[Senate Hearing 117-203]
[From the U.S. Government Publishing Office]


                                                        S. Hrg. 117-203

                    NOMINATION OF DR. ROBERT CALIFF
                 TO BE COMMISSIONER OF FOOD AND DRUGS,
                     FOOD AND DRUG ADMINISTRATION,
                             DEPARTMENT OF
                       HEALTH AND HUMAN SERVICES

=======================================================================

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                    ONE HUNDRED SEVENTEENTH CONGRESS

                             FIRST SESSION

                                   ON

EXAMINING THE NOMINATION OF ROBERT MCKINNON CALIFF, OF NORTH CAROLINA, 
 TO BE COMMISSIONER OF FOOD AND DRUGS, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES

                               __________

                           DECEMBER 14, 2021

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions
                                
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        Available via the World Wide Web: http://www.govinfo.gov
        
                               __________

                                
                    U.S. GOVERNMENT PUBLISHING OFFICE                    
46-783 PDF                 WASHINGTON : 2023                    
          
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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                    PATTY MURRAY, Washington, Chair
BERNIE SANDERS (I), Vermont          RICHARD BURR, North Carolina, 
ROBERT P. CASEY, JR., Pennsylvania       Ranking Member
TAMMY BALDWIN, Wisconsin             RAND PAUL, M.D., Kentucky
CHRISTOPHER S. MURPHY, Connecticut   SUSAN M. COLLINS, Maine
TIM KAINE, Virginia                  BILL CASSIDY, M.D., Louisiana
MAGGIE HASSAN, New Hampshire         LISA MURKOWSKI, Alaska
TINA SMITH, Minnesota                MIKE BRAUN, Indiana
JACKY ROSEN, Nevada                  ROGER MARSHALL, M.D., Kansas
BEN RAY LUJAN, New Mexico            TIM SCOTT, South Carolina
JOHN HICKENLOOPER, Colorado          MITT ROMNEY, Utah
                                     TOMMY TUBERVILLE, Alabama
                                     JERRY MORAN, Kansas

                     Evan T. Schatz, Staff Director
               David P. Cleary, Republican Staff Director
                  John Righter, Deputy Staff Director
                           
                           
                           C O N T E N T S

                              ----------                              

                               STATEMENTS

                       TUESDAY, DECEMBER 14, 2021

                                                                   Page

                           Committee Members

Murray, Hon. Patty, Chair, Committee on Health, Education, Labor, 
  and Pensions, Opening statement................................     1
Burr, Hon. Richard, Ranking Member, a U.S. Senator from the State 
  of North Carolina, Opening statement...........................     4

                               Witnesses

Califf, Hon. Robert, M.D., Durham, NC............................     7
    Prepared statement...........................................     9

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.
Murray, Hon. Patty:
    Letters of Support for the Nomination of Robert Califf.......    42
    New England Journal of Medicine on the safety of Mifepristone    82
Braun, Hon. Mike:
    SFLAction Chemical Abortion Testimony-Toni McFadden..........    93

    Letter of Opposition for the Nomination of Robert Califf.....    80

 
                    NOMINATION OF DR. ROBERT CALIFF
                 TO BE COMMISSIONER OF FOOD AND DRUGS,
                     FOOD AND DRUG ADMINISTRATION,.
                             DEPARTMENT OF
                       HEALTH AND HUMAN SERVICES

                              ----------                              


                       Tuesday, December 14, 2021

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.
    The Committee met, pursuant to notice, at 10:01 a.m., in 
room G50, Dirksen Senate Office Building, Hon. Patty Murray, 
Chair of the Committee, presiding.
    Present: Senators Murray [presiding], Sanders, Casey, 
Baldwin, Murphy, Kaine, Hassan, Smith, Rosen, Lujan, 
Hickenlooper, Burr, Collins, Cassidy, Braun, Marshall, Scott, 
Romney, and Tuberville.

                  OPENING STATEMENT OF SENATOR MURRAY

    The Chair. Good morning. This Committee will come to order. 
The Senate Health, Education, Labor, and Pensions Committee 
will please come to order. Today we are holding a hearing on 
the nomination of Dr. Robert Califf to serve as Commissioner of 
the Food and Drug Administration. Ranking Member Burr and I 
will each have an opening statement, then Senator Burr will 
introduce the nominee.
    After Dr. Califf's testimony, Senators will have 5 minutes 
for a round of questions. And while we were again unable to 
have this hearing fully opened to the public or media for in-
person attendance, live video is available on our Committee 
website at help.senate.gov. And if you are in need of 
accommodations, including closed captioning, you can reach out 
to the Committee or to the Office of Congressional 
Accessibility Services.
    We received Dr. Califf's formal nomination on November 
15th, his Office of Government Ethics paperwork on November 
17th, and his Committee paperwork on November 22nd. Dr. Califf, 
thank you for joining us. You are a long ways away there, but 
we can see you.
    Dr. Califf. I think I can see you there, thank you.
    [Laughter.]
    The Chair. I want to welcome your family who is with you 
today, your wife, Lydia, your son Sam, your daughter Sharon, 
your son in law, Chris, and your grandchildren, Brooke and Noah 
as well. Welcome to all of you. Families across the country 
count on the Food and Drug Administration every day to follow 
the science and the data and keep them safe, and COVID-19 has 
put that rule in the spotlight like never before. This pandemic 
has been incredibly hard on our Nation. It has killed over 
800,000 Americans and upended our lives in countless ways.
    As we continue our work to end this crisis and rebuild our 
Nation stronger and fairer, we are all grateful for the 
tireless work of FDA scientists to review and authorize safe 
and effective tests, treatments, and of course, vaccines for 
COVID-19.
    While the COVID-19 pandemic remains one of the most urgent 
challenges in our Nation, there are countless other ways FDA 
works--that work matters to families. Every day people put the 
well-being of themselves, their families, and even their pets 
in FDA's hands. When we sit down for a meal, we count on FDA's 
efforts to ensure the safety of our food supply and provide us 
with the information we need to make healthy choices.
    When we get our prescriptions filled or rely on medical 
devices to stay healthy, we count on FDA's work to uphold the 
gold standard of safety and effectiveness. The FDA needs strong 
leadership to continue that work and to address other pressing 
challenges--challenges like the opioid crisis. We lost over 
100,000 people to drug overdoses between April 2020 and April 
2021. That is an all-time high and nearly double the number of 
deaths we saw only 5 years ago. Challenges like youth tobacco 
use. E-cigarettes and other flavored tobacco products have led 
to skyrocketing tobacco use among kids.
    According to the CDC, 2 million youth use e-cigarettes and 
a quarter of that group uses them daily. Challenges like 
antimicrobial resistance, a threat which could make current 
treatments for infections fundamentally ineffective, and common 
procedures like joint replacements or organ transplants and C-
sections life threatening. Challenges like improving health 
equity. We know too many communities are left behind in our 
public health response, including in clinical trials, which 
historically have left out certain populations like people who 
are pregnant, people of color, and others.
    This undermines people's health by delaying information 
they and their health care providers need to understand how a 
treatment will affect them specifically or whether it is safe 
during pregnancy, and by making it hard to identify differences 
in the safety and efficacy of treatments for these patient 
populations. So over the last few years, I have repeatedly 
raised the need for FDA to improve diversity in clinical 
trials. Then there is the constant challenge of keeping pace 
with discovery. Senator Burr and I both are focused on making 
sure FDA stays ahead of the massive discoveries and 
technological advances being made in medical science and 
biotechnology.
    While we need a strong leader at FDA to tackle all of these 
challenges, we also need to make sure we are giving the agency 
the tools it needs to do this work and keep our families safe. 
That is why in the year ahead, this Committee is continuing its 
long tradition of working in a bipartisan way to reauthorize 
all the user fee programs set to expire in 2022. The user fee 
programs are critical to supporting the agency's work to review 
and approve products and uphold the gold standard of safety and 
effectiveness in a timely and efficient manner.
    Without these programs, it would take longer for FDA to 
help bring safe and effective medical devices to the U.S. 
market and to review generic and biosimilar drugs, which can 
lower drug costs by offering patients cheaper alternatives for 
drugs they need. And as we work to support FDA's drug review 
process, we also need to stop drug companies from misusing the 
process to keep cheaper drugs off the market.
    Patients desperately need us to fight skyrocketing drug 
costs with every tool in our arsenal, and that includes making 
sure affordable drugs are not kept off the shelf by 
pharmaceutical companies who are gaming the FDA approval 
system. We also need to make sure the Food and Drug 
Administration has the authority it needs to keep families safe 
from products that have gone for too long with too little 
scrutiny. When it comes to cosmetics, we have discovered known 
carcinogens like asbestos and formaldehyde in products like 
baby powder, children's makeup kits, and hair products.
    When it comes to dietary supplements, people across the 
country who are looking to make healthy choices are faced with 
a shelf full of products that make claims about their health 
benefits but lack rigorous oversight because FDA does not have 
the authority to collect basic information about those products 
or even to know what products are on the market. Families 
across the country buy and use these items every day. They 
deserve to know all the products they entrust their health to 
are subject to type of careful FDA oversight they already trust 
to keep their food and drugs and medical devices safe.
    Families also deserve to know they have an experienced 
leader at the FDA who understands the many challenges our 
Nation is facing and the importance of ensuring science comes 
first. Dr. Califf has worked on these issues before, when he 
was previously confirmed to lead FDA in an overwhelmingly 
bipartisan vote. I look forward to working with him again to 
ensure FDA continues to protect families across the country, 
uphold the gold standard of safety and effectiveness, and put 
science and data first.
    Throughout this crisis, FDA has empowered its experts and 
ensured its decisions are based in science and data. And as we 
have seen him in the growth of misinformation around issues 
like vaccines and reproductive health care, maintaining that 
commitment to always put science first will be more important 
than ever to maintaining the trust of the American people.
    Now, before I turn it over to Ranking Member Burr for his 
opening remarks, I seek unanimous consent to put in the record 
13 letters in support of Dr. Califf's nomination signed by more 
than 90 organizations representing health care providers, 
academic research, and patient advocates, including a letter 
from six former FDA Commissioners appointed by Presidents of 
both parties. So ordered.

    [The following information can be found on page 42 in 
Additional Material:]

    The Chair. I will turn it over to Ranking Member for your 
opening remarks and for introducing Dr. Califf.

                   OPENING STATEMENT OF SENATOR BURR

    Senator Burr. Thank you, Madam Chair. Thank you for holding 
this important hearing today. With the indulgence of the Chair, 
I am going to include Dr. Califf's introduction in my opening 
statement before the Committee. Dr. Califf, last time you were 
here interviewing for this job, I introduced you to my 
colleagues as a wonderful father, grandfather, great doctor, 
great man. Let me say to my colleagues, all that remains the 
same today. Welcome back. Dr. Califf is a distinguished North 
Carolinian who previously served as Commissioner of the Food 
and Drug Administration under President Obama from February 
2016 until January 2017.
    Prior to becoming Commissioner, Dr. Califf served as the 
Deputy Commissioner of the FDA's Office of Medical Products and 
Tobacco beginning in February 2015. Before joining the FDA, Dr. 
Califf was a Professor of Medicine and Vice Chancellor for 
Clinical and Translational Research at Duke University in 
Durham, North Carolina. Dr. Califf spent more than 35 years in 
leadership roles at his alma mater, including the positions of 
Director of Translational Medicine Institute and the Director 
of Clinical Research Institute. He has also worked to move the 
promising field of translational science forward as the 
director of the Clinical Trials Transformation Initiative.
    Dr. Califf currently is the head of Clinical Policy and 
Strategy for Verified Life Science and Google Health at 
Alphabet, Google's parent company. His experience also includes 
serving as vice Chancellor for Health Data Science and Director 
of Duke Forge and the Donald F. Fortin, M.D. Professor of 
Cardiology at the Duke University School of Medicine. Dr. 
Califf's unique perspective as an FDA Commissioner, coupled 
with his understanding of partnerships with the private sector 
and academia that assist in fueling innovation will be vital if 
confirmed as the next FDA Commissioner.
    Dr. Califf, thank you for being here to answer questions 
today. I say to my colleagues, I am not sure you could write a 
resume of somebody more qualified to be considered for 
Commissioner of the FDA than Rob Calif. To your family, you 
should be proud today. All of the criticism he will endure 
during this process is the result of his own success. Thank you 
for the sacrifice that you are making to allow him to return to 
the FDA. I am thankful to finally have an opportunity to hold a 
hearing on one of the most significant positions in the 
Administration during the worst pandemic in over a century.
    This Administration has left the FDA Commissioner position 
open since January 20th, almost a full year in the middle of a 
pandemic. I am disappointed that it took so long, but I am glad 
to see you here again sitting before this Committee. Since your 
last--since you were last here, the FDA has made some major 
strides in updating and modernizing their behavior.
    Now, in the midst of a global response to the pandemic, so 
much more is at stake. The FDA is responsible for ensuring the 
safety and effectiveness of medical devices, medical products 
in the United States and protecting our Nation's food supply.
    Safety and efficacy is your mission. Is the product safe 
for use and does it work as intended? FDA regulates 
approximately $0.20 of every dollar in the U.S. economy. The 
products and practices it regulates are diverse, and there will 
be more demands on your time than there are hours in a day.
    You are familiar with the FDA as an agency and with its 
responsibilities, its challenges, and its ability to reach the 
lives of every American. Because of FDA's reach, there are 
infinite things that you could do if you are confirmed, but 
your priorities should align with where FDA can have the 
greatest impact, supporting the next generation of biomedical 
science and innovation, and protecting our Country from public 
health threats. It has been almost 5 years since you last 
served at the FDA.
    You will be a newcomer to the agency's pandemic response 
and to the ways the FDA has improved over the past 2 years. You 
are filling the shoes of a legend. The Nation has been 
fortunate to have Janet Woodcock at the helm. The FDA success 
is her success, and we need to build on that. I have 
significant concerns that FDA could revert to its old ways of 
doing things, going back to the ways before COVID.
    Your last--you last led the agency during peacetime. We 
need a wartime Commissioner who will lead us through the next 
phase of the response to coronavirus, and build a stronger, 
more nimble FDA for patients and America's consumers. The past 
2 years have tested the FDA. Its authorities and regulatory 
practices have come under scrutiny as the gatekeeper for 
medical countermeasures needed to protect us against 
coronavirus. The pandemic has exacerbated existing systemic 
challenges at the agency and created entirely new ones that you 
will face if confirmed.
    The FDA has made historic progress. The agency finally 
leaned into its authorities to move as quickly and safely as 
possible. It worked with manufacturers to develop and rapidly 
scale up manufacturing of 3 vaccines, 12 treatments, and more 
than 420 tests to protect us against, detect, and diagnose a 
virus. Many of these countermeasures were developed and 
authorized for use in a matter of months or even weeks, without 
compromising safety and efficacy, a testament to the agency and 
its partnership with innovators. FDA provided flexibility and 
certainty. It made all the difference. The next Commissioner 
cannot take their foot off the gas. The agency has come too 
far.
    The FDA's regulatory readiness is important for the next 
threat that we will face, but also for the unmet needs for 
devastating diagnosis like cancer, Alzheimer's, and ALS. The 
pandemic demonstrated that medical products can be developed 
more quickly without compromising the FDA's gold standard. The 
time it takes to develop a new drug increased from an average 
of 7 years in 1997 to 9 years in 2017.
    According to NIH, it can take up to 7 years to develop a 
diagnostic. We need to go the other way. We developed 
treatments and vaccines for COVID in under a year and 
diagnostic test in a matter of a few months. Many vaccines and 
treatments used during COVID leveraged platform technology that 
we can adapt to address new targets. I think they are one of 
the best ways to accelerate development at the FDA is to work 
with innovators to streamline the development and review of new 
products built on these cutting-edge platforms, whether for new 
pathogen or for a lifesaving, life changing disease.
    Next year, this Committee will be charged with evaluating 
the FDA's user fee program and consider their reauthorization. 
I have strong, deeply held feelings about this important 
program. I have served in Congress for all but the first user 
fee process. Since their creation, user fee programs have grown 
to enormous sizes. Over the decades, the PDUFA program fees 
collected have roughly doubled, and MDUFA program fees have 
more than quadrupled. This growth in user fees from industry 
weakens FDA's accountability to Congress and to patients that 
we serve.
    The purpose of the user fee program is to supplement the 
money FDA received from Congress for the review of medical 
products to bring treatments and therapies to the American 
people as quickly as possible. Today, after all, the agencies 
have been through, with what they have been through with the 
pandemic response, our approach to the user fees will 
undoubtedly, undoubtedly look different.
    Today, after all the--as FDA and industry work to finalize 
the commitment letters for Congress to review next year, I 
expect that each agreement will take stock of lessons learned 
over the last 2 years. Dr. Califf, should you be confirmed, I 
look forward to working with you during the most important user 
fee cycle that this Committee has faced. I spent almost 30 
years working to hold the FDA accountable so that the 
American--Americans benefit from innovative medicines.
    The best way for the agency to achieve this goal is to 
provide clear, predictable pathways for markets--for products 
to come to market. FDA has made progress on this for some of 
the products it regulates, approving lifesaving drugs and 
medical devices every year.
    FDA has issued specific guidance for rare disease, cell and 
gene therapy, and complex generic drugs, but more work remains 
to speed the slow gears of regulation. FDA also still has much 
to do to provide a clear and predictable pathway to market for 
tobacco products and diagnostic tests. Leadership, vision, and 
understanding of the innovation of products are critical to 
fair, predictable regulatory pathways for any product regulated 
by the FDA.
    The Centers for Tobacco Products receives the second 
highest user fee dollars of any center at the agency, except 
for the drug center. More than a decade after receiving 
authority from Congress, FDA just recently issued the 
foundational rules to provide a regulatory roadmap for a new 
and potentially less harmful tobacco product.
    Can you imagine if FDA did not have foundational 
regulations for the review of new drugs while still requiring 
products to submit applications? Despite 13 years and more than 
$7.5 billion, it has authorized under the premarket pathway 
only one, one, Vapor product, a class of product that can 
provide a new, potentially less harmful alternative for 
lifelong smokers.
    CTP is charged with the regulation of tobacco products, 
which includes a mission to regulate these products for the 
protection of public health. It is not meeting that mission, 
either. According to data FDA gave me in 2019, CTP spent 
millions more on advertisements than it did on enforcement 
against bad actors. Dr. Califf, should you be confirmed, I 
would ask you to take a hard look at the Tobacco Center and get 
the house in order. Enormous innovation is occurring in areas 
of diagnostic tests. We have experienced this innovation 
throughout the pandemic response.
    The laboratory community rapidly developed tests to detect, 
diagnose, and surveil the coronavirus. There was confusion 
early on in the response as to whether these tests were under 
FDA's regulatory purview, and if so, what was required of them 
to be available to the American people.
    Public health officials, test developers, providers, and 
patients need the law to provide regulatory certainty and 
predictability that allows for innovation to continue on the 
same trajectory we are experiencing during the pandemic.
    Dr. Califf, I hope you can agree that Congress needs to 
speak to resolve this decades old issue once and for all. If 
you are confirmed as Commissioner, which I expect you will be, 
you will be responsible for maintaining FDA's mission as we 
enter a new era of biomedical innovation. This new era rule 
will require FDA to recruit, higher, and retain the right 
talent. FDA has long faced systemic hiring challenges. It will 
be on--it will be one of the top challenges that you face as a 
Commissioner.
    If you are confirmed, I look forward to working with you to 
help to address this issue. You will be responsible for policy 
decisions to help Americans as they safely return to normal 
life, to prepare to respond to future pandemics, and to build 
upon successful policies that have enabled medical innovation 
to reach patients more quickly. Effective and accountable 
leadership at FDA is paramount.
    My questions today are intended to make sure that you are 
up to the task of leading the FDA while we are still battling a 
once in a lifetime pandemic. I urge you to focus on what 
matters most, to not lose sight of all the ground gained, and 
to use the tools we have given you to your fullest extent. I 
look forward to our conversation today and hearing your plans 
for returning to the agency to address many challenges that we 
face. With that, Madam Chair, I yield the floor.
    The Chair. Thank you, Senator Burr. We will turn it over to 
Dr. Califf for his opening remarks. Again, welcome to our 
Committee, and welcome to your family as well.

 STATEMENT OF HON. ROBERT CALIFF, M.D., DURHAM, NORTH CAROLINA

    Dr. Califf. Thank you so much, Chair Murray and Ranking 
Member Burr. I want to thank you and Members of the Committee 
for inviting me here today to discuss my nomination to be 
Commissioner of the Food and Drug Administration.
    Five years ago, I was before you in the same position. Much 
has happened over those 5 years, including the devastating 
COVID-19 pandemic, but many fundamental issues I addressed at 
that time remain important areas for the FDA, our Country, and 
the world to advance toward an era of unprecedented health.
    I am excited to be accompanied by my family today and thank 
you for your kind introductions of them. Also want to take a 
moment to honor my parents who were with me at the last meeting 
and who passed away peacefully in their 90's.
    The support of my family has been essential to my career. 
This unique opportunity to help create a better world for my 
grandchildren is personally motivating. I previously served 
with pride as FDA Commissioner, and I am honored that President 
Biden has nominated me to lead the FDA for a second time.
    I want to thank Dr. Janet Woodcock, the rest of the FDA 
leadership team, and the entirety of the FDA workforce for 
their exemplary service over the years, and especially during 
the COVID-19 pandemic. To the many Committee Members I have met 
with over the last several weeks, about 23 total, including 
Committee Members, I thank you all for your willingness to 
share with me your perspective on ways the FDA can better serve 
the American people.
    If confirmed, I will be a Commissioner who understands the 
importance of working closely with Congress, as well as other 
parts of the executive branch. I will also be a Commissioner 
who can hit the ground running because of my past experience as 
a civil servant and in leading the agency.
    My career has been dedicated to advancing the health of 
individuals and the public as a physician, researcher, and 
leader in both the public and private sectors, as well as 
academia. My family, like many American families, has 
experienced firsthand how important it is to find a critical 
balance between appropriate safeguards for patients and 
innovative treatments.
    My daughter was born with a serious congenital heart defect 
requiring open heart surgery as an infant. My mom benefited 
directly from the accelerated approval of new drugs from 
multiple myeloma that without a doubt and in meaningful years 
to her life. My professional experiences too have shaped my 
understanding of our health system over the years.
    As a physician, I care for people with serious 
cardiovascular disease, and I worked with colleagues on the 
development and evaluation of life saving medicines and 
technologies for the treatment of heart disease that have 
helped millions of Americans.
    This experience also taught me about the painstaking work 
of developing a safe and effective medical product, then 
conducting the critical clinical trials and seeking FDA 
approval for that product. In this process, the majority of 
proposed new drugs and devices failed because the risks 
outweigh the benefits. I learned firsthand that it is essential 
that we produce high quality evidence to sort the effective and 
effective treatments.
    My first priority, if confirmed, will be emergency 
preparedness and response. The FDA must continue to be a strong 
partner in battling COVID-19, taking into account lessons 
learned from the pandemic so we can apply them to the ongoing 
current pandemic and so we are ready for the next one.
    Second, all FDA's actions regarding the products of the 
agency, that the agency regulates, must focus on protecting 
consumers and patients. Safety matters. Now is the time to 
develop a systematic approach to evidence generation that will 
improve patient safety and provide a much more efficient way to 
understand the benefits and risks of medical products when used 
in practice, and to ensure that our food is safe. And we must 
protect kids from tobacco products.
    As surveys indicate, youth use remains at an alarming rate. 
Our Nation is also experiencing an epidemic of addiction and 
overdose, with over 100,000 overdose deaths recorded over a 12 
month period for the first time ever. FDA must work with the 
public health, clinical, and policy committees to turn the 
tide.
    Third, FDA must stay current on the latest advances in 
science and technology in order to provide guidance to industry 
and stakeholders on everything from clinical trial conduct to 
regenerative medicine to best practices for protecting the 
safety of the U.S. food supply.
    With each of these priorities, a common thread is my 
commitment to ensuring that the agency is more inclusive, 
diverse, equitable, and accessible in the work it does for the 
American public.
    As I work to implement these priorities, attracting and 
retaining FDA scientific workforce maybe even more important 
than any particular policy because it is the agency's day to 
day decision-making that protects the public.
    This is a once in a generation time for public health, and 
the FDA must continue to play a vital role in protecting and 
promoting the health of all Americans by leveraging the 
acceleration of technology and biomedical knowledge.
    If confirmed, I would be honored to lead the agency again. 
Thank you for allowing me to testify before you today, and I am 
happy to take your questions.

    [The prepared statement of Dr. Califf follows:]

                 prepared statement of robert m. califf
                              
                              INTRODUCTION
    Chair Murray and Ranking Member Burr, I want to thank you and 
Members of the Committee for inviting me here today to discuss my 
nomination to be Commissioner of the Food and Drug Administration 
(FDA). Five years ago, I was before you in the same position. Much has 
happened over those 5 years, including the devastating COVID-19 
pandemic, but many fundamental issues I addressed at that time remain 
important areas for the FDA, our country and the world to advance 
toward an era of unprecedented health.

    I am excited to be accompanied by family today. Sitting behind me 
are my wife of 48 years and high school sweetheart, Lydia; two of our 
three children, Sharon and Sam; and two of our six grandchildren, 
Brooke and Noah. I also want to take a moment to honor my parents, who 
were with me at the last hearing, and who passed away peacefully in 
their 90's. The support of my family has been essential to my career. 
The unique opportunity to help create a better world for my 
grandchildren is personally motivating.

    I previously served with pride as FDA Commissioner, and I am 
honored that President Biden has nominated me to lead the FDA for a 
second time. I also want to thank Dr. Janet Woodcock, the rest of the 
FDA leadership team, and the entirety of the FDA workforce for their 
exemplary service over the years and especially during the COVID-19 
pandemic.

    To the many Committee Members I have met with over the last several 
weeks: I thank you all for your willingness to share with me your 
perspectives on ways the FDA can better serve the American people. If 
confirmed, I will be a Commissioner who understands the importance of 
working closely with Congress, as well as other parts of the executive 
branch. I will also be a Commissioner who can hit the ground running 
because of my past experience as a civil servant and in leading the 
Agency.
                               BACKGROUND
    My four-decade career has been dedicated to advancing the health of 
individuals and the public as a physician, researcher, and leader in 
both the public and private sector--as well as academia. But, like each 
of you, my understanding of our health system was shaped by both my 
personal and professional life experiences, which will guide my work at 
the FDA, if confirmed.

    Personal

    My family, like many American families, has experienced firsthand 
how important it is to find a critical balance between appropriate 
safeguards for patients and innovative treatments.

    My daughter was born with a serious congenital heart defect 
requiring open heart surgery as an infant. My mom benefited directly 
from the accelerated approval of new drugs for multiple myeloma that, 
without a doubt, added meaningful years to her life.

    Professional

    My professional experiences, too, have shaped my understanding of 
our health system over the years. When I began my career as a 
cardiologist, heart attack was the leading cause of death in the United 
States and our understanding of the cause of heart attack was limited. 
I, along with a global network of health professionals, worked to 
figure out why. Together we developed ``clot busting'' drugs to restore 
blood flow to the heart, improve the recovery of the heart muscle and 
help prevent future heart attacks. We also developed life-saving 
technologies, including balloon angioplasty, cardiovascular stents, and 
implantable defibrillators, that have helped millions of Americans; and 
we stopped the development of numerous drugs and devices for which the 
risks outweighed the benefits. Thanks to these technologies death rates 
from acute heart problems have been cut in half.

    This experience also taught me about the painstaking work of 
developing a safe and effective medical product, then conducting the 
critical clinical trials and seeking FDA approval for that product. 
Like clinical decisions, FDA decisions are best made when the evidence 
is robust. My career has been focused on developing better systems for 
generating reliable evidence to support the everyday decisions that 
consumers, patients, clinicians and policy makers must make to achieve 
better health.
                               PRIORITIES
    My priorities, if confirmed, would be: emergency preparedness and 
response; consumer and patient protection; and modernization and 
innovation.

    When it comes to emergency preparedness and response, the FDA must 
continue to be a strong partner in battling COVID-19. And, it must have 
infrastructure in place that reflects lessons learned from this 
pandemic so it is ready for the next one.

    Second, all FDA's actions regarding the products the agency 
regulates must focus on protecting consumers and patients. Safety 
matters. Now is the time to develop a systematic approach to evidence 
generation that will improve patient safety and provide a much more 
efficient way to understand the benefits and risks of medical products 
when used in practice. The FDA must continue to build the science base 
needed to give people confidence that their food is safe and their 
medical products are safe and effective. And we must protect kids from 
tobacco products, as surveys indicate youth use remains at an alarming 
rate.

    Our Nation is also experiencing an epidemic of addiction and 
overdose, with over 100,000 overdose deaths recorded over a 12-month 
period for the first time ever. FDA must work with the public health, 
clinical and policy communities to turn the tide.

    Third, FDA must stay current on the latest advances in science and 
technology in order to provide guidance to industry and stakeholders on 
everything from clinical trial development to best practices for 
protecting the safety of the U.S. food supply.

    With each of these priorities, a common thread is my committment to 
ensuring that the agency is more inclusive, diverse, equitable and 
accessible in the work it does for the American public.

    As I work to implement these priorities, I would also continue my 
previous focus on investing in our workforce. Attracting and retaining 
the FDA's scientific workforce may be more important than any 
particular policy because it is the agency's day-to-day decision-making 
that protects the public. The scientific and technical world is moving 
quickly--the FDA needs the talent to keep up and protect the public 
while supporting scientific innovation.
                               CONCLUSION
    This is a once-in-a-generation time for public health, and the FDA 
must continue to play a vital role in protecting and promoting the 
health of all Americans by leveraging the acceleration in technology 
and biomedical knowledge. If confirmed, I would be honored to lead the 
agency again. Thank you for allowing me to testify before you today, 
and I am happy to take your questions.
                                 ______
                                 
    The Chair. Thank you very much, Dr. Califf. We will now 
begin a round of 5 minute questions, and I ask my colleagues, 
please keep track of your clock and stay within your 5 minutes. 
Dr. Califf, let me begin. The opioid use epidemic continues to 
cause tremendous harm to far too many families and communities.
    As I mentioned in my opening statement, the new CDC data 
shows that more than 100,000 people died of drug overdose in 
the 12 months ending in April 2021. That is a new and very grim 
record high. During your time as FDA Commissioner, you started 
the process of reevaluating how the agency approached the 
approvals of opioid. What are the actions the FDA can take to 
address this worsening crisis?
    Dr. Califf. Senator Murray, I really appreciate your 
bringing this up right at the start because the opioid crisis 
and the addiction crisis overall, now with synthetic opioids 
and stimulants on the streets of America, it is gut wrenching 
for American families.
    I think all of us know someone who has been affected by it. 
I have had relatives in the last year who have been prescribed 
30 days of opioids for minor surgery, for example, so I know we 
have work to do. I am happy to go over my history and working 
on this problem since 1999.
    But you asked about what we need to do now, and I think we 
need to learn from all that has happened over the last several 
decades with this and reassess where we are today, because 
whatever we have done up until now is not enough. It is going 
to take all hands on deck, and specifically, the FDA needs to 
redouble its efforts on prescriber education. This is an area 
that has been worked on since my tenure, but it still needs a 
lot of work, as evidenced by my own family's prescriptions.
    Second, we need to continue to keep track of the use of 
opioids and crack down on those who are using them 
inappropriately or prescribing inappropriately. We need to 
redouble our efforts to develop medications for pain and also 
behavioral therapies.
    Here I would point to the PCORI Network and the NIH co-
laboratory that just published a paper showing that cognitive 
behavioral therapy is effective for chronic pain. We still have 
a lot of work to do because we are not seeing a lot of these 
medications that are not addictive being developed at this 
point.
    Then I would say, finally, we are all going to need to work 
together because the problems now with the explosion of this 
epidemic on the streets of America with these synthetic opioids 
is going to require that all of HHS work together. There is a 
concerted plan, and I would call your attention to it. I am all 
on board for the FDA to play its role in this plan.
    The Chair. Okay, thank you. On another topic, right now we 
are seeing the Omicron variant of COVID-19 spread and quickly 
learning about its impact. As we have seen throughout this 
pandemic, access to diagnostic testing is a critical component 
of our public health response, allowing the Government to 
understand new variants, respond quickly.
    If confirmed, what would you do to make sure that the 
country is well equipped to handle future testing needs for 
COVID-19?
    Dr. Califf. Well, I am a big data person and I think 
essential in the development of tests for a population as large 
as the United States, and as a matter of fact for the world, is 
that we understand the operating characteristics of the tests 
and the underlying technology.
    I was just thinking about this yesterday because my son Sam 
was feeling kind of punky after his third--his booster dose of 
the vaccine yesterday and he stopped in at the local drugstore, 
got a rapid test. It was negative, and then we all felt Okay 
about Sam getting on the plane.
    I think we have really got to redouble our efforts now with 
Omicron on the scene because we know it has a much higher rate 
of reinfection of people who have already been infected or in 
breakthrough infections and people that are vaccinated. So 
this--I am well aware of the issues with testing in general. It 
is complicated.
    I can answer questions in more detail, but fundamentally we 
have got to work together to make the tests available so that 
they are not expensive. Every family should have a quantity of 
tests that they can use for purposes like Sam yesterday.
    The Chair. Okay, thank you. I will reserve the balance of 
my time. We do have votes at 11 a.m.
    Senator Burr.
    Senator Burr. Thank you. Thank you, Madam Chair. Let me 
just note for Members that 55 percent of FDA's budget is 
approved through the appropriations process in Congress. 45 
percent of the FDA budget comes from user fees. I would tell 
you this is an alarming trend that we have seen over two 
decades of the reliance on the industry to fund an agency that, 
quite frankly, Congress could fund.
    Dr. Califf, you have been--you have had the benefit of a 
previous tour of the FDA. Should you get the opportunity to 
return, you will have more years of academic and industry 
experience under your belt and likely with more time to achieve 
your goals than the 10 months of your last term of service. 
What is going to be your biggest priority at the agency?
    Dr. Califf. Well, Senator Burr, as we discussed in terms of 
priorities, obviously the pandemic is No. 1, and it is not just 
this pandemic. I was around for the wide guidance at the end of 
my tenure last time around, and I am fully aware of the need 
for the FDA to help develop platforms that will be essentially 
ready to go when emergencies come up.
    We need also a workforce which is capable of working with 
those technologies. But in addition to that, as I said, we have 
got to find the right balance of protecting Americans in a safe 
way and being innovative in the development of products that 
can move along quickly. And essential in that priority is the 
development of a better evidence generation system. You 
yourself have advocated for more rapid approval.
    If we do that, we have got to have a system that can keep 
track of the benefits and risk of the use of these treatments 
over time so that when we find something that is not so good, 
we stop using it. When we find it really is good, we got to use 
it much more often. And I can go into much more detail about 
how to go about that.
    Senator Burr. I look forward to working with you on that. 
You have a history with the risk evaluation and mitigation 
strategy or REMS for the drug, Mifepristone. Many around the 
country have asked that you address this issue. Do you believe 
that the FDA needs to take any action to further weaken the 
REMS for this or similar drugs? Or can you reassure us that no 
changes are needed at this time?
    Dr. Califf. Senator Burr, I appreciate the importance of 
this question. As you are well aware, a fundamental principle 
at FDA is that Americans should have access to drugs that are 
safe and effective for their FDA indicated use, and guiding 
those decisions is the best available evidence with core 
scientific principle, just like any other area regulated by the 
FDA.
    I am aware, as are you, that FDA has filed a court document 
indicating that its review of the REMS stay on the Mifepristone 
is soon going to be available. As you know, in this position I 
am in now, I am not involved in those discussions and I can't 
predict the outcome, but I have great confidence in the FDA 
staff that they will use the latest available evidence and core 
scientific principles to make the best possible decision.
    Senator Burr. More than 265 treatments and therapies have 
been approved under the accelerated approval pathway and have 
made a marked difference in cancer treatment. The accelerated 
approval pathway dates back to 1992, when patients diagnosed 
with HIV or AIDS had no effective treatment to help them. The 
accelerated approval pathway is a successful and important 
pathway at FDA. It brings us game changers faster.
    It has recently been the subject of scrutiny, but I think 
it is one of the best ways to show that we are serious about 
breakthroughs and bringing new hope to Americans battling 
things like ALS, cancer, or Alzheimer's. Can you commit to me 
and to patients who may rely on cutting edge treatments that 
you will not support efforts to narrow this pathway or raise 
the bar for drugs to be approved under those pathways?
    Dr. Califf. Senator Burr, first, let me just say that one 
great thing about the FDA is it is always under scrutiny from 
every angle. In fact, it is often said the best position for 
the FDA is when all sides are, I won't use the word, but are 
angry, I will just put it that way, about the decision. I 
think--I am a fan of accelerated approval for the right 
conditions. As you well know, I have spent countless hours with 
patient groups, people with rare genetic diseases, cancer, 
serious diseases for which there is no treatment.
    American people prefer to get earlier access. But I would 
also stress, as we discussed in your office, it doesn't stop 
there. The very fact of accelerated pathway means that we are 
accepting that there is more uncertainty, and the FDA has 
tremendous latitude about the decision it makes with those 
pathways. And that means we have got to have a better system to 
evaluate these products as they are used on the market. And I 
think there are ways that we can do that.
    Now, technology is making this possible in a way that just 
wasn't possible before, so I would really look forward to 
working with you on that part of it also.
    Senator Burr. I look forward to working with you on those 
post approval reviews as well. Thank you, Madam Chair.
    The Chair. Thank you.
    Senator Sanders.
    Senator Sanders. Thank you, Madam Chair. And Dr. Califf, 
thanks so much for being with us and thank you for your years 
of work as a physician. Dr. Califf, I am sure you were aware, 
the pharmaceutical industry is probably the most powerful 
special interest here in Washington, DC. It has spent over $4.5 
billion on lobbying and hundreds of millions of dollars in 
campaign contributions over the past 20 years, not to mention 
the huge amount of money it spends on advertising.
    As Senator Burr mentioned, on top of all of that, 45 
percent of its budget comes from user fees. And one of the 
major reasons why the pharmaceutical industry, among many 
others, is so powerful is its close relationship with the FDA 
and other regulators in Washington. As you may know, over the 
past 40 years, 9 out of the last 10 FDA Commissioners went on 
to work for the pharmaceutical industry or to serve on a 
prescription drug company's Board of Directors.
    A gentleman named Curtis Wright, who was not a Commissioner 
but a high ranking official, in 1996, left the FDA to receive a 
$400,000 compensation package at Purdue Pharma, less than a 
year after he approved OxyContin with a label that said it was 
``very rare'' for patients to become addicted to that opioid. 
Tragically, obviously, that was not the case. Unfortunately. 
Dr. Califf, you are not the exception to that rule.
    Since you left the FDA in 2017, you have made several 
hundred thousand dollars from pharmaceutical companies and have 
received consulting fees for Merck, Biogen and Eli Lilly. 
According to your financial disclosure form, you own up to--you 
currently own up to $8 million in stock of major pharmaceutical 
companies.
    At a time when the American people are outraged by the high 
cost of prescription drugs, deeply disturbed about what 
happened with Purdue and OxyContin, what kind of comfort can 
you give to the American people when you have been so closely 
tied to the pharmaceutical industry yourself? How are they 
going to believe that you are going to be an independent and 
strong voice against these enormously powerful special 
interests?
    Dr. Califf. Senator Sanders, I do appreciate your concerns 
and I am totally with you on the concept that the price of 
pharmaceuticals is way too high in this country. I have a 
public record on this. It is in print in a number of articles 
that have been written. With regard to my own status, I am a 
physician first and foremost. In the early part of my career, I 
spent working in intensive care units taking care of----
    Senator Sanders. I don't have a lot of time. I apologize. 
Could you answer the question? You own millions of dollars in 
stock. You are going to consultant to the industry. How can the 
American people feel comfortable you are going to stand up to 
this powerful special interest?
    Dr. Califf. Senator Sanders, I have a history of doing 
that. But I would also point out this Administration has the 
most stringent ethics pledge in the history of administrations. 
They have reviewed my status. I have agreed to the ethics 
pledge, and FDA and HHS have excellent staff whose job it is to 
make sure that those ethics pledge----
    Senator Sanders. Thank you. Let me ask you another--I 
apologize. There is not a lot of time. According to the FDA's 
website, its mission is to ``make medical products more 
effective, safer, and more affordable, more affordable.'' If 
confirmed, what would you do to make the outrageously high cost 
of prescription drugs in this country more affordable?
    Do you believe, for example, that when the Federal 
Government pours millions and millions of dollars into the 
development of a drug, we should have a reasonable pricing 
clause which prevents the drug companies for charging, for 
charging consumers what they have already paid to develop? Do 
you believe in reasonable pricing?
    Dr. Califf. I certainly believe in reasonable pricing. And 
four specific things, I will just quickly mention, just rail 
them off. No. 1, we need to develop even more robust generics. 
90 percent of prescriptions are generic. The biosimilars 
program needs to continue to develop that scenario where----
    Senator Sanders. But do you believe--again, I apologize, 
just not a lot of time. When the Federal Government puts money 
into the development of a drug, should consumers be protected 
from high prices, yes or no?
    Dr. Califf. In any situation, consumers should be protected 
from high prices.
    Senator Sanders. Should Medicare be able to negotiate 
prescription drug prices?
    Dr. Califf. Yes, and I am on record. There was a policy of 
the previous Administration----
    Senator Sanders. You think Medicare should do what the 
Veterans Administration does?
    Dr. Califf. Well, I can't say exactly what the Veterans 
Administration----
    Senator Sanders. VA pays half the price that Medicare pays 
for its drugs. Should Medicare do what the VA----
    Dr. Califf. I am on record of being in favor of Medicare 
negotiating with the industry on prices.
    Senator Sanders. Thank you very much.
    The Chair. Thank you.
    Senator Romney.
    Senator Romney. Thank you, Madam Chair. Appreciate the 
chance to hear from you, Dr Califf. And we had the chance to 
discuss some of these things when we were together in my office 
and I would like to raise them again, in part so they are on 
the record, but in part also to elaborate on them. One is with 
regards to two clinical trials.
    There is a perspective that drugs that are approved are, 
the clinical trials are paid for by the industry, by the drug 
companies themselves, and that the Government itself doesn't 
have the occasion to develop its own clinical trials and to 
promote the evaluation of a product which the Government may 
think is of interest, but there is no company that is 
interested in pursuing it.
    Does the Federal Government fund clinical trials at all? 
And No. 2, should we do more of that? And if so, how?
    Dr. Califf. Well, first of all, thank you and I enjoyed our 
discussion. I hope the Government will continue to do what it 
has done, is to fund clinical trials. I, over time have been 
one of the highest funded NIH investigators doing independent 
clinical trials when I was in academia.
    As we discussed, the industry does fund its own clinical 
trials for its own purposes. But there are many issues of 
public health, essential public health importance where only 
the Government can fairly ask the question. And your 
institutions on Utah have been key contributors to those 
clinical trials that have been done. I would like to see more 
Government funded trials so that we ask the unbiased questions 
about which therapies are the best for which people.
    Last, I will mentioned PCORI, the Patient-Centered Outcomes 
Research Institute, which Congress graciously just refunded for 
10 years, is created just to do that particular part on behalf 
of patients. As a doctor, the most common question I got is 
which treatment is best for me, and that takes comparative 
clinical trials that the Government is very well suited to do.
    Senator Romney. Thank you. I don't happen to be a believer 
in this horse deworming product known as ivermectin. But it is 
my recollection that is something which is actually going 
through clinical trials funded by the Government, not by the 
industry. Is that correct?
    Dr. Califf. That is correct. The NIH is funding two large 
trials right now, one of which using a network which I helped 
create with the NIH and this Patient-Centered Outcomes Research 
Institute. So I think we also see treatments, and I made the 
point in my opening statement. Most of what we develop, no 
matter how good the science looks, turns out to have risks that 
supersede the benefit.
    Only 10 percent of drugs that make it into human clinical 
trials actually make it to market because of this problem. So 
we have got to have an open mind. We have got to do the trials 
and then we have to follow the science, follow the data.
    Senator Romney. Thank you. I was made aware of a practice 
that perhaps you could elaborate on, which is that a product 
may be approved for usage by a physician but limited in when it 
can be used or how it can be used.
    I am thinking with regards to monoclonal antibodies, it was 
related that individuals in a hospital with advanced COVID had 
been in the hospital for several days, wanted to get a 
monoclonal antibody treatment, but was told you can't get that, 
we won't allow you to have that in the hospital, the FDA 
doesn't allow us to treat you with monoclonal antibodies, even 
though at the beginning of the disease they would have been 
potentially effective. Later on, we don't think they are, so we 
won't treat you.
    That seems to be an awfully unfair way to deal with someone 
who is in a life threatening circumstance. Is that the correct 
practice? Is that a correct understanding rather of that 
practice? And does it make sense? And if so, why?
    Dr. Califf. Well, I will try to be brief and the answer 
here. First of all, let me just say I followed this closely 
because we knew monoclonal antibodies were highly likely to be 
effective against SARS-CoV-2 because they worked for the first 
SARS epidemic, which fortunately was stopped early and never 
became a global pandemic.
    As these drugs were developed, it is an amazing effect of 
90 percent reduction in death and hospitalization, but most 
effective if used early. And that really should be the focus. 
And I think that is the basis for which the practice that you 
described may have evolved. Very effective, if at all, in 
people who go--as you know, you get sick with the virus and 
then a week or 10 days later, you may get sick enough to enter 
the hospital. By that point, there is much less effect.
    Now, the specific practice of preventing prescription of 
antibodies, I am not aware that is happening, but it may be, 
and I think that would need to be looked at in context. There 
are some people who don't develop an antibody response where 
the treatment may be effective.
    Senator Romney. Thank you. I have got more questions, but 
my time is up. Madam Chair, thank you.
    The Chair. Thank you.
    Senator Casey.
    Senator Casey. Thank you, Chair Murray. Doctor, thanks for 
your willingness to commit more time to public service at the 
FDA. We are grateful for your willingness to do that. I wanted 
to raise at least two subjects with you. One is over the 
counter monograph reform and then also antimicrobial 
resistance.
    But first, on the over-the-counter monograph reform, I 
appreciate the commitment you expressed during our meeting with 
regard to implementation of the reform law that was passed last 
year as part of the CARES Act, and I also appreciate the work 
and the challenges that FDA confronts with implementation.
    We are grateful for the steps that have been taken so far 
to implement the law. This--the law, as you know, included new 
tools for both the FDA and the over-the-counter industry to 
facilitate innovation accompanied by appropriate regulatory 
oversight. This includes the user fees that accompany the 
regulatory authority to enable FDA to build out a modern over-
the-counter regulatory system with the necessary human 
resources.
    I appreciate the early implementation milestones, such as 
the deemed administrative orders being issued. So here is my 
question, as this implementation continues, will you commit to 
the following, No. 1, ongoing communication and transparency 
with Congress? No. 2, transparency with regard to--with the 
public health and industry stakeholders?
    Dr. Califf. Yes. Thank you, Senator, and thank you for 
getting this through. It is--in the world of regulation, this 
is pretty exciting. And I personally visited the drug store 
early this morning to get an over-the-counter medicine, and it 
was noticeable to me as Commissioner last time around that we 
needed to do something so that these monographs could be 
updated as innovation is made, but we also were empowered to 
look at the safety of these over-the-counter products. So it is 
really appreciated, and I do commit to transparency and 
discussion with you and others in Congress.
    Senator Casey. Thanks, doctor. Next on antimicrobial 
resistance, this is an issue that presents right now urgent 
public health challenges. According to the Centers for Disease 
Control and Prevention, there are more than 2.8 million 
antimicrobial--antibiotic resistant, I should say, antibiotic 
resistant infections in this country every year, causing more 
than 35,000 deaths.
    This Committee has tackled this issue in a number of ways 
over the years, including the passage of the so-called GAIN 
Act, the Generating Antibiotic Incentives Now Act, and that was 
back in 2012. The GAIN Act gave FDA new tools and provided new 
incentives to drug developers to encourage them to meet this 
urgent public health threat. Yet since that time, we have made 
very little progress in getting new antibiotics approved to 
combat these drug resistant infections.
    Numerous experts have expressed concerns that the COVID-19 
pandemic could exacerbate the spread of antimicrobial resistant 
infections. And I want to note the work with Senator Cassidy on 
this. We have been able to work with him on this and other 
Members of the Committee. What do you see as the barriers to 
more antimicrobial drug development? And how would you work to 
support that drug development within the FDA, if confirmed?
    Dr. Califf. Thank you for raising this issue. And while we 
are so consumed with the pandemic right now, we cannot lose 
sight of this other threat. In my lecture after leaving the 
FDA, I gave, safety and effectiveness of medical products, 
food, tobacco and always put in preparation for emergencies.
    At the time, 5 years ago, people sort of scratch their 
heads like, what is that? I think we all know what that means 
now. But we can't lose sight of the fact that we could get a 
super resistant bug, and if we don't have antibiotics on the 
shelf that are ready to go, we are going to have a big problem.
    It will be difficult, if not impossible, to treat. This 
involves a whole variety of things, one of the most important 
of which is one health, the combination of animals and human 
evaluation, because many of these resistant bacteria are 
developed in animals that are treated with antibiotics.
    But in addition, there is what you mentioned. We have to 
have a system of developing antibiotics, essentially not 
intending to use them because you want to hold them in reserve. 
And there are several mechanisms to do that I would look 
forward to working with you on.
    One pathway you have already passed in Congress and that is 
in motion now, but we are going to have to do a lot better or 
we may be taken by another surprise, and we don't want another 
one like the current pandemic.
    Senator Casey. Thanks, doctor.
    The Chair. Thank you.
    Senator Braun.
    Senator Braun. Thank you, Madam Chair. Dr. Califf, enjoyed 
our conversation in my office not too long ago, and we covered 
a broad array of topics. I have been one interested in 
reforming health care in general to add transparency, 
competition to it, FDA specifically, and I think we did cover 
some discussion on making it more agile, especially on maladies 
that don't have really good treatments out there.
    You said you would be amenable to that. I like to hear 
that. This is a question I have asked since the origin of the 
COVID kind of navigation, and now we got a lot of data. We are 
lucky that we did have Warp Speed. We got the vaccine done. 
Looks like with variants, they are going to be renditions of it 
that we still need to tackle.
    Whether vaccines will be the only leg that we use--I have 
been a believer that it needs to be broader. In the subject of 
therapeutics, are you willing to put the same interest in 
developing therapeutics, especially in light of the fact that 
some either choose not to get it for the wrong or right reason?
    Where does that fit in your opinion in terms of the 
relative importance, especially given the fact that it looks 
very difficult logistically, we will get the world vaccinated 
in a way to suppress variants? How important are therapeutics, 
and where will you be, your posture in terms of promoting that 
second leg, if not a third one down the road in terms of 
protecting against it in the first place? Focus on the 
therapeutics.
    Dr. Califf. I am a cardiologist, so we are fairly well 
known in the medical community as being aggressive people over 
the garden therapeutics, and I think it has made a huge 
difference in heart disease. We have drugs and devices, many of 
which I have worked on in my career, and I think the same holds 
here. Vaccines are far and away the first line of defense, in 
addition to the behavioral measures that we all know about. But 
for people who were unlucky enough to get infected, 
particularly those that are high risk, the therapeutics are 
absolutely essential.
    Already made the point with Senator Romney, the 
therapeutic, antibiotics have a 90 percent effect, and now it 
looks like we have oral antivirals that may also be in that 
category.
    We have got to stay on top of this because the virus 
doesn't really care about us, it is mutating constantly, and we 
have got to have platforms that will produce therapeutics just 
in time for the variants as they come up. But so, therapeutics 
is a big part of the FDA. It is a big part of my history, and I 
will definitely work hard on this.
    Senator Casey. I think from what you said there that you 
are willing to acknowledge that it is going to have to be a 
significant part of how we tamp this down over time and I am 
glad to hear that. Another question I have. Under your 
leadership, in 2016, the FDA weakened the risk evaluation and 
mitigation strategy on protocols on Mifepristone--hard to 
pronounce, but a drug that is used, early in the stages of when 
you are entertaining an abortion.
    A recent study analyzed 423,000 taxpayer funded abortions 
between 2002 and 2015, and I have got a question. Do you think 
that we need to be in that relaxed kind of interpretation of 
that particular approach? Or is this something you are going to 
listen to current information and technology on so that you 
give a full kind of consideration of that particular 
methodology on abortions?
    Dr. Califf. Well, as I have already discussed with Senator 
Burr, I do appreciate the question. There is a document filed 
by FDA in court about the evaluation of the data on 
Mifepristone. And, the reevaluation is imminent. I am not 
involved in that particular reevaluation, but I can assure you 
the staff will be looking at the latest data and applying the 
best science and make the best possible decision. I have 
confidence in that staff, and I know them well.
    Senator Braun. I think that is in the context of what we 
are seeing, even with what the courts are taking up in terms of 
trying to get the proper balance on Roe v. Wade and that issue 
is going to be out there. And I think to many Americans, it is 
an important, including the question I just asked.
    Madam Chair, I ask unanimous consent to submit for the 
record the testimony of an individual that experienced 
complications resulting from a chemical abortion drug.
    The Chair. Without objection.

    [The following information can be found on page 93 in 
Additional Material:]

    Senator Braun. Thank you.
    The Chair. Senator Murphy.
    Senator Murphy. Thank you very much, Madam Chair. Dr. 
Califf, thank you for your continued willingness to serve the 
country. I am going to submit two questions for the record that 
I hope you will take a hard look at. One, on the continued 
delay in regulating medical gases. This is something that there 
is bipartisan interest in. The current regulatory system just 
doesn't work for medical gases, and we would love for you to 
take a look at how we can expedite that process. And second, a 
question for the record on the issue of counterfeit medical 
products.
    We are thinking about bipartisan legislation here that 
would provide some new authorities to crack down on counterfeit 
products. We have obviously seen a disturbing growth in the 
distribution of counterfeit devices during the pandemic, PPE 
and testing kits at the top of the list.
    But the two questions I would love to have you answer in 
person are on mental health drug development and drug 
shortages. On this question of mental health drug development, 
it is pretty stunning the slow pace that we have seen of new 
and transformative drugs in the mental health space.
    Right now, there are some products in the pipeline like for 
schizophrenia. But overall, relative to the need, we aren't 
seeing enough new innovative products come forward. And that 
has to do in part because of the complex patient populations 
that we are talking about here that can make research and 
clinical trials and data collection more complicated.
    You have written about the need to streamline the clinical 
trial process and the opportunity for digital technology to 
expand people that can participate in trials. Do you think that 
reform can help unlock more research and more clinical trials 
for individuals with behavioral health needs?
    Dr. Califf. I mean, the short answer would be yes, but I 
would like to give a slightly longer answer. I won't take too 
much time because this is an area of great passion for me and 
experience. I don't think people in America realize enough that 
before the pandemic, we were experiencing an unprecedented 
reduction in our life expectancy in the U.S., largely driven by 
the opioid crisis, that is addiction, and also by suicide.
    In addition to common chronic diseases, it is often driven 
by people who are in despair and not taking the best care of 
themselves. And we also haven't talked enough about the fact 
that in addition to the disparities that we all know of, with 
up to 10 year difference in life expectancy according to race 
and ethnicity, we have an enormous urban, rural issue in this 
country where the rapid decline in life expectancy are people 
in rural America.
    I don't see any way to connect to everybody in America 
except through digital technology, but it should be 
supplemented by people on the ground who help people deal with 
digital technology in the local community.
    I see this as the way forward. We started a drug addiction 
program in Dayton, Ohio, where the highest mortality rate per 
population was occurring. And in that take all comers program, 
the ability to use telehealth to reach people in rural Ohio has 
made an enormous difference. So that is a longer answer to say, 
yes, let's get on it. We need to do something about this.
    Senator Murphy. Well, and I appreciate that answer. I want 
to make sure that we are, focusing on more widespread and 
traditional behavioral health disorders, not simply on 
addiction, where we need--drug development is covering both. 
But it is still pretty stunning that in the area of treating 
depression today, we are living in a trial and error world.
    We still lack the data necessary to be able to know with 
the kind of certainty with like what drugs are going to work 
right off the bat. And a lot of patients have to try and fail 
on multiple therapies before they find the one that works. And 
so I look forward----
    Dr. Califf. I have led my own number of failed clinical 
trials trying to develop new treatments for depression 
specifically and also for anxiety. So we have got--I completely 
agree, we have got to address these very prevalent mental 
health conditions directly.
    Senator Murphy. Quickly on the issue of drug shortages. In 
2012, the FDA Safety and Innovation Act gave FDA new tools to 
address drug shortages. And I just want to make sure that we 
are looking into the future where we might have increased 
tensions with countries that are critical to our drug supply 
chain. Do you think that FDA has the authority it needs to 
really think 5, 10, 15 years down the line to look at shortages 
that may result based on changes in our relationships with 
economic allies?
    Dr. Califf. Senator Murphy, I really appreciate that 
question. And let me just say I was serving on the National 
Academy of Medicine Supply Chain Committee, which is due to 
produce a report any minute now. I can't reveal what is in the 
report but let me just say I don't think people are aware of 
the tenuousness of our current supply chain.
    We have to have transparency and build in resilience, or we 
are going to be at risk. And in fact, if you talk to hospitals 
and medical practices, it has already happened that we have 
fallen short of critical supplies periodically. So we really 
need to work on this.
    The Chair. Senator Cassidy.
    Senator Cassidy. Hey, Mr. Califf, nice to see you.
    Dr. Califf. Great to see you.
    Senator Cassidy [continuing]. From afar. I am told that--I 
was out at another Committee hearing, but I am told that 
Senator Sanders asked if you support negotiation and you 
agreed. Now, do you think that the FDA has a role in this 
negotiation? Let me first ask you this.
    Dr. Califf. No, and we were a bit short on time, so I was 
trying to compress my answers. I mean, I have a published 
record saying, I think negotiation is a good idea, but that is 
not the role of the FDA. So that is the answer.
    Senator Cassidy. That is fine. I also want to associate 
myself with Senator Casey's remarks about the work we are doing 
on antimicrobial resistance. And I think you--I know you will 
be very aware of that, and how do we come up with ways for 
these necessary antibiotics to somehow have a business plan 
which works, so just to mention that as well.
    Dr. Califf. I really appreciate your help with that. And I 
remember in 2016 sitting there with all of the relevant 
agencies and you are trying to keep track of the microbial 
underpinnings on a global basis because we are all connected, 
and we, it is a great place for big data if you love the 
science, but we have got to figure out how to get a handle on 
this.
    Senator Cassidy. You had mentioned in a conversation we had 
prior to this that I had raised the issue, and I want to 
follow-up on it just to set the stage, we know that complex 
generics, if I remember my term are correct, that for example 
the EpiPen, that you could change whether or not you turn the 
device to the left or to the right, and that would give a lease 
of life of exclusivity upon the product.
    Dr. Gottlieb suggested, your predecessor, to allow 
equivalency between, Okay, you can--you don't have to turn left 
or right, it can still be considered the same product, but with 
alternative instructions. You had mentioned great idea, but 
that FDA needed tools to allow that to be implemented. We 
didn't follow-up in the conversation. Is there more you want to 
say to that?
    Dr. Califf. I would just say, it is going to take a lot of 
work for me to get completely up to date on all the current 
tools that are at our disposal. But your point is so well 
taken. I think you and I agree that what we want to reward is 
innovation and creating new things that make a difference in 
people's health. People should do well if they do that. But 
having legal tricks that extend patents and reduce 
competitiveness, I just don't think that's a good idea under 
any circumstances.
    Senator Cassidy. Let me ask, how long would it be until you 
think you could come back to this Committee with 
recommendations as to how we can address those legal tricks to 
give FDA the ability to offset them, if you will?
    Dr. Califf. Well, I would say to give a specific time, but 
it should be short. I mean, I am not ignorant on the issue, and 
we had a good list in 2016, but I think a number of those 
things on the list have already been taken care of, like the 
buying a generic company to prevent the competition from 
occurring. I think these things you all have already helped 
with, so I want to make sure I have got the updated list. It 
should be fairly, very quick, I would think.
    Senator Cassidy. Next--thank you, I look forward to that. 
Next, we had spoken again offline about the accelerated 
pathway, and how the Biogen drug for Alzheimer's obviously 
addressing the need, which is devastating, but there is a lot 
of concerns about efficacy, safety, and cost. And you had 
mentioned using big data in order to have a quicker answer on 
drugs such as this. I would like you to elaborate on that, 
please.
    Dr. Califf. Sure. Well, we have essentially 300 million 
plus Americans with electronic health records, and our health 
data is being used all the time in clinical practice. A lot of 
my career has been on the issue of how do we use that data, 
organize, curate it, make it useful for research.
    It sometimes startles people when I say the data is good 
enough to use in clinical practice, as you well know, but not 
good enough for research, and people say, wait a minute, how 
can that be, that it is good enough for me, but not good enough 
to draw a conclusion. I think we are well down the road now and 
having a functional system, but also want to assure people I am 
not talking about willy nilly analysis of data.
    I am talking about, well, planned studies, frequently the 
use of randomization. And if we look at the UK during the 
pandemic, that is what they did. They organized as a country, 
they took on the big questions, and they have answered a lot of 
questions very succinctly, with the advantage they don't have 
to spend a ton of money collecting what is already in the 
electronic health record.
    Senator Cassidy. Let me ask you, do you need more--do you 
need different rules that we have to give you? Or can you do 
that with existing authority?
    Dr. Califf. I think the FDA has adequate authority, but I 
think the system, because this takes many players. CMS has to 
be involved. The private health sector has to be involved. And 
I think the most important thing is to develop a system that 
gives Americans trust that their data can be used not for 
someone else necessarily, but for their own benefit.
    I mean, if I had a heart attack today, I would feel a lot 
better if I knew how all the other people like me had faired 
with the different treatments. And so it is in my interest to 
share data, but we got to develop--I think we do have work to 
do to develop a system that Americans will trust to allow this 
to happen.
    Senator Cassidy. I look forward to your further thoughts on 
how to develop that system, and I thank you for your vision. I 
yield.
    The Chair. Thank you.
    Senator Hassan.
    Senator Hassan. Well, thank you, Madam Chair and Ranking 
Member Burr. And I want to thank our witness and your family 
for your willingness to serve. Dr. Califf, I want to return to 
the topic of opioids. In 1995, the FDA first approved 
OxyContin, as you have acknowledged, a very powerful opioid 
drug. Since then, more than 500,000 people have died from 
opioid related overdoses.
    In 2020 alone, over 357 granite staters in my home state 
lost their lives due to opioid overdoses, and tragically, many 
people first became addicted to opioids through a legal 
prescription for OxyContin or other FDA approved drugs. First 
question, did the FDA make a mistake when it approved OxyContin 
in 1995?
    Dr. Califf. I think if we look back, approving OxyContin 
with no long term studies and no assessment of the addictive 
capabilities is something that could have been done 
differently.
    Senator Hassan. In 2001, the FDA revised the OxyContin 
label to indicate that the drug should be used not just for 
short term pain, but when a ``continuous around the clock 
opioid analgesic is needed for an extended period of time.''
    In other words, the FDA specifically indicated OxyContin 
for long term use to treat chronic pain. Former FDA 
Commissioner David Kessler, who led the agency in 2001, has 
since said that there are no studies on the safety or efficacy 
of opioids for long term use, and has called the FDA's 2001 
decision a mistake and a, ``blank check'' for the industry. Do 
you agree with that assessment?
    Dr. Califf. Well, the only little part of I disagree with 
is there are now long term studies underway, but at the time, 
he said, I think that it was accurate, and it could have been 
done differently. I mean, I am an evidence based person, and if 
we are going to instruct people to take drugs for long periods 
of time, we need long term studies.
    Senator Hassan. Well, look, it is an old adage, but it is 
worth repeating, the first step toward fixing a problem is 
admitting that you have one. Repeatedly, I have asked FDA 
officials about this, and I get this kind of vague answer about 
whether the 2001 relabeling was a mistake. And its failure to 
admit to having created problems for more than 20 years is part 
of why we have an opioid crisis in the first place.
    It is still troubling to me that we don't have direct 
acknowledgment by FDA and FDA officials that they made mistakes 
and that in 2001 the decision to re-label created an even worse 
problem. Let me just move forward to one other thing, you 
became FDA Commissioner in 2016.
    By that time, we did know an awful lot about the addictive 
nature of OxyContin and the problems with the label from 2001. 
Why didn't you take action to change the OxyContin label when 
you led the FDA in 2016?
    Dr. Califf. Well, what I did was to, several things, one is 
to take--support these long term studies that needed to be done 
to get the evidence and also contract with the National Academy 
of Medicine to reset the format for the evaluation of opioids. 
The tradition of FDA is to evaluate risk and benefit for the 
person for whom the drug is prescribed. This affects many other 
people in society and that was successfully done, so I do 
believe it has set the framework for that.
    Senator Hassan. But doctor, when you listed in response to 
Senator Murray's question, when you listed what we need to do 
going forward on opioids, you said we need to reassess some 
things, we need more prescriber education. You cited your own 
family's experience with getting a 30 day prescription for 
opioids for minor surgery. If the label were different, the 
doctor wouldn't have prescribed that family member the 30 day 
prescription. So explain to me why we shouldn't aggressively be 
pursuing relabeling.
    Dr. Califf. I think as the evidence comes in, we are going 
to need to aggressively look at relabeling. And that was the 
purpose of setting a different framework so that we would have 
a legal framework for doing that.
    Senator Hassan. The evidence has been here for a long time. 
It is the evidence of thousands of people, hundreds of 
thousands of people dying in this country. It is the evidence 
that I see when I go to the funeral of a constituent who has 
been in recovery multiple times and has relapsed.
    It is the evidence that I see when I go to the funeral for 
that constituent's sister and listen to a mother who has lost 
two adult daughters to this illness despite their repeated 
attempts to enter recovery. There is plenty of evidence about 
what we need to do about this epidemic and the FDA needs to 
take the lead. Thank you, Madam Chair.
    The Chair. Thank you. I am--we have three votes, and I am 
going to go vote, and turn the gavel over to Senator Burr. The 
next two Senators will be Senator Tuberville and Senator Smith.
    Senator Tuberville. Thank you, Madam Chair. Thank you, Dr. 
Califf, for being here today and bringing your family, and 
being part of this and continue to want to service such a tough 
time in our Country. Very quickly, the State of Alabama. We 
have lost people in our state because of testing. We don't get 
to them quick enough in the rural areas. What is your 
suggestion on that?
    Dr. Califf. Well, I mean, we have got to make tests 
available and either free or low cost, and they need to be 
readily available in the person's home. There is also just a 
tremendous amount of education that we need to do to make sure 
that people are aware that when they have symptoms or when they 
think they have been exposed, they should get tested because of 
the extreme risk, particularly if their high risk.
    In the rural population, as I have already stated, there is 
a huge amount of common chronic disease that really means that 
we have a lot of high risk people in the rural areas. And I 
wouldn't understate the critical importance of education 
programs for the primary care practices in rural areas. These 
folks are overwhelmed and incredibly busy, and we got to catch 
people early on because these treatments that we talked about 
are highly effective if used early.
    Senator Tuberville. Yes. While we are on this subject, what 
is your thought about this new pill that they have come out 
with, I forget which company, this new therapeutic that they 
are saying is very effective?
    Dr. Califf. Well, there is the saying in God we trust, all 
others must bring data when it comes to the FDA. So the press 
releases out, I think, this morning on something that looks 
really exciting. And there is every reason to believe that a 
direct antiviral should work because it works in other viral 
diseases.
    I really look forward to the FDA's evaluation of the actual 
data, which I think is going to be done very quickly, just like 
the other therapeutics. And the idea that if you are unlucky 
enough to get infected, let's say even if you are vaccinated, 
the idea that there is a 90 percent effective treatment is 
truly exciting.
    Senator Tuberville. In my former job, the last 10 years of 
my 40 years of coaching, I would bring players in, and more and 
more each year, a higher percentage of kids would come in 
taking drugs. You would bring 25 in, 20 years ago, there might 
be one, maybe two that take an insulin or something like that.
    Now you bring 25 and half of them are taken attention 
deficit drugs like Ritalin. I think we are overprescribing 
these drugs. I think we get them involved in drugs at too early 
of an age. What are your thoughts about these mental health 
drugs that Senator Murphy was talking about?
    Dr. Califf. Well I think there is sort of a Goldilocks 
thing here, not too big, not too small. And we have got to find 
the right place for each treatment, for each type of problem 
that people have. And the only way we really know that is to do 
the clinical studies, get the evidence, and then we know what 
the risks and benefits are. Too often with children, we have 
not had the right evidence early on and the docs are guessing, 
the prescribers, maybe a nurse practitioner are guessing about 
what the best treatment is.
    I mean, my answer this week is, got to double down on 
getting the evidence. We have talked about some of the ways of 
doing it already this morning using electronic health records 
and such. Once we have the evidence, if someone is 
prescribing--I think in the example, the Senator Hassan said of 
the opioids, if someone's prescribing a bunch of unnecessary 
stuff, we need to have a system that deals with that 
effectively.
    I think almost all the drugs on the market, they--the drugs 
have been shown to be effective for an FDA approved indication, 
but when they get out beyond those indications, we have got a 
lot of work to do to get the right evidence.
    Senator Tuberville. Thank you, Dr. Califf.
    Senator Burr. Senator Smith.
    Senator Smith. Thank you very much. Dr. Califf, welcome to 
the Committee, and welcome to your family, and thank you for 
your willingness to serve again as FDA Commissioner. And I 
appreciated our conversation of a couple of weeks ago, I think 
it was now, and I just want to say I particularly appreciated 
your commitment to advancing equity. I think that is a matter 
of such great importance. I want to follow-up first, though--I 
am going to try to touch on two or three things.
    I want to follow-up first on a question that Senator Murray 
brought up, touching on how we can get more rapid COVID-19 
testing to the market. As COVID-19 becomes more endemic, 
affordable, available, and in-home rapid testing is going to be 
so much--so essential. And the FDA has taken steps to 
streamline the review process for authorizing COVID-19 tests, 
including rapid tests.
    Some policy folks are arguing that we should be 
reclassifying rapid COVID-19 tests as a public health tool 
rather than as a medical device, and that this would help to 
increase supply and reduce prices. So I am wondering if you 
could, Dr. Califf, could you based on your experience, what do 
you think about this idea? What do you see as the downsides? 
And what more do you think that we could do to speed up the 
supply and lower the price of rapid tests at home?
    Dr. Califf. Well, that exact solution--well, first of all, 
thanks for the question. I think you may not have been here 
when I mentioned my son, Sam, back here, got two rapid test 
yesterday because he wasn't feeling too good after his booster 
shot and it was negative. So I fully personally appreciate the 
impact of having readily available rapid tests. But that 
specific solution, I don't think it solves a problem. It may be 
one pathway, I would have to study it. What I do know, I mean, 
I started my career evaluating cardiovascular tests. This was 
in 1978. It was a long time ago.
    But the principles are the same, and the purpose of the 
test is really important. A test to screen for a disease, a 
test to diagnose the disease, a test to determine the 
prognosis, what is the likely outcome, the operating 
characteristics that you measure are different. And we do need 
to have a system, and I know Senator Burr and others are 
working on this, now we need to have a system that takes these 
different purposes into account.
    Just like with a drug, a drug may have a use and several 
different indications, and the dose may even be different in 
different indications. So we got to have a flexible system that 
takes these things into account and an evidence generation 
system that makes sure that when we are using it for one 
purpose or another, we actually understand what the test result 
means.
    Senator Smith. If you are confirmed as FDA Commissioner, 
will you commit to reviewing the current process for 
authorizing tests and take steps to streamline this process, 
and make sure you let us know if there are things that we need 
to be doing here at the Committee to support that effort?
    Dr. Califf. Yes. Yes, I would very much look forward to 
working with you on that, and I would actually get back to 
where I started my career, so I would find it in an already 
sort of way pretty, pretty exciting.
    Senator Smith. Thank you. That is good. Dr. Califf, while 
the FDA doesn't set the price of prescription drugs, the FDA 
has significant power to bring more low cost generics and 
biosimilars to market. This has been a big priority of mine. In 
fact, the first bill that I introduced when I came to the 
Senate is a bill to prevent parking of--the parking situation 
that we have.
    In fact, this is a bipartisan bill that I have with Senator 
Braun, and it would prevent generic manufacturers from getting, 
and name brand manufacturers, from gaming the system and help 
to streamline getting those generic drug approvals done. Could 
you talk a little bit about how you would use the tools at your 
disposal at the FDA to prevent anti-competitive behavior like 
parking in the prescription drug market?
    Dr. Califf. I think I have already mentioned, in 2016 we 
had a long list of ways pharmaceutical companies could extend 
the patents or otherwise get around the intended move to 
generic status after an appropriate period of patent 
exclusivity. And I think there is no other way than making a 
list, and it is a little bit like Whack-A-Mole. You have to--
there are really smart people on the other side looking for 
ways to circumvent the rules.
    You got to be on your toes, and then in some cases, FDA has 
the same power to make a difference. And in other cases, it 
would involve something that we would need from Congress to 
help take care of it, as in the case that you mentioned.
    I would also mention, I am very aware in the supply chain 
issues that we have got to shore up the generic supply chain 
while we are also reducing the costs. And that is a big issue 
we need to pay attention to.
    Senator Smith. I absolutely agree with that. In the 
interest of time, I am going to submit for the record my final 
question, which is around how to address the need to include 
more pregnant women in clinical trials. And I will submit that 
question to you. Thank you.
    Dr. Califf. Thank you. I want to take a quick second and 
say that, as you know, I work very hard on including children 
and clinical trials, and that work is getting better and 
better. Pregnant women is a big frontier. It is a very high 
risk situation.
    Everybody is concerned. But if we don't do the studies, we 
end up with, like my daughter, who I mentioned had congenital 
heart disease. I have a granddaughter sitting back here, too. 
But when you have a chronic disease, you need to take medicine 
for it, even if you are pregnant. We have almost no studies 
that addresses those issues. So, I would really look forward to 
working with you on that issue.
    Senator Smith. Thank you very much. Thank you, Mr. 
Chairman.
    Senator Burr. Senator Collins.
    Senator Collins. Doctor, I was very pleased to hear you say 
twice this morning that your first priority is improving 
emergency preparedness so that we are better able to counter 
the inevitable next pandemic that comes our way. As you know, 
from our discussion, for a number of years, I have been very 
concerned that the United States drug market is increasingly 
reliant on the manufacture of active pharmaceutical ingredients 
at facilities overseas.
    In fact, the FDA in 2019 testified that 72 percent of the 
facilities that manufacture APIs are located overseas, a lot of 
them in China and in India. In addition, we know that China has 
virtually cornered the market on manufacture of the 
antibiotics. I am very concerned that we see, as we saw with 
India, when there is a pandemic like COVID that countries began 
to hoard medicines that were destined for our markets.
    I strongly believe that part of reforming the medical 
supply chain has to include incentivizing manufacturers using 
both carrots and sticks to locate their facilities in the 
United States, starting with the 100 essential medicines list. 
And perhaps we could link it to participation in the VA health 
program, for example. Perhaps tax incentives are needed. What 
are your thoughts on our vulnerabilities in the supply chain?
    Dr. Califf. Thank you, Senator Collins, for the question. 
And as I have mentioned already, I served on the National 
Academy of Medicine Supply Chain Committee, which is about to 
come out with its report, so I don't want to say too much about 
the specific recommendations there.
    But your facts are correct, and in the discussion I just 
had with Senator Smith, the active pharmaceutical ingredients 
are not just for innovator drugs that we think about, but also 
for generics, where often we don't have enough competitive 
entities in what has become sort of a commodity business.
    We need a number of steps to make the system more 
resilient. Purely on-shoring is probably not the complete 
solution, but it is a part of it that is significant. But we 
need the supply chain to be secure and resilient in multiple 
directions, and a transparent system for knowing where things 
are in the supply chain, which we currently don't have.
    I would mention one other thing, manufacturing in places 
and exciting technology that people have been working on and 
the idea that you can make a pill now with a small machine in a 
local area is something that I believe is coming, and we need 
to accelerate that as quickly as we can.
    Senator Collins. In 1997, as a new Senator, I founded the 
Senate Diabetes Caucus, which my colleague Jeanne Shaheen co-
chairs with me now. And it was after meeting with children with 
Type I Diabetes and their parents. And in the years subsequent 
to that meeting, there have been many advances in technologies 
such as continuous glucose monitors and far better pumps and a 
closed system. But there is still not a cure or disease 
modifying therapy yet approved for Type I Diabetes.
    This year, the FDA has reviewed and held two advisory 
committee meetings for therapies for Type I Diabetes. One is a 
biologic that may delay the clinical onset of Type I by as long 
as 3 years in those at high risk. The other is cellular therapy 
made from donor pancreas for those who suffer from severe 
hypoglycemia.
    In addition, there have been press reports that claim an 
individual has been cured from Type I Diabetes as result of new 
therapy. How would be FDA under your leadership continue to 
foster cutting edge science at the various centers we have 
created for Type I Diabetes therapies and devices?
    Dr. Califf. Well, thank you for that, and let me just say 
that it is exciting. These two types of diabetes, which are 
different in terms of their origins and the idea that you could 
cure a person with Type I Diabetes, which has been a lifetime 
consignment to insulin therapy up until now, is very exciting.
    I think we would like to continue this very healthy 
relationship between the patient community, the industry that 
makes products, and the regulators who have to determine if the 
products are safe and effective. And let me just point out, I 
think this is actually a paradigm. Multiple myeloma, which my 
mom had, or cystic fibrosis would be other examples where when 
you have an activated patient community with a group of 
families that are dedicated, it creates a very different 
situation where investment comes into the area.
    People think of new therapies because they know that people 
are going to participate in the clinical trials and the 
turnaround and getting the evidence is quick. And then when 
practitioners go to treat the disease, they can have confidence 
they are doing the right thing because they have strong 
evidence.
    I would frankly love it if more people copied that model, 
and it bothered me a lot at FDA when I would work with diseases 
that had no effective advocacy because they couldn't benefit 
from the kind of things that you created.
    Senator Collins. Thank you.
    The Chair. Senator Rosen.
    Senator Rosen. Thank you, Madam Chair. And thank you, Dr. 
Califf, for being here and for your willingness to serve. We 
really appreciate that. I want to go over telehealth and remote 
monitoring for a minute, because of course, as we have seen 
throughout the pandemic, telehealth has become more important 
than ever for improving access to care, especially among our 
rural and our underserved areas. It is critical that agencies 
work together, like you said, to ensure coverage, payment 
policies, regulation of technology to keep up with the pace of 
innovation.
    Like with telehealth, home monitoring equipment has rapidly 
changed and become an important tool for addressing a range of 
conditions away from the doctor's office. From diabetes, like 
Senator Collins was talking about, to heart disease, which you 
are an expert in. It has also become a popular tool for people 
to monitor their own health and the health of their children 
through smart devices like their smartwatches.
    If confirmed, what would you do to clarify the regulatory 
pathways for manufacturers of such devices and products 
specifically to ensure that they are both consistent, 
efficient, safe, just make sure they are really doing what they 
are supposed to and maybe not--maybe helping to promote care, 
but not in place of care?
    Dr. Califf. Really appreciate that question, and it is a 
passion of mine. I mean, cardiology basically goes back to 
measuring all kinds of things about people and then designing 
interventions that work, and you made a couple of really, 
really important points. First, we are seeing this decline in 
life expectancy that I have already talked about, dominantly in 
rural America now, and it needs to be dealt with. There aren't 
going to be enough nurses and doctors to go to every community 
and provide the care that is needed, so we have got to employ 
digital technology.
    But it also can't be digital technology alone. And I would 
just put forward this is not the FDA's purview, but I would put 
forward that the workforce of people needed in the communities 
to help people interact with digital technology. Now that you 
all have graciously passed the law that will fund broadband for 
all of America. That is a great place by which people in rural 
areas can get employment.
    Then, with regard to the regulation, this is a complicated 
area, and I can assure you that people have not dealt with 
patients and the issues and health can make really bad mistakes 
and the use of technology because I haven't seen what happens 
when the technology is misused, and someone is hurt and badly 
damaged. And so safety is an issue here, just like everywhere 
else.
    On the other hand, if you are too heavy handed in the 
regulation, you are impeding a field where essentially, with 
traditional devices, you make a change and you go all the way 
back to the manufacturing plant. With software, you just update 
the code much like we are all used to doing with our iPhones. 
So there is a spectrum here. There is a Center for Digital 
Health in the FDA, and Bakul Patel who runs it I have 
tremendous confidence.
    I think, we will have to work across that spectrum. But I 
would echo more than anything else what you said about, it is a 
human interface issue, not just a person using the technology, 
but they are going to need a workforce that can help them use 
it.
    Senator Rosen. Well, I am glad you brought that up because 
broadband, of course, I worked on that and the infrastructure 
bill, and that is really important, and workforce, how do we 
potentiate the telehealth, all the opportunities we have.
    But as you talk about coordination, I know it is not the 
FDA's purview, but what could you do maybe differently than you 
might have done in the past, now with, of course, technological 
changes we have, to improve the coordination between FDA and 
CMS, and of course Congress to be sure that all of us are 
moving forward in the same path to provide outcomes that are 
great for people? It is their health, right. We want positive 
outcomes.
    Dr. Califf. I think one of the greatest lessons from my 
previous time as Commissioner is that it is something I already 
knew, but you have to experience it to realize we are all just 
people. And I was reflecting back on Senator Hassan, and I 
certainly made a number of mistakes, and we have all made 
mistakes. One of the elements that comes into play here is that 
the coordination across Federal agencies is a lot more human 
and complicated than you would think on the outside.
    I was surprised to see the defense mechanisms that exist 
across the Federal Government that we need to break down. And 
so I very much learned a lot and I really look forward to 
working with the HHS family and also with Congress to solve 
these kinds of problems, where we think about the FDA has an 
essential critical, well-defined role, but if we ran it like a 
relay race where we just threw the baton down and then the next 
person had to pick it up and figure out where to go, that 
doesn't work. And so we do have distinct roles, but those 
interfaces are absolutely critical.
    Senator Rosen. Yes, I think you are right. We have to work 
concurrently on all of this instead of maybe consecutively, 
like you were saying. I see that my time is up. Thank you so 
much. I will submit the rest of my questions for the record.
    Dr. Califf. Thank you.
    The Chair. Thank you.
    Senator Marshall.
    Senator Marshall. Thank you, Madam Chair. Dr. Califf, 
welcome. And again, thanks for visiting with me one on one, and 
we appreciate your willingness to put your life out here in 
front of all of us. Ranking Member, my good friend Senator Burr 
spoke a little bit earlier about real world evidence.
    June of this year, I thought there was enough evidence for 
boosters that as a prescribing physician myself, I would have 
recommended it and I did recommend it for my parents and for 
senior citizens and probably people with health care risk. So 
in June, I thought there was enough real world evidence, but it 
was fall by the time the FDA moved on it and really November 
before my parents were able to get it.
    I saw the Delta wave coming. And if we could have got those 
boosters in senior citizens arms this summer, we would have 
saved tens and thousands of lives. How can we move more quickly 
with real world evidence with a drug or vaccine that has 
already had FDA clearance, but just a new use?
    Dr. Califf. Well, let's dream a little bit, but I don't 
think dream is far away if we get the human aspects of this 
right. There is no technological limitation now to having 
immediate access to all of the transactions that are occurring 
in our health system, the treatments that people get, the 
conditions that they are diagnosed with, and their outcomes. 
But we have a labyrinth of information that needs to be knitted 
together to make that happen so that we have information and as 
close to real time as possible.
    You have seen an approximation of this with the COVID 
tracker that we all look at every day that shows us almost in 
real time the number of cases, the hospitalization rates, and 
the death rates. And so it is very much, if I am confirmed, 
part of my agenda to get the rules in place, the systems in 
place, as I have discussed, to give people confidence that it 
actually is in their interest to share data.
    But for that to work, we got to have those rules right and 
those who misuse people's information need to be severely 
punished.
    Senator Marshall. Thank you. If I think about the last 20, 
30, 40 greatest miracle drugs that came, have come to fruition 
in this world, that maybe all of them have a relationship to 
the United States. What would the international price index, if 
that was instituted in this country, or Medicare price 
negotiation, any type of price fixing by the Government, what 
would that do to innovation in our world of medical--of drugs?
    Dr. Califf. Well, Senator Marshall, I am not sure we will 
completely agree on this one but let me just say that I do 
think that there needs to be, wealthy countries need to share 
in the cost and in paying their fair share for drugs. I am sure 
you agree with that. And so, in any kind of negotiation that 
occurs, if we go too far, it will squelch innovation.
    But we are going to find a sweet spot, which I would argue 
is a little bit off right now because I am acutely aware that, 
for example, almost a quarter of cancer patients are not 
following through on the chemotherapy because they don't have 
the financial means to pay for these effective drugs.
    People think of cardiology, my specialty is sort of nuts 
and bolts, bread and butter. But it turns out financial 
toxicity is now a significant issue for patients with 
cardiovascular disease. So I do think we need an adjustment to 
find the sweet spot, but I also think other countries need to 
pay their fair share.
    Senator Marshall. Thank you. RU486 is a drug I have never 
prescribed as an obstetrician gynecologist, but unfortunately I 
have had to take care of patients with complications from it, 
typically in the emergency room. These patients not only have 
physical complications, hemorrhaging and bleeding, but certain 
psychological challenges after they have had that abortion.
    This kind of remorse afterwards, and I am very troubled by 
HHS's casual attitude about the prescription--about prescribing 
RU486. Are you committed that should be in the hands of 
physicians and prescribers and not handed out like candy?
    Dr. Califf. Well, as we have already discussed, I think the 
FDA has to make this decision based on the latest data and the 
scientific principles. And as we have already discussed also, I 
know more information is soon to become available. I am not 
involved in those discussions, but I do trust the FDA staff to 
make good decisions.
    Senator Marshall. Okay. I guess I have got time for one 
more. I was frustrated last year that the FDA moved really 
quickly on some testing for coronavirus, but not on T cell 
testing. As a clinician, I just want to have the choice, the 
ability. I don't want the FDA to decide for me whether I should 
use the T cell--I just want to know if it is safe, it is 
available.
    What can you do to make sure that the FDA going forward is 
not choosing winners and losers, and why wouldn't you 
prioritize the T cell every bit as much as some of the other 
testing? It just felt like that became a political turmoil 
rather than trying to do what is best and letting clinicians 
decide.
    Dr. Califf. When I came along in the 1970's, cardiology was 
really exciting, and immunology was this evolving field. It was 
just amazingly complicated. It was really hard to understand. 
We have come a long way, and there is no question that T 
cells--I mean, when you think about it, the B cells now protect 
us from the acute infection, particularly in the nasal pharynx 
with the pandemic. The T cells are--that is what is called into 
effect in the long term to prevent death and hospitalization.
    I am totally with you that we need to have T cell testing, 
but it is also without going into laborious detail, and it is 
not my area of expertise, I would just say that it is 
complicated because just measuring something in the blood of 
someone doesn't give us the information we need because the T 
cells have a memory.
    When they get the right stimulus, they swung into action 
and created an army of T cells come in and do the job. So I 
would just say, I know the FDA is interested in this.
    I personally think it is a critical issue that we need to 
continue to work on, but we have to have reliable tests that 
give us the information we need. And maybe the combination of 
evolving tests and the real world evidence that we have talked 
about will give us the information that we need.
    Senator Marshall. Thank you so much. I yield back.
    The Chair. Thank you.
    Senator Lujan.
    Senator Lujan. Thank you, Chair Murray. Doctor, we have 
seen a new record high of opioid deaths, with more than 100,000 
Americans dying over a 12 month period. In New Mexico, these 
numbers mean a loss of a loved one from overdose every 14 
hours. The FDA has a long track record of proving dangerous 
opioids without considering public health. A Federal judge 
presiding over county and state cases against opioid 
manufacturers and distributors recently wrote, ``it is accurate 
to describe the opioid epidemic as a manmade plague 20 years in 
the making.
    While courts are holding opioid manufacturers and 
distributors accountable for their actions that caused this 
epidemic, it is clear that the FDA missed clear signs regarding 
the risks and benefits of opioids, which created the crisis to 
take hold.''
    In response to a question around the role of the FDA about 
curbing the use of dangerous and addictive prescription drugs, 
you responded, one of those answers is better prescriber 
education, which I agree with. The question that I have is, 
doctor, will you commit to reevaluate the labels?
    Dr. Califf. Well, Senator, I am committed to do a 
comprehensive review of the status of opioids early in my 
tenure, like in the first few months, should I be confirmed. 
That would include everything, including the labels. Now I 
would look forward to talking with you about the details of the 
issues that are involved in doing that, but I am committed to 
do a comprehensive review of the opioid situation, including 
the labels.
    Senator Lujan. I think that in your testimony, you also 
shared that a family member that received a 30 day supply for 
an acute issue. Had there been more accurate labeling 
requirements, I don't think that would have happened, in 
addition to the education. And I think that is one of the 
important changes that must take place. Another area that I 
raised when we met personally as well is the FDA convened an 
advisory committee of scientific experts with a matter of 
significant public interest, especially as involved, highly 
controversial or in need of a specific type of expertise.
    In 2014 the FDA approved Zohydro, which is a pure 
hydrocodone drug, despite the FDA Advisory Committee strongly 
voting against approval in a vote of 11-2 due to the known 
dangers of overdose and death. It goes back to what that judge 
said, a crisis 20 years in the making that is manmade.
    My question is, as a person that would be in charge of the 
FDA, if your advisory committee or one of the FDA advisory 
committees voted overwhelmingly like this, 11-2, on Zohydro, 
what would you do?
    Dr. Califf. Well, as I have already said, had the long term 
studies been done and we had the evidence, I think that 
decision would have been different. It was not the right 
decision in the context that it was in. With regard to advisory 
committees, I think we had a good discussion about this, and I 
actually went back and looked.
    It turns out the FDA makes a decision that is not identical 
to the advisory committee about 25 percent of the time, but 
three-quarters of those 25 is for a more stringent reduction in 
the use of a product instead of more use. So I think when there 
is an 11-2 vote, the leaders of FDA really need to take a close 
look and make sure they----
    Senator Lujan. If I can interrupt, I appreciate the 
evaluation looking at the FDA. I am talking about opioids, and 
I am talking about constituents that are dying and mistakes 
that the FDA has made 1 year after another. I am sick and tired 
of the United States approving one opioid to fix another. It is 
the dumbest thing that I have--I just, I don't understand it. 
This is stupid. People are dying because of it.
    Heroin, if I may. Heroin didn't get developed out on the 
streets. It was developed in a lab by a pharmaceutical company. 
And then here in the United States, we keep approving one after 
another. Specific to an 11-2 vote on an opioid, doctor, what 
would you do if you got that vote on something specific to this 
with Zohydro, and subsequent to that, the FDA approved more 
without even going to the advisory committee, they just said, 
oh, we are going to ignore them, and I am going to continue to 
approve these opioids and kill more people across America. What 
would you----
    Dr. Califf. Senator, I wasn't there at that time, but in my 
leadership role, we instituted a mandatory advisory committee 
and also the framework of societal consideration. There are 
almost no opioids coming through the FDA now for approval. That 
has really been shut down. And I think the roles that I played 
were critical in doing that. But I think, I can't argue with 
your points.
    Senator Lujan. Chair Murray, I have several other questions 
for the record, especially around non-addictive pain therapies, 
which I think we need to be doing more about. And I do look 
forward to following-up on that line of questioning.
    There must be more done here in the United States about 
taking this issue seriously, rather than companies and families 
making billions of dollars and building empires off the deaths 
of our constituents and our families. It is just not right, and 
something has got to change, and I am hoping, doctor, that you 
can be that person. Thank you, Chair Murray.
    Dr. Califf. Let me assure you, I am going to--if I am 
confirmed, I am going to take a very aggressive approach on 
this and I appreciate your concerns.
    The Chair. Thank you.
    Senator Scott.
    Senator Scott. Thank you, Madam Chair. And thank you, Dr. 
Califf, for spending some time with us today talking about some 
really important issues that we could all spend a day talking 
about. I only have 5 minutes. Good news for you. So my first 
question is that you are coming into a very important position 
in the midst of really headwinds in the public health space. 
And I appreciate the enormity of your responsibilities, if you 
are confirmed, to lead the FDA.
    How do you view the FDA's role in granting emergency use 
authorization for the new, as well as repurposed products to 
address the COVID-19 pandemic? Should the FDA use a wider 
latitude to ensure multiple avenues, for instance, drugs like 
by budesonide as well as COVID-19 testing kits, making sure 
that they are available to combat the pandemic?
    Dr. Califf. Well, as you know--and thanks, Senator, it is 
good to be here with a fellow South Carolinian. I am wearing my 
South Carolina bow tie today that my dad had.
    Senator Scott. I am just glad it is not Clemson, but 
continue----
    [Laughter.]
    Dr. Califf. Hey, I am a Clemson man----
    Senator Scott. I know. I am just joking.
    Dr. Califf. You are all aware, and it was during my tenure 
that the EUA guidance was written, that potential benefits need 
to be weighed against the potential risk. That is authority the 
FDA is given. And so there is a lot of latitude on the types of 
things that you mentioned.
    Yet I would still point out we need--we do need to have 
enough evidence that we can make a fair assessment of what the 
potential is, and we need a system in this country, as I have 
emphasized over and over, that produces the evidence more 
quickly.
    Because under that framework, it is possible you could get 
it wrong. There is a, it is different if you have actually 
measured the benefits and risk and then you are confident about 
it. And so it is finding that right balance that is really in 
play for the FDA.
    Senator Scott. No doubt. I would suggest that based on the 
severity of the challenge in the public space, that taking the 
appropriate calculated risks, it seems to be necessary nowadays 
more than it has been in the past. And I think we can do that 
in a way that involves coming to good decisions consistently.
    On the front, long view of public health, I am excited 
about the role that the mRNA played in bringing the vaccine to 
the forefront and saving millions of lives. What is the future 
of that technology for future needs in the vaccine arena, No. 
1?
    No. 2, I think about the 7,000 rare blood diseases that 
have very few therapies, treatments of any sort, and I focus a 
little bit more on CRISPR technologies for things like sickle 
cell anemia and that path going forward.
    Do you see (A), more application for CRISPR in the rare 
blood space or blood disease space, and (B), on the future 
forefront of the mRNAs and vaccines, is that future as bright 
as it appears it could be with the use of these technologies?
    Dr. Califf. Well, this is one of the things, Senator, where 
the excitement of being part of this is what keeps me going and 
coming back. I mean, I am old enough to remember when the Human 
Genome Project was just being developed, and now we have the 
code for the genome, and what you are describing are the 
downstream consequences of that with reading the code and 
producing proteins and other substances that determine whether 
we are sick or healthy. And there are a whole array of 
technologies specifically with mRNA.
    I think it as a platform for vaccines, this is something 
that we have only dreamed about, but it is a reality now. And 
this took a collaboration of FDA scientists, and of course, 
academia and the private sector all working toward a common 
goal over decades. But you also mentioned CRISPR, and the 
ability to change the fundamental genome is an amazing 
possibility, but also has significant risks.
    Like everything else, we have got to come up with the 
ideas, try out, and measure things and see what really works. 
But almost nothing could be more exciting than curing a rare 
genetic disease with a gene substitution, perhaps for life.
    I think for people with sickle cell disease, I have done a 
lot of work in NHLBI with Gary Gibbons, who is a great leader 
there. I think this is something that is really needed, and it 
ties in, chronic treatment for sickle cell disease, not going 
so well in this country because many of the patients live off 
the beaten path of the big high tech centers. And we have got 
to get treatments that are more effective.
    Senator Scott. Yes. And, Madam Chair, if you allow 30 
seconds.
    The Chair. Yes, we have several more Senators and votes 
going so.
    Senator Scott. Thank you very much. So I would just say 
that I think we should at least take a second to thank Dr. 
Francis Collins for his work on the product project that really 
has produced amazing results for our Nation and frankly for the 
world, his work--I know he is retiring or just retired. His 
work has been amazing for all of mankind, No. 1.
    No. 2, I would suggest that as we look into that future, 
the ethical issues around the new technologies like CRISPR will 
continue to pop up around the world. I know that China has had 
some challenges already with the use of CRISPR, and so what 
becomes the solution also becomes a problem. That is called 
reality. And hopefully will wrestle with those ethical issues 
in the public forum sometime in the very near future.
    The Chair. Thank you.
    Senator Baldwin.
    Senator Baldwin. Thank you, Chair Murray. I appreciated the 
chance to visit with you in advance of this hearing, and I 
wanted to raise an issue that we discussed when we met, the 
misuse of dairy terms on non-dairy products. It is an ongoing 
problem, and it is unfair to dairy farmers and processors in 
Wisconsin and across the country.
    The American Academy of Pediatrics has called attention to 
the misuse of dairy terms because of the potential of these 
improperly labeled impostors to suggest false nutritional 
equivalency to milk. I have been working on this issue for 
years, and I am very glad that the FDA has been moving forward 
toward providing the industry an updated regulatory guidance.
    Dr. Califf, if confirmed, you will have the ability to 
right this wrong, which is a product, frankly, of FDA's lack of 
action enforcing its very own rules. Will you commit to 
finalizing guidance without delay and providing a fair outcome 
that preserves the use of dairy terms for dairy products and 
that resolves this matter once and for all?
    Dr. Califf. Yes, thank you. I mean, there is almost nothing 
more fundamental about safety than people understanding exactly 
what they are ingesting, so I am committed to making this a 
priority, if I am confirmed.
    Senator Baldwin. Thank you. At the beginning of the COVID-
19 pandemic, our Nation experienced a critical shortage of 
donated blood. As one effort to alleviate the shortage, I led 
many of my colleagues in urging the FDA to update its outdated 
and discriminatory policies that unnecessarily restrict blood 
donation by gay and bisexual men. I was pleased to see the 
agency answer our call and shorten the deferral policy for men 
who have sex with men from 12 months down to 3 months.
    This is certainly a step in the right direction, but any 
policy that singles out an entire group of people rather than 
focusing on an individual's personal risk is unscientific and, 
in my opinion, wrong. We have come a long way in our ability to 
screen blood and tissue, and the science no longer supports the 
use of these restrictions. Will you commit to working with me 
to ensure that the FDA's donor policies are based on 
individualized risk and not rooted in stigma?
    Dr. Califf. Short answer is, yes. And I will just point out 
that I was an intern at University of California, San Francisco 
when the epidemic started. We didn't know what it was until 3 
years into it. And so I understand the origin of this and there 
were problems with the blood supply at the time.
    But we have come a long way with the blood supply, and I am 
fully aware that there is a study underway to look specifically 
at individual risk assessment, and I pledge to bring this home 
as quickly as we possibly can as this study results come in.
    Senator Baldwin. Thank you. I know the FDA has been working 
overtime to evaluate a large number of e-cigarette premarket 
tobacco applications. And I am encouraged that the agency has 
set a high bar for flavored e-cigarettes to be authorized for 
sale in the U.S.
    But I am concerned by reports that companies are taking 
advantage of loopholes in the law and switching from making e-
cigarettes to making flavored synthetic nicotine products. 
These products are increasingly popular, and they continue to 
be targeted to our Nation's children.
    As FDA Commissioner, how would you work to address the rise 
in youth use of synthetic nicotine? And will you commit to 
working with Congress to ensure that the FDA has the 
authorities and resources it needs to crack down on these 
addictive products?
    Dr. Califf. Yes. And first, let me just say, as Senator 
Burr pointed out, Mitch Zeller is retiring as head of the 
Center for Tobacco Products, so appointing the right person in 
that job is absolutely one of the most important roles at the 
agency. And second, this is not limited to children. I may have 
some family members using synthetic nicotine.
    I learned as I was going through the paces here, and what 
people don't realize is that there are two enantiomers of 
nicotine, one of which is not occurring in nature, that are in 
this product and its properties are not known. So we have got 
to close this loophole so that we make sure that we understand 
the risks and benefits and particularly deal with the issues in 
children.
    Senator Baldwin. Thank you.
    The Chair. Thank you.
    Senator Hickenlooper.
    Senator Hickenlooper. Thank you, Madam Chair. And Dr. 
Califf, thank you for your public service and enjoyed our 
conversation last week. I hope I wasn't too hard on you. Let me 
start with a fact that the United States and New Zealand are 
the only two countries that permit television advertising for 
pharmaceutical companies. Last year, the industry spent about 
$4.5 billion on these ads.
    I think there are a number of studies that show that the 
soft music, the glossy scenery does soften and can distort a 
consumer's ability to carefully evaluate the impact of the 
drugs. Do you think that the FDA needs to take more active role 
in ensuring that there is oversight, sufficient oversight in 
this type of advertising?
    Dr. Califf. Yes, Senator. First of all, let me just point 
out I got one Colorado taxpayer sitting behind me here and 
another payer back home in Colorado couldn't make it to the 
hearing, so we much appreciate that you are here and----
    Senator Hickenlooper. Let's forget the questions. We will 
just go to----
    [Laughter.]
    Dr. Califf. But yes, and I would go beyond that. I mean, I 
am a doc. And if you, I think if you have docs as this has been 
done, none of us like the fact that there is advertising of 
drugs, but we don't make those laws. So the FDA has to regulate 
it.
    I think we need an across the board update and a much more 
active FDA in terms of getting the right information. It is 
right there in the mission statement of the FDA to make an 
understanding of the science behind medical products and their 
use for the public. And but it is not just advertising done on 
TV, like you are used to seeing, there is a huge amount of 
information going on social media that we are going to have to 
deal with.
    As I have talked with 23 of you folks, part of the message 
is if I am confirmed, I am going to be very aggressive in this 
area of medical misinformation because one could argue that it 
is killing more people than any particular disease right now.
    Senator Hickenlooper. That is very sobering. We talked a 
little bit about global clinical trials, and we have a number 
of international partners that are doing critical work around 
the efficacy of drugs and risk versus benefit. Clearly, we 
could save money and accelerate getting to the final conclusion 
on a number of new innovations and new inventions. What can the 
FDA do to collect data from interconnected clinical trials from 
our global partners? In other words, what more could the FDA be 
doing?
    Dr. Califf. Yes, I am really excited about this. It was in 
1988 that I did my first global clinical trial. It was the 
amazing invention of the fax machine. Actually, this is before 
the internet was available. Students these days have a hard 
time actually understanding what that means that there was no 
internet. And we could enroll 40,000 people in cardiovascular 
trials in dozens of countries overnight, almost.
    We need to get back to that because fundamentally most 
people want to volunteer for research, if they can do it. And 
what we have got to do is to use digital technologies to 
interconnect people better, curate information more 
effectively.
    Much like, as I have mentioned the UK did in COVID with 
their recovery project, we should build a real of clinical 
trials very quickly that are representative of the population 
and get the answers that we need with larger populations.
    I think the FDA can lead the way, it needs to work, as we 
mentioned with Senator Romney in conjunction with CMS, and of 
course, the NIH.
    Senator Hickenlooper. Right, absolutely. We are seeing also 
a crisis now, I think and COVID is only exaggerated what 
already existed, but as you say, the misinformation that is out 
there in social media and in the regular media as well around 
not just prescription drugs per se, but around the FDA's role.
    I think there is--we discussed a number of the movie 
treatments and television episodes around obviously the opioids 
and the issues there with the Sackler family have been well 
covered, but it is a larger question of mistrust between FDA 
employees going in and working for the large pharmaceutical 
companies and back and forth. How do you go about rebuilding 
people's trust in the system?
    Dr. Califf. Well trust once lost is hard to regain. That is 
an all-time statement, and I think it is true. We are going to 
have to be much more aggressively outgoing and work on every 
single aspect of transparency that we can.
    Again, if confirmed I do think as a 70 year old person with 
nothing to gain, I think through most of my career, I have done 
a pretty good job of calling out other people when they need to 
contribute.
    I mean, a key element to me is that the medical profession 
and the nursing profession, health systems, we all need to work 
together to build trust where the evidence is solid and show 
that we should be trustworthy. It is one thing to say we will 
have a PR campaign about trust. It is different to show that 
you are trustworthy.
    If confirmed, I would really look forward to working on 
this because as I said, this may be, we have a lot of great 
medical therapies now, but if people get the wrong information 
and don't take advantage of them or take things that don't work 
or are dangerous, we have really lost the game at that point. 
Communication is absolutely critical.
    Senator Hickenlooper. I appreciate your candor. I yield 
back.
    The Chair. Thank you.
    Senator Burr, any final comments?
    Senator Burr. Thank you, Madam Chair. I think we have 
exhausted all the questions of Committee Members on my side. 
Let me take this opportunity to publicly congratulate and thank 
Francis Collins for his leadership at the National Institute of 
Health. He will be missed and can enjoy retirement. He is a 
little bit older than you, Rob--can enjoy your retirement----
    Dr. Califf. If I could, Senator, let me just say, I mean 
one of the regrets I have if I am confirmed is, I had so much 
fun working with Francis Collins. He is smart on a lot of areas 
where I know nothing and I would like to think I contributed 
something more in the clinical areas to his knowledge, so. But 
I hear he is going to be in the area still working in his lab, 
so he will still be available for consults.
    Senator Burr. Well, I am sure Francis will make himself 
available. As it relates to you, I believe you bring a unique 
skill set at a pivotal time in global innovation. You faced 
questions on many subjects today, and I think all would agree 
that you have a daunting job in front of you, if confirmed.
    Let me summarize that what we need right now is leadership, 
leadership that is transparent, leadership that is--displays of 
trustworthiness by not just people in the industry and in 
Government, but by consumers, by the American people. I think 
you are well-prepared to provide that type of leadership.
    Madam Chair, I encourage my colleagues to support the 
nomination of Rob Califf and to do that as expeditiously as we 
can.
    The Chair. Thank you very much. And as we end this hearing 
today, I do want to make clear Mifepristone has a strong track 
record of safety and effectiveness, and when it comes to 
women's health, I do expect FDA decision to be made based on 
science, just as I do all of FDA's decisions.
    Dr. Califf, I will be watching closely to make sure 
decisions are governed by the data, not by politics. And I do 
ask unanimous consent to submit for the record a study 
published in the New England Journal of Medicine on the safety 
of Mifepristone.

    [The following information can be found on page 82 in 
Additional Material:]

    The Chair. With that, I will end our hearing today. I would 
like to thank Dr. Califf for joining us and all of our 
colleagues as well. I look forward to be working with you to 
make sure FDA continues to uphold the gold standard and put 
science and data first and keep families across our Country 
healthy and safe.
    For any Senators who wish to ask additional questions, 
questions for the record will be due Wednesday, December 15th 
at 5 p.m., and the hearing record will remain open for 10 
business days until December 29th for Members who wish to 
submit additional materials for the record.
    With that, the Committee stands adjourned.

                          ADDITIONAL MATERIAL
                          
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    [Whereupon, at 12:08 p.m., the hearing was adjourned.]

                                  [all]