[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                    
          
-----------------------------------------------------------------------------------     

                   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

                              ----------                              


                      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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