how do we know?
Without objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Tonko. Thank you, Mr. Chair.
As scientists learned more about the virus that causes
COVID-19 and the best approaches to keeping us all safe, it was
important that decisions made about public health guidance and
investments evolved alongside it. This means that information
and guidance were revised to keep up with our growing
understanding of the virus. And despite criticisms of those
changes, it is in the best interest of the Nation to ensure
that the public is armed with the best information that we have
at the time.
So, Dr. Califf, as we have discussed, vaccination is our
best shot at keeping the American public safe and healthy.
Observing how the virus itself changed over time led to the
development of new vaccines like the bivalent booster to target
new variants of SARS-CoV-2. Why is it important for FDA's
regulation of biologics and vaccines to be responsive to
emerging science about SARS-CoV-2?
Dr. Califf. Well, I think the emergence of these new
variants is proof of principle right there. And if we didn't
have all the research going on to look at the variants, to
produce them in laboratories, to test whether it is therapeutic
antibodies or vaccines, we couldn't keep up, and we would lose
the effectiveness of our vaccinations over time.
So just like with flu vaccines that are updated every year,
we are going to need to update our COVID vaccines in the same--
not exactly the same, but in a similar way.
Mr. Tonko. I appreciate that. And Dr. Califf, how does new
scientific information from the study of an infectious disease
allow FDA to better determine the safety and efficacy of new
vaccines or treatments and evaluate if they are ready to be
publicly deployed?
Dr. Califf. Now, here I would stress two types of
information. One is biological information coming from
laboratories, both those that are funded at NIH and what
industry is doing and the community of universities around the
world. It's the only way to keep up and to know that the
vaccine that you're proposing actually has activity against the
specific variant.
But the second kind that Dr. Walensky has talked about over
and over, in the end, the true test of anything the FDA does is
what the effect is in the intact human being. We need an
ethical deal. You think about yourself or me. When I get sick,
I hope that a lot of other people have volunteered their data
so that I will get the right treatment, because my doctor will
know.
We have had some discussion about this. Doctors are smart.
I am one. I think I am pretty smart. But I am a lot smarter if
I have the evidence. So I call a doctor alone eminence-based
medicine. A doctor armed with evidence is evidence-based
medicine. It is much better. It will only work if we volunteer
our data and participate in research.
Mr. Tonko. I hear the evidence-based argument.
Dr. Walensky, I know that reopening schools safely was a
priority for you and the Biden administration from day one. So
can you explain CDC's approach to using public health data to
provide schools the guidance they need for teachers, school
staff, and children to return to in-person learning?
Dr. Walensky. Absolutely. So we--as we create our
guidance--and as you know, this was a priority for me--46
percent of schools initially opened, 63 percent within months.
And then, by the new--by the fall, it was up to 95 percent in
terms of getting schools back open.
So we used a layered mitigation strategy. Remember, at the
time there were no vaccines for children. We were vaccinating
adults, but we didn't have vaccines for children. So what were
the strategies that we could use? Vaccination was one of them.
Masking was another. Distance at the time, when we had high
levels of community transmission, was yet another.
And then we saw these ecological studies, cohort studies in
States that said when these jurisdictions had masks on and
these jurisdictions didn't, there was more infection in the
schools when the masks were off that schools had to close
because masks were off. And it was based on those kinds of
studies, whether it be in Georgia or Wisconsin or Arizona or
across the country, where we were able to amend our guidance in
real time as those variants emerged, as Dr. Califf noted.
Mr. Tonko. Thank you very much.
And with that I yield back. Mr. Chair, I do--did have some
questions for Dr. Tabak, but will get that to you in writing.
Thank you.
Mr. Griffith. I thank the gentleman. The gentleman yields
back. I now recognize the gentlelady, Dr. Miller-Meeks from
Iowa, for her 5 minutes.
Mrs. Miller-Meeks. Thank you, Mr. Chair, and I thank all
the witnesses who are here.
Dr. Walensky, you and I have had the opportunity and the
pleasure, if you will, to receive testimony before and ask
questions. I am a physician. I am also a former director of the
Iowa Department of Public Health. And when it comes to trust in
our agencies, if you've lost me that means there is a lot that
has to be answered for, and oversight that has to be taken care
of.
I have vaccinated individuals, all 24 of my counties in my
district. I was vaccinated. But even now there still persists
this nonrecognition of infection-acquired immunity, of herd
immunity, of immunity that exists. And the purpose of a vaccine
is to do what? It is to confer immunity.
So the failures of the CDC and the FDA--and I won't get
into the NIH--were both administrations.
There was the first failure to--not to develop testing in
an appropriate, adequate fashion for COVID-19, despite the fact
that there was already a test with high specificity and
sensitivity from the University of Iowa.
The failure of the CDC to use real-world evidence and data
when studies from Israel or other countries showed that viral
transmission still existed, despite vaccination.
The failure of the CDC and other public health
organizations to acknowledge infection-acquired immunity,
despite data from other countries, and that there were waning
antibodies within 1 month after vaccine.
The failure to acknowledge infection-acquired immunity or
natural immunity, and mandate vaccines to those who already
have immunity. And I put forth a bill to mandate that all
insurance companies, public and private, cover for antibody
testing and T cell antibody testing to get to this point.
The failure of the CDC to acknowledge myocarditis and
pericarditis in young people and still advocate for vaccines in
young men despite that risk, which, as we talked about finally
last year, that there is a risk benefit that has to be
considered but was not considered in these mandates.
Menstrual irregularities in young women.
I think that when you are trying to message to the public--
and I can tell you, as a public health director, what I
conveyed to my staff was that our credibility was the most
important thing that we had in public health. And so, when we
can't acknowledge what our common concepts and what my local
public health individuals and officers and physicians and
nurses were acknowledging back at home but we are not receiving
through the CDC, has created a lack of trust in extremely
important institutions.
The failure of the FDA to utilize their own advisory boards
when approving vaccines, especially in certain age groups, and
rushing approval in these age groups, and then their slowness
to advance any therapeutics.
And what evidence can you tell me, the evidence-based
research that shows 6-foot distancing is appropriate?
It is demoralizing and it is depressing that agencies that
were once held in such esteem cannot translate and transfer
research and evidence and respond to real-world evidence when
they come up with strategies and policies. It is not just a
messaging problem. It was a problem of bias within the
agencies.
So I was the sole Member of Congress to advocate on
Congress during the COVID-19 markups and hearings for increased
funding for public health and local public health and local
public health grants.
So, Dr. Walensky, currently States and localities must
apply for a CDC grant funding for chronic diseases vis-a-vis
different applications, submissions, and portals for each
specific programing grant. Heart disease and stroke, diabetes,
and 14 cancer programs, for example, all require this. These
applications are burdensome. They require vast amounts of time
and resources, and often States and localities must hire
specific grant coordinators to handle the process.
It appears that a much simpler approach, such as the grants
to local public health, would be for States to work through a
block grant process, submitting one application to CDC for
funding for specific chronic diseases that will meet the needs
of their specific State.
Many of these entities already are operating on slim
margins, which is also why, quite honestly, I found it
appalling that less than one half of 1 percent of the American
Rescue Plan dollars in 2021 at the height of the pandemic went
to fund State and local public health workers who are on the
front lines of fighting COVID-19, all with tremendously
innovative policy and procedures to combat the disease.
Updating the grant structures to be more streamlined could
reduce administrative burden for both States and the internal
CDC review process. Plus, if we require appropriate reporting,
we can ensure each State is putting the money to good use,
something that should be of paramount focus, given the alarming
rates of fraud and abuse within the COVID-related dollars. Has
the CDC considered this structure?
Dr. Walensky. Yes, thank you, Dr. Miller-Meeks, and thank
you for advocating for local public health, which I think is a
critically important part of one of the lessons learned as part
of COVID-19.
Results-based partnerships is one of the key things that we
learned and--in our CDC review, in CDC Moving Forward. And part
of our organizational structure has actually streamlined where
our local public health departments come.
I can tell you, as part of the $3.2 billion that went out
for workforce grants, it didn't just go to States, it went to
States and local jurisdictions for exactly the reasons that you
note.
Mrs. Miller-Meeks. Yes, I think currently----
Mr. Griffith. The gentlelady yields back.
Mrs. Miller-Meeks [continuing]. Our local public health has
the trust that the CDC is lacking.
Mr. Griffith. The gentlelady yields back.
Mrs. Miller-Meeks. I yield back.
Mr. Griffith. I recognize the gentleman from Maryland, Mr.
Sarbanes.
Mr. Sarbanes. Thank you very much, Mr. Chairman. Thanks to
all of you.
I know this is part of your job, coming up here and
testifying, but I just always feel guilty when you spend 3
hours here away from your primary responsibility. So thank you
for your testimony.
Dr. Walensky, I was going to talk with you a little bit
more about the whole data picture. I know you have answered a
ton of questions already today about that, but I want to
understand a little bit better where the line is, in terms of
being able to build a sophisticated and as-accurate-as-it-can-
be model or platform for both tracking and forecasting
infectious disease, whether it is a COVID outbreak or anything
else, where the line is between what you can collect through
the voluntary cooperation of public health officials, private
labs, et cetera, and what you can't really do without the
authority to force that.
I am--as I ask you that question, I am thinking about the
dashboard that Hopkins built which became a go-to place for
many of us, and billions of impressions, people all over the
world using that to kind of see the heat map when it came to
the COVID spread across a number of different categories and
measures, which--my sense is--was largely being done by rolling
up publicly available data in many places, qualifying it where
it needed to be qualified or disclaimed, so that people
consuming it understood, you know, how much weight to give it
on a particular day, but became a fairly reliable go-to picture
of what was happening.
But to the extent you have signaled that you need more
authority to build the kind of robust data platform and
collection vehicle that you would like to see, describe maybe
in a little more detail maybe an example or something of where
that line is and why working with the tool kit you have right
now just isn't sufficient.
Dr. Walensky. So I bucket it into two different areas. One
is our data modernization efforts. That is building the
highways. Our--can you--can your jurisdiction, your district
send data to CDC in the similar way that the one next to you
can send data to the CDC, and then CDC can rapidly receive it
and give it back to you so you can see what is happening in the
districts around you?
That is a data modernization issue. We are working on that.
It is because we lacked that modernization, those data
highways, that we only had 187 healthcare facilities in the
country that could provide us with data electronically on
COVID. We are now up to 22,000. Those resources are being put
to good use, and we have numerous examples of how we have been
able to use those highways for mpox reporting and many other
things.
Once those highways are built--and we will need more
resources to build robust highways across this country--we have
another challenge, and that is do the cars drive on the
highways? Right now, we only have--we only receive those data
that are voluntarily reported in the absence of a public health
emergency.
So you're exactly correct. The Hopkins website does data
scraping, web scraping, so that they can see what is publicly
available. We at CDC would like the gold standard of what is
happening at the States because it is reported from the States.
But we only get that voluntarily. Even today, I can't tell you
how many people have been vaccinated in the hospital. We don't
have data systems that can do that. We don't have authority to
collect it, and it is not voluntarily reported.
So after this public health emergency is taken down, we are
currently, again, working through data use agreements. We will
lose data on testing. So--and we are--we will lose data on--
some data on immunizations. We are working through data use
agreements, but that is just one infection--that is just one
infectious disease. And so that leaves us really vulnerable if
we don't have reporting coming to the CDC on what is happening
in influenza and what is happening in RSV and what is happening
on many of these other----
Mr. Sarbanes. Let me ask you on the hospital front. I mean,
obviously, HHS and other agencies have leverage with respect to
hospitals, based on all kinds of other engagements. Are you
saying that leverage can't be used to pull data in from those
places? You have to have a separate authority to do that?
Dr. Walensky. Well, first of all, we would have to rely on
partnerships with other agencies, and that is exactly what we
did through the public health emergency. And we are receiving
some of those data through the public health emergency. But we
don't have that authority independent of relying on those
partnerships. And it is not as robust, not necessarily. The
data that are collected for purposes of CMS may or may not be
all of the data that we need for purposes of tracking a new
outbreak.
Mr. Sarbanes. OK, thank you.
I yield back.
Mr. Griffith. The gentleman yields back. I now recognize
the gentlelady of Florida, Mrs. Cammack.
Mrs. Cammack. Thank you, Mr. Chairman, and thank you to all
our witnesses for appearing before us today.
First, is it Dr. ``Tay-back'' or ``Tah-back''?
Dr. Tabak. It is ``Tay-back.''
Mrs. Cammack. ``Tay-back''?
Dr. Tabak. Yes.
Mrs. Cammack. I appreciate that. I have heard it multiple
ways said today. I want to be----
Dr. Tabak. I answer to ``Hey, you.'' It is OK.
Mrs. Cammack. OK, I appreciate that. All right, Dr. Tabak,
you have been with NIH since 2000. Do you believe that Stanford
Medical School, Oxford, and Harvard hire ``fringe medical
professors''?
Dr. Tabak. It depends on the individual professor.
Mrs. Cammack. OK. Well, the reason that I ask is because on
October 8th of 2020 you were cc'd on an email from the then-
head of NIH, Dr. Francis Collins, to Dr. Anthony Fauci.
Now, I am going to refresh your memory on the contents of
this email. It says, ``Hi, Tony and Cliff. This proposal,
citing the Great Barrington Declaration from the three fringe
epidemiologists who met with the Secretary, seemed to be
getting a lot of attention, and even a co-signature from Nobel
Prize winner Mike Leavitt at Stanford. There needs to be a
quick and devastating published takedown of its premises. I
don't see anything like that online yet. Is it underway?''
Signed, ``Francis.'' Again, you were cc'd on this email.
Yes or no, Dr. Tabak, did you communicate with Dr. Collins
with you about these doctors or the Great Barrington
Declaration, other than when emailing Dr. Fauci?
Dr. Tabak. I have no recollection of speaking to him about
that.
Mrs. Cammack. Yes or no, are you aware of other instances
where either Dr. Collins or Dr. Fauci planned to have the media
publish articles to discredit other scientists or doctors
during the COVID-19 pandemic?
Dr. Tabak. I am not aware of any such instance.
Mrs. Cammack. Of course. Now, as deputy ethics counselor at
NIH, aren't there ethical concerns about using the U.S.
Government to silence scientific speech, particularly peer-
reviewed speech?
When the stakes are so high, right, as they were during the
height of COVID-19, shutting down economies, keeping kids in
schools, increased rates of mental illness, addiction, suicide,
et cetera--and now, of course, we know that the collusion
between Twitter and the Biden administration has come to
light--does that not concern you?
Dr. Tabak. I am unaware of any collusion. I know there is
ongoing litigation----
Mrs. Cammack. You know what? That is good. I am glad.
Dr. Tabak. So I can't comment.
Mrs. Cammack. I am going to enlighten you, then.
So just a few months after that email, this email that you
were cc'd on between Dr. Francis Collins and Dr. Fauci--you
have records of this, and I am sure there are others--just a
few months after that, Twitter was directed by the Biden
administration to deplatform multiple scientific accounts,
doctors, Nobel Prize winners.
They went so far as, on March 14th, 2021, in internal
communications between top Twitter executives and the Biden
administration, to say, ``We are very angry. The Biden
administration needs a push to deplatform these multiple
accounts.'' These deplatforming of accounts were, of course,
related to the Great Barrington Declaration, and they said,
according to the Biden administration to Twitter, that not
enough had been done to silence these doctors.
Dr. Tabak, did you provide Dr. Collins with any ethical
counsel or advice on this matter?
Dr. Tabak. This is a subject of ongoing litigation, and I
can't comment on anything related to the social platform.
Mrs. Cammack. Who else at NIH did you talk to about the
Great Barrington Declaration and its authors?
Dr. Tabak. I don't recall speaking to anybody about that at
NIH, quite frankly.
Mrs. Cammack. OK. I know I am running low on time, but I
will say this. Contrary to some of the comments that have been
made here today--and we are not going to get to the bottom of
this in 53 seconds. But contrary to the comments of some of my
colleagues today--actually, just now, apologizing to you all
for appearing before this committee, saying that we are taking
you away from your primary responsibility--you have a
responsibility to appear before this committee, just as we have
a constitutional responsibility for oversight. That is our duty
to the American people. If I were you, I would clear your
schedule. This will come to light.
I appreciate you all being here today. Thank you.
Mr. Griffith. The gentlelady yields back, and I recognize
the gentlelady from California, Ms. Barragan.
Ms. Barragan. Thank you, Mr. Chair.
I want to remind the public, because it was a--there was a
comment made that there had been no hearings on COVID, but we
did have a hearing in June of 2020 on the response to the
COVID-19 disaster. And a lot of that, as I remember, was a
disaster under the prior administration of the response, the
lack of response, the lack of acknowledging the seriousness.
And I remember even claims about you can inject bleach to deal
with it. I mean, the misinformation and the disinformation is a
huge concern because, clearly, we know it has public health
impacts. And it is really unfortunate when science is not taken
seriously and when the misinformation and the disinformation
continues.
I want to thank you for the work that you do day in and day
out. I know that your primary concern is of Americans and
making sure that we are doing all we can to fight infectious
diseases and noninfectious diseases.
Dr. Walensky, I want to thank you for your willingness to
not just do the work but to go across this country and travel
into communities, to meet constituents and meet public health
officials. Thank you for coming to my own district in Watts
last year to talk about the importance of awareness in
vaccines, something that I believe saved millions and millions
of lives, and that nobody really should have died in the
numbers that we saw happen.
So let me start, Dr. Walensky, with you with a non-COVID
question, really. Heart disease, diabetes, cancer, and
Alzheimer's are some of the most common causes of illness,
disability, and death affecting a growing number of Americans.
Many chronic diseases disproportionately impact people of
color, people in low-income neighborhoods, and others whose
life conditions place them at increased risk for poor health,
especially during infectious disease outbreaks.
Can you talk a little bit about and discuss what the CDC is
doing in this space, and the important role the CDC plays in
addressing noninfectious diseases?
Dr. Walensky. Yes, thank you so much for that. I think it
is critically important to recognize our role in our infectious
diseases, for sure, and in noninfectious diseases as well--so,
as you know, heart disease, mental health, opioids, diabetes,
cancer--in the prevention and outreach for all of those
noninfectious diseases.
What I think is lost is--in the conversation and also
critically important, is the intersection of the two. So those
people who have the most severe outcomes from COVID-19 and
continue to are those who have those chronic medical
conditions. It is because we have a partnership in
cardiovascular disease, we have that work ongoing, that we can
have subject matter experts in both of those coming together
when we have a public health threat like COVID-19.
Similarly, with Zika--devastating infectious disease for
pregnant moms, maternal mortality, anencephaly in children--it
is because during the Zika outbreak that we had our infectious
experts and infectious disease working alongside our birth
defects experts that we could rally a response so quickly.
And then, maybe the third very vivid example that I will
give is in the opioid challenges that we are having now, over
100,000 deaths per year. But we have also those who have
suffered from nonfatal overdoses related to injection drug use.
The coincidence of opioid use and HIV and hepatitis C and
endocarditis, where I have spent much of my career, is really
why it is so critical that we in public health are addressing
both of those together. Thank you.
Ms. Barragan. Great, thank you.
Dr. Tabak, I want to quickly get you in. Trial diversity is
essential to develop effective and safe vaccines for all
populations. But this is not always the case in the development
of new vaccine treatment. While developing multiple COVID-19
vaccine candidates in record time, the NIH did include a
diverse pool of trial participants. Dr. Tabak, how was the NIH
able to achieve this, and why is it important as we think about
future pandemic preparedness?
Dr. Tabak. We were able to do this first by encouraging the
vaccine manufacturers to ensure that they included a diverse
population.
But we also had to gain the trust of the individuals
particularly from marginalized communities. And we did that by
taking advantage of equities within those communities: trusted
persons, pastors, pharmacists, and so forth within the
community who would allow us to share information about COVID,
information about vaccines and therapeutics, and, of course,
the reason why it is important for all people to participate in
clinical research.
Ms. Barragan. Great, thank you so much.
My time is expired; I yield back.
Mr. Griffith. I thank the gentlelady. I now recognize Mr.
Palmer of Alabama for 5 minutes.
Mr. Palmer. Thank you, Mr. Chairman.
I think the largest frustrations with your agency's
handling of COVID is with the information released on masks and
the vaccine. Up until 2022 CD guidance was used as a premise to
keep children as young as 2 years old in masks on public
transportation and in the schools.
One of the things that really struck me was the video of a
2-year-old and his family being kicked off a plane because the
2-year-old wouldn't wear a mask. I have three kids. I remember
them being 2. And that would have been a challenge, if the kid
didn't want to wear the mask.
Randomized controlled trials are described as the gold
standard for producing robust evidence for public health
guidance. Randomized controlled trials, otherwise known as
RCTs, could have provided strong data about the effectiveness
or ineffectiveness of forcing children to wear masks in the
classroom.
Mr. Tabak, are you familiar with the Cochrane Review on
masking that was recently published?
Dr. Tabak. I am peripherally aware of that. But, of course,
this is in the expertise of the CDC Director. I would defer to
her.
Mr. Palmer. OK. Dr. Walensky, are you familiar with that?
Dr. Walensky. I am familiar with that. Thank you.
Mr. Palmer. And you are also then aware that the study
basically said that it really didn't make much difference, even
if you wore an N95, whether----
Dr. Walensky. Yes, I----
Mr. Palmer [continuing]. For influenza or COVID.
Dr. Walensky. I would love to address that Cochrane Review;
I know it well.
So Cochrane Review looked at randomized controlled trials
related to COVID-19, but other respiratory viruses. Of course,
COVID-19 is different because it has presymptomatic
transmission rather than postsymptomatic--rather than alone
post-asymptomatic transmission.
One of the limitations of that study, in addition to the
fact that it included randomized trials from before COVID-19,
was that--and it stated in the study--is that people actually
had limited uptake of using masks. So, of course, randomized
trials that look at mask use but people are not wearing them,
are going to have----
Mr. Palmer. For the record, it was 9 studies in over
276,000 people. That is a pretty----
Dr. Walensky. But if they don't take--uptake the
intervention, then it is not going to prove working.
It is also the case that our masking guidance was very much
related on cohort studies and many other studies.
Randomization, as you can imagine, of a mask versus no-mask
approach----
Mr. Palmer. Well, let me ask you this.
Dr. Walensky [continuing]. During the height of the COVID-
19 pandemic would have been a challenge.
Mr. Palmer. All right. But once the CDC imposes this
mandate--and public pressure forced you to lift it--how many
randomized controlled trials--and I will go back to Mr. Tabak,
or Dr. Tabak--did the NIH fund concerning the effectiveness of
children masking in the classroom setting?
Dr. Tabak. I am not aware of any.
Mr. Palmer. So you didn't do any?
Dr. Tabak. I am not aware of any. I would have to check to
make sure that----
Mr. Palmer. You know, that is part of the problem with this
is that I had doctors who spent years in medicine telling me
that the masks were not effective, and yet these were being
forced on people. They were forced on schoolkids.
And, you know, when you combine--particularly young kids,
we are seeing the devastating impact that it had on their
educational attainment. And it kind of surprises me that the
NIH, CDC didn't do any followup testing, even while this was
going on to determine the effectiveness of this and the impact
it was going to have on kids.
Dr. Walensky. Yes, I appreciate--you know, in order to do a
randomized clinical trial you need to actually have equipoise
in the question. And ultimately, what would happen--what
happened is that there were so many studies that demonstrated
time and time again in the height of COVID transmission that
masks were working to prevent transmission that I am not sure
anybody would have proposed a clinical trial because, in fact,
there wasn't equipoise to the question anymore.
Mr. Palmer. Well, let me ask you this. It was--Dr.
Walensky, it was reported by Bloomberg, Fox that CDC altered
its guidance for public schools numerous times after getting
influenced, pressured, scolded by the teachers unions. And you
said that the teachers did not need to be vaccinated to reopen
the schools, and the teachers unions pushed back. And Jen Psaki
was forced to say that you were talking in your personal
capacity. Is that true?
Dr. Walensky. I was very motivated as I came in to get our
schools open, and I think that was very clear, and it was very
successful in our efforts.
I had been working on the front lines of healthcare and had
seen that we were able to safely bring healthcare workers into
the hospital, treating COVID patients. So I did see that----
Mr. Palmer. She said you were speaking in your personal
capacity. How do you differentiate between your personal
capacity and----
Dr. Walensky. I--no----
Mr. Palmer [continuing]. Your professional capacity?
Dr. Walensky. First, as I said that, which I believe was on
February 3rd, I said it from an official CDC capacity. And I
believe Jen Psaki--I can't speak to her comments, but I was
definitely in my CDC capacity when the comments were made.
And in fact, we reopened schools----
Mr. Palmer. All I want to know is----
Mr. Griffith. Hang on.
Mr. Palmer [continuing]. In the last seconds that I have
got here is----
Mr. Griffith. Your time is up, Mr.----
Mr. Palmer [continuing]. You took input from the unions----
Mr. Griffith. Mr. Palmer, your time is up.
Mr. Palmer [continuing]. But did you take input from the
parents?
Dr. Walensky. Actually, we did outreach to over 50
organizations, including parent organizations and
superintendent organizations, as well as teachers
organizations. So we did a wide scope of outreach for that
guidance. Thank you.
Mr. Griffith. The gentleman yields back. He can follow up
with written questions. Now I recognize the gentleman from
Indiana, Mr. Pence.
Mr. Pence. Thank you, Chairs McMorris Rodgers, Griffith,
and Guthrie, and Ranking Members Pallone, Castor, and Eshoo,
for holding this hearing. And thank you to the witnesses today.
I appreciate you being here.
I do not have a medical background, so I am going to go off
the reservation a little bit, Mr. Chairman.
At the onset of the pandemic, the Trump-Pence
administration acted quickly to respond to the impacts on our
healthcare system and build a long-term strategy to develop
innovative solutions and save lives, which you all continued
when you came into your jobs.
Hoosiers and all Americans were fortunate for the work of
the Trump-Pence administration to advance a historic White
House Coronavirus Task Force, which resulted in the development
of world-leading vaccines and therapeutics.
As a shameless point of personal privilege, Mr. Chair, I
would like to thank my brother, Michael, the Vice President of
the United States, for his humble leadership. I would like to
thank him for his wisdom. I would like to thank him for the
countless hours he put in standing up the Coronavirus Task
Force. And most importantly, as I have listened to the
testimony and the questions today, I would like to thank him
for his clear and transparent communications to the American
public and among your organizations.
And maybe--I don't want to lecture to you, some people do,
that is not my style--but maybe a little more communication on
your part over the last couple of years would have given people
more of a sense of confidence, which--I have heard a number of
my peers today say there is a confidence deficit, and something
that--difficult to earn, easily lost. And that seems to be what
has happened across the country. I know my constituents feel
that way for what you all, all three of your organizations, are
doing.
What is your thought? Do you think you have communicated
adequately over the last 2 years?
And I will start with you, Dr. Tabak.
Dr. Tabak. There is always room for improvement, and we
continue to work at that.
Dr. Walensky. Similarly, as part of CDC Moving Forward,
communications is a key aspect. We need to do more risk
communications, overhaul our website. Those are things that we
are actively engaged in for exactly the reasons of lessons
learned.
Dr. Califf. I would completely agree. We need to continue
to work on it.
I wasn't here the first 2 years, so I had a chance to
observe it on the outside.
I would also point out we have a new thing with the
onslaught of misinformation, which is very much hurting the
confidence of the public, often completely misdirected, and
raises a number of difficult questions that none of us really
anywhere were prepared to deal with. The vastness of the
internet, the complexity of the information is something that
we are all going to have to work on dealing with appropriately.
Mr. Pence. Well, sure. Thank you. You know, I am really
proud of my brother, the former Vice President, because he got
ahead of all this. The internet existed back then, as well.
Misinformation allegedly was out there, the Russian hoax being
an example.
But I would encourage you all, then, if you should get out
and talk, if you should communicate with the things you have
done or plan on doing, get ahead of the communication. I know
the American people and the people in the Indiana 6th District
would very much appreciate it.
With that I yield back.
Mr. Griffith. I thank the gentleman, he yields back. I now
recognize the gentleman from Texas, Mr. Crenshaw, for his 5
minutes. And he will be our last witness.
Mr. Crenshaw. All right. Thank you, Mr. Chairman.
Mr. Griffith. Questioner.
Mr. Crenshaw. And thank you to my friend from Indiana for
making that point. Maybe I will expound upon it slightly, which
is--I agree wholeheartedly.
You know, the point of this is not to just get engagement
on social media and get a good clip out of it and bash you guys
over the head. The goal is to, indeed, bring back trust into
our public health institutions and help you understand the
perception of many Americans.
Only about 40 percent believe that our public health
institutions are ready for the next pandemic and that they
trust them. That is a glaring statistic. We are seeing
declining vaccination rates for children. That is a glaring
statistic as well.
And I would definitely recommend that the overall
communication goal should not to be speaking in these
absolutist terms, which has long been a problem, especially
with people like Dr. Fauci when he was clearly wrong, when it
is clearly a nuanced discussion. And that makes people
skeptical, and you get discredited as a result.
Dr. Walensky, I want to bring up a very specific example of
this. As you know, the CDC's Advisory Committee on Immunization
Practices held its annual meeting to review the CDC's
immunization schedules last fall. These schedules--child,
adolescent, and adult--consist of a list of vaccines that the
CDC recommends for individualsS based on their age group.
Now, historically, they have relied on--or States have
relied on ACIP's recommendations when determining vaccines,
what vaccines will be required for schools and childcare
settings. Obviously, that makes sense, especially for childhood
diseases that are uniquely transmissible in that specific
group. And of course, many of these vaccines do mitigate
transmission.
The question I have is in October of 2022 the advisory
committee broke public health norms by deciding to add the
COVID-19 vaccine, including those under emergency use
authorization, to the childhood immunization schedule. That
includes the bivalent booster shots. Now, obviously, they are
not a mandate, but they, of course, are largely followed.
So, I mean, how do you view the cost benefit of scheduling
brand-new bivalent booster shots for this age group,
considering the children are at a very low risk from COVID-19,
75 percent of children have already caught the virus, and the
vaccine is known to do pretty little to prevent transmission in
this age group?
Dr. Walensky. I am really grateful that you ask that
question, so I can correct the record here so that everybody
understands.
First of all, we have had 2,000 pediatric deaths from
COVID-19. It is the number-one respiratory and infectious
killer. That was just published last week in JAMA. So less
infected, less deadly than to an 80-year-old but still deadly
for a pediatric infection.
The important thing, I think, that is really--that we need
to recognize is the reason that ACIP recommended and CDC put
forward getting the COVID-19 vaccine on the pediatric schedule
is not--it was only because it would--it was the only way it
could be covered in our vaccines for children program. It was
the only way that our uninsured children would be able to have
access to the vaccines. That was the reason to put it on the
schedule. It can't be eligible for vaccines for children
program for--to be available to the uninsured unless it is on
that schedule. That was the reason to put it there.
Thank you for allowing me to correct that.
Mr. Crenshaw. OK. I want to move to the FDA and kind of a
different subject. And the subject is this.
I--we are going to have a lot more hearings like this,
where we need to fix this problem, where we have innovators
throughout the United States who want to save people's lives
and the FDA crushes their dreams and crushes their potential.
Their investors pull out, they have no chance of getting
through the burdensome clinical trial process that the FDA
imposes upon them, nor can they even communicate with anyone at
the FDA to figure out what they even need to do. It is a
glaring problem.
To give you a couple of examples just out of the Houston
area, scientists at Baylor College of Medicine spearheaded a
low-cost, easy-to-make vaccine, Corbevax, that is already
aiding in the global fight against COVID-19, and we can't get
it through here.
Researchers at Texas A&M Health and University of Texas MD
Anderson Cancer Center in Houston are testing PUL-042. It is an
inhaled therapeutic. They can't get that through, either.
I could go on and on on non-COVID-related, very obvious
treatments for--and biomedical devices that they can't even get
a call back from the FDA.
What are you guys doing to fix this? Because people are
dying and not getting treatment they need, while innovators
around the country are trying to fix that, and the FDA is
stopping them.
Dr. Califf. I will say we could always do better, but let
me just say I have been on all sides of this fence. I have been
an inventor, I have worked on companies recently, you know,
before my nomination. I have worked in universities. We lead
the world in innovation. We lead the world in new companies. We
are doing better than any other country.
I completely disagree with your characterization of this,
but, of course, we always could do better.
Mr. Crenshaw. No, we lead the world in innovation. That is
different than saying that our FDA is helping with that----
Dr. Califf. We lead the world in translating ideas into----
Mr. Crenshaw [continuing]. And not inhibiting it.
Dr. Califf [continuing]. Therapies that are effective for
us and for the rest of the world, by far. And as far as I know,
no one in the world disagrees with that characterization.
Mr. Crenshaw. Well, I mean, does the European Medicines
Agency, are they just the Wild West? I mean, are they just
approving things willy nilly? Is that how you view them?
I mean, why not work with them, when----
Dr. Califf. I am good friends with my EMA colleagues, and I
have gotten products through the EMA and the FDA. The EMA is a
great organization.
We lead the world in innovation----
Mr. Griffith. The gentleman's time----
Dr. Califf [continuing]. And successful companies.
Mr. Crenshaw. Thank you, Chairman, and I respectfully
request we focus on that particular problem on a different
hearing. Thank you.
Mr. Griffith. I suspect we will. Thank you very much.
Let me thank the witnesses. It has been a long hearing. We
appreciate you taking the hard questions. We will have followup
questions, I am sure. But seeing that there are no further
Members wishing to ask questions, I thank you all for being
here.
That being said, before adjourning, I ask unanimous consent
to insert into the record the documents included on the staff
hearing documents list.
Without objection, that will be the order.
[The information appears at the conclusion of the hearing.]
Mr. Griffith. All right. That being said, pursuant to
committee rules, I remind Members--that would be you and me,
Cathy.
Mrs. Rodgers. OK.
Mr. Griffith. I remind Members that they have 10 business
days to submit additional questions for the record, and I ask
the witnesses to submit their response within 10 business days
upon receipt of the questions.
As you know, several people didn't get through their
questions and said they were going to provide you all with
written questions. We would appreciate those being answered.
Without objection, the subcommittee is adjourned.
[Whereupon, at 1:54 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
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