[Senate Hearing 118-204]
[From the U.S. Government Publishing Office]


                                                        S. Hrg. 118-204

                    NOMINATION OF MONICA BERTAGNOLLI
                     TO BE DIRECTOR OF THE NATIONAL
                          INSTITUTES OF HEALTH

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

                                HEARING

                                 OF THE

                    COMMITTEE ON HEALTH, EDUCATION,
                          LABOR, AND PENSIONS

                          UNITED STATES SENATE

                    ONE HUNDRED EIGHTEENTH CONGRESS

                             FIRST SESSION

                                   ON

 EXAMINING THE NOMINATION OF MONICA BERTAGNOLLI TO BE DIRECTOR OF THE 
                     NATIONAL INSTITUTES OF HEALTH

                               __________

                            OCTOBER 18, 2023

                               __________

 Printed for the use of the Committee on Health, Education, Labor, and 
                                Pensions
                                
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          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                 BERNIE SANDERS (I), Vermont, Chairman
PATTY MURRAY, Washington             BILL CASSIDY, M.D., Louisiana, 
ROBERT P. CASEY, JR., Pennsylvania       Ranking Member
TAMMY BALDWIN, Wisconsin             RAND PAUL, Kentucky
CHRISTOPHER S. MURPHY, Connecticut   SUSAN M. COLLINS, Maine
TIM KAINE, Virginia                  LISA MURKOWSKI, Alaska
MAGGIE HASSAN, New Hampshire         MIKE BRAUN, Indiana
TINA SMITH, Minnesota                ROGER MARSHALL, M.D., Kansas
BEN RAY LUJAN, New Mexico            MITT ROMNEY, Utah
JOHN HICKENLOOPER, Colorado          TOMMY TUBERVILLE, Alabama
ED MARKEY, Massachusetts             MARKWAYNE MULLIN, Oklahoma
                                     TED BUDD, North Carolina

                Warren Gunnels, Majority Staff Director
              Bill Dauster, Majority Deputy Staff Director
                Amanda Lincoln, Minority Staff Director
           Danielle Janowski, Minority Deputy Staff Director
                            
                            
                            C O N T E N T S

                              ----------                              

                               STATEMENTS

                      WEDNESDAY, OCTOBER 18, 2023

                                                                   Page

                           Committee Members

Sanders, Hon. Bernie, Chairman, Committee on Health, Education, 
  Labor, and Pensions, Opening statement.........................     1
Cassidy, Hon. Bill, Ranking Member, U.S. Senator from the State 
  of Louisiana, Opening statement................................     3

                                Witness

Bertagnolli, Monica, to be Director of the National Institutes of 
  Health, Bethesda, MD...........................................     7
    Prepared statement...........................................     8

                          ADDITIONAL MATERIAL

Statements, articles, publications, letters, etc.
Marshall, Hon. Roger:
    Bayh-Dole Op-Ed in The Washington Post, April 11, 2002.......    38

                        QUESTIONS FOR THE RECORD

Response by Monica Bertagnolli to questions of:
    Senator Sanders..............................................    39
    Senator Kaine................................................    40
    Senator Hickenlooper.........................................    40
    Senator Markey...............................................    41
    Senator Casey................................................    42
    Senator Lujan................................................    43
    Senator Cassidy..............................................    44
    Senator Paul.................................................    53
    Senator Collins..............................................    58
    Senator Murkowski............................................    58
    Senator Braun................................................    60
    Senator Marshall.............................................    60
    Senator Tuberville...........................................    61
    Senator Mullin...............................................    63
    Senator Budd.................................................    64

 
                    NOMINATION OF MONICA BERTAGNOLLI
                     TO BE DIRECTOR OF THE NATIONAL
                          INSTITUTES OF HEALTH

                      Wednesday, October 18, 2023

                                       U.S. Senate,
       Committee on Health, Education, Labor, and Pensions,
                                                    Washington, DC.

    The Committee met, pursuant to notice, at 10 a.m., in room 
430, Dirksen Senate Office Building, Hon. Bernard Sanders, 
Chairman of the Committee, presiding.

    Present: Senators Sanders [presiding], Murray, Casey, 
Baldwin, Kaine, Hassan, Smith, Lujan, Hickenlooper, Markey, 
Cassidy, Collins, Murkowski, Braun, Marshall, Romney, 
Tuberville, Budd, and Barrasso.

                  OPENING STATEMENT OF SENATOR SANDERS

    The Chair. All right. Let's go. Okay. Thank you all for 
being here and the Senate Committee on Health, Education, 
Labor, and Pensions will come to order. This morning, we will 
be considering the nomination of Dr. Monica Bertagnolli to 
serve as the Director of the U.S. National Institutes of 
Health.

    Let me begin by welcoming Dr. Bertagnolli to our Committee. 
We look forward to hearing from you and we thank you for being 
here today. And I see you have brought along a fellow Wyomian--
or is that what it is? We welcome Senator Barrasso as well.

    The NIH, with a budget of more than $47 billion, is the 
largest funder of medical research in the world. This research 
has led to new treatments and prescription drugs that have 
significantly improved the lives of Americans and people 
throughout the entire world, and I think all of us, every 
single American should be very proud of those accomplishments.

    But having said that, let me say a few words about my 
concerns. I don't have to tell any American that the health 
care system in our Country is broken and it is failing. We 
spend almost twice as much per capita on health care as any 
other industrialized nation, yet we have 85 million people who 
are uninsured or underinsured.

    We don't have enough doctors, nurses, dentists, mental 
health specialists. Our life expectancy is lower than other 
major countries and is actually in decline today. And very 
relevant to the hearing that we are conducting right now, we 
spend as a nation the highest prices, we pay the highest prices 
in the world for prescription drugs, in some cases 10 times 
more than the people in other nations, while the largest drug 
companies made over $112 billion in profits last year and pay 
their CEOs exorbitant compensation packages.

    One out of four Americans cannot afford to pay for the 
medicine they need, and thousands of families face financial 
ruin as they pay prices that they cannot afford for the 
prescription drugs that keep them alive.

    Think about it for one second. Millions of people get sick. 
They go to the doctor. Doctor writes out a prescription. They 
cannot afford to fill the prescription the doctors write. How 
insane is that? But it is not just the high cost of 
prescription drugs impacting individuals.

    In the largest hospital in my State of Vermont, and I don't 
think it's terribly different elsewhere, the high cost of 
prescription drugs account for 20 percent of the overall budget 
for the hospital, and that drives insurance costs up as well. 
Prescription drugs impact hospital costs big time. In other 
words, the outrageously high cost of prescription drugs in 
America is a crisis and it must be addressed.

    Adding insult to injury, not only has the Federal 
Government not effectively regulated the price of prescription 
drugs, but the taxpayers of this country have over the years 
provided hundreds of billions of dollars in research and 
development into new prescription drugs that have provided 
enormous benefits, financial benefits to some of the most 
profitable pharmaceutical companies in the country.

    For example, in America today, the median cost of new 
cancer drugs has gone up by more than 300 percent over the past 
decade, even though 85 percent of the initial foundational 
cancer research was funded by the U.S. taxpayer.

    We are putting money, rightfully so, into research to deal 
with cancer, and yet we pay outrageously high prices. In June, 
this Committee released a report that found that the average 
price of new treatments that NIH scientists helped invent over 
the past 20 years is $111,000. In virtually all cases, American 
taxpayers are paying far more than people in other countries 
for the exact same medicine that the NIH and taxpayers helped 
develop.

    Here are just a few examples from this report. Astellas and 
Pfizer charge Americans with prostate cancer over $165,000 for 
XTANDI, while the exact same drug can be purchased in Japan for 
just $20,000. This is a drug developed by American taxpayer 
dollars. Johnson and Johnson charges Americans with HIV $56,000 
for SYMTUZA, while the same exact treatment can be purchased in 
the UK for just $10,000--a product developed with U.S. tax 
dollars.

    Gilead charges Americans with non-Hodgkin's lymphoma 
$424,000 for Yescarta, or the exact same therapy can be 
purchased in Japan for just $212,000. And the list goes on, and 
on, and on. We pay for the research, drug companies develop the 
drug, they make billions, and then they charge us the highest 
prices in the world for the product. One last example.

    After receiving $12 billion from the Federal Government, 
Moderna has quadrupled the price of the COVID vaccine, a 
vaccine that was literally co-invented by NIH scientists, to 
$128, while the exact same medicine--same vaccine will be 
available in Europe for as little as $26. Really? Anybody here 
think that vaguely makes sense?

    We developed the research. We pay for it. We pay the 
highest prices of the world, how people can't afford it--
doesn't make sense to me. In my view, at this very difficult 
moment for American health care, and we are in a crisis 
situation, we need a NIH Director who is prepared to take on 
the greed of the pharmaceutical industry and use every tool at 
his or her disposal to substantially lower the outrageous cost 
of prescription drugs.

    The 1,800 well-paid lobbyists from the pharmaceutical 
industry who are all over this place may not be happy about 
that thought, but that is precisely what the American people 
want. The status quo is not working. We need fundamental 
changes in the way that the NIH addresses the crisis of 
prescription drugs.

    We need NIH directors prepared to reinstate and expand the 
reasonable pricing clause, make sure the pharmaceutical 
companies set reasonable prices for new prescription drugs 
developed with taxpayers, etcetera, etcetera. The whole lot of 
things the NIH can do. Now, is the NIH alone going to solve the 
problem?

    Of course not. Other agencies, the Administration has got 
to be active as well. You know, the media describes what goes 
on in Congress as we are a very divided nation. Well, we are. 
But I will tell you this, whether you are a Conservative 
Republican, a Progressive, a Democrat, or an Independent, you 
know what we all agree on?

    Every poll tells us that. And that is they want--the 
American people want Congress to deal with the outrageously 
high cost of prescription drugs. That is what we have got to 
do. Senator Cassidy, you are recognized for your opening 
remarks.

                  OPENING STATEMENT OF SENATOR CASSIDY

    Senator Cassidy. Thank you, Chair Sanders. Today, the 
Committee considers the nomination of Dr. Monica Bertagnolli to 
be the next Director of the National Institute of Health. And 
Dr. Bertagnolli, thanks for being here.

    Thanks for taking on this job and going through this 
Committee, which I know must be stressful, but again, very 
pleased to have you. You have an incredibly impressive resume, 
and I say that as a physician who formerly was in academics but 
has no resume that compares with yours and is reflected by the 
support that you have from the scientific community.

    There is no questions regarding scientific qualifications, 
but there are people that will ask questions regarding your 
overall ability to lead the NIH in the next phase, and this is 
what my remaining remarks will be about.

    Everybody knows the NIH's role in strengthening America's 
biomedical research and supporting public health, especially 
during a crisis. Unfortunately, it became a lightning rod for 
partisan debates during the COVID-19 pandemic, and that eroded 
the trust between the NIH and the public.

    First and foremost, you will be tasked to rebuild the 
relationship with Congress and the public, being a leader that 
represents the interests of all Americans and not just of the 
scientific community.

    This means making the agency more transparent and 
accountable to Congress while also advancing cutting edge 
science, effectively communicating to the American people, and 
rebuilding trust between public health officials and the 
biomedical research community.

    The NIH Director must also protect and strengthen the 
valuable public, private partnerships that make up our 
biomedical research enterprise. And sometimes our public, 
private partnership was underestimated, but clearly, the 
private and the public partnership has been what has made the 
United States a leader in innovative drugs.

    Last month, I issued a request for information from 
stakeholders on modernizing the NIH, and this will include buy 
in from all. I look forward to hearing from you about your 
vision for the agency and how you shall achieve. Now, during 
our meeting, we spoke about bioethical issues, including fetal 
tissue and embryonic stem cell research, and the use of 
hormones and other gender transition interventions on children.

    Frankly, at times you avoided getting into specifics, 
citing a lack of expertise. But as the Director, you will have 
to have this expertise. You will need to be prepared to weigh 
in on topics that are not in your research specialty, but 
across the entire enterprise, making the policy decisions that 
will shape the direction of biomedical research.

    While you will consult with experts and take input from 
your institute directors, you are ultimately the person who 
decides. I point out that this hearing is apparently happening 
today, it was not going to otherwise, because of a publicly 
acknowledged deal the Biden administration cut with Chair 
Sanders to implement partisan drug pricing policies in exchange 
for advancing your nomination.

    Biden administration officials told us in a hearing earlier 
this year that policies similar to those in the deal that have 
been reported could risk future partnerships between the 
Government and the private sector. By the way, future 
partnerships critical to generating the cures important for 
cancer and Alzheimer's and for the next pandemic.

    The partnerships that are the foundation of the U.S. 
biomedical research enterprise, which, by the way, leads the 
world in developing these cures. It is concerning that the 
Administration would jeopardize the long term success of this 
enterprise for the short term goal of advancing your 
nomination.

    Last week, I asked President Biden and Secretary Becerra 
for a full accounting of any deals cut with Members of Congress 
relative to advancing your nomination. At 5.43 p.m. last 
night--this is kind of the problem. At 5.43 p.m. last night, I 
received basically a form letter that provided no information 
and intentionally ignored the request it was supposedly 
responding to. The Administration was not forthcoming about any 
deals with Members of Congress, even though some of those 
details have been reported in the press.

    Now, Senators expected to vote in your confirmation should 
be aware of any such deal prior to the nomination. That is not 
you, it is the process. And we speak about the breakdown of 
trust is like rhetoric, inflammatory rhetoric, which is true, 
true, true, but not related, is driving a process by the 
Administration on something that we should know about, but we 
are not being told.

    Another example, in June, Senator Tuberville and I sent the 
Acting NIH Director a letter about NIH funded projects that 
resulted in the death of two adolescents. We didn't get a 
response to that letter till September 15th, a week after the 
Biden administration struck the deal to move your nomination. I 
believe you when you say that you are committed to transparency 
and rebuilding the NIH's relationship with Congress.

    I appreciate that commitment, but I have concerns given the 
Administration's history of failing to respond to congressional 
oversight requests, particularly from Members of this Committee 
who are responsible for that oversight.

    Rebuilding NIH's relationship with Congress will require a 
strong Director who can overcome partisan divisions, overcome 
the Administration's deliberate stonewalling of requests from 
Members of this Committee for that information pertinent to the 
work of this Committee, and work with both Republicans and 
Democrats to improve trust in our Federal health institutions.

    That means being open and responsive to this Committee, 
which will directly oversee your work as NIH Director, if you 
are confirmed. I look forward to hearing how you shall fulfill 
these parts of the job and move the NIH forward. I thank you, 
and with that, I yield.

    The Chair. Thank you, Senator Cassidy. And now, I would 
like to welcome our nominee, Dr. Monica Bertagnolli has served 
as the Director of the National Cancer Institute since October 
2022.

    Prior to that role, Dr. Bertagnolli was a surgeon at 
Brigham and Women's Hospital and the Richard E. Wilson 
Professor of Surgery of the Field of Surgical Oncology at 
Harvard Medical School. Dr. Bertagnolli is a longtime member of 
the American Society of Clinical Oncology, where she has served 
as both President and a member of the Board of Directors.

    I thank her for being here today, and I now turn it over to 
Senator John Barrasso to introduce her.

    Senator Barrasso. Well, thanks so much, Mr. Chairman. And I 
am pleased to welcome to the Senate and to the Committee Dr. 
Monica Bertagnolli, who is a fellow physician and a Wyoming 
native.

    President Biden has nominated her to be the Director of the 
National Institutes of Health, and it is certainly not every 
day that one of Wyoming's very own is nominated for such a high 
position in our Nation. Dr. Bertagnolli has devoted her entire 
life to medicine and medical research.

    She earned a Bachelor's degree in Engineering from 
Princeton University, graduated from the University of Utah's 
Medical School, and completed her surgical residency training 
at Brigham and Women's Hospital in Boston.

    She then went on to be a research fellow in tumor 
immunology at the Dana-Farber Cancer Institute in Boston, and 
she later served as the Chief of Surgical Oncology for over a 
decade. She has continued caring for patients at Brigham and 
Women's Hospital while being a renowned cancer researcher.

    She has also served as a Professor in Surgical Oncology at 
Harvard Medical School. She has trained not only the next 
generation of doctors, but also cancer researchers. And this 
makes her a perfect fit to serve as our current Director of the 
National Cancer Institute.

    While many may know that she is a well-respected physician 
and researcher that she is, Wyoming knows her as part of a 
multi-generation ranching family, and I am proud to say that 
she has never forgotten where she came from.

    As I have traveled and met with folks across Wyoming, in 
the Mountain West, I have heard of her great work, not only as 
a doctor, but also on the ranch. So that includes the ranch 
neighbors. If you want to know about somebody, you talk to 
their neighbors and their ranching neighbors.

    They speak of her grit, her endurance, and her 
determination. Her commitment to the land and the livestock 
speaks volumes about her character and her courage. She 
understands the needs of rural health and of frontier medicine.

    She has used her background, medical as well as the values 
that she learned growing up, to improve health care for all 
Americans. She serves as an adviser to the Huntsman Cancer 
Institute in Salt Lake City, Utah, which is a designated cancer 
institute for Wyoming.

    She also advised Huntsman on how to reach patients in rural 
areas. She focused on reducing burdens on patients by using 
local cancer treatment clinics. One is in the Sweetwater 
Regional Cancer Center in her hometown of Rock Springs, 
Wyoming. Her firsthand experience in accessing health care in 
rural America gives her a perspective that is often lacking in 
Washington.

    She has an extensive track record of cultivating private, 
public partnerships to push medical innovation forward. I know 
this background will serve her well as the Director of the 
National Institutes of Health. I have tremendous appreciation 
and admiration and respect for Dr. Bertagnolli.

    With that being said, Mr. Chairman, I do have serious 
concerns about the way this Administration has handled the 
COVID pandemic, has politicized Government agencies such as the 
NIH, has attacked health innovation through the Inflation 
Reduction Act.

    I think it is important that this position be filled with 
someone with a critical and an open mind, ready to tackle the 
important challenges ahead. And for all these reasons, Mr. 
Chairman, I support the nomination of Dr. Monica Bertagnolli to 
serve as the Director of the National Institutes of Health.

    Thank you, Mr. Chairman.

    The Chair. Thank you, Senator Barrasso.

    Senator Cassidy. Mr. Chairman, can I ask a quick question. 
Do you have to be Italian to be from Wyoming? You know what I 
am saying? I am just thinking that.

    [Laughter.]

    Senator Barrasso. Well, in a bipartisan way----

    [Technical problems.]

    Senator Barrasso. Well, Mike Enzi, Republican. There was a 
former Congressman, Tito Ron Calio, who is also from Rock 
Springs, Wyoming. So, it helps.

    [Laughter.]

    The Chair. Okay. With that introduction, Dr. Bertagnolli, 
the stage is yours, please. Welcome. Turn the mic on, please.

STATEMENT OF MONICA BERTAGNOLLI TO BE DIRECTOR OF THE NATIONAL 
               INSTITUTES OF HEALTH, BETHESDA, MD

    Dr. Bertagnolli. There we go. Chairman Sanders, Ranking 
Member Cassidy, and Members of the Committee, thank you for 
considering my nomination to be Director of the National 
Institutes of Health. It is an honor to appear before you today 
to share my vision for the NIH.

    I want to thank President Biden for trusting me with this 
nomination, and Senator Barrasso for the very kind 
introduction. I also want to thank my husband, Alex, and my two 
children for their unwavering support and unqualified love. I 
grew up on a ranch in Southwestern Wyoming.

    My early inspiration was my uncle. He was a primary care 
physician whose practice included traveling across the entire 
state, it is a big state, to provide expert care to veterans, 
and it was his devotion to his patients that inspired me to 
pursue medicine. Like millions of Americans, when my father had 
cancer, the care he needed was hundreds of miles away.

    I have seen firsthand what it means to deliver care to 
those living in rural communities. I have spent my entire 
professional life working to improve cancer prevention and 
treatment. I have done this as a surgical oncologist, 
researcher, as a professor of surgery helping to train the next 
generation of doctors and scientists.

    As a physician scientist, I have run major clinical trials, 
helped to advance innovative research, and pushed hospitals and 
institutions to make sure that the most effective treatments 
are available to all patients.

    For the past year, I have had the tremendous privilege of 
serving as the Director of the National Cancer Institute and 
working toward the President's Cancer Moonshot goal to end 
cancer as we know it. My experience has given me great 
appreciation for the inner workings of NIH and for what more is 
possible.

    Recently, though, I found myself in a different position, 
as a patient when I was diagnosed with breast cancer. I was 
fortunate to have my cancer diagnosed very early. I have 
completed my treatment. My prognosis is excellent. I also had 
access to outstanding care, knowing full well that not every 
patient has that same chance.

    Most importantly, every treatment I received was supported 
by NIH funded research. I am grateful beyond words to the 
patients who joined the clinical trials before me, the doctors, 
and researchers who were able to use that information to make 
the best decisions. There is so much that excites me about the 
possibility of leading the extraordinary team at NIH, if 
confirmed.

    First, there has never been more potential for progress 
than what we have today. We just need to harness it. NIH can 
and must support research that is equitable and accessible to 
all populations, and this includes dramatically increasing 
clinical trials that reflect the full diversity of Americans, 
because we know that is what yields the best results. We should 
capitalize on new innovations in uncovering fundamental 
biology, in health information technology, and in exciting new 
data analytics.

    We must interrogate the broad range of behavioral and 
social science challenges we face today, while laying the 
foundation to address new issues that will arise in the future. 
Second, we have an unprecedented opportunity to embrace and 
increase access to innovation.

    As a physician researcher for more than 30 years, I have 
seen the transformative power of NIH research to produce 
results that save lives. But I have also seen the patients 
whose prospects were compromised by preventable factors.

    We should be able to guarantee that the American people are 
getting a return on their investment by ensuring that health 
care innovations are available and affordable for everyone. 
Finally, we must restore faith and trust in our Nation's top 
scientists.

    I am committed to ensuring that NIH continues to be the 
steward of our Nation's medical research and a force of 
innovation and discovery. But we must also continue to support 
education in all fields of biomedical research and to inspire 
young people to become doctors and scientists so that our 
critically important work will continue for generations. None 
of this NIH can do alone.

    I look forward to partnering with Congress and many others 
to advance discovery and apply the results of our research to 
better the lives of every American. Again, I want to thank you 
for the opportunity to appear before you today, and I look 
forward to your questions.

    [The prepared statement of Dr. Bertagnolli follows.]
                prepared statement of monica bertagnolli
    Chairman Sanders, Ranking Member Cassidy, and Members of the 
Committee, thank you for considering my nomination to be Director of 
the National Institutes of Health (NIH). It's an honor to appear before 
you to share my vision for the NIH.

    I want to thank President Biden for trusting me with this 
nomination and Senator Barrasso for the kind introduction. I also want 
to thank my husband, Alex, and my two children for their unwavering 
support and unqualified love.

    I grew up on a ranch in southwestern Wyoming. My early inspiration 
was my uncle, a primary care physician whose practice included 
traveling across the state to provide expert care to veterans--and it 
was his devotion to his patients that inspired me to pursue medicine. 
Like millions of Americans, when my father had cancer, the care he 
needed was hundreds of miles away, and prohibitively expensive, so I 
have seen firsthand what it means to deliver care to those living in 
rural communities.

    I have spent my entire professional life working to improve cancer 
prevention and treatment. I have done this as a surgical oncologist, 
researcher, and as a professor of surgery helping train the next 
generation of doctors and scientists. As a physician-scientist, I have 
run major clinical trials, helped to advance innovative research, and 
pushed hospitals and institutions to make sure the most effective 
treatments were available to all patients.

    For the past year I have had the tremendous privilege of serving as 
the director of the National Cancer Institute and working toward the 
President's Cancer Moonshot goal to end cancer as we know it. My 
experience has given me new appreciation for the innerworkings of NIH, 
and what more is possible.

    More recently though, I found myself in a different position: as a 
patient, when I was diagnosed with breast cancer. My prognosis is very 
favorable. I was fortunate to have my cancer detected early. I also had 
access to excellent care, knowing full well that not every patient has 
that same chance. Most importantly, every treatment I have received was 
supported by NIH-funded research. I am grateful beyond words to the 
patients who joined clinical trials before me and the doctors and 
researchers who were able to use that information to make the best 
decisions.

    My fidelity to ensuring that high-quality, affordable care is 
available to everyone is informed by my own life experiences. If 
confirmed, I will work every day to enhance health, lengthen life, and 
reduce illness for all Americans--and in so doing, fulfill the mission 
of the NIH.

    There is so much that excites me about the possibility of leading 
the extraordinary team at NIH.

    First, there has never been more potential for progress than we 
have today--we just need to harness it. NIH can and must support 
research that is equitable and accessible to all populations regardless 
of income or zip code--that includes dramatically increasing clinical 
trials that reflect the diversity of Americans because we know that's 
what yields the best results. We should also improve the experience of 
people and communities whose health depends on the knowledge that 
cutting-edge research brings. We should capitalize on new innovations 
in uncovering fundamental biology, in health information technology, 
and in exciting new data analytics. And we must interrogate the broad 
range of behavioral and social science challenges we face today while 
laying the foundation to address new issues in the future.

    Second, we have an unprecedented opportunity to embrace and 
increase access to innovation. As a physician-researcher for more than 
30 years, I have seen the transformative power of research to produce 
results that save lives, but I've also seen the patients whose 
prospects were compromised by preventable factors. As we work to bring 
innovation to patients, we must ensure that we deploy NIH's research 
further, and wider, and that we deliver results that work for everyone. 
Throughout all this, we should be able to guarantee that the American 
people are getting a return on their investment by ensuring healthcare 
innovations are available and affordable for everyone.

    Finally, we must restore faith and trust in our Nation's top 
scientists. NIH is the steward of our Nation's medical research, and I 
am committed to ensuring that NIH continues to be a force of innovation 
and discovery. To do that, we need to make science accessible to all 
communities and inspire young people to become doctors and scientists, 
to continue this critically important work for generations.

    None of this NIH can do alone. I look forward to partnering with 
Congress, and many others, to bring research into every community and 
apply the results to better the lives of every American.

    Again, I want to thank you for the opportunity to appear before you 
today. I look forward to your questions.
                                 ______
                                 
    The Chair. Dr. Bertagnolli, thank you so much for being 
with us. Let me begin the questioning by picking up on a point 
you just made, and you put in your written remarks as well. You 
said, and I quote--and it goes without saying that everybody 
here wishes you the very best in your struggle with breast 
cancer.

    Dr. Bertagnolli. Thank you.

    The Chair. You said, and I quote, ``every treatment I have 
received was supported by NIH funded research,'' correct?

    Dr. Bertagnolli. Correct.

    The Chair. Can you give us some idea, based on your 
expertise, about how much treatment for breast cancer costs in 
this country today? Somebody has breast cancer over a period of 
years, how much is it going to cost?

    Dr. Bertagnolli. Chairman Sanders, that is a widely 
variable result. I truly could not give you an estimate because 
breast cancer is incredibly complicated and can range anything 
from a simple surgery to years and years and years of very 
extensive----

    The Chair. Would I be wrong in saying that for some 
individuals, it will cost hundreds of thousands of dollars for 
treatment?

    Dr. Bertagnolli. I believe that is correct.

    The Chair. What do you say, as a physician yourself, to 
somebody who was undergoing treatment for a drug or treatment 
that was developed by taxpayer dollars that they can't afford 
or are going to go deeply in debt to pay for?

    What does one say to a person to say thank you for your tax 
dollars developing the drug, but I am sorry you can't afford 
the treatment you need to save your life. How does one respond 
to that person?

    Dr. Bertagnolli. Yes. Chairman Sanders, I have to tell you 
that I have sat in a clinic next to patients of my own who, for 
one reason or another, could not afford their treatment. It is 
a tragedy.

    I sincerely appreciate you championing the cause of 
affordable and accessible care for all Americans. And if 
confirmed, I will work with you to the fullest extent of my 
abilities to also ensure that is the case.

    The Chair. Well, thank you for your thoughts. Let me be 
rather specific. If you are confirmed to be the next NIH 
Director, will you commit to reinstating and expanding the 
reasonable pricing clause in NIH contracts?

    In other words, if the Federal Government puts money into 
the research and development of a drug, will you insist that 
the price that drug is charged in America is not higher than it 
is charged in other countries around the world given the fact 
that we paid for the research and development?

    Dr. Bertagnolli. Chairman Sanders, I can say that I myself 
believe that the American people deserve a fair return on the 
investment that Congress has placed within the National 
Institutes of Health and the research that we do.

    I will commit to working to make sure that the benefits of 
our research are affordable and available to all the American 
people. I cannot give further specifics at this time about the 
execution of that plan.

    The Chair. You are not prepared to tell us that when 
taxpayers spend billions on a drug, they will not be asked to 
pay the highest prices in the world for what they paid for?

    Dr. Bertagnolli. Chairman Sanders, I am more than prepared 
to say that I will do whatever I am able to bring--make sure 
that affordable and accessible care is available for everyone 
who needs it.

    The Chair. Doctor, Astellas and Pfizer are charging 
Americans with prostate cancer over $165,000 for XTANDI, while 
the exact same drug can be purchased in Japan for just $20,000. 
$165,000, $20,000 in Japan.

    This is a drug that was developed by NIH funded scientists 
at UCLA. Do you think the price of XTANDI is reasonable? Should 
we be paying eight times more for a drug that taxpayer dollars 
developed than the people in Japan?

    Dr. Bertagnolli. Chairman Sanders, my focus is on making 
sure that the American people have access, and availability, 
and can afford the health care that can save lives, and that is 
what I will make a commitment to.

    The Chair. Right now, we pay by far the highest prices in 
the world for prescription drugs. The results are higher 
insurance premiums, higher hospital costs, then millions of 
people not able to get the drugs they desperately need.

    Will you commit to us that you will work to make sure that 
Americans do not pay higher prices for prescription drugs in 
this country than people around the world?

    Dr. Bertagnolli. Chairman Sanders, it would be a great 
honor to be able to work with you to make sure that the 
American people have access to the care that they need to live 
long and healthy lives.

    The Chair. Okay. My time is up.

    Senator Cassidy.

    Senator Cassidy. I defer to Senator Collins.

    Senator Collins. Thank you very much, Senator Cassidy. 
Welcome, doctor. The National Cancer Institute that you 
currently lead has the largest budget and research program of 
the 27 institutes and centers at the NIH.

    Cancer research is vitally important, and I strongly 
support it. I am interested in how you will balance NI--NCI 
priorities while making any NIH wide budget decisions. For 
example, President Biden's budget request proposes a 
substantial increase for the NCI, but it flat funds research 
for Alzheimer's disease and diabetes, which collectively affect 
more than 40 million Americans.

    If confirmed, how will you balance your background in 
cancer research and your leadership at NCI with the need to be 
fair in evaluating agency wide priorities?

    Dr. Bertagnolli. I will thank you for that question, 
Senator Collins. And I will say that, first of all, if 
confirmed, my commitment as NIH Director is to the health and 
vitality of every single American.

    But I can give you some specifics to address your specific 
question. How does a cancer surgeon really lead an organization 
that deals with the huge spectrum of conditions that the 
American people face? I have two answers to that.

    First, as a cancer doctor, I took care of patients of all 
ages, all walks of life, all different health states. I am very 
familiar to working with colleagues in cardiology, in mental 
health, in opioid use disorder, in kidney disease to take care 
of my patients with cancer.

    I feel very comfortable engaging with the broadest possible 
team of researchers focused on bringing health to people. But 
second, one of the things that to me is the most exciting about 
the opportunity to lead the organization is the fact that so 
many of the diseases that we are working on, individual 
diseases in our relative silos, really have many common 
elements.

    The need to access--to have care access to every community, 
but even down to the biology. So, what I want to--my field of 
research was in inflammation and how inflammation causes 
cancer. Well, guess what? Inflammation is one of the major 
inciting factors behind Alzheimer's disease, behind autoimmune 
disease, behind long COVID, behind arthritis. So many things.

    Both on a scientific level and on the taking care of human 
beings level, I am really excited for this opportunity to lead 
NIH.

    Senator Collins. As you know from our discussion in my 
office, I would like to see NIH fund more projects and more 
research looking at the role of inflammation in Alzheimer's 
disease, for example, instead of just funding amyloid plaque, 
important though that is, research. We have had that 
discussion.

    My time is growing short, so let me switch to diabetes. 
Along with Senator Murray and Senator Shaheen, I had the honor 
of co-hosting again this year at the JDRF Children's Congress 
this summer, and the NIDDK Director, Dr. Griffin Rogers said 
that with continued research, it is possible to imagine that 
people could lead a life free of the burden of type 1 diabetes 
and its complications, which is very exciting.

    We have, as you know, a special diabetes program that is up 
for renewal, and this Committee has overwhelmingly approved its 
reauthorization. I want to make certain that you understand 
that program is intended to supplement and not supplant the 
regular appropriations. Part of the program goes for type 1 
diabetes.

    Part of that program goes for type 2 diabetes, with a 
special focus on Native Americans and Alaskan Americans. So, I 
would like to hear your reassurance that you do understand that 
is additional funding.

    Dr. Bertagnolli. Oh, thank you, Senator. I will just say 
that the researchers and team at the NIH are deeply grateful 
for the resources we get from Congress that allow us to serve 
people and embrace with the greatest enthusiasm particular 
communities and efforts that focus on serving people. So, thank 
you.

    Senator Collins. Thank you.

    The Chair. Senator Murray.

    Senator Murray. Thank you very much. Welcome, Dr. 
Bertagnolli. Really nice to see you. And thank you so much for 
your willingness to take on this position at a really critical 
time, because, as you know, NIH has an absolutely critical 
mission supporting medical research and making groundbreaking 
discoveries that really help everyone stay healthy and keep our 
Nation competitive and give patients hope for the future.

    Really appreciate your being here and your willingness to 
go through this process and lead this agency. The agency also 
does really critical work, in coordination with a lot of other 
agencies, to protect public health and prepare for--our Nation 
for pandemics and a lot more.

    Again, thank you. Let me start by asking you, I know at the 
National Cancer Institute you have done a lot to address cancer 
related disparities for women. So, in that vein, I wanted to 
ask you today, across NIH programs and initiatives, do you plan 
to strengthen research to specifically improve women's health 
inequities, including women's midlife health--outcomes?

    Dr. Bertagnolli. Thank you for that question, Senator. It 
is very clear that there are many health issues in women that 
are understudied, that really lack knowledge and deserve to 
have spotlight shine on them and renewed efforts to be able to 
provide data to support women's health.

    I can give you a couple of examples that are really top of 
mind for me. We have a maternal health, I think it is fair to 
say, crisis. We had 750 women die either during childbirth or 
for 1 year after childbirth in 2019. In 2021, it was 1,200. 
Why? We have to understand that.

    That is like--that is kind of an immediate need that rises 
to the top. But there are many other things. The whole life 
cycle of women's health, from childhood all the way through 
senior adulthood.

    That we know women are different. They react to diseases 
different. And we know that we lack the data to know how to 
best care for them. So, you raise a commitment that--something 
I can easily commit to and say it is very important to me.

    Senator Murray. Good. Thank you. And I am working with a 
number of other women Senators on some midlife health outcomes, 
so I will follow-up with you on that. I think that is really 
critical that we look at as well.

    But let me focus on something you just said, and that is 
the maternal health crisis. That is something I spent a lot of 
time on. It is a huge issue facing women, as you just 
mentioned, especially since the Dobbs decision.

    I wanted to ask you, what can NIH do to improve maternal 
health outcomes, specifically talk about that for especially 
Black and Native American women who face some of the highest 
mortality, maternal mortality rates in our Nation? Can you talk 
a little bit more about that?

    Dr. Bertagnolli. Yes, thank you very much. So, I think this 
raises the issue--it is a twofold issue. It is an issue of 
understanding how to care for women during the time of 
childbirth and immediately afterwards make sure that their 
health is optimal. But it also raises an issue of disparities 
in access to care and in engaging with people as physicians and 
caregivers, being able to listen to them, to understand them 
and to relate to them.

    I think that the maternal health crisis raises not only 
important biological and medical care issues, it raises really 
important social issues. We need to understand people and their 
social makeup if we are going to help them best.

    Senator Murray. Okay, great. And we will work with 
following you up on that as well. But let me ask you about the 
fentanyl crisis and the opioid epidemic. Communities are 
really, as you know, hit hard by that.

    The Lummi nation lost five members of their tribe to 
fentanyl overdoses in just one week. And King County has seen a 
record number of fentanyl overdose deaths this year. So, I 
wanted to ask you, if confirmed, how will you work to support 
research that addresses inequities in access to quality mental 
health care and treatment for substance use disorders through 
NIH programs and support those underserved communities that are 
really harmed by the national mental health crisis and the 
rising rate of opioid overdose deaths?

    Dr. Bertagnolli. Yes. Thank you very much for your 
championing this issue. I myself have lost patients to the 
opioid crisis, so I have seen what it does. Absolutely 
devastating tragedy for our communities.

    It has increased so much over the last years, and 
disproportionately affects certain communities, although really 
has spread across the entire spectrum of our Nation. I can 
commit to working with you and on continuing the great 
awareness that the NIDA has for understanding this issue deeply 
in ways that bring solutions to the people who need it.

    Like many things, it has to do with not only medical care 
and understanding better treatment, it deeply has to do with 
getting that treatment to the people who need it.

    Senator Murray. Thank you. Thank you very much, Mr. 
Chairman.

    The Chair. Thank you.

    Senator Cassidy.

    Senator Cassidy. I defer to Senator Tuberville.

    Senator Tuberville. Thank you, Senator. Doctor, thanks for 
being here. Congratulations on your nomination. Before I start, 
I would like to say something about your nomination. It is 
really nothing against you.

    I would like to take the opportunity to draw a comparison 
between this nomination and other nominations pending in the 
Senate, ones that I am holding from passing by unanimous 
consent. Your predecessor, Dr. Collins, was approved by 
unanimous consent in 2009, only 4 weeks after being nominated.

    The HELP Committee did not even hold a regular hearing like 
this. You have faced a much different confirmation process. 
Your nomination was held up by Chairman Sanders, which is his 
prerogative.

    We have no--we have had no confirmed NIH Director for 21 
months. Back in June, Chairman Sanders publicly vowed to oppose 
your nomination until he received the Administration's 
comprehensive plan on lowering drug prices, which we all know 
that is what he is about, and a lot of us are about.

    As I recall, he promised to hold up not only your 
nomination, but all HELP related nominations going through the 
HELP Committee. As a Senator, he has a right to do that. He 
wanted a policy concession from the Biden administration, and 
apparently he got one. I was one of the many who want us to 
have a confirmed NIH Director.

    A lot of people have wanted us to have a confirmed 
Director. It is not unusual, but I don't remember any Democrats 
saying the sky was falling because we didn't have a confirmed 
NIH Director, because this is a very important position. I 
don't remember Democrats calling the Chairman names or even 
threatening him.

    I don't remember anybody wanting to change the rules of the 
Senate because of it. I didn't really say a word about it. If 
it weren't for hypocrisy around this place, I don't think we 
could have anything to do. Chairman Sanders got what he wanted.

    On September 8th, Chairman Sanders announced at the White 
House met his demands and he announced this hearing. Chairman 
Sanders used his prerogative as a Senator. I don't have all the 
details of the concessions the Biden administration made 
Chairman Sanders, but I respect his rights as a Senator. 
Frankly, I appreciate Chairman Sanders' defense of the 
Legislative Branch.

    We ought to legislate around here. That is what we were 
sent here to do. We weren't elected to just outsource our jobs 
to Joe Biden or any other President. Mr. Chairman and I don't 
agree on everything, but at least he is standing up for what he 
believes in and the power of the Senate.

    I will get off my horse now and ask you a question. This 
very,--being an educator, this really touches me here. The NIH 
funded a recent study about the psychosocial functioning in 
transgender youth after 2 years of hormones.

    According to the letter NIH sent to Ranking Member Cassidy 
and me, the research seeks to understand the physical and 
psychosocial effects of medical intervention to evaluate the 
effectiveness of existing medical treatments already in use 
among transgender youth.

    As you know, two young people committed suicide who were 
part of the study. That is obviously a tragedy. But what 
concerns me even more is the fact that the NIH was funding this 
research. And beyond that, I believe the NIH even called the 
study a success.

    That is sick. It sounds to me like the NIH totally dropped 
the ball on quality control and oversight. So, if confirmed, 
how would you make sure nothing like that ever happens on your 
watch?

    Dr. Bertagnolli. First, Senator, I really thank you for 
your affirmation of the critical importance of NIH and what we 
are--and that we are here to serve the American people, and 
just how critical that is and how important this job is.

    To that end, in response to your question, we have the 
greatest responsibility to ensure two things. First, that we 
serve all people, all people, all walks of life, and that we 
really are here to achieve the health of all.

    But that No. 2, any research that we do that involves human 
beings, people, is conducted according to the highest ethical 
principles so that we make sure that the research is intending 
to do no harm, to achieve benefits, and is done in ways that 
have maximum respect for the dignity of people.

    If confirmed as NIH Director, I will affirm to you that 
will be my mode of action and my highest priority for all human 
research.

    Senator Tuberville. Thank you. One more quick question, 
Chairman. The NIH used to be universally respected, 
nonpolitical organization before COVID, but that trust has been 
broken, especially in rural parts like my State of Alabama.

    You are from a rural Wyoming, so you get the real 
perspective, and you understand just how much people in those 
parts of the country in particular have lost confidence in our 
public health institutions. They feel totally overlooked. What 
would you do as NIH Director to help gain back some of that 
respect in rural areas?

    Dr. Bertagnolli. Thank you so much for that question, and I 
will be very, very brief. Two things. No. 1, I believe deeply 
in the doctor, patient relationship. That is incredible value. 
That is trust.

    A patient comes and puts their life in the hands--and their 
health in the hands of their doctors. And anything that we can 
do to strengthen the doctor, patient relationship is something 
that we should pursue to the fullest extent possible.

    Then second, I believe in education at all levels, being 
very--and relating--our patients joining us in research to the 
fullest extent possible. Not science here and people here, but 
people joining us to do science. I think that also engenders 
great trust in the process if it is done in a respectful and 
appropriate way.

    The Chair. Thank you.

    Senator Kaine.

    Senator Kaine. Thank you, Chair Sanders. And 
congratulations, Dr. Bertagnolli. I am happy to support your 
nomination. Every time a representative of the NIH comes before 
us, I asked for an update on the Recovery Initiative.

    Congress provided NIH with $1.15 billion in funding to 
advance understanding, prevention, and treatment of the long 
term effects of COVID, including long COVID. And this is a 
topic very important to me because I live with a mild form of 
long COVID.

    Because I have been public about that, I hear from people 
every day. In this body, I have colleagues, a former Senator or 
colleague, former colleague, Senator Inhofe, Senator Young have 
talked about long COVID experiences.

    My wife went to a lawyer last week with a friend of ours to 
help her file for bankruptcy because her treatments for long 
COVID that knocked out her balance now leave her in a situation 
where if she doesn't file for bankruptcy, she could lose her 
home.

    I was at an event Monday and a technology CEO came up and 
talked to me about his wife's experience with acceleration and 
deceleration of her heart rate, which is fairly common long 
COVID symptom.

    About 5.3 percent of Americans now have long COVID, and of 
those--that group, 80 percent suggest that their long COVID 
significantly limits life activities. Americans depend on 
research coming out of NIH to help understand how to treat, 
cure, prevent symptoms that are often debilitating.

    It frustrates and saddens me to hear how many long COVID 
folks who are dealing with it have both had a negative impact 
on their life, but often face skepticism and disbelief as they 
describe their symptoms to employers and others.

    I am also frustrated when I hear long COVID sufferers 
indicate that NIH isn't doing enough on the issue and that 
their voices aren't being heard. Let me tell you what patient 
advocates tell me.

    That NIH isn't considering the input of those living with 
long COVID in the design and enrollment of long COVID clinical 
trials. That NIH is not as responsive as it should be to 
advocate outreach. That with Recover being spread across 
multiple institutes, there is a lack of clear leadership, and 
the initiative lacks kind of a point person that is held 
responsible for decision-making.

    There is a lack of transparency in the budget and future 
plans for the initiative. Dr. Bertagnolli, I know your work in 
the cancer institutes has not put you directly into this space, 
and so your knowledge of the inner workings of the Recovery 
Initiative are limited at this time.

    But should you be confirmed as Director, I ask that you 
continue to work with me to address the concerns of those 
living with long COVID, including that you commit to meeting 
with patient advocates to discuss these issues.

    Dr. Bertagnolli. Senator Kaine, thank you very much for 
that question. And I can absolutely confirm that I will work 
with you on this issue. I think this is one of the greatest 
tragedies we have recently seen.

    I will tell you one thing that is something I live by in my 
research, I love the expression, nothing about us without us. 
This comes from the people with lived experience community. We 
call them the patient advocates.

    I love that expression because it really is the way we need 
to do our science. Not only are we then serving them because we 
are listening to them, but all the other issues of trust and 
accountability and respect for the people we serve happen when 
you do that. So you have hit something that goes to my core, 
and I would be delighted to work with you.

    Senator Kaine. Thank you. Thank you very much. Next topic I 
want to ask you about is pediatric cancer research.

    Along with Senator Moran and 13 other bipartisan Members of 
this body--of this Committee and the full body, we introduced a 
bill called the Gabriella Miller Kids First Research Act 2.0 to 
reauthorize a program that is aimed at combating childhood 
cancer.

    The legislation is the result of continuing efforts by the 
Miller family to fight childhood cancer. And their revelation 
to me 10 years ago that of the NIH research budget, only a 
very, very tiny percent, less than 1 percent was devoted to 
pediatric research in the cancer space. I am pleased to say 
that the bill was voted out of Committee last month with a very 
strong bipartisan support.

    I know you are familiar with the challenges in combating 
childhood cancer, in particular. As Congress looks to 
reauthorize the critical program, can you tell me how NIH will 
continue to expand its efforts using data sharing to speed up 
research, for example, particularly for childhood diseases such 
as pediatric cancers?

    Dr. Bertagnolli. Yes, thank you. And this has been a major 
focus of my work since coming to NCI and would absolutely be 
carried over at NIH.

    I just, since time is brief, the beautiful, beautiful 
Gabriella Miller, when she looked into that camera, I am sure 
you have seen it, looked into that camera, and I am 
paraphrasing, I don't remember exactly, but she looked in that 
camera and she says, quit talking, get working or something 
like that.

    It just gets to your heart, and we take that very seriously 
and that is what inspires us to go forward.

    Senator Kaine. Thank you very much. I yield back.

    The Chair. Thank you.

    Senator Cassidy.

    Senator Cassidy. I defer to Senator Marshall.

    Senator Marshall. All right. Thank you, Senator Cassidy. 
Mr. Chairman, I want to submit for the record first an Op-Ed in 
The Washington Post, April 11th, 2002, by a Democrat Senator 
from the great State of Indiana, Senator Birch Bayh, and, of 
course, one of my boyhood heroes, the late great Senator Bob 
Dole from the State of Kansas. And it is an Op-Ed about the 
Bayh-Dole Act.

    [The following information can be found on page 38 in 
Additional Material:]

    Senator Marshall. I am sure Dr. Bertagnolli you are 
familiar with this, that this encourages, entices the private 
practice to seek public, private research collaboration rather 
than poking on its own proprietary research. If confirmed, will 
you commit today to uphold the integrity and intent of Bayh-
Dole?

    Dr. Bertagnolli. Thank you, Senator. And I, if confirmed, I 
will commit to uphold the integrity of the Bayh-Dole Act.

    Senator Marshall. Thank you. Next, I want to talk about 
research. In 2022, nearly half of all NIH funding went to 
institutes in just five states, and they happened to all be on 
the coasts. I think that when we send all that research in one 
or two geographical locations, you have incest, you have a 
decreased randomness of thought, and it pickles things up.

    The University of Kansas Cancer Center second to none NCI 
designated comprehensive cancer center since 2012. The Kansas 
State University received NIH funding in 2021 to support it 
becoming a national leader in emerging infections.

    Children's Mercy Research Institute in Kansas City, 
advancing the genomic medicine, developmental behavioral 
health, and pediatric brain cancer research. Will you commit to 
actually correcting these issues so innovative research in the 
Midwest are equally prioritized?

    Dr. Bertagnolli. Thank you, Senator. And not only will I 
commit, I can give you an example of where my past work has 
really already tried to achieve this.

    When I ran a cancer clinical trials group, one of my main 
goals was to make sure those trials reached as many communities 
as we possibly could, and we partnered with a wonderful 
physician practice in Laredo, Texas, serving the border 
community, a wonderful physician who served the Oglala Sioux 
community at Pine Ridge Indian Reservation, and a wonderful 
oncologist in my own hometown of Rock Springs, Wyoming.

    I agree with you completely, NIH research has to reach 
everywhere, and there are many, many centers of great 
excellence that we should have the ability to engage.

    Senator Marshall. Okay. Well, my next question is a lot 
tougher one. And Dr. Bertagnolli, you and I both protect a very 
honored profession.

    When I think about the horrors of medicine, the great 
horrors of medicine, the things we got wrong, think of 
bloodletting, I am afraid that 100 or 200 years from now, those 
same historians are going to go back and compare irreversible 
mutilation of adolescents for transgender surgery, 
irreversible, emphasizing, and giving them irreversible 
medication is going to be one of those two horrors that they 
are going to be talking about.

    They are going to be talking about bloodletting and the 
horrification of disfiguring surgery for people that 80 percent 
of them just in a couple more years, once they have some 
hormones of their own, are going to say maybe that wasn't a 
good idea. And before you answer this question, I want you to 
think about the oath that you and I took. And it is way over 
quoted, but it is above all, do no harm.

    Above all, do no harm. So here is my question, should 
taxpayers fund gender reassignment experiments or research that 
are purely cosmetic, where you destroy healthy tissue and 
organs, or when they use FDA approved products off label with 
significant negative, irreversible impacts?

    Again, this off-label use isn't treating diseases or 
illnesses. Should taxpayer funds be used to do research or fund 
these irreversible, horrifying, irreversible procedures and the 
use of these hormones off-label?

    Dr. Bertagnolli. Senator, thank you very much, because it 
is very clear that you are--share my concern over the well-
being of the LGBTQ community, especially young, vulnerable 
people. What I can tell you is that if confirmed, I will commit 
to leading NIH to conduct the research that will achieve the 
very best health for these vulnerable and special individuals.

    Senator Marshall. I am sorry to cut you off, but right 
there, do you believe that it is Okay to fund this type of 
research where these irreversible procedures are being done? Do 
you think there is any experiment that you can think would 
justify irreversibly damaging these poor little boys and girls 
who are 14, 15 years old? Would you fund that type of research?

    Dr. Bertagnolli. Any research that we do, Senator, with 
regard to human subjects has to be done in a way that does no 
harm and produces the maximum benefit to the people that are 
participating in the research. And that will be the principle 
with which I approach any research, especially for this 
vulnerable population.

    Senator Marshall. Thank you. I yield back.

    The Chair. Senator Smith.

    Senator Smith. Thank you, Chair Sanders, and Ranking Member 
Cassidy. And thank you so much, Dr. Bertagnolli, for being 
here. It is wonderful to see you again, and I am just delighted 
to have the opportunity to support your nomination on this 
Committee and also as we move you forward to confirmation.

    I would like to actually follow-up on something that 
Senator Barrasso started with and focused on, which is your 
personal experience in Wyoming, experience in rural America. I 
am not going to ask you about the ranch, although I would be 
tempted to. But I think it meshes with a very clear policy 
interest of mine, which is around our rural health and a focus 
on rural health.

    We know that in health care settings across the country 
there is a real shortage of health care workers and that this 
effect is really felt particularly intensely in rural 
communities that are struggling to maintain hospitals and 
maintain access to care.

    Now, we have had some important innovations over the last 
several years, I would point specifically to telehealth, as a 
way of delivering care, but could you please just talk with us 
a bit about, as you think about your own personal experience in 
rural communities, how can the NIH ensure access to the most 
advanced medical research and other treatments, regardless of 
and especially if you live in small towns and rural places in 
this country?

    Dr. Bertagnolli. Well, thank you so much for that question. 
Our job is not done if we just produce an effective treatment 
or an effective approach--the job is not nearly done.

    Our job is only done when people are living long and 
healthy lives free--and so. That means that a critical area of 
NIH research needs to be health care delivery research. And I 
will just give you a quick personal note. Town where my parents 
lived in central Wyoming, no hospital within 100 miles.

    Through city, through state, community, Federal, and tribal 
participation there is a new hospital being built there, and I 
am committed to seeing that new center in that new location be 
brought into the research enterprise so that we can understand 
how these kinds of Federal, state, tribal partner--community 
partnerships can be brought to bear to be able to deliver 
better care. Just one example.

    Senator Smith. Well, that is great, and you--I appreciate 
what you are highlighting, which is the importance of 
partnerships, but also the real importance of NIH attention to 
training and research opportunities in rural communities, 
because I think there is a lot of good data to show that if you 
are trained in a rural place, then you are much more likely to 
stay in that rural place.

    There are good examples, good best practices for how to do 
that. And I have to say I share Chair Sanders's concerns 
about--our challenge is delivering care in this country. And 
so, I think there is lots for us to work on there.

    Another area that I want to just touch on before I wrap up 
is the importance of focusing on research around mental health 
care. This is something that, again, is a very, very important 
issue to me. Less than 5 percent of the NIH's health budget 
goes to the National Institute of Mental Health.

    Less than 5 percent of the overall budget, while one in 
five or about 20 percent of Americans are going to experience 
some sort of mental health issue every year. So, we know that 
mental health and physically--physical health are not like two 
completely separate things. That is brain health and the rest 
of your body health.

    Could you talk a bit about how you view the NIH's role in 
focusing on that connection between mental and physical health, 
brain health and the rest of your body health? And given this 
low percentage of funding, how can the NIH advance research on 
mental health?

    Dr. Bertagnolli. Oh, thank you. I think, first of all, 
mental health affects every single disease we treat.

    Senator Smith. Yes.

    Dr. Bertagnolli. It affects whether--how someone can manage 
their cancer journey. It affects how somebody can--who has got 
kidney failure is able to get the needed care. It affects every 
single thing we do.

    One of the things that I am really excited about, if 
confirmed on taking on the role, is to really focus on all of 
these interactions between the various institutes where there 
are common themes that need to be addressed in--or even in 
order to treat these of individual diseases.

    Mental health is overarching and really needs to get into 
every research institute. That is No. 1. And then No. 2, that 
will also help us best leverage the funding that goes into the 
Mental Health Institute, being able to pull on that for--
through the resources throughout the entire NIH.

    Thank you for your advocacy and raising this really 
important issue of raising awareness.

    Senator Smith. Thank you. Thank you very much, Mr. Chair.

    The Chair. Thank you, Senator.

    Senator Cassidy.

    Senator Cassidy. I defer to Senator Budd.

    Senator Budd. Thank you, Ranking Member, Mr. Chairman. Dr. 
Bertagnolli, thank you for being here. Congrats on your 
nomination. It is a great state you come from.

    Research tells us that children in the womb respond to and 
that they can feel pain at 12 weeks, and fetal anesthesia is 
recommended for surgeries at 13 weeks.

    Doctor, before obtaining consent for a fetal tissue 
donation, will you commit to requiring NIH contractors and 
grantees that they explicitly inform mothers that their child 
will feel pain during an abortion by 12 weeks of pregnancy?

    Dr. Bertagnolli. Thank you for raising this issue, Senator. 
I believe that it--the policies and procedures that govern any 
research with fetal tissues really prohibit any discussion 
whatsoever with the mother toward even the possible use of such 
tissue for research. So, it would not be acceptable for me to 
affirm this. That interaction is not allowed to take place.

    Senator Budd. Thank you. Chairman, I yield back.

    The Chair. Senator Hassan.

    Senator Hassan. Thank you, Mr. Chairman. And thanks to you 
and Ranking Member Cassidy for this hearing. Dr. Bertagnolli, 
it is so good to see you and congratulations on your 
nomination.

    Thank you for your willingness to serve. I want to follow-
up on a line that you heard from Senator Murray and just now 
from Senator Smith. The National Institute on Drug Abuse at the 
NIH plays a vital role in responding to emerging trends in 
substance use and addiction.

    This institute has contributed substantially to our 
understanding of medication assisted treatments for opioid use 
disorder and help validate the effectiveness and safety of 
evidence based medications to treat addiction, such as 
buprenorphine. As a result of NIH's leadership, buprenorphine 
is now widely accepted as a gold standard of care for 
individuals struggling with opioid use.

    Last year, I worked with Senator Murkowski to pass into law 
the Mainstreaming Addiction Treatment Act, which eliminated an 
unnecessary hurdle for providers who are prescribing 
buprenorphine and further expanded access to this lifesaving 
treatment.

    However, despite this push to increase access, research 
shows that high levels of stigma and lack of provider education 
still stand in the way of individuals receiving medication 
assisted treatment. Doctor, can you tell us how you will 
develop strategies to eliminate the stigma around medication 
assisted treatment?

    Dr. Bertagnolli. Oh, thank you for that question. And yes, 
I think that the overall issue of substance abuse is, first of 
all, it is a tragedy. And second of all, that tragedy is 
compounded when on top of it there is also stigma associated 
with the disease.

    That stigma needs to be combated at every step. I always 
fall back to, what is the first and most important 
relationship? That is the treating physician and the patient 
together. I think trust between those two individuals is 
absolutely key trust and support.

    But then I also think we can do more to raise community 
awareness in every regard. And this is yet another area of what 
is the best way, the most respectful way, the most appropriate 
way to garner community support for individuals battling 
substance abuse.

    This is another really important area of research to make 
sure that we know how to do it respectfully and well.

    Senator Hassan. Well, thank you. Would you commit to 
continuing to grow the National Institute on Drug Abuse's work 
on treatment for substance use disorders?

    Dr. Bertagnolli. I will commit to working with you to fully 
pursue work at NIH to end the scourge of substance abuse.

    Senator Hassan. Thank you. I want to move to a different 
topic. Antibiotic resistance is a serious emerging threat to 
global public health. In July, you and I discussed the NIH's 
important role in antimicrobial resistance research and 
development.

    We need to work together to encourage the development of 
new medications that are able to treat infections that are 
unresponsive to current antibiotics. Doctor, how do you 
envision NIH's role in the public, private partnership to 
combat antimicrobial resistance?

    Dr. Bertagnolli. Certainly, this is a critical issue for 
drug development and has--which has been successful in a long 
time--to a certain degree in being able to head off the 
continual problem of antimicrobial resistance, and I fully 
support any research that can help us get to that aim for 
people.

    I will also add that like virtually everything we do in 
medicine, there is also a social and an educational component 
to this, right. So, it is not just finding a new drug to beat 
the bug. It is making sure that prescribing practices for 
antibiotics or use in agriculture, all of these other efforts 
that really are--can be--can make the problem worse and 
perpetuate the problem also need to be an area of our research 
to be able to combat.

    Senator Hassan. Well, I thank you for that. Are there other 
new strategies that you could be looking at to improve clinical 
trials for new antimicrobial medications? Because I understand 
the last point you made, but I think we also need to make sure 
that we are continuing the research so that we have new classes 
of these medications.

    Dr. Bertagnolli. Yes, thank you. This is a very important 
issue for clinical trials. I will also just take it as a side 
to say we have so much work to do in the clinical trials arena.

    One of the other commitments I want to make is for clinical 
trials, since it has been one of my core expertise, that are 
faster, more inclusive, more--and more responsive to the needs 
of people. It is one of the major initiatives that I would like 
to see happen at NIH.

    Senator Hassan. Well, I appreciate that. I just also want 
to look forward to working with you. I am interested in 
bipartisan approaches to support innovative microbial--
antimicrobial research, including through leveraging the tax 
code, and I really look forward to working with you and the 
rest of the department to achieve this goal. Thank you, Mr. 
Chair.

    [Technical problems.]

    Senator Cassidy. I defer to Senator Murkowski.

    Senator Murkowski. Thank you both to the Chairman and to 
the Ranking Member. Doctor, thank you for being here and taking 
our questions. I appreciate the response that you have just 
provided to Senator Hassan about clinical trials.

    I am very invested in and very focused on what is happening 
within clinical trials for ALS. I have got a personal 
connection. I think so many of us do have a personal connection 
and we recognize just really the horrific progression of that.

    I will submit to you a pretty specific question about how 
we can make ALS clinical trials more efficient, looking for 
perhaps alternative sources to better or more precisely measure 
ALS progression.

    But it is what you have just said about leaning into this 
and placing a priority on it is something that I appreciate, 
and I look forward to further conversations with you on that. 
You have already responded to questions that I had.

    Senator Smith asked about rural health. That is obviously 
something that coming from Alaska, we would certainly encourage 
greater research in rural areas that don't have care delivery 
sites.

    One of the other issues that I wanted to bring up was what 
Senator Murray raised with menopause research. I was able to 
meet with some advocates just a few weeks ago. And, it is just 
shocking to me to know that one of the life stages in women, 
whether you like it or not, is menopause and how little we 
actually know about the impacts and many of the treatments for 
health--for adverse health conditions that are associated with 
menopause in particular. Let me ask my question about 
infectious diseases.

    We, in Alaska, are plagued and have been for a long period 
of time, but it continues throughout our state. We see 
preventable chronic infectious diseases, particularly 
tuberculosis and hepatitis C.

    As of 2021, Alaska had the highest incidence of TB in the 
country. Again, we have very rural areas. Hep-C, the rates 
there have been increasing statewide now for two decades 
despite the availability of the curative treatments. I have 
been in small rural airports and run into public health workers 
that are there just solely and specifically to monitor what we 
are seeing with hepatitis C.

    I would ask how the NIH would approach coordinating with 
other Federal agencies, whether it is the state, the local, the 
tribal Governments to do more with eradicating these chronic 
infectious diseases, not only tuberculosis and hep-C, but the 
sexually transmitted infections as well.

    Because again, this is an area where we see rates that are, 
in my view, beyond intolerable. So, whether there are 
possibilities for cheap point of care testing for STI. Talk to 
me a little bit about what progress we could make or what we 
could hope for.

    Dr. Bertagnolli. Oh yes, thank you, Senator. I am not an 
infectious disease specialist, and I was not previously aware 
of these unique features of the citizens of Alaska.

    Senator Murkowski. It is rough.

    Dr. Bertagnolli. Yes. I can comment briefly, though, and 
say that certainly for hepatitis C and tuberculosis, and 
perhaps even for sexually transmitted diseases, that the two 
keys to managing when it is prevalent within a population are 
diagnosis, detection. I mean, hepatitis C can be silent for 
decades and people don't realize they have it, so they don't 
get the proper treatment.

    The same with tuberculosis. Many workplaces institute 
routine screening. Certainly, if you work in the hospital, you 
get screened every single year, and it is through that 
screening--and to identify individuals that need treatment, are 
a really important part of control. Instituting the best 
approaches for that.

    Again, I have to defer to colleagues who are experts in 
infection control, but I would be very pleased, if confirmed, 
to work with you to address these specific issues for the 
people of Alaska.

    Senator Murkowski. Well, and we do have some great experts 
that are on the ground who are very familiar with this. But it 
is the coordination that I am hoping that we will be able to 
see between Federal, tribal, state, local. So, thank you very 
much. Thank you, Mr. Chairman.

    The Chair. Thank you.

    Senator Casey.

    Senator Casey. Mr. Chairman, thanks very much. Dr. 
Bertagnolli, thank you for putting yourself forward for this 
position, especially at this time with so many challenges that 
we face as a Nation. For more than a decade, I have led the 
annual bipartisan appropriations letter advocating for funding 
for the National Institutes of Health.

    Most recently working with Senator Tillis on a letter that 
was joined, we were joined by 56 other United States Senators. 
And at the end of that letter this year, we say, and this is 
just quote in one part of the letter, ``if we are to continue 
grappling with emerging threats, as well as improve the health 
of Americans and the quality of their lives, we must continue 
to invest in biomedical research that has a potential to save 
money, improve lives, and offer an economic return for our 
Nation.''

    We are proud to be able to do that and we will continue to 
advocate for robust funding for the National Institutes of 
Health. I don't have to remind anyone the reach and the scope 
of the National Institutes of Health.

    They literally touch the lives of every American, and we 
are at a time where there is both enormous potential for 
advancements in health science, but also great, great 
challenges such as the risk of disinformation and the decreased 
trust in medical experts.

    The National Institutes of Health in my home State of 
Pennsylvania provides tremendous value despite those challenges 
that I mentioned. Pennsylvania researchers successfully compete 
for thousands of grants each year, totaling over almost $2.5 
billion.

    The funding directly supports more than 28,900 jobs in 
Pennsylvania and also contributes to a thriving life sciences 
sector in the state. So, we have a lot at stake as a 
commonwealth, but also for our Country.

    I want to commend the work that you have done at the 
National Cancer Institute related to pediatric cancers, 
diseases which were almost universally fatal decades ago, but 
which are now largely survivable thanks to investments in 
research.

    If confirmed, how will you work to ensure that the NIH is 
continuing to invest in children's health and that children are 
being appropriately represented in clinical studies?

    Dr. Bertagnolli. Yes. Thank you very much for that 
question. There has long been, I think you--I can--you 
recognize that children have been definitely understudied and 
certainly the conditions that affect them have not been--not 
received as much attention from the pharmaceutical industry as 
some adult diseases.

    What can we do at NIH? A couple of things. First of all, 
recognizing the importance of developing collaborative 
mechanisms that bring pediatric cases together for study and 
knowledge. Pediatric--many pediatric cancers are rare diseases, 
and one of the great successes that we have had at NCI has been 
to bring together a community of patients, researchers, and 
caregivers around bringing together data from those taking care 
of pediatric cancer cases across the nation.

    But it doesn't obviously stop at NCI. Every single disease 
center needs to focus on the youngest Americans, making sure 
that we address their needs with clinical trials that are 
targeting the--targeting the diseases that they suffer from. 
Last thing I will say, prevention. Prevention is key.

    All of us need to prevent. Prevention has to start when we 
are children, right. And so, not only targeting diseases that 
kids have, but targeting new strategies to make sure they get 
the preventive therapies that can last them a lifetime, I think 
are one of the strongest ways we can influence their health 
overall.

    Senator Casey. Thank you very much, doctor. I wanted to 
finally ask you about work that I have done with regard to rare 
disease patient groups over the years.

    One challenge that has come up repeatedly is the difficulty 
in demonstrating that a potential therapy is effective due to 
poor natural histories of those--of these rare and ultra-rare 
diseases.

    Can you talk about the role NIH can play when working with 
the FDA to support research into rare diseases that can help 
advance our understanding and support the development of safe, 
effective therapies?

    Dr. Bertagnolli. Yes. Thank you, Senator. I can give you a 
very specific example of this one. The NIH Clinical Center is 
an absolute treasure.

    There is a program at the NIH Clinical Center today that I 
can speak to most easily because it has to do with pediatric 
cancers, that takes very rare pediatric--people with very rare 
pediatric tumors, assemble the team all the way from basic 
biology to clinical trials, importantly has--and partners, 
public, private partnerships and partners to bring together a 
community to be able to treat that disease.

    Those individuals all come to the clinical center so that--
throughout the nation. It is incredibly moving when you see 
people who have a rare disease or children with a rare disease, 
their families there, for the first time meeting another person 
who has that really rare disease, it is an incredibly moving 
experience, and that community built around that, centered 
around our clinical center is making tremendous progress one by 
one.

    I would like to see that model scaled dramatically.

    Senator Casey. Thank you, doctor. Thank you, Mr. Chair.

    The Chair. Senator Cassidy.

    Senator Cassidy. Hey, Dr. Bertagnolli. I have got lots of 
questions, so if I interrupt you--please be tight with your 
answers, and if I interrupt you, I will apologize in advance.

    You said during your staff interview you support the 
reasonable pricing clause included in the recent contract with 
BARDA, but you were not familiar with the NIH experience in the 
90's. Clinton administration NIH Director Harold Varmus stated, 
when rescinding the policy, extensive review indicates that the 
pricing clause has driven industry away from potentially 
scientific--potentially beneficial scientific collaborations, 
and eliminating the clause promotes research that enhances the 
health of the American people.

    Research America, an alliance of hundreds of organizations 
advocating for biomedical research, expresses concerns about 
the policies that would ``discourage the uptake of 
breakthrough--discourage the uptake of breakthrough discoveries 
by the private sector. This would be detrimental to patients.'' 
Would you apply reasonable pricing clauses to NIH contracts if 
confirmed?

    Dr. Bertagnolli. Ranking Member Cassidy, my absolute utmost 
priority would be securing effective treatments----

    Senator Cassidy. That is not my question. My question, 
would you apply reasonable contract pricing clauses to NIH 
contracts?

    Dr. Bertagnolli. I cannot commit to any specific action at 
this time.

    Senator Cassidy. I am asking you to commit to not an 
action.

    Dr. Bertagnolli. But I will work with you on this issue 
because I share your desire to make sure people have access to 
the treatments----

    Senator Cassidy. Of course, my concern is, based upon Dr. 
Varmus's experience, that if you do institute, you are going to 
stop the translation of basic research to taking care of 
patients.

    This is not something that we need to kind of pussyfoot 
around. History tells us that if you do it, patients are 
damaged despite whatever rhetoric would be out there. So, I 
hope that you would be more forthright in your kind of 
embracing this issue. We have got scientific evidence.

    My gosh, if we are doctors, we should actually look at the 
evidence, not listen to the rhetoric. I say that because I know 
that patients are going to be damaged by this and that should 
be our highest calling. I don't mean to rag, but I just get 
frustrated. Okay. Also, what about march-in rights?

    You mentioned that you want to lower cost. People argue for 
march-in rights. Your predecessor, Francis Collins, 
consistently said during his tenure that the NIH does not have 
authority to use march-in rights to lower drug prices. It goes 
against congressional intent if you only use it to lower drug 
prices. Do you support using march-in rights to ``lower drug 
prices''?

    Dr. Bertagnolli. Again, Ranking Member, I cannot commit to 
any particular policy right now. In my----

    Senator Cassidy. No, the law specifically gives you three 
ways to use it and one of them does not include lowering drug 
prices. I mean, we are just asking you, are you going to follow 
the law? That would be the action.

    Dr. Bertagnolli. I will follow all the laws of our land, 
certainly. And again, my goal will be to make sure that people 
get the treatments that they need.

    Senator Cassidy. Sounds good. Sounds like--with that 
answer, you are answering my previous question that you 
wouldn't do the other thing. Let me ask you about another 
issue.

    Secretary Becerra chose not to continue an NIH ethics 
advisory board reviewing extramural fetal tissue research for 
appropriateness during the previous Administration. Presumably 
a panel like this would help achieve what you tell me your 
preference is of ensuring fetal tissue is only used as a last 
resort.

    I am told there were members of this board who supported 
fetal tissue research but still rejected some of the research 
projects put forward by NIH for the board's review because of a 
lack of informed consent.

    Now, you stressed the importance of informed consent in an 
earlier answer. These pro-fetal tissue advocates rejected these 
proposals because of the lack of informed consent, but 
Secretary Becerra has discontinued this board, providing that 
safeguard. Do you agree with Secretary Becerra's decision to 
not continue this board?

    Dr. Bertagnolli. Senator, I do not have enough information 
about those specific actions to really comment on Secretary 
Becerra's decision. What I can affirm for you is that any 
research needs to be conducted according to the most stringent 
ethical principles----

    Senator Cassidy. I accept that, but this board was making 
sure that was the case and it rejected some of those. It was 
the mechanism by which you, what you were telling me was 
actually executed. The informed consent was not done. If we 
stipulate my, as a theoretical, that what I laid out, the facts 
are correct, would you support reinstituting the board?

    Dr. Bertagnolli. Again, I can't comment on the specifics of 
that activity. I can just say that if confirmed, I will uphold 
the principles of ethical human research.

    Senator Cassidy. It has been 4 years almost since the 
COVID-19 pandemic began. We still actually don't know where the 
virus originated. Many studies and reports have explored 
plausible alternatives.

    Experts agree that further research is needed. Do you 
believe the Federal Government should do everything it can to 
determine the cause of COVID-19, including the possibility it 
emerged from a lab that was conducting gain of function 
research?

    Dr. Bertagnolli. Ranking Member Cassidy, I think no one 
wants to know what the true origin of the last COVID pandemic 
was more than the biomedical research community----

    Senator Cassidy. How will you accomplish that?

    Dr. Bertagnolli. To the fullest extent of our ability to 
gather the data, and have access to the data, and make a 
valid----

    Senator Cassidy. Making it public?

    Dr. Bertagnolli. Make data that we have available public 
and accountable to the American people, yes.

    Senator Cassidy. Okay. I yield.

    The Chair. Senator Baldwin.

    Senator Baldwin. Thank you, Mr. Chair. Dr. Bertagnolli, 
welcome to the HELP Committee, and congratulations on your 
nomination. A number of us on the HELP Committee are also on 
the Appropriations Committee and I want to address the budget 
for the Fiscal Year 2024.

    Despite the challenges that we had faced in writing a Labor 
HHS appropriations bill because it included the availability of 
less funding overall than we had in Fiscal Year 2023, our 
bipartisan Fiscal Year 2024 bill builds on our long standing 
commitment to NIH and biomedical research in general.

    We secured critical increases in our bill for some of the 
agency's most important programs, $100 million increase for 
mental health research, $100 million increase for Alzheimer's 
disease research, $60 million increase for cancer research, and 
$12 million for a new palliative care research program.

    As a cancer researcher, I wonder if you can describe how 
the recent investments in NIH, and specifically in cancer 
research, have advanced care for patients and improved 
outcomes.

    But I also want to have--challenge you to talk about the 
impact that the House passed--I am sorry, not the House passed, 
the House bill that is pending that has drastic cuts in 
biomedical research, how you would tackle that if that became 
law.

    Dr. Bertagnolli. Thank you, Senator. First, let me say that 
I speak for everyone at NIH to say that we are deeply grateful 
for what we receive from the Federal Government in order to 
conduct our research.

    No. 2, let me speak as a physician to say that over my 30 
plus years of being a physician, I have seen the tremendous 
advances that have been made as a result of NIH funding. I am 
not going to take down the clock in the many advances that have 
happened just in the last year. Just let me assure you that 
people are living better, longer as a result of NIH research.

    I think that you are also asking to address how changes in 
funding will impact what we do. I will just say that every 
penny we get, we will use to the fullest extent possible to 
secure health for the American people.

    We will focus on the issues that Congress brings to us as 
important, and I really embrace working with you on those key 
issues. And then finally, if our budget--there is a chance that 
our budget will force us to leave opportunities on the table, 
because the opportunities are enormous. And I will just leave 
it there.

    Senator Baldwin. Okay. There have been two biosafety 
incidents involving the H5N1 virus at the University of 
Wisconsin, Madison.

    In both cases, there was a lack of guidance and oversight 
from NIH, which I find very, very concerning. As Chair of the 
Labor HHS Appropriations Subcommittee, I worked to secure 
language and funding focused on this issue in our bipartisan 
Fiscal Year 2024 bill.

    In addition to directing NIH to articulate the roles and 
responsibilities of investigators and in institutions 
conducting this research, the Fiscal Year 2024 bill would 
establish for the first time an office at NIH to serve as a 
resource and to provide tools and guidance to the research 
community.

    Dr. Bertagnolli, what steps would you take to enhance the 
oversight of NIH funding research involving potential pandemic 
pathogens?

    Dr. Bertagnolli. Thank you very much for your advocacy for 
this very, very important issue. Potential pandemic pathogen 
research stands to achieve great benefit for people by allowing 
us to respond immediately and save lives, but it also has risk.

    I can commit to you, if confirmed as NIH Director, that I 
will fulfill the highest possible oversight for programs that 
engage in this kind of research--review and oversight to make 
sure that they are conducted safely and achieve the benefit we 
know, we can see for the American people.

    Senator Baldwin. Thank you, Mr. Chair.

    The Chair. Senator Markey.

    Senator Markey. Thank you, Mr. Chairman, very much. Let me 
just begin by saying that LGBTQ people are living in a national 
state of emergency. More than one in two transgender and non-
binary youth have seriously considered attempting suicide.

    When elected officials use their bully pulpit to target 
gender affirming care or create barriers to evidence based 
lifesaving treatment and fuel the fire of the youth mental 
health crisis, this is a driving force in a nationwide campaign 
of discrimination, and it is unacceptable to LGBTQ youth, young 
people.

    Let me just say this very clearly, trans rights are human 
rights, and I am never going to stop fighting for essential 
research and investments in the care which you need to make 
sure that everyone is free to exist as their authentic selves, 
and we won't rest until you are free to live openly, 
authentically, and safely.

    Doctor, thank you for being here today. I have heard from 
many people in Massachusetts, including many oncologists, about 
your excellent work and your leadership, and it is clear that 
you have a commitment to public investment to drive research 
that will improve Americans' health, treat illness, and to cure 
disease.

    Last year, Congress passed my bipartisan Children Media and 
Research Advancement Act requiring the National Institutes of 
Health to conduct research on technology and media's effects on 
infants, children, and adolescents, and provided the NIH with 
$15 million to launch this program.

    We already know that big tech's exploitation of younger 
users is driving a mental health crisis, and this research will 
further document the serious harms caused by the online 
platforms' insatiable appetite for children and teens' personal 
Information.

    Doctor, if confirmed, will you commit to prioritizing that 
research? We have an epidemic, a mental health epidemic amongst 
teens and adolescents in America.

    Dr. Bertagnolli. Thank you, Senator Markey. As the parent 
of very recently teenagers, I can certainly comment to a great 
concern about the amount of time spent in front of computers 
and the worry of a parent as to what that really is doing.

    I can commit to you that this is a very important issue for 
NIH research, understanding what this new technology means for 
our young people, really everyone, but certainly more of a 
focus on the young.

    I also know that this is an issue that is a great concern 
for our Surgeon General, and I also looking--look forward to 
working with others across HHS on this issue.

    Senator Markey. Yes, the Surgeon General has identified the 
problem. Senator Cassidy and I already have, coming out of the 
Commerce Committee successfully, an upgrade of the protections 
for kids online up to age 17, and we are hoping to move that on 
the Senate floor.

    But we also need the documentation from NIH as to the 
underlying pathology which is being created as we sit here 
right now. Since the passage of the National Alzheimer's Plan 
Act and Alzheimer's Accountability and Investment Act that 
Senator Collins and Senator Warren--Warner and I have worked 
on, NIH research has contributed to significant advancements to 
understand and treat Alzheimer's, yet we have a ways to go.

    We are just beginning to understand the impact of air 
pollution and environmental justice on the brain. Black, brown, 
disabled, and rural Americans face discrimination and other 
barriers to access to treatment, including expensive treatments 
or long travel times to care.

    Family caregivers still struggle every day with providing 
care to their loved ones with Alzheimer's. Doctor, can you just 
tell us how you view the NIH's role in continuing to lead 
Alzheimer's research in new directions, center equity, and 
access and support to family caregivers who are so often at the 
frontlines of providing care.

    Dr. Bertagnolli. Thank you so much, Senator, for that 
question. It raises many issues that I will just go back to 
maybe my core approach to things such as this.

    First, understanding the biology of what has produced this 
condition. And that means going all the way back, maybe even 
into very early years of life, so that we can think about 
prevention rather than treatment. That is really critical and 
encompassing a very broad population of people to inform that.

    Next, though, dealing with what we have today, people who 
are really suffering families for which this is a tremendous 
burden and having difficulties. Developing new treatments that 
can work now for people suffering from the disease.

    As you have already said, it is part of NIH to think about 
care delivery, and that means delivering for the caregivers, 
taking care of the caregivers, because they are a really 
important part of what helps us achieve health.

    Senator Markey. Thank you. And again, our goal is to 
continue to increase funding for NIH. Research is medicine's 
field of dreams from which we harvest the findings that will 
give hope to families, that we can find a cure for Alzheimer's. 
And NIH is really the National Institutes of Hope for all those 
Alzheimer's families. Thank you. Thank you, Mr. Chairman.

    The Chair. Senator Braun.

    Senator Braun. Thank you, Mr. Chairman. Last week, the 
House Oversight Committee subpoenaed Acting NIH Director Tabak 
for documents relating to the investigation of Dr. Moran.

    Dr. Moran is a top adviser to Dr. Fauci who is accused of 
using a personal email to avoid public accountability, and 
according to him, delete anything he did not want to see in The 
New York Times regarding the origins of COVID.

    The Subcommittee released emails allegedly from Moran's and 
requested information in June and again in September. If 
confirmed, will you comply with any subpoenas the House sends 
to you relating to the origins of COVID-19?

    Dr. Bertagnolli. Oh, thank you, Senator Braun. And I just 
can reassure you that I take Congress's responsibility for 
oversight for the NIH, and if confirmed, my responsibility as 
Director of the NIH to be compliant with policies regarding 
that oversight extremely seriously. I can confirm that if I 
assume the position, to be accountable and transparent, and to 
work with you to resolve these important issues.

    Senator Braun. Have you ever spoken to Dr. Moran about the 
COVID-19 pandemic?

    Dr. Bertagnolli. No, Senator. I don't know Dr. Moran.

    Senator Braun. Will you commit to not use a personal email 
for official NIH business, or to try to shield conversations 
from the American public?

    Dr. Bertagnolli. Yes, Senator. Absolutely.

    Senator Braun. Also, I would like to comment before I got 
one more question for you. Senator Hawley and I actually passed 
legislation asking the White House to release all the material 
they hold in classification on the origins of COVID-19. There 
is a law out there, and they have not complied with that.

    We are still trying to get them to comply with that law. 
And remember, you are working for that Administration. So, this 
one is a question in terms of any relationship you have got 
with big pharma.

    I think you have received millions of dollars from big 
pharma to support your research, and you sat on the board of 
several companies receiving stock options and bonuses. Our 
Country relies on its public officials to have their best 
interests in mind when performing their duties as public 
servants.

    How can the American people be sure that as NIH Director 
you would be focused on the job at hand rather than boosting 
the business of any past associates in the pharmaceutical 
industry?

    Dr. Bertagnolli. Thank you for that question. I just want 
to confirm for the record that the funding that I received from 
pharmaceutical companies was to conduct research. That none of 
that formed my own personal salary.

    The only salary I received during that work was from 
Brigham and Women's Hospital, a salary set based on my academic 
rank. I have one instance of receiving a payment directly from 
a pharmaceutical company. It was for service on the board of 
directors of a single pharmaceutical company.

    But finally, the more important question. I completely 
agree with the need to have one goal, one constituency that I 
am serving, and that is the health of the American people, and 
I will----

    Senator Braun. Thank you for that. One quick final question 
here. I think you have signed an agreement with Senator Warren 
about what you might do after this post.

    From the information I have got is that you won't seek 
employment or compensation from any pharmaceutical company. Is 
that correct? And does that mean then, if you do, you will turn 
down those offers?

    Dr. Bertagnolli. Well, the agreement with Senator Warren is 
designed to assure the American people and to Congress that I 
will act with the goal of the very best interests of the 
American people, if confirmed for this job.

    I have agreed for a time of 4 years after stepping down in 
Government that I will not accept employment at a major 
pharmaceutical company.

    Senator Braun. Thank you very much.

    The Chair. Senator Hickenlooper.

    Senator Hickenlooper. Thank you, Mr. Chair. And thank you, 
Ms. Bertagnolli. Appreciate your service and be willing to step 
in at this key time. Emerging Technologies, AI is top of mind. 
They are becoming ingrained into various parts of our lives. 
Health care is absolutely no exception.

    AI is primed to assist with trial design, real time 
monitoring, predictive analysis, go down all the different 
aspects of clinical trials which are so expensive. I think we 
all have agreed, over a long period of time, that the cost is a 
barrier to progress.

    Dr. Bertagnolli, do you think that the advent of AI will 
help create efficiencies in our clinical trial systems, and are 
there particular pitfalls we should be mindful of when 
considering technology in trials?

    Dr. Bertagnolli. Yes. Thank you very much for that 
question. Machine learning approaches, artificial intelligence 
are really wonderful new computational methods that we are all 
very, very excited about.

    We have long had the scale of data that we just do not 
allow us to analyze it properly. However, the more we learn, 
the more we use these techniques, the more we realize that they 
have to be like any tool used in a very careful and responsible 
manner, particularly when it comes to human research.

    The short answer is yes, absolutely. This is very exciting, 
but with a qualifier that the design, and conduct, and type of 
data used to train these models need to be very, very carefully 
considered to make sure we are getting the results that really 
matter and are meaningful for all people.

    Senator Hickenlooper. Any specific pitfalls that you would 
want to put on the record?

    Dr. Bertagnolli. I think that, I guess the most serious one 
that we hear about a lot is an AI method that might be designed 
and trained on one particular ethnic group or one particular 
category of people who have perhaps more access to treatment 
than in other, and then it gets a result that continues to 
disadvantage others who need to be included in that kind of 
research.

    I think that is one really serious one. But there are many. 
It is a computational method, after all, and it has to--it has 
to be doing what we want it to do.

    Senator Hickenlooper. Right. And oftentimes the algorithms 
aren't as transparent as some of us might like it.

    Dr. Bertagnolli. Exactly. Exactly. Thank you.

    Senator Hickenlooper. Harvard and Brigham and Women's 
Hospital created the Multi-Regional Clinical Trials Center. 
Obviously, you are very familiar with given your time at both 
institutions.

    The Center's prime focus is improving the safety and 
efficacy of global clinical trials. They have trained 
representatives literally from dozens of countries, what is 
good clinical process and what is good clinical practice. This 
leadership, I think, is critically important and often 
underestimated the significance of it.

    We live in an interconnected, wonderfully diverse world, 
but that interconnectedness and diversity does have its own 
challenges as well. And I think we should be making sure that 
we utilize all available data to inform our research decisions.

    What more do you think that NIH could be doing to encourage 
the use of safe and rigorous global clinical trials?

    Dr. Bertagnolli. Thank you for that question. I actually 
have personally conducted global clinical trials in the area of 
cancer, and that was done through the use of very careful 
protocols that delivered data in very careful formats and that 
also monitored sites so that we knew exactly what care was 
being delivered as part of the trial that was testing a 
treatment.

    Those, for things that really matter, that level of quality 
is very, very important. I will just add parenthetically, 
though, there are other things that we can do in public health 
globally that don't necessarily need to fit into that very 
tight model, so we should look at everything that we can to 
help inform our work.

    Senator Hickenlooper. Could not have said that any better 
myself. And I think that Dr. Bertagnolli's eagerness and 
optimism is a reflection of her Western roots, which I have 
great appreciation for. I have other questions, but I will 
submit them on written record, and thank once again the witness 
for being here, for your commitment to public service, and turn 
back to the Chair.

    The Chair. Thank you.

    Senator Lujan.

    Senator Lujan. Thank you, Mr. Chairman, and to our Ranking 
Member for this important hearing and this conversation.

    Dr. Bertagnolli, it is an honor to be with you today, and I 
want to begin by recognizing and thanking you for your help in 
providing archived data from the National Cancer Institute 
regarding radiation exposure from atmospheric nuclear testing 
in Western states, especially as we have an opportunity to 
provide more support for these families across the country.

    I am very honored to have worked with Senators Hawley and 
Senator Crapo with the support of 61 of our colleagues for the 
inclusion of these provisions in the National Defense 
Authorization Act. Thank you for that as well. Dr. Bertagnolli, 
the Institute Development Award, IDeA, with a small e, if you 
will.

    The program plays a huge role in building capacity in 
biomedical research across the entire State of New Mexico. For 
example, the New Mexico networks of biomedical research, which 
are located on the New Mexico State University campus, provides 
a collaborative biomedical research environment for more than 
10 other institutions across my state.

    Despite the program targeting half of the country, IDeA's 
budget is around 0.9 percent of the overall NIH budget. If 
Congress were to provide additional funding specifically for 
IDeA, how would you, as NIH Director, expand the program?

    Dr. Bertagnolli. Well, first of all, thank you, Senator 
Lujan. First of all, I would be delighted because as I think 
you have already heard in this hearing, I really want to see 
NIH research expand to encompass all of our Country, not just a 
few advantaged locations.

    I would look forward to expanding that program, not only by 
partnering with the outstanding academic institutions within 
the IDeA states as they grow out their educational and research 
outreach programs, but also for programs that we have that are 
national infrastructure, such as the National Clinical Trials 
Network, and other infrastructure that literally goes down into 
individual communities.

    It would be very welcome and quickly applied into action.

    Senator Lujan. I appreciate that. And on the same note, do 
you support increasing IDeA program's state participation 
across other major research programs beyond the currently 
available mechanisms to programs such as those supporting 
biomedical research facilities, instrumentation, and training?

    Dr. Bertagnolli. Yes, Senator. I view this as one way we 
can engage more of the American people in the research that we 
conduct, and I think it would be very positive.

    Senator Lujan. I appreciate that. You touched on this with 
your previous response around clinical trial diversity, and I 
appreciate your commitment to increasing clinical trial 
diversity participation.

    An opportunity still exists to increase diversity among 
research staff that would have implications for diversity in 
research participants. A clinical research workforce that 
itself is diverse, is better able to prioritize, connect, care 
for, and successfully recruit a diverse participant population 
in research.

    How will you ensure that NIH is granting funding to 
clinical trial research staff that reflect the people impacted 
by the study's conditions?

    Dr. Bertagnolli. Yes. Thank you. This is a priority. It is 
a priority. Why? Because we know that, as you have already 
alluded to, a diverse research staff, like a diverse care 
staff, brings excellence, really brings better outcomes for the 
people that we serve.

    How are we doing this specifically? Targeting programs to 
identify very talented individuals who come from diverse 
backgrounds, giving them opportunities to participate, and then 
supporting them through educational and other support programs 
to make sure that they succeed.

    There are numerous efforts like this across all of NIH, and 
I would like to see this expanded even more.

    Senator Lujan. I appreciate that. And, Mr. Chairman, I have 
some other questions I will submit into the record, and I yield 
back.

    The Chair. Thank you very much.

    Senator Cassidy, you wanted a second round?

    Senator Cassidy. Yes, please. Dr. Bertagnolli, you had said 
that you would maintain the Biden administration's policy for 
allowing fetal tissue research, but that it should only be used 
as a last resort. How could you ensure that fetal tissue is 
only used as a last resort?

    Dr. Bertagnolli. Thank you, Senator. Understanding the 
great sensitivity of many people and passionate feelings of 
many people on the issue of fetal tissue research, I would want 
to be very respectful of that.

    Again, if confirmed as NIH Director, my job is to serve 
everyone, including the communities who care deeply about how 
that tissue are used.

    Absolutely, I would follow the laws of the land in every 
aspect, and I would also follow within the laws of the land, 
the dictate is we are trying to achieve maximal good for 
people. We are trying to cure major diseases. That is our 
highest goal. But we need to do it with respect and obviously 
follow the law.

    Senator Cassidy. But let me ask, because that slippery 
slope, we are doing this for an end and therefore the means are 
justified. The specific question was, how would you ensure that 
fetal tissue is only used as a last resort?

    Dr. Bertagnolli. Thank you. I would follow our principles 
of review and oversight over the use of this tissue, which I 
understand is very stringent and asks that particular question 
as--by the review boards is one aspect of approving its use.

    Senator Cassidy. Okay. Now I am going to ask you some 
questions related to obesity. My state, unfortunately, is 50th 
or 49th in terms of obesity. So, I am told that the amount of 
funding directly for obesity--and by the way, we know this, but 
just for context, obesity is a major driver of health 
disparities, disproportionately affecting the poor, those of 
color, but also whites.

    It is a major driver of morbidity from heart disease, from 
cancer, from COVID-19. We know that. I am told that the funding 
at NIH that is specific for obesity is only about $100 and 
roughly $1.2 billion a year, about 2.5 percent of the budget.

    Again, but a major driver of health disparities, and of 
morbidity, and of all the things that you and I know of. So 
arguably, funding for obesity has lag--is lagging way behind 
funding for other conditions relative to its impact upon 
society.

    How can we better address this issue? Would you commit to 
increasing funding for obesity? How do we better address the 
foundation--foundational, translational, and implementation of 
research for obesity?

    Dr. Bertagnolli. Thank you, Senator. Thank you very much. I 
will say that from my current position as the Director of the 
National Cancer Institute, obesity and the rising obesity 
epidemic is one of the major causes of cancer in the United 
States.

    We recognize this. And there has been a tremendous amount 
of work done by NCI to identify the ideology of this, how 
obesity drives cancer, and how that can be overcome. So, I 
can't speak to the way the funding has been distributed now, 
but I can assure you that this is yet another one of those 
topics that does not belong in a silo, for which we have got to 
work across all of the institutes that can have a piece of 
owning this problem.

    Then the last thing I will say, again, stigma, making sure 
that people who suffer from this condition are respectfully 
included as being part of the solution to the problem.

    Senator Cassidy. I accept that. One suggestion, I am told 
that nutrition obesity research centers have kind of funding 
which is kind of stagnant. And just to increase that funding 
would be a place to start.

    Again, if we are talking about something which is driving 
cancer, heart disease, hip replacement, you name it. I used to 
tell my medical students, obesity is here, and it has a hydra 
head. We seem like we just focus more on the manifestations 
than we do on the creature itself. If we address the creature 
itself, we address all these. That seems to have been lost. If 
you could address that, that would be great.

    Dr. Bertagnolli. If confirmed, I would be really delighted 
to work with you on this. I agree that this is a very serious 
health problem that takes a multifaceted approach, and I agree 
that is something that we need to work on and would love to 
work with you on.

    Senator Cassidy. Thank you. I yield.

    The Chair. See, I knew, Senator Cassidy, that if we waited 
long enough, there would be an issue we would agree on, and 
obesity certainly is an epidemic. It is impacting diabetes and 
a host of other issues, and something this Committee must and 
will deal with on this. There is an issue that we didn't touch 
upon today.

    I have raised my deep concerns that there are many millions 
of Americans who cannot afford the outrageous cost of 
prescription drugs in this country, and that is something that 
the NIH must deal with.

    But there is another issue that we didn't talk about, and 
that is that we look at the global situation, we look at 
developing countries and millions of people throughout the 
world who are struggling to feed their families.

    What we find is that many of the prescription drugs 
consumed are consumed in developed--in the developed world. The 
poor people around the world cannot afford the medicines they 
need. Medicines, by the way, which may cost a few cents to 
produce. And they don't get it, and they die, or they suffer.

    The--sorry, all right. Okay. Thanks. Last May, President 
Biden announced that the U.S. Government would share some NIH 
funded COVID patents with the World Health Organization to 
expand access in low and middle income countries.

    If confirmed, will you build on this commitment and make 
sure that medicines developed with NIH dollars are accessible 
and affordable in low and middle income countries? Will you 
ensure NIH funded technology is shared with manufacturers in 
developing countries so that they can produce the medicines 
that people need at a price they can afford?

    Dr. Bertagnolli. Senator, I will. I can confirm that I 
will. I share your concern. I share your passion for bringing 
life giving care to not just the United States, but the world. 
And I will work with you on this issue.

    The Chair. All right. I would hope that you would 
appreciate that in some cases these drugs cost a few pennies to 
manufacture and yet they are not getting it to people for whom 
it might be life or death. That is something that you will pay 
attention to?

    Dr. Bertagnolli. I will--confirm that I will be very 
delighted to work with you on this issue. It is critically 
important.

    The Chair. Okay. Well, thank you very much, Dr. 
Bertagnolli, for being with us today. That concludes our 
hearing. As a reminder, the Committee will have a markup next 
Wednesday, the 25th, on this nominee and a few others.

    For any Senators who wish to ask additional questions, 
questions for the record will be due tomorrow, Thursday, the 
19th at 5.00 p.m. The Committee stands adjourned.
                                ------                                


                          ADDITIONAL MATERIAL

                          The Washington Post

              our law helps patients get new drugs sooner
                      By: Birch Bayh and Bob Dole
    April 11, 2002

    As co-authors of the Bayh-Dole Act of 1980, we must comment on the 
March 27 op-ed article by Peter Arno and Michael Davis about this law.

    Government alone has never developed the new advances in medicines 
and technology that become commercial products. For that, our Country 
relies on the private sector. The purpose of our Act was to spur the 
interaction between public and private research so that patients would 
receive the benefits of innovative science sooner.

    For every $1 spent in government research on a project, at least 
$10 of industry development will be needed to bring a product to 
market. Moreover, the rare government-funded inventions that become 
products are typically five to 7 years away from being commercial 
products when private industry gets involved. This is because almost 
all universities and government labs are conducting early stage 
research.

    Bayh-Dole did not intend that government set prices on resulting 
products. The law makes no reference to a reasonable price that should 
be dictated by the government. This omission was intentional; the 
primary purpose of the act was to entice the private sector to seek 
public-private research collaboration rather than focusing on its own 
proprietary research.

    The article also mischaracterized the rights retained by the 
government under Bayh-Dole. The ability of the government to revoke a 
license granted under the act is not contingent on the pricing of a 
resulting product or tied to the profitability of a company that has 
commercialized a product that results in part from government-funded 
research. The law instructs the government to revoke such licenses only 
when the private industry collaborator has not successfully 
commercialized the invention as a product.

    The law we passed is about encouraging a partnership that spurs 
advances to help Americans. We are proud to say it's working.

    The writers are, respectively, a former Democratic Senator from 
Indiana and a former Republican Senator from Kansas.
                                 ______
                                 

                        QUESTIONS FOR THE RECORD

Response by Monica Bertagnolli to Questions of Senator Sanders, Senator 
Kaine, Senator Hickenlooper, Senator Markey, Senator Casey and, Senator 
                                 Lujan
                            senator sanders

    Question 1. In some cases, the National Institutes of Health (NIH) 
owns the underlying patents for key drugs, but then gives away 
exclusive control over the drug to pharmaceutical companies. For 
example, the National Cancer Institute (NCI) is on the verge of giving 
an exclusive license to a small biotech linked to a former NCI employee 
for a promising cancer treatment that may cost Medicare billions of 
dollars, even as NIH invented the treatment, currently manufactures the 
treatment, and runs clinical trials. One report called this exchange 
``The NIH's `How to Become a Billionaire' Program.''

        a. If confirmed, how would you ensure publicly owned inventions 
        are not given away? Will you commit to only offer exclusive 
        licenses when they are ``reasonably necessary to provide the 
        incentive for bringing the invention to practical 
        application,'' as required under 35 U.S.C. Sec.  209(a)(2)?

    Answer 1. I commit to fully complying with all the laws that govern 
my role as the NIH Director including the requirements of Section 209 
that you point out. I recognize the importance of making certain that 
the taxpayer sees a fair return on their investment in the science and 
innovation that NIH produces with taxpayer funding. To that end, I 
agree that the private sector must not realize unfair profits that are 
the result of publicly funded research. I commit to working with you 
and the HELP Committee in an effort to execute on these shared goals. I 
want to reiterate too that NIH's role isn't just to identify medical 
care innovation and understand the best treatment, but to ensure that 
we can deliver that care and treatment to all people who need it in a 
way that is affordable and accessible.

    Question 2. In addition to march-in rights, the NIH has failed to 
use other tools that could make medicines affordable. Will you commit 
to using ``royalty-free'' rights to introduce additional low-cost 
producers, under 35 U.S.C. Sec.  202(c)(4), for medicines developed 
with Federal funding?

    Answer 2. If confirmed as NIH Director, I will use all the tools at 
my disposal to expand access to the treatments and technologies 
developed using NIH research to reach the patients that need them 
across the United States. To achieve this goal, I would consider the 
use of ``royalty-free'' rights as one mechanism to potentially help 
lower the cost of medicines.

    Question 3. NIH currently does not disclose critical information 
the public needs to assess how much drugs cost to develop. Will you 
commit to publicly reporting the full, disaggregated costs of taxpayer-
funded clinical trials?

    Answer 3. I firmly recognize the importance of transparency, 
especially when it comes to taxpayer spending. If confirmed as NIH 
Director, I look forward to working with you and the HELP Committee to 
identify ways to further increase transparency around taxpayer-funded 
clinical trials.

    Question 4. The ``Stevens Amendment'' requires recipients of 
taxpayer dollars to disclose how much of their own money they are 
putting into projects that receive Federal funding. Will you commit to 
following the law, so that the public is given timely and useful 
information about the respective contributions of the Federal 
Government, compared to private partners, for new treatments and cures?

    Answer 4. I commit to fully following the law. If confirmed as NIH 
Director, I look forward to being a faithful steward of taxpayer 
dollars and ensuring that we do the most with every penny we are given. 
I firmly believe that transparency and accountability are paramount to 
restoring trust and faith in the agency.

    Question 5. Over 4,000 clinical trials, including many that are 
funded by NIH, violate existing reporting requirements under Federal 
law. Will you commit to withholding grant money to responsible parties 
who fail to comply with ClinicalTrials.gov reporting requirements?

    Answer 5. I commit to fully following the law. If confirmed as NIH 
Director, I will work with the NIH team to ensure that NIH takes 
appropriate action in situations where grant recipients have failed to 
meet reporting requirements.

    Question 6. If confirmed, will you support routinely licensing 
technologies invented by government scientists and through taxpayer 
funds to health and humanitarian organizations like the Medicines 
Patent Pool in order to promote access to life-saving medicines in low-
and middle-income countries?

    Answer 6. If confirmed as NIH Director, I commit to using all the 
tools at my disposal to increase access to technologies and techniques 
developed through taxpayer investment to reach as many people in need 
as possible, in the United States and with our partners around the 
world.

    Question 7. In addition to many topics, the National Institutes of 
Health (NIH) plays an important role in primary care research. 
Currently, the NIH spends approximately $108 million on primary care 
research, which accounts for less than 0.2 percent of NIH's overall 
funding. When comparing spending to delivery of care, the U.S. spends 
5-7 percent on primary care while approximately 50 percent of doctors' 
visits are with primary care. This amounts to a disproportionately 
small investment in research compared to the amount of care delivered 
in the primary care setting.

        a. Patient interaction with primary care equates to better 
        quality and life and better health outcomes. However, without a 
        single Federal entity charged with coordinating and advancing 
        primary care research, primary care clinicians must rely on 
        research from other health care settings, such hospitals, sub-
        specialty groups, or single disease states to inform their 
        thinking around the delivery of care.

        b. Dr. Bertagnolli--do you believe that there is a greater role 
        for the NIH when it comes to coordinating and advancing primary 
        care research? How as NIH director would you ensure that NIH 
        can play a role in advancing primary care research?

    Answer 7. I agree, primary care is critical to good overall health 
and if confirmed, I look forward to working with you on this.

                             senator kaine

    Question 1. Despite progress in recent decades to reduce smoking 
rates, the public health impact of the mortality and morbidity 
associated with smoking remains staggering. In fact, according to a 
recent report from the Centers for Disease Control and Prevention, over 
28 million U.S. adults currently smoke. Unfortunately, too many smokers 
seek to quit, but are unsuccessful in their quit attempts. Dr. 
Bertagnolli, efforts to address the smoking rate in the U.S. cuts 
across many Federal agencies. Where do you see NIH's role in reducing 
smoking rates?

    Answer 1. NIH supports research on tobacco use prevention, 
including projects in regulatory science, addiction, tobacco control, 
health effects, cancer prevention, and behavioral studies. NIH-
supported research shows that menthol in cigarettes makes it easier to 
start smoking by reducing the harshness of tobacco. To help inform the 
FDA's tobacco regulatory priorities, NIH and FDA have a unique 
interagency partnership called the Tobacco Regulatory Science Program 
(TRSP), administered through the NIH Office of Disease Prevention. In 
April 2022, TRSP-sponsored research was cited in FDA-proposed rules to 
prohibit menthol as a characterizing flavor in cigarettes and ban all 
characterizing flavors (other than tobacco) in cigars.

                          senator hickenlooper

    Question 1. The CDC has found that Black women are two to three 
times more likely to die from pregnancy-related complications than 
white women--with many of these deemed ``preventable.'' The NIH has 
significantly prioritized maternal health research, across various 
Centers. Dr. Bertagnolli, if confirmed, how will you make sure that the 
results of this research are clearly disseminated to providers, 
educators, and most of all, patients?

    Answer 1. This issue is a top priority for NIH, and would be one of 
my priorities if confirmed. NIH has a number of initiatives and 
activities dedicated to addressing maternal health. The Implementing a 
Maternal Health and Pregnancy Outcomes Vision for Everyone (IMPROVE) 
Initiative supports research to reduce preventable causes of maternal 
deaths and improve health for women before, during, and after delivery 
with a special emphasis on health disparities and populations that are 
disproportionately affected, such as racial and ethnic minorities, very 
young women and women of advanced maternal age, and people with 
disabilities. I want to reiterate too that NIH's role isn't just to 
identify medical care innovation and understand the best treatment, but 
to contribute to efforts that ensure that we can deliver that care and 
treatment to all people who need it in a way that is affordable and 
accessible. This is critically important for maternal health care, 
especially in communities of color who have been impacted by the 
maternal health crisis.

    Question 2. Dr. Bertagnolli, what is your philosophy toward 
entering into public-private partnerships and, if confirmed, what will 
your approach to these partnerships be?

    Answer 2. The NIH funds primarily basic, translational, and early 
stage clinical research and relies on partnership with private sector 
to bring discoveries to market. Public-private partnerships can be an 
effective tool for ensuring that the research that NIH conducts is 
translated into techniques and treatments that improve the health 
outcomes for people across the United States. My experience as 
researcher and as Director at the NCI only underscores and validates 
this view for me. I look forward to working with you to ensure that 
public private partnerships at NIH reflect a balanced partnership 
between the private sector and the American people.

    Question 3. Valley Fever is an infection caused by a fungus 
primarily found in the soil of the semi-arid desert regions of the 
southwestern United States, including Colorado. Thanks to climate 
change, Valley Fever has been diagnosed in every state. When the soil 
is disturbed, the fungus can become airborne and inhaled, ultimately 
causing infection.

        a. Last year, the World Health Organization released a 
        troubling report identifying the top fungal priority pathogens 
        to serve as a guide to research, development, and public 
        health. Listed among those priority pathogens, were 
        coccidioides (Valley Fever). Studies have used climate 
        projections to model Valley Fever's expanding geographical 
        range. It found that by 2100, the affected areas will more than 
        double, and the number of people who will become sick will 
        increase by 50 percent.

        b. Given these alarming projections, do you agree that Valley 
        Fever poses a real threat to human and animal health?

    Answer 3. The National Institute of Allergy and Infectious Diseases 
(NIAID) is committed to advancing research on Valley fever, including 
the development of a safe and effective Valley fever vaccine. The 
increasing threat that Valley fever poses to public health underscores 
the urgent need for the development of safe and effective medical 
countermeasures. If confirmed, I look forward to working with you to 
advance this research.

                             senator markey

    Question 1. It is estimated that in 2021 around 2.5 million adults 
in the U.S. had an opioid used disorder. Medication-assisted treatment 
(MAT) has been proven to be safe and effective in treating opioid use 
disorders (OUDs), yet research published in August 2023 in the Journal 
of the American Medical Association found that only 1 in 5 adults 
received MAT to threat their OUD. Last year, Dr. Nora Volkow, Director 
of the National Institute on Drug Abuse, affirmed that American doctors 
should ``absolutely'' be allowed to prescribe methadone directly to 
patients. Allowing physicians who are board certified in addiction 
medicine and addiction psychiatry to prescribe methadone is consistent 
with the bipartisan Modernizing Opioid Treatment Access Act.

        a. How will you commit to working across agencies to implement 
        research findings at NIH to improve access to OUD medications 
        like methadone?

    Answer 1. The opioid crisis has been devastating for so many 
communities and if confirmed, I look forward to working with you and my 
colleagues across the Administration to combat this crisis. I agree, 
there is a need to continue to expand access to evidence-based 
treatments for opioid use disorder (OUD), and increase access to 
naloxone for overdose reversal. With funding from the NIH HEAL 
Initiative, NIDA has significantly expanded its support of rapid, 
multi-site clinical trials; medication development; implementation 
science; and additional priority areas to address the overdose crisis.

    Question 2. This summer was the hottest ever recorded; 21 of the 30 
hottest days ever recorded occurred in July of this year alone. Climate 
change not only wreaks havoc on our physical environment, but on our 
individual health and our health systems. Extreme heat is responsible 
for almost 235,000 emergency department visits and over 56,000 hospital 
admissions, resulting in almost $1 billion in associated health care 
costs. How would you lead the NIH in approaching climate change from a 
public health perspective from a strategic and funding perspective?

    Answer 2. Everyone is affected by the changes we are seeing in the 
climate. Climate change is creating new risks to human health, safety, 
quality of life, and economic growth. NIH launched the Climate Change 
and Health Initiative (CCHI) in December 2021 and expanded the research 
portfolio with fiscal year 2023 funds to understand health impacts, 
inform intervention science, and ensure health equity to develop the 
knowledge communities need to adapt and prevent further health impacts 
from climate disasters. The Initiative is funding transdisciplinary 
biomedical research and training to build a diverse workforce that can 
identify risks, optimize mitigation health benefits, and develop 
interventions to reduce or prevent impacts from climate change. This 
NIH-wide initiative on Climate and Health is just one way the NIH is 
moving toward integrating data on environmental factors more completely 
into our studies of many diseases. If confirmed, I look forward to 
working with you to address the public health aspects of climate 
change.

    Question 3. Massachusetts was recently selected to be one of ARPA-
H's two satellite hubs. The Investor Catalyst Hub will allow for 
collaboration among researchers, entrepreneurs, and investors to 
facilitate innovative health research and expedite breakthroughs in 
medical research. How do you plan to leverage NIH's new agency, ARPA-H, 
and the innovation hubs to facilitate research into emerging 
technologies, including artificial intelligence and machine learning?

    Answer 3. ARPA-H was proposed as a new entity in the fiscal year 
2022 President's Budget Request and was established in the Consolidated 
Appropriations Act, 2022. ARPA-H has a distinct, but complementary 
mission to NIH. If confirmed, I look forward to continuing to work 
closely with ARPA-H to ensure there is effective coordination on 
research as well as leveraging expertise of both organizations.

                             senator casey

    Question 1. The National Institute of Minority Health and Health 
Disparities recently designated people with disabilities as a ``health 
disparities population.'' This was a highly sought after designation by 
the diverse disability communities across the country. The designation 
has the potential to address a decades-long wrong of excluding people 
with disabilities as a population to be included in health research. 
What steps will you take to implement the designation and to ensure 
people with disabilities in the research conducted across all NIH 
institutes and their activities?

    Answer 1. This designation recognizes the importance and need for 
research advances to improve our understanding of the complexities 
leading to disparate health outcomes and multilevel interventions and 
is one of several steps NIH is taking to address health disparities 
faced by people with disabilities and ensure their representation in 
NIH research. I also want to stress that as a mother of a son with 
disabilities, this is an important issue to me on a personal and 
professional level and if confirmed, I look forward to working with you 
to ensure people with disabilities are included in research conducted 
across NIH.

    Question 2. I have heard from many patients and families about the 
terrible burden of sepsis--children who have died, adults who have lost 
limbs, and other serious outcomes. There are common themes to their 
stories: misdiagnosis, delayed diagnosis, and racial and age 
disparities in outcomes for sepsis patients. How can the NIH contribute 
to a better understanding of the causes of sepsis, and further the 
timely identification and treatment of sepsis for all sepsis patients?

    Answer 3. NIH supports many studies focused on sepsis, some of 
which are clinical trials that will evaluate the effectiveness of 
potential treatments. Other scientists seek molecular clues in 
patients' blood that could diagnose sepsis early or predict who might 
be more prone to the condition, allowing doctors to prevent it. Some 
try to find ways to estimate when and how a sepsis patient's condition 
will decline, or if a certain therapy is appropriate for particular 
patients. Still others examine sepsis in specific populations, such as 
premature babies; people with known risk factors, such as diabetes, 
cancer, or kidney or liver disease; or long-term sepsis survivors. If 
confirmed, I look forward to continuing to working with you on this 
issue.

    Question 3. We know that early screening and detection of cancer is 
critical to ensure timely treatment, but many people either aren't 
receiving recommended screenings on time, or experience delays between 
screening and diagnosis. If you are confirmed, what further actions do 
you believe NIH can take to advance our research and practice of early 
screening for different types of cancer, and where do you see the 
greatest potential for improvement?

    Answer 3. This is a critically important issue. As a breast cancer 
patient myself, I know that my own hopeful prognosis is directly linked 
to the fact that I caught this disease in its early stages. Increasing 
uptake of cancer screening is an important priority across the National 
Cancer Institute (NCI). NCI supports several key programs, 
partnerships, and individual research grants that aim to increase 
screening access and uptake. To give one example of many, the 
``Accelerating Colorectal Cancer Screening and Follow-up through 
Implementation Science (ACCSIS)'' Program is a Cancer Moonshot 
Initiative that supports research to improve colorectal cancer 
screening, follow-up, and referral for care among populations that have 
low colorectal cancer screening rates. NCI is also supporting several 
research efforts to reduce barriers and increase uptake of cervical 
cancer screening, including in rural areas. Activities to increase 
cancer screening in rural regions are also part of NCI-Designated 
Cancer Centers' Community Outreach and Engagement efforts. There 
continues to be critical work in this field that NIH is well equipped 
to lead.

                             Senator Lujan

    Question 1. Minority-Serving Institutes (MSIs) are institutions of 
higher education that serve significant percentages of students from 
historically underrepresented communities. MSIs are unique in that they 
all support the common mission of meeting the needs of the communities 
they serve to ensure access and retention among institutions of higher 
education.

        a. How can the NIH support and leverage MSI strengths and 
        capabilities to ensure they are able to keep up with other 
        large research institutions and contribute to the larger 
        biomedical research enterprise? What would you do as NIH 
        Director to better support MSIs?

    Answer 1. Increasing diversity both in the communities that NIH 
serves and in researchers and scientists who make up NIH is a top 
priority for me. Throughout my career I have worked with diverse 
communities and different types of providers. We know that a diverse 
research staff like a diverse care staff brings scientific excellence 
and brings better outcomes for the people that we serve.

    The Research Centers in Minority Institutions (RCMI) program 
develops and strengthens the research infrastructure necessary to 
conduct state-of-the-art biomedical research and foster the next 
generation of researchers from underrepresented populations. It 
provides grants to institutions that award doctoral degrees in the 
health professions or health-related sciences and have a historical and 
current commitment to serving students from underrepresented 
populations. If confirmed, I look forward to working with you to better 
support MSIs and other efforts to support underserved communities.

    Question 2. Valley Fever is an infection caused by a fungus 
primarily found in the soil of the semi-arid desert regions of the 
southwestern United States, is endemic in New Mexico, and has been 
diagnosed in every state. When the soil is disturbed, the fungus can 
become airborne and inhaled, ultimately causing infection.

        a. Last year, the World Health Organization released a report 
        identifying the top fungal priority pathogens to serve as a 
        guide to research, development, and public health. Listed among 
        those priority pathogens, were coccidioides (Valley Fever).

        b. Given these reports, do you agree that Valley Fever poses a 
        real threat to human and animal health? Do you commit to 
        prioritizing research to prevent and treat Valley Fever and 
        other fungal infections?

    Answer 2. The National Institute of Allergy and Infectious Diseases 
(NIAID) is committed to advancing research on Valley fever, including 
the development of a safe and effective Valley fever vaccine. The 
increasing threat that Valley fever poses to public health underscores 
the urgent need for the development of safe and effective medical 
countermeasures. If confirmed, I look forward to working with you to 
advance this research.

    Question 3. In the past decade, we have seen a growing body of 
research pointing to promising implications for the use of psilocybin-
assisted therapy in the treatment of mental health. When it comes to 
improving and expanding access to mental health treatment, I am in 
favor of thinking creatively.

        a. How can NIH expand the resources available for research 
        focusing on psilocybin-assisted therapy, and would you be 
        supportive of such measures as director?

    Answer 3. I enjoyed the opportunity to talk with you about this 
issue during our meeting this summer. Natural therapies such as 
psilocybin offer a new and interesting avenue for research. We can and 
we must do more to address mental health issues and trauma in 
Americans, and that includes research into new treatments.

    Some types of psychedelic drugs, such as psilocybin, have shown 
promise as therapies for treatment-resistant depression and post-
traumatic stress disorder. Important research questions remain, and the 
NOH funds more than 70 currently active projects on the therapeutic use 
of psychedelics. If confirmed, I look forward to working with you on 
this issue.

    Question 4. Diet-related diseases including obesity, diabetes, high 
blood pressure, heart disease, and stroke disproportionately impact our 
Native communities.

        a. As Director, how will you advance NIH's research investments 
        in nutrition security, diet-related diseases, and diet-related 
        health disparities in the U.S.?

    Answer 4. This is a critical issue and if confirmed, I look forward 
to working with you to address diet-related diseases, as well as other 
areas where Native communities are facing disparate impacts. Health 
conditions linked to poor diet constitute the most frequent and 
preventable causes of death in the U.S. and are major drivers of health 
care costs. The Office of Nutrition Research (ONR) lead NIH-wide 
coordination and development of new collaborations focused on nutrition 
research within and outside NIH. ONR's Food Is Medicine Initiative 
includes support for nutrition science research addressing medically 
tailored meals and groceries, produce prescriptions, nutritious food 
referrals, culinary medicine programs, and teaching kitchens.

    I will also add that from my current position as the director of 
the National Cancer Institute, the rising obesity epidemic is one of 
the major causes of cancer in the United States. We recognize this, and 
there's been a tremendous amount of work done by NCI to identify the 
ideology of this--how obesity drives cancer and how that can be 
overcome.

    Question 5. The topic of diet and its impact on our health does not 
belong in a silo and is one in which we must work across all of the 
institutes.

        a. In 2015, the NIH announced plans to end chimpanzee research 
        and retire all government-owned chimpanzees in laboratories to 
        sanctuary following an Institute of Medicine report that 
        determined that chimpanzees are unnecessary for most biomedical 
        and behavioral research. As you may know, there are still 28 
        chimpanzees stuck at the Alamogordo Research Facility in New 
        Mexico after the NIH reversed its decision and announced in 
        2019 that it will not be retiring government-owned chimpanzees 
        to sanctuary.

        b. What is your plan as Director to carry out the promise made 
        by the NIH to retire all chimpanzees to sanctuary as the CHIMP 
        Act (passed by Congress in 2000 and reauthorized in 2013) 
        requires by law?

    Answer 5. I appreciated the chance to learn about this issue during 
our conversation this summer and I am committed to carrying out the 
goals of the CHIMP Act to ensure that these chimpanzees get the 
sanctuary and care they deserve.
                                 ______
                                 
Response by Monica Bertagnolli to Questions of Senator Cassidy, Senator 
   Paul, Senator Collins, Senator Murkowski, Senator Braun, Senator 
         Marshall, Senator Tuberville, Mullin and, Senator Budd
                            senator cassidy
    Leadership and Vision

    Question 1. During your nomination hearing, I asked you about your 
ability to lead NIH through its next phase. This will require effective 
leadership that can make policy decisions and stand up for the best 
interests of the agency and the patients NIH research serves.

        a. What role does the NIH Director have in making policy 
        decisions for the agency?

        b. If confirmed, how will you make policy decisions for the 
        agency?

        c. Will you defer to the White House and other political 
        appointees at the Department of Health and Human Services?

    Answer 1. The NIH Director is responsible for ensuring that the 
overall NIH community never loses sight of the core principles that 
guide the NIH's mission: to seek fundamental knowledge about the nature 
and behavior of living systems and the application of that knowledge to 
enhance health, lengthen life, and reduce illness of people across the 
United States. If confirmed as NIH Director, I will always make 
decisions, with full fidelity to the laws passed by Congress and signed 
by the President, that serve to further this mission.

    Question 2. If confirmed, what will your top priorities be as NIH 
director?

    Answer 2. If confirmed to serve as NIH director, my top priorities 
include:

          Ensuring that NIH supports research that is equitable 
        and accessible to all populations--that includes dramatically 
        increasing clinical trials that reflect the diversity of 
        Americans because we know that's what yields the best 
        scientific results. This is critical to capitalizing on new 
        innovations in uncovering fundamental biology, in health 
        information technology, and in exciting new data analytics. And 
        we must interrogate the broad range of behavioral and social 
        science challenges we face today while laying the foundation to 
        study and address new issues that will arise in the future.

          Embracing and increasing access to innovation. As a 
        physician-researcher for more than 30 years, I have seen the 
        transformative power of NIH research to produce results that 
        save lives, but I've also seen the patients whose prospects 
        were compromised by preventable factors. We should be able to 
        guarantee that the American people are getting a return on 
        their investment by ensuring that healthcare innovations are 
        available and affordable for everyone.

          Restoring faith and trust in our Nation's top 
        scientists and scientific integrity. I am committed to ensuring 
        that NIH continue to be the stewards of our Nation's medical 
        research and a force of innovation and discovery. We must also 
        continue to support education in all fields of biomedical 
        research and to inspire young people to become doctors and 
        scientists, so that our critically important work will continue 
        for generations.

    Question 3. What specific actions will you take in your first few 
months as director to achieve each of these priorities?

    Response: If confirmed as NIH Director, I would take the following 
actions to address each priority:

          Ensuring that NIH-supported research is equitable and 
        accessible to all populations: This goal must be embraced 
        across all NIH programs. To ensure this, I will first work with 
        the Director of NIH's National Institute on Minority Health and 
        Health Disparities to develop and disseminate a set of guiding 
        principles that all NIH program leaders can adopt to achieve 
        this goal. This goal and principles for execution will be 
        addressed in all of my initial planning meetings with NIH 
        Institute and Center Directors, and I will require each to 
        provide a plan for how their Institute or Center will make 
        significant progress to eliminate health inequities. Finally, 
        if confirmed as NIH Director, I will monitor progress toward 
        this critical goal throughout my entire tenure and hold all 
        leaders accountable for progress.

          Embracing and increasing access to innovation: If 
        confirmed, I will lead with the mandate that every effort 
        undertaken by NIH must be viewed through the lens of ``how does 
        this directly and significantly improve the health of our 
        Nation?''. This means that, beginning with the initial planning 
        phases, I will require that every major project consider and 
        account for how, if successful, its products and services will 
        be effectively adopted by the Nation's biomedical research and 
        health care delivery communities to serve all who can benefit.

          Restoring faith and trust in our Nation's top 
        scientists: The NIH Director has a powerful position as the 
        leader of the world's largest biomedical research institute. It 
        is critical that the Director use this position to engender 
        trust by ensuring that all funds received from the American 
        people are responsibly managed to provide clear and tangible 
        benefits to our citizens, that all NIH activities are conducted 
        according to the highest possible ethical standards, and that 
        NIH work is executed in a transparent and accountable manner. 
        If confirmed, one of my first actions will be to broadly 
        communicate NIH's commitment and my personal commitment to 
        these principles. In addition, I consider our front-line health 
        care providers and educators to be key partners in restoring 
        people's trust in science. If confirmed, I will develop a 
        program to engage and support these partners so that they are 
        able to communicate the value of biomedical research widely and 
        effectively.

    Question 4. Based on your time at NCI and your career as an 
investigator, do you see any specific opportunities for improvement 
within NIH or areas in need of reform? If so, please explain in detail.

    Answer 4. There are always opportunities for reform and improvement 
and, if confirmed as NIH Director, I look forward to helping lead NIH 
during this next phase. I believe we need a major focus on our clinical 
trial operations so that clinical trials can be better, faster, and 
more inclusive of the population which we serve.

    We also need to pay attention to our data collection and use 
throughout all of NIH and do an assessment of who we are reaching to 
understand how we can continually track and monitor progress to address 
disparities.

    In addition, I want to carefully revisit the distribution of 
funding to institutions and individuals across the U.S. with a focus on 
making sure we buildup outreach to Institutional Development Award 
(IDeA) states and other research teams that have been historically 
under supported by NIH. NIH research has to reach everywhere; and there 
are many, many centers of great excellence across the country that we 
should engage in order to most effectively advance science.

    Question 5. As you know, NIH has a decentralized structure in which 
individual institute and center directors retain substantial power.

        a. How do you intend to navigate this dynamic as NIH director 
        and lead the agency as a whole?

    Answer 5. I firmly believe collaboration with and between the 
individual institutes and centers will be critical. As NIH Director, I 
intend to put forward a new initiative on data sharing which will 
establish the policies and infrastructures as well as the central 
support system to allow institutes and centers to better coordinate and 
share data from the broad research community.

    I also believe there is an opportunity to reimagine the National 
Library of Medicine as a knowledge center for the world. Finally, there 
is an opportunity for NIH to lead in developing best practices on how 
to leverage artificial intelligence and machine learning. These 
activities, alongside many others, will help eliminate silos and ensure 
that we are maximizing NIH to its fullest potential.

    Question 6. Under current law, NIH is required to maintain a 
Scientific Management Review Board (SMRB) to advise on NIH's structure 
and operations. However, the SMRB was last chartered in 2011 and has 
not been effectively leveraged.

        a. Will you commit to reestablishing and fully utilizing the 
        SMRB?

        b. If so, what specific areas related to NIH's structure and 
        operations would you charge the SMRB with reviewing?

    Answer 6. If confirmed, I commit to review the groups that advise 
the NIH Director to ensure that we can ensure that NIH's operation and 
structure is run effectively with the maximum benefit to the American 
people.

    Question 7. One of the statutory functions of the NIH director is 
to conduct priority-setting reviews and provide direction on institute 
and center operations.

        a. What steps will you take to carry out these 
        responsibilities, if confirmed?

        b. What criteria will you apply to prioritize institutes and 
        centers for review?

    Answer 7. If confirmed, I commit to ensuring proper stewardship of 
taxpayer funds. NIH priority setting principles include funding 
meritorious science, portfolio balance, and balancing public health 
needs with scientific opportunities. Scientific priority setting at NIH 
encourages input from a range of sources, including the research 
community; public forums; the Advisory Committee to the NIH Director; 
U.S. Congress; Administration objectives; and consultation with 
advocacy groups, professional societies, and research participants. The 
NIH Director provides overall leadership to the Institutes and Centers 
(ICs) and the Office of the Director (OD) offices, especially on 
efforts involving several components of the agency. Strategic plans 
developed by individual ICs and OD offices, committees composed of 
representatives from multiple ICs, and interagency working groups 
describe a multitude of scientific priorities and themes of interest to 
the agency. If confirmed, my guiding principle will be to conduct all 
of these activities in a manner that achieves maximal health benefits 
to the American people and the world.

    Question 8. You've spoken about your interest in establishing 
agency-wide systems to leverage data analytics, artificial 
intelligence, and machine learning.

        a. How will you balance these goals with protecting the privacy 
        and security of human subject data and ensuring appropriate 
        informed consent?

    Answer 8. Data science is foundational to NIH's acceleration of 
biomedical research. NIH supports innovative technologies and promotes 
best practices in data science to streamline data access, facilitate 
data management, and enhance data interoperability through the adoption 
of data standards, the use of unique persistent identifiers, and common 
data elements. NIH supports capabilities to broaden the use of clinical 
and healthcare data while preserving participants' anonymity and 
enhancing informed consent. New technologies capture and analyze the 
rich and abundant data from wearable monitors as an integral component 
of telehealth and are collected in the All of Us program and others.

    I also want to emphasize the importance of informed consent and 
individual participation in the research process as fundamental to our 
strategy. In addition, data safety and security of data are critical, 
and we must take all required measures to assure this. If confirmed, I 
look forward to working with you to ensure that while we enhance our 
data science capabilities, that we also protect the privacy and 
security of individuals while continuing to collaborate and data-share 
to further break down silos at NIH.

    Bioethics Issues

    Question 9. Do you believe that Congress, or NIH and the scientific 
community, should set the policy for whether embryonic stem cells or 
fetal tissue are acceptable to use in research?

    Answer 9. As NIH Director, I will follow the laws, including with 
respect to this type of research.

    Question 10. What safeguards would you use to ensure that human 
fetal tissue is used as a last resort?

    Answer 10. If confirmed, I commit to fully upholding the principles 
and established standards of ethical human research. I recognize and 
appreciate the great sensitivity and passionate feelings of many people 
on the issue of fetal tissue research, and I want to be respectful of 
that. As I shared before the Committee, it is my belief that my job is 
to serve everyone, including the communities who care deeply about how 
fetal tissue is used. As NIH Director, it is my responsibility to 
follow the laws of the land in every aspect and ensure that while we 
work to achieve the maximal good for people, we do so in a way that 
follows our principles of review and oversight of fetal tissue.

    Question 11. During your nomination hearing, you said you would 
lean upon the principles of ethical human subjects research and 
institutional review boards (IRB) to ensure that fetal tissue research 
is conducted appropriately. However, as is clear in the findings of 
NIH's Human Fetal Tissue Research Ethics Advisory Board in Fiscal Year 
2020, even proposals that successfully pass IRB and peer review can 
lack sufficient ethical protections, particularly around informed 
consent.

        a. If you continue to permit the use of fetal tissue in 
        research, how specifically would you ensure NIH-funded 
        researchers are doing so in a responsible and consistent 
        manner?

    Answer 11. If confirmed, I commit to prioritizing this issue and as 
a first step, reviewing the findings of the NIH's Human Fetal Tissue 
Research Ethics Advisory Board in Fiscal Year 2020 as well as providing 
review when future fetal tissue research comes before the NIH for 
review to assure fidelity to the highest ethical standards.

    Question 12. In your role at NCI, is there currently or has there 
been past work done with embryonic stem cells?

    Answer 12. The NIH Research Online Reporting Tools (RePORT) 
includes reporting on NIH-supported research projects by various 
research topics and categories. This includes reporting on projects 
studying human embryonic stem cells and non-human embryonic stem cells 
to advance biomedical research across diseases and conditions, 
including cancer. This response addresses NCI-supported research 
projects utilizing human embryonic stem cells. In fiscal year 2022, the 
last year for which NIH has final data, the Institute supported twenty-
four projects involving human embryonic stem cell research. Projects 
were supported based on scientific merit and in accordance with NIH 
policies.

    Question 13. In your role at NCI, is there currently or has there 
been past work done with fetal tissue?

    Answer 13. In fiscal year 2022, the institute supported five 
projects studying human fetal tissue to advance cancer research. 
Projects were supported based on scientific merit and in accordance 
with NIH policies.

    Question 14. Have you conducted research in your personal capacity 
using fetal tissue or embryonic stem cells?

        a. If so, please provide the dates such research was conducted 
        and the outcome of this research.

    Answer 14. I have never used embryonic stem cells. I used fetal 
tissue once in approximately 1988 under the direction of a senior 
scientist when I was a trainee in a research lab in the Department of 
Tumor Immunology at the Dana Farber Institute. The research studied how 
T cells could be programmed to eliminate tumors. As a first step, we 
needed to understand how T cells could be programmed to eliminate 
abnormal cells and the only way to do that was to look at T cells of 
fetal tissue because these had not yet encountered any type of abnormal 
or ``foreign'' cell. The result was that we found no difference in the 
way fetal T cells responded to our approaches to eliminate tumors than 
in regular adult T cells and, as a result, we did not do any further 
research using fetal tissue.

    Question 15. If confirmed, will you continue to allow NIH-funded 
research to use NIH-approved embryonic stem cell lines? If so, why?

    Answer 15. If confirmed as NIH Director, it is my responsibility to 
follow the laws and ensure that, as we work to achieve the maximal good 
for people, we do so in a way that follows our principles.

    Question 16. On August 31, a new stem cell line was submitted for 
NIH review. There are already 502 NIH-approved stem cell lines.

        a. What is the scientific value of continuing to approve new 
        lines?

        b. At what point do you believe there will be enough stem cell 
        lines?

        c. What steps can NIH take to advance the transition away from 
        using embryonic stem cells and fetal tissue in biomedical 
        research?

    Answer 16. Newer human embryonic stem cell lines are being derived 
under conditions that are better for clinical use, such as reduced 
exposure to animal products. Future embryonic stem cell lines may also 
have mutations associated with particular diseases and enable research 
on those disease mechanisms.

    We do not know where the next cure or treatment will come from, and 
maximizing access to diverse tools, methods, and experimental systems 
is critical for enhancing the likelihood of success in advancing the 
NIH mission. I am committed to upholding the highest standards in 
research as a responsible steward of public funds.

    Question 17. This March, you retweeted a tweet from the official 
HHS Twitter account stating that ``transgender health care is health 
care. PERIOD.''

        a. Do you stand by this tweet?

    Answer 17. As shared in my opening statement, I believe we must 
provide care for all people, including trans individuals, to ensure 
that they can live healthy and productive lives. How to best achieve 
these outcomes is a private decision between a doctor and their 
patient.

    Question 18. If so, please explain. You have suggested that you 
would permit NIH to proceed with research on transgender youth, citing 
a lack of available science. As you know, I have expressed serious 
concerns about an NIH-funded observational study on transgender youth 
where two participants died by suicide.

        a. How would you ensure that future studies on this issue, 
        especially involving children, would be safe and live up to 
        ethical scrutiny?

    Answer 18. Like you, I share deep concern over the mental health of 
young people, particularly those in the LGBTQ+ community who face 
unique challenges. If confirmed, I will ensure that NIH takes seriously 
the protection of participants in NIH-funded clinical research while 
also better understanding the impact of medical treatment in 
transgender youth.

    Question 19. While I appreciate that NIH has to date only funded 
observational studies related to transgender youth, NIH is responsible 
for the health and well-being of all participants in NIH-funded 
research. The use of observational studies rather than interventional 
studies does not absolve NIH and its investigators of this 
responsibility.

        a. What specific steps will you take as director to ensure that 
        participants in taxpayer funded NIH studies, including 
        observational research, are fully protected in keeping with the 
        spirit of the Common Rule, not just complying with the letter 
        of the law?

    Answer 19. If confirmed, I will ensure that NIH takes seriously the 
protection of participants in NIH-funded clinical research while also 
better understanding the impact of medical treatment in transgender 
youth. To underscore this, I firmly believe any research that we do 
with regard to human subjects has to be done in a way that does no harm 
and produces the maximum benefit to the people that are participating 
in the research. And that will be the principle with which I approach 
any research, especially for this vulnerable population.

    Question 20. As a researcher, do you believe that biological sex is 
a relevant variable that must be considered in biomedical research?

    Answer 20. Consideration of biological sex may be critical to the 
interpretation, validation, and generalizability of research findings. 
Adequate consideration of all sexes in experiments and disaggregation 
of data by sex allows for sex-based comparisons and may inform clinical 
interventions. Appropriate analysis and transparent reporting of data 
by sex may therefore enhance the rigor and applicability of preclinical 
biomedical research. NIH expects that sex as a biological variable will 
be factored into research designs, analyses, and reporting in 
vertebrate animal and human studies.

    Question 21. As the head of NIH, would you maintain the current 
policy that requires biological sex be factored into research design, 
analysis, and reporting?

    Answer 21. Consideration of sex may be critical to the 
interpretation, validation, and generalizability of research findings. 
Adequate consideration of both sexes in experiments and disaggregation 
of data by sex allows for sex-based comparisons and may inform clinical 
interventions. Appropriate analysis and transparent reporting of data 
by sex may therefore enhance the rigor and applicability of preclinical 
biomedical research. NIH expects that sex as a biological variable will 
be factored into research designs, analyses, and reporting in 
vertebrate animal and human studies.

    Question 22. How will you ensure that research is not compromised 
as a result of external pressures to regard sex as a social construct 
versus a biological variable?

    Answer 22. As listed on nih.gov, sex is a biological category based 
on reproductive, anatomical, and genetic characteristics, generally 
defined as male, female, and intersex. Meanwhile, gender is a social 
construct that varies from society to society and can change over time. 
As NIH director, I look forward to prioritizing the importance of 
studying LGBTQ+ communities, a population that has been historically 
understudied.

    Other Policy Issues

    Question 23. NIH funding for obesity and related research is 
significantly low relative to the burden of disease in the United 
States. This is particularly concerning, given that obesity strongly 
correlates with other diseases and conditions in which NIH invests 
billions each year.

        a. If confirmed, how will you prioritize obesity, from basic 
        science to clinical research, across NIH and improve the output 
        of existing NIH funding for this work?

    Answer 23. From my current position as the Director of the National 
Cancer Institute (NCI), I recognize that obesity and the rising obesity 
epidemic is one of the major causes of cancer in the United States. 
There has already been significant work done by NCI to identify the 
etiology of this--how obesity drives cancer and how that can be 
overcome. Much more needs to be done, however, for cancer as well as 
for many other disease states associated with obesity and metabolic 
syndrome. If confirmed, I can assure you that this is an area where we 
will work across all of the Institutes to address this problem.

    Question 24. Your predecessor made a commitment to retire all NIH-
owned and--supported chimpanzees to the Federal sanctuary at Chimp 
Haven in Louisiana, as mandated by the CHIMP Act.

        a. How do you plan to prioritize the transfer of the remaining 
        chimps at Alamogordo Primate Facility, as well as other 
        facilities that still possess NIH-owned or NIH-supported 
        chimpanzees, to their long overdue retirement at Chimp Haven?

    Answer 24. I remain committed to carrying out the goals of the 
CHIMP Act to ensure that these chimpanzees get the sanctuary and care 
they deserve.

    Question 25. How can we support the recruitment and retention of 
young investigators?

        a. What specific strategies would you consider implementing to 
        accomplish this goal?

    Answer 25. My greatest accomplishment to date has been helping 
train the next generation of scientists. These are the physicians, 
surgeons, and scientists who are tackling the most ambitious and 
complex issues in medicine today. As a clinical researcher, I know what 
it takes day-to-day to run laboratories on the cutting edge of science 
and as a leader, I've been proud to help harness structural changes at 
hospitals and institutions to make sure that we are bringing these 
treatments to Americans as effectively and efficiently as possible.

    NIH has various programs to enhance support of early career and 
postdoctoral researchers. This is a top priority for me, and I look 
forward to working with you to further cultivate and support talent 
entering the biomedical and behavioral research workforce.

    Question 26. How can NIH be more supportive of researchers from 
outside the traditional NIH grantee community who want to contribute to 
cross-cutting biomedical research?

    Answer 26. NIH is committed to funding meritorious research, 
regardless of the source of the proposal. If confirmed, I will remain 
committed to increasing equity of the research we fund. Notably, NIH 
just announced simplified peer review criteria which has the goal of, 
among other things, minimizing the effect of reputational bias and 
ensuring the best proposals from a scientific perspective rise to the 
top.

    Question 27. How will you bolster cybersecurity protections across 
the agency, particularly related to research participant data?

    Answer 27. Data science is foundational to NIH's acceleration of 
biomedical research. NIH supports innovative technologies and promotes 
best practices in data science to streamline data access, facilitate 
data management, and enhance data interoperability through the adoption 
of data standards, the use of unique persistent identifiers, and common 
data elements. NIH supports capabilities to broaden the use of clinical 
and healthcare data while preserving participants' anonymity and 
enhancing informed consent. New technologies capture and analyze the 
rich and abundant data from wearable monitors as an integral component 
of telehealth and are collected in the All of Us program and others. If 
confirmed, I will require optimal safety and security procedures for 
all sensitive data, and, as this landscape is constantly shifting, I 
look forward to working with you to ensure we have the right balance of 
data and security.

    Question 28. What opportunities do you see to improve NIH's 
relationships and collaborations with other agencies?

    Answer 28. NIH's collaborative efforts with other HHS agencies as 
well as across government are vital to transforming fundamental 
scientific and technical information into effective, knowledge-based 
approaches that advance the health and safety of the public, such as 
disease treatments, preventive interventions, protective health 
policies and regulations, and public health campaigns. In turn, the 
information provided by other HHS agencies on public health needs 
informs the policies and priorities of NIH-funded research. If 
confirmed, I look forward to working with my colleagues across HHS and 
the U.S. Government to improve the health of the American people.

    Question 29. How can NIH help better position the U.S. 
internationally, particularly in the context of China and other 
countries' biotech ambitions?

    Answer 29. As the world grows increasingly connected, NIH remains 
committed to developing and sustaining relationships with partners 
around the globe. Recent events, including the COVID-19 pandemic, have 
illuminated the importance of a coordinated approach to global health 
aligned with humanitarian and scientific values. Geographic boundaries 
do not prevent infectious disease spread, nor should they prevent the 
advancement of research on such diseases. For this reason, NIH 
collaborates internationally with foreign governments and 
organizations.

    The safety, security and health of our people are our highest 
concern, and as we work across borders, it is imperative that NIH 
uphold the highest standards of oversight and accountability while 
continuing to further NIH's leadership as the world's premier medical 
research institute.

    Question 30. As you likely know, Louisiana is an Institutional 
Development (IDeA) Program state, as are many states represented on 
HELP. Despite these investments in research capacity building, no 
Louisiana institutions rank in the top 50 NIH funding recipients, and 
relatively few institutions in the top 50 represent rural or 
underserved patients. While you've spoken generally about your 
commitment to making sure NIH research reaches more Americans, I would 
like more specifics.

        a. How specifically will you work to more evenly distribute NIH 
        extramural research funding across the country?

    Answer 30. Growing up on a ranch in Wyoming, I have seen firsthand 
what it means to deliver care to those living in rural communities. NIH 
can and must support research that is equitable and accessible to all 
populations, and this will be a top priority of mine. The Institutional 
Development Award (IDeA) has been critical to building research 
capacity, supporting competitive basic, clinical, and translational 
research, faculty development, and infrastructure improvement, in 
states that historically have had low levels of NIH funding. If 
confirmed, I look forward to working with you to continue to make sure 
all states and communities are participating in the research 
enterprise.

    Question 31. You've spoken before about your experience growing up 
in a rural area.

        a. What ideas do you have to improve rural access to clinical 
        trials?

        b. How do you plan to implement these ideas at NIH?

        c. What other opportunities do you see to modernize clinical 
        trials, and how can NIH better coordinate with FDA?

    Answer 31. Growing up on a ranch in Wyoming, I've seen how rural 
communities and underrepresented groups have too often lacked access to 
quality care. When my father had cancer, there was no one within 200 
miles who could get him the care he needed. His story is all too 
familiar and is the story of millions of Americans who can't access or 
afford health care. I've spent my career searching for and implementing 
ways to take our discoveries and turn them into better health for 
people everywhere. As the leader of a large national clinical trial 
collaborative, I have seen firsthand how working with local providers, 
including tribal providers, expands access to patients in rural areas. 
NIH can and must truly support research at the community level, 
research that is inclusive and accessible to all populations regardless 
of county or zip code.

    Question 32. What steps will you take to improve the rigor and 
reproducibility of NIH-funded research?

    Answer 32. Two of the cornerstones of science advancement are rigor 
in designing and performing scientific research and the ability to 
reproduce biomedical research findings. This is a top priority for me 
and if confirmed, I look forward to working with you.

    Question 33. How can NIH research become more outcomes-driven, 
particularly in terms of improving the utility and success of its 
clinical research (e.g. having more NIH-funded trials producing well-
powered results)?

    Answer 33. NIH is committed to supporting clinical research studies 
that are more transparent, efficient, faster, more inclusive, and more 
responsive to the needs of people and build trust. At the heart of 
every clinical study are the study participants who contribute their 
time and energy to help make it a success.

    NIH has long recognized that the public is an equal partner in the 
research it supports, and it is critical to have meaningfully public 
engagement them in the planning, implementation, and dissemination of 
research. In addition, NIH is employing new methodologies and study 
designs to ensure that clinical trials are well-powered and produce 
meaningful results. NIH is committed to enhancing our scientific 
research review process to ensure that the highest quality clinical 
research is funded. If confirmed as NIH Director, I look forward to 
working with the NIH community to uphold these objectives.

    Question 34. What role, if any, do you believe NIH has to play in 
the drug pricing debate?

    Answer 34. The NIH funds primarily basic, translational, and early 
stage clinical research and relies on partnership with private sector 
to bring discoveries to market. I share concerns about high drug prices 
and the burden they place on patients and families, particularly the 
uninsured and the underinsured. Patient access to new therapies is 
something that NIH should be thinking through, including ways to engage 
the community, address broader concerns about price, and ensure good 
stewardship of taxpayer dollars. I look forward to working with you to 
address this issue if confirmed as the NIH Director.

    Question 35. During the hearing you noted that if confirmed as NIH 
director you would work to ensure that the ``benefits of our [NIH] 
research are affordable and available'' to the American people. Given 
that NIH does not have a role in determining access or prices for 
agency-funded products, what actions were you referring to by this 
comment?

    Answer 35. If confirmed, one of my top priorities will be 
increasing access to innovation. As a clinician-researcher for more 
than 30 years, I have seen the transformative power of experimental 
therapy in saving lives, but I've also seen the patients whose cancer 
could have been successfully treated but was compromised by preventable 
factors--including late diagnosis or inability to access or afford 
health care. As we work to bring innovation to patients, we must ensure 
transparency and accountability for taxpayer-funded research, 
guaranteeing that the American people are getting a return on their 
investment with health care innovation that is both accessible and 
affordable.

    Question 36. Several Members of our conference have expressed 
frustration over a lack of transparency from NIH on document request 
and other inquiries related to gain-of-function research.

        a. What steps do you plan to take to improve the responsiveness 
        and transparency of NIH to Congress?

    Answer 36. I deeply respect the oversight functions of Congress and 
its role in improving current policies and programs. I am committed to 
ensuring that NIH is appropriately responsive to congressional 
oversight requests consistent with the constitutionally mandated 
accommodation process.

    Question 37. What opportunities do you see for more targeted 
research on rare and orphan diseases?

    Answer 37. While individual rare diseases are uncommon, they 
collectively affect 25-30 million Americans. NIH has several programs 
that support rare disease research. The National Center for Advancing 
Translational Sciences (NCATS) established the Division of Rare Disease 
Research Innovation, which facilitates and coordinates NIH-wide 
activities involving research for a broad array of rare diseases. This 
division develops and maintains a centralized data base on rare 
diseases, coordinates and liaises with organizations worldwide 
concerned with rare diseases research and orphan products development, 
and advises the Office of the Director on matters related to NIH-
sponsored research involving rare diseases. One example of this 
research is Rare Disease Clinical Research Network, which is funded by 
NCATS and 9 other Institutes and Centers (ICs). If confirmed as NIH 
Director, I intend to continue the important work the agency is doing 
to address rare diseases.

    Question 38. Several years ago, the NIH launched the NIH Pediatric 
Research Consortium to better coordinate pediatric research activities 
across multiple Institutes and Centers.

        a. If confirmed, will you commit to review the activities of 
        the consortium and publicly report on its outcomes, as well as 
        potential process improvements to ensure it is achieving its 
        stated aims and objectives?

    Answer 38. NIH support for pediatric research currently totals more 
than $4 billion. The NIH Pediatric Research Consortium (N-PeRC) aims to 
harmonize these activities across institutes, explore gaps in the 
overall pediatric research portfolio, and share best practices to 
advance science. The consortium meets several times a year to discuss 
scientific opportunities and potential new areas of collaboration, 
including efforts to enhance research training for the next generation 
of pediatricians. If confirmed, I would be pleased to work with you to 
advance pediatric research at NIH.

    Question 39. Currently, policies such as paylines, success rates, 
and impact scores used in the review process vary widely across NIH.

        a. Should NIH take a more unified approach to funding policies 
        across its institutes and centers?

        b. What steps would you take to make NIH's funding strategy 
        more transparent for applicants?

    Answer 39. Following NIH's rigorous two-stage peer review process, 
IC Directors make final funding decisions taking into consideration the 
research program priorities of their ICs in the context of the existing 
funding portfolio. A one-size-fits-all approach may not be successful 
in achieving the goals of each IC. If confirmed, I am committed to 
identifying potential areas in which NIH can be more transparent about 
its funding process and strategy, while following all applicable laws 
and regulations.

    Question 40. Do you anticipate that NIH will change any of its 
operations or focus areas in response to the creation of ARPA-H?

    Answer 40. ARPA-H was proposed as a new entity in the fiscal year 
2022 President's Budget Request and was established in the Consolidated 
Appropriations Act, 2022. ARPA-H has a distinct, but complementary 
mission to NIH. If confirmed, I look forward to continuing to work 
closely with ARPA-H to ensure there is effective coordination on 
research as well as leveraging expertise of both organizations.

    Question 41. How will components of NIH, such as the National 
Center for Advancing Translational Sciences and the Common Fund, that 
also support high-risk high-reward research, differentiate themselves 
from ARPA-H?

    Answer 41. ARPA-H has a distinct, but complementary mission to NIH, 
including the work of the National Center for Advancing Translations 
Sciences and the Common Fund. If confirmed, I look forward to 
continuing to work closely with ARPA-H to ensure there is effective 
coordination on research as well as leveraging expertise of both 
organizations.

    Ethics

    Question 42. If confirmed, do you commit to providing the 
Committee, including minority Members, with information and/or 
documents in the requested timeframe?

    Answer 42. I deeply respect the oversight function of Congress, 
including this Committee, and its role in improving current policies 
and programs. I am committed to ensuring that NIH is appropriately 
responsive to congressional oversight requests consistent with the law 
and the Constitution.

    Question 43. If confirmed, do you commit to providing the 
Committee, including minority Members, with briefing requests from you 
and/or your staff, within the requested timeframe?

    Answer 43. I deeply respect the oversight function of Congress, 
including this Committee, and its role in improving current policies 
and programs. I am committed to ensuring that NIH is appropriately 
responsive to congressional oversight requests consistent with the law 
and the Constitution.

    Question 44. Do you commit to providing the Inspector General and 
the Government Accountability Office with any information, briefings, 
and documents they may request?

    Answer 44. If confirmed as NIH Director, I am committed to working 
in good faith with all entities that are responsible for conducting 
oversight of NIH, including Congress, the Office of the Inspector 
General, and the Government Accountability Office.

    Question 45. Do you commit to not seeking a waiver from your ethics 
pledge?

    Answer 45. As part of the Biden-Harris administration ethics 
pledge, I have committed to recusing myself for 2 years from all 
particular matters involving specific parties involving my former 
employer or former clients. As I do in my current position as NCI 
Director, I will also continue to work with the agency's ethics 
officials--if confirmed--to identify and resolve any potential 
conflicts of interest. Any matters involving specific parties involving 
my former employer or former clients will be handled by the appropriate 
entities at NIH without my participation. If confirmed, I am committed 
to bolstering public trust in government and rendering decisions based 
on the best available data and science.
                              senator paul
    Question 1. Congress is running a $1.7 trillion deficit. The 
Federal debt is about 100 percent of GDP. To address our fiscal crisis, 
I have proposed legislation, the ``five penny plan,'' to apply modest 5 
percent spending reductions across the Federal Government. The NIH has 
a budget of $44 billion, and this year it received a budget increase of 
9 percent. Over its lifetime, the NIH has received average annual 
budget increases of 11 percent. The economy is not growing that fast. 
Taxpayers' incomes are not growing that fast. Can you commit to 
recommending options for reducing NIH spending so that the NIH can do 
its part to eliminate the Federal deficit?

    Answer 1. NIH investment drives growth of the whole biomedical 
research enterprise. Discoveries arising from NIH-funded research 
provide a foundation for the U.S. biomedical industry, which 
contributes over $69 billion to the U.S. GDP each year and supports 
over 7 million jobs. As NIH Director, I commit to always being a 
faithful steward of taxpayer dollars, to ensure we use every penny to 
its fullest extent, and root out waste, fraud, and abuse to ensure 
fidelity to that mission.

    Question 2. How will you address redundancies in research topics 
across the institutes and centers within the NIH to ensure that 
taxpayers receive the maximum benefit for their money?

    Answer 2. I take seriously the stewardship of taxpayer dollars, 
including minimizing redundancy of research. If confirmed, I will work 
with Institute, Center, and Office Directors to consider strategies for 
research prioritization and reducing redundancy, potentially through 
leveraging novel technology.

    Question 3. To compete scientifically with other advanced nations, 
we must not allow science to become politicized or dictated by 
ideology. We advance scientific knowledge by challenging prevailing 
assumptions, yet today it is more difficult to get an NIH grant that 
challenges prevailing (and politically correct) assumptions on a range 
of issues, including (1) the long-term health effects of puberty 
blockers on minors; (2) quality research on whether gender transition 
surgery is beneficial or harmful; (3) randomized controlled studies on 
the efficacy of face masks to prevent the spread of upper respiratory 
viral illnesses such as COVID-19; and (4) randomized controlled trials 
to investigate whether repeatedly getting booster vaccinations against 
upper respiratory viruses such as COVID-19 are effective or whether 
they yield diminishing returns because of immune imprinting and immune 
exhaustion. If confirmed, what policies will you put in place at the 
NIH to prevent or reduce confirmation bias in decisions about issuing 
research grants?

    Answer 3. As scientists, eliminating confirmation bias is one of 
the most important things we can and must do in our line of work. 
Without challenging our preconceived notions, we risk our ability to 
innovate and deliver for the American people. If confirmed as NIH 
Director, I believe it is imperative that I model a transparent 
research atmosphere where colleagues feel comfortable challenging the 
status quo and disagreeing with one another. We must not be afraid of 
hard conversations. If confirmed, I look forward to working with you to 
determine the best policies and practices to deliver on that mission.

    Question 4. As a director of a research funding organization, is it 
appropriate for the NIH Director or any institute director within the 
NIH to advocate for specific public health policies or policies that 
may discourage open scientific debate, as scientists are afraid to 
contradict those that control their research funding?

    Answer 4. This question is paramount to what it means to be a 
leader, both at NIH and beyond. It is the responsibility of NIH 
leadership across the institutes to help inform and shape the issues 
facing Americans health and well-being, while continuing to ensure that 
they foster an environment that allows for disagreement and candid 
discussion.

    Scientists must always encourage open scientific debate and have 
the courage to challenge the status quo. As history has taught us, 
science is always changing, and we must be ready to reevaluate the 
conclusions that came before in light of new evidence. The most 
dangerous attitude in science is one that stifles our ability to 
question. It is my goal to be a role model in this space.

    Question 5. A 2022 Swedish study reviewed ``published data on bone 
development in transgender adolescents, focusing in particular on 
differences in age and pubertal stage at the start of puberty 
suppression, chosen strategy to block puberty progression, duration of 
puberty suppression, and the timing of re-evaluation after estradiol or 
testosterone administration. Results consistently indicate a negative 
impact of long-term puberty suppression on bone mineral density, 
especially at the lumbar spine, which is only partially restored after 
sex steroid administration. Trans girls are more vulnerable than trans 
boys for compromised bone health.'' \1\ Do you believe the long-term 
safety of gender affirming therapy in minors, including pharmaceutical 
administration, has been established by the FDA?
---------------------------------------------------------------------------
    \1\  Ciancia S, Dubois V, Cools M. Impact of gender-affirming 
treatment on bone health in transgender and gender diverse youth. 
Endocr Connect. 2022 Sep 28;11(11):e220280. doi: 10.1530/EC-22-0280. 
PMID: 36048500; PMCID: PMC9578106.

        a. If not, should gender affirming therapy in minors be 
---------------------------------------------------------------------------
        considered experimental and subject to FDA oversight?

        b. Do you believe gender affirming therapy should require the 
        consent of a parent or legal guardian?

    Answer 5. As current NCI Director and NIH Director nominee, I can't 
speak to FDA's role on this issue. If confirmed as NIH Director, my 
role may include providing data on gender affirming therapy and its 
impact, but it would not extend to the parental/guardian consent 
structure of personal medical decision that exist outside of NIH.

    Question 6. Does the NIH fund, request, direct, and/or otherwise 
facilitate classified life sciences research?

    Answer 6. To my knowledge as NCI Director, NIH does not fund, 
request, direct, or otherwise facilitate classified life sciences 
research.

    Question 7. It is widely accepted that pandemics can come from 
nature, from laboratory accidents, or from deliberate releases by 
humans. Are you aware of the NIH or any other agency performing a 
formal cost-benefit analysis to inform decisions on whether to create 
or publicly identify a new potential pandemic pathogen?

    Answer 7. As NCI Director, I am not aware of the NIH or any other 
agency performing such an analysis.

    Question 8. In the past, the NIH has failed to fully comply with 
its requirements for oversight of enhanced potential pandemic pathogens 
research mandated by the HHS P3CO Framework. If confirmed, how will you 
ensure that enhanced potential pandemic pathogens research proposals 
are forwarded to HHS for the risk-benefit and risk-mitigation review 
mandated by the HHS P3CO Framework, and how will you ensure that 
officials who failed to do so under your predecessors are held 
accountable?

    Answer 8. Potential pandemic pathogen research stands to achieve 
great benefit for people by allowing us to respond immediately and save 
lives, but it also has risk. If confirmed as NIH Director, I am 
committed to adhering to all relevant oversight policies and protocols 
for programs that engage in this kind of research, to make sure that 
they are conducted safely and achieve the benefit we know we can see 
for the American people.

    Question 9. Do you believe Federal oversight of synthetic 
bioengineering gain-of-function research is adequate? If not, what 
reforms would you like to see?

    Answer 9. I believe we can and must continually revisit and review 
our policies as science advances to ensure that we are identifying 
areas for improvement. If confirmed as NIH Director, I look forward to 
reviewing our polices and identifying any areas for reform.

    Question 10. If Congress finds that the COVID-19 pandemic 
originated from a laboratory-acquired infection of a virus that had 
been part of gain-of-function experiments, would you support a ban on 
viral gain-of-function research funding by the NIH? If not, why not?

    Answer 10. I am committed to working with Congress on all efforts 
to improve biosecurity policies and to enhance our pandemic 
preparedness.

    Question 11. HHS initiated debarment of the Wuhan Institute of 
Virology from receiving Federal funding for the next 10 years. However, 
according to the NIH website, over two dozen other animal labs in 
China, including many with ties to the Chinese Communist Party (CCP), 
are currently eligible for more taxpayer funding. Additionally, 
Government Accountability Office (GAO) audits in March and June 2023 
detailed problematic NIH loopholes that exempt labs in China and other 
foreign countries from oversight and transparency required of U.S. labs 
that receive taxpayer dollars. A recent review of Federal spending 
identified millions of U.S. tax dollars still being sent to Chinese 
animal labs for virus experiments, including at several labs run by or 
tied to the CCP. Do you think the NIH should be sending tax dollars to 
labs in China?

        a. Do you think it makes sense for the NIH to exempt labs in 
        China, Russia, and other foreign countries receiving taxpayer 
        dollars from adhering to the same reporting, oversight and 
        biosafety rules that govern domestic labs, especially ones 
        handling dangerous pathogens?

    Answer 11. NIH supports research to better understand the 
characteristics of animal viruses that have the potential to spill over 
to humans and cause widespread disease. We must collaborate with 
researchers in other countries where these sorts of viruses are 
prevalent because once a virus spreads to humans, it is not contained 
by geographical boundaries. The body of research on pathogens and 
infectious diseases is what has made it possible for the U.S. 
Government to move so quickly to get a COVID-19 vaccine in an 
unprecedented timeframe. Countless lives have been saved as a result.

    In addition, if confirmed as NIH Director, I will be committed to 
upholding all critical policies related to scientific review, 
monitoring and accountability, no matter the location of the research.

    Question 12. Some of the boards overseeing NIH-funded clinical 
trials continue to mandate COVID-19 vaccination even though vaccination 
status is not germane to the research being conducted or the data being 
analyzed. Do you think it is ethically problematic for boards that are 
entrusted with overseeing clinical trials to mandate COVID-19 
vaccination during study enrollment even when vaccination status is not 
relevant to the integrity of the data?

        a. Will you commit to ensuring that NIH funding recipients do 
        not discriminate against unvaccinated candidates for 
        participation in clinical trials?

    Answer 12. NIH does not have a blanket policy requiring COVID 
vaccination for participation in clinical trials, but specific trials 
may have additional requirements that are set by the clinical trial 
sponsor based on the information that is being gathered for that 
particular trial.

    Question 13. If confirmed, how will you ensure that congressional 
requests for information are answered promptly and in full, and how 
will you ensure that officials who failed to do so under your 
predecessors are held accountable?

    Answer 13. I deeply respect the oversight function of Congress and 
its role in improving current policies and programs. I am committed to 
ensuring that NIH is appropriately responsive to congressional 
oversight requests consistent with constitutionally mandated 
accommodation process.

    Question 14. Will you publicly commit to releasing all records 
requested by Members of Congress?

    Answer 14. I deeply respect the oversight function of Congress and 
its role in improving current policies and programs. I am committed to 
ensuring that NIH is appropriately responsive to congressional 
oversight requests consistent with the constitutionally mandated 
accommodation process.

    Question 15. The next NIH Director will be tasked with leading the 
development of the agency-wide strategic plan for fiscal years 2026-
2030. As you know, this is an important responsibility that sets out 
agency priorities for the next 5 years. During the previous strategic 
planning process, the NIH only gathered stakeholder input on a short, 
rough framework of the proposed strategic plan, preventing the public 
from providing feedback about specific language or programmatic 
details. In addition, it is unclear how that input was considered as 
the agency developed its final strategic plan. Given the tremendous 
amount of taxpayer money spent to fund the agency's work, the public is 
due the opportunity to comment on a full draft plan and transparency on 
how that feedback is incorporated into the final strategic plan. To 
ensure public accountability, how will you enhance transparency and 
opportunities for stakeholder input during the development of the 
upcoming NIH Strategic Plan?

    Answer 15. NIH is the steward of our Nation's medical and 
behavioral research, and I am committed to ensuring that NIH continues 
to be a force of innovation and discovery. To do that, we need to 
rebuild trust in science and engage with the American people 
transparently and consistently in our efforts. I look forward to 
engaging with the broadest possible group to bring health solutions to 
the American people.

    Question 16. Is it reasonable for intramural NIH scientists to 
receive patent royalty payments for their taxpayer-funded research 
discoveries?

        a. If you believe royalties are appropriate to attract top 
        scientists to the NIH, can you explain how it helps science in 
        this country if the NIH recruits the top scientists away from 
        universities and other research institutions around the 
        country?

    Answer 16. The Federal Technology Act of 1986 authorizes government 
agencies to license their inventions in exchange for royalties that the 
agency can use to fund further research. NIH typically receives annual 
minimum royalty payments and a percentage of the sales of the end-
product. The law requires that NIH pay a portion of the royalties it 
receives to the inventors according to a statutory formula (15 U.S.C. 
3710c) and the remainder to the NIH Institutes where the inventions 
were made. NIH-funded universities and research hospitals have similar 
programs governed by the Bayh-Dole Act of 1980 (35 U.S.C. 202(c)(7). 
Royalties to NIH also pay for the cost of obtaining patents. If 
confirmed as NIH director, I would ensure that all NIH policies are 
consistent with the law.

    Question 17. Many academic scientists receive funding from both the 
government and the pharmaceutical industry. Does this funding mechanism 
create a potential conflict of interest?

        a. Should the NIH try to ensure that there are academic 
        scientists who are independent of the pharmaceutical industry?

        b. How can such scientific independence be accomplished?

    Answer 17. NIH requires the disclosure of all sources of research 
support, foreign components, and financial conflicts of interest for 
senior/key personnel on research applications and awards. NIH uses this 
information when making its funding decisions to determine if the 
research being proposed is receiving other sources of funding that 
could be duplicative, has the necessary time allocation, or if 
financial interests may affect objectivity in the conduct of the 
research. I am committed to ensuring proper stewardship of taxpayer 
dollars.

    Question 18. Should the NIH coordinate its research activities with 
pharmaceutical companies?

    Answer 18. The NIH funds primarily basic, translational, and early 
stage clinical research and relies on partnerships with the private 
sector to bring discoveries to market. Coordination with private 
companies, like those in the pharmaceutical industry, can lead to 
accelerated innovation toward techniques and treatments that improve 
the health outcomes for people across the United States. I believe, 
however, that NIH must always ensure that companies do not unfairly 
profit from the investment that taxpayers have made into NIH for the 
public good, and that public investment yields public benefits. I look 
forward to working with you to ensure that NIH coordination with 
private industry remains a balanced partnership between the private 
sector and the American people.

    Question 19. Documents obtained by the independent watchdog group 
OpenTheBooks revealed that between 2009 and 2021, approximately 54,000 
royalty payments totaling $325.8 million were paid by third party 
entities to NIH researchers credited as co-inventors. However, 
important information including the sources of the payments was 
redacted by the NIH. To avoid the appearance of conflicts of interest, 
will you commit to disclose publicly any royalty payments to NIH 
researchers by third parties, including the sources of those payments?

    Answer 19. If confirmed, I am committed to transparency, and 
ensuring that the NIH provides information to the public consistent 
with applicable law.

    Question 20. A bill I introduced, the FDA Modernization Act 2.0, 
which became law on December 29, 2022, amended the Federal Food, Drug, 
and Cosmetic Act to remove an outdated animal testing mandate and give 
drug sponsors the freedom to use modern alternatives to animal testing 
to assess the safety and effectiveness of new drugs. Unfortunately, 
despite the change in law, there have been several recent examples of 
expensive testing on dogs and other animals that were commissioned by 
the NIH and only canceled and determined to be unnecessary after 
criticism from Congress and independent watchdog groups. How would you 
improve the current review system to ensure the NIH does not spend 
taxpayer dollars wastefully on drug tests on animals that are no longer 
required by law?

    Answer 20. All animals used in NIH-funded research are protected by 
laws, regulations, and policies to ensure the smallest possible number 
of subjects and the greatest commitment to their welfare. This includes 
ensuring that harm and distress is minimized as much as possible. 
Domestic institutions receiving funds from the Public Health Service 
(PHS) must conduct research involving live vertebrate animals in 
accordance with the PHS Policy on the Humane Care and Use of Laboratory 
Animals (PHS Policy). The PHS Policy requires all institutions to 
comply, as applicable, with the Animal Welfare Act and other Federal 
statutes and regulations relating to animals. Compliance with this 
Policy is a collaborative effort between the NIH, scientific 
investigators, and research institutions.

    The NIH Office of Laboratory Animal Welfare (OLAW) provides 
oversight of compliance with the PHS Policy in all NIH-supported 
research that involves vertebrate animals. All institutions that 
conduct PHS funded research, testing, or training are responsible for 
ensuring animal welfare and are obligated to protect the Federal 
investment in these activities. OLAW investigates allegations 
concerning animal welfare and appropriate animal care in NIH-funded 
studies. NIH-funded institutions must report promptly to OLAW any 
violation of the PHS Policy. OLAW considers these reports and requires 
the institution to make appropriate corrections and to prevent further 
violations.

    If confirmed as NIH Director, I will work to ensure NIH continues 
to comply with all applicable laws and policies and continues to 
support the use of alternatives to animal testing, when appropriate.
                            senator collins
    Question 1. The next generation of biomedical scientists are key to 
helping us unlock cures for diseases such as Alzheimer's, diabetes, and 
cancer. A robust research ecosystem that supports the post-doctoral and 
early career workforce is critical and ensures that the NIH retains its 
place as the world's leading biomedical research agency. For example, 
post-doctoral researchers at MDI Biological Laboratory in Bar Harbor 
are studying how diet and nutrition can increase lifespan and protect 
against age-related diseases. What are your plans to support post-
doctoral training initiatives across NIH?

    Answer 1. My greatest accomplishment to date has been helping train 
the next generation of scientists. These are the physicians, surgeons, 
and scientists who are tackling the most ambitious and complex issues 
in medicine today. As a clinical researcher, I know what it takes day-
to-day to run laboratories on the cutting edge of science and as a 
leader, I've been proud to help harness structural changes at hospitals 
and institutions to make sure that we are bringing these treatments to 
Americans as effectively and efficiently as possible.

    NIH has various programs to enhance support of early career and 
postdoctoral researchers. This is a top priority for me, and I look 
forward to working with you to further cultivate and support talent 
entering the biomedical and behavioral research workforce.

    Question 2. NIH has a long and venerable history of Institutional 
research. What is your vision for the evolving role of intramural 
research programs, and what changes in emphasis or operation do you 
plan?

    Answer 2. NIH's Intramural Research Program conducts distinctive, 
high-impact laboratory, clinical, and population-based research, 
facilitates new approaches to improve the health though prevention, 
diagnosis and treatment, responds to public health emergencies, and 
trains the next generation of biomedical researchers. If confirmed, I 
look forward to continuing this important work.

    Question 3. There is considerable concern about the ever-increasing 
cost of biomedical research. Yet the NIH has not followed with an 
associated increase in individual extramural research support, 
specifically for R01 grants, the staple support for individual academic 
research programs. How will you meet this challenge?

    Answer 3. NIH understands and is aware of the increasing fiscal 
pressures that institutions and scientists face when conducting 
biomedical research, including the effects of inflation on the costs to 
do research (see for example this recent publication). If confirmed as 
NIH Director, I will work closely with you and with IC Directors to 
implement approaches that enable us to fund as many scientists as we 
can, while also assuring that those scientists who are funded have 
enough support to be successful.
                           senator murkowski
    Question 1. One of my priorities in the Senate is trying to find 
ways to help end ALS. I have a personal connection to the disease. One 
of the problems with clinical trials and ALS is the endpoint, the ALS 
FRS score. It is currently the only accepted endpoint in ALS clinical 
trials because until now, there really hasn't been any better way 
developed to measure progression. However, technology has progressed 
and ALS clinical trials are starting to bring promise. I would 
appreciate a commitment to working with NINDS to develop and sponsor 
programs to measure ALS progression using alternative methods of ALS 
progression, to determine if they would provide a better measure of ALS 
progression and clinical endpoints. Alternatives could include 
progression of movement with muscle accelerometers, progression of 
speech with voice recordings, which have been used in several ongoing 
natural history studies in the ALS community.

        a. If there were more precise measures of ALS progression 
        within ALS clinical trials, it could bring us closer to finding 
        a treatment for ALS. The subjective ALS FRS score alone will 
        not lead us to clinical trial success. Newer technologies will 
        bring us closer much faster. Can I get your commitment to 
        working on this issue, and to make ALS clinical trials more 
        efficient?

    Answer 1. ALS is a devastating fatal disease, and it is so 
important to be able to accurately track its effects in individual 
people, as a critical step in research to combat this disease. We are 
seeing some exciting new technology that can help, and I would be 
honored to work with you to advance these important clinical trials.

    Question 2. Dr. Bertagnolli, having grown up in rural Wyoming, you 
have written extensively about disparities in access to clinical trials 
for rural populations and have suggested several opportunities for 
improvement including by use of tech platforms, information sharing 
among academic networks, improved Electronic Health Record 
interoperability, and aligning with the close-knit cultural bond of 
rural communities.

        a. Given your personal experience working with rural 
        populations, how do you plan to close the gap in research 
        conducted far from major population centers, especially among 
        rural AI/N populations? How do you propose to perform research 
        in rural areas without care delivery sites?

    Answer 2. I have seen firsthand what it means to deliver care to 
those living in rural communities. NIH strives to make clinical trials 
as accessible as possible and has established programs to increase 
participation among rural communities. Several NIH programs are seeking 
to expand the footprint of clinical trials to more patients including 
rural populations through decentralized trial design and remote 
monitoring.

    To give you a concrete example of my own work, when I ran a cancer 
clinical trials group, one of my main goals was to make sure those 
trials reached as many communities as we possibly could. And we 
partnered with a wonderful physician practice in Laredo, Texas, serving 
the border community; a dedicated physician who served the Oglala Sioux 
community at Pine Ridge Indian Reservation; and a wonderful oncologist 
in my own hometown of Rock Springs, Wyoming. I understand firsthand 
that the challenge of bringing both care and research to all 
communities is considerable, but it is one that we must overcome.

    NIH research must reach everywhere; and there are many, many 
centers of great excellence that we should have the ability to engage.

    Question 3. The estimated yearly impact of menopause symptoms on 
the economy annually is $1.8 billion due to missed workdays, but there 
have been few advancements in treatment in the last few decades. 
Research in this subject area has been deprioritized since the early 
2000's.

        a. As NIH Director, would you commit to prioritizing research 
        on women's health in general, and identifying improved 
        treatments for the adverse health conditions associated with 
        menopause in particular?

    Answer 3. Multiple NIH Institutes are funding research to advance 
the understanding and impact of changes experienced by women during 
menopause, providing effective alternatives for the relief of 
menopausal symptoms, and examining the ways menopause affects women's 
overall health and well-being. If confirmed, I commit to continuing to 
this important research.

    Question 4. Alaska continues to be plagued by preventable chronic 
infectious diseases such as tuberculosis and hepatitis C. As of 2021, 
Alaska had the highest incidence of tuberculosis in the country due to 
very high rates in rural areas, especially in our Southwest region. 
Rates of hepatitis C have been noted to be increasing statewide for two 
decades despite the availability of curative treatments. The NIH has 
also recently reported promising research around temperature-stable 
vaccines for TB.

        a. How would the NIH approach coordinating with other Federal 
        agencies, state, local, and Tribal governments toward the goal 
        of eradicating chronic infectious diseases such as tuberculosis 
        and hepatitis C?

        b. Under your leadership, would you commit to funding research 
        for technologies such as temperature stable vaccines for 
        tuberculosis which could help to address disparities in 
        infectious disease treatment and prevention for rural 
        populations?

    Answer 4. I would be very pleased, if confirmed, to work with you 
to address these specific issues for the people of Alaska. As you 
mentioned, an experimental tuberculosis vaccine that can be stored at 
room temperature was safe and provoked an immune response in a phase 1 
clinical trial. If proven effective in larger trials, the vaccine could 
make tuberculosis prevention more accessible to those most at risk. 
This is just one example of more approaches to combating infectious 
disease in diverse communities. NIH is eager to work with state, local, 
and tribal governments to advance this research.
                           senator mike braun
    Question 1. Recently, leaked documents indicated that HHS has 
implemented a new mandate requiring all its employees to use a person's 
preferred pronouns, even if those pronouns do not align with the 
person's biological sex. Alarmingly, the policy does not mention any 
first amendment rights against compelled speech or the free exercise of 
religion, the Religious Freedom Restoration Act, or any religious 
accommodations.

        a. Do you support this policy?

    Answer 1. I firmly support employee rights and protections related 
to gender identity.

    Question 2. Will you commit to ensuring that all at NIH are granted 
their full first amendment rights by protecting religious 
accommodations and free speech?

    Answer 2. If confirmed as NIH Director, I am committed to ensuring 
that all Constitutional rights, including first amendment rights, are 
protected for all NIH employees.
                            senator marshall
    Question 1. We appreciate your statement that you would preserve 
the integrity of the Bayh-Dole Act. However, we would like you to 
clarify what you mean on preserving the integrity of the Bayh-Dole Act. 
Earlier this year, the U.S. Department of Health and Human Services 
announced a working group to review its march-in authority, and it 
remains unclear the agreement reached by the Biden administration and 
HELP Committee Majority in moving this nomination forward. One needs to 
look no further to confirm the intent of the Bayh-Dole Act than the 
letter of the law and the U.S. Senators that wrote it. In a 2002, 
former Senators Birch Bayh and Bob Dole penned an op-ed in response to 
misinformation on march-in rights authority and the intent of the Bayh-
Dole Act.

        a. If confirmed, will you follow the letter of the law and 
        precedent set by the Obama, Trump, and Biden administrations, 
        along with your predecessor Francis Collins, that you do not 
        have the authority to weaken IP protections by marching-in on a 
        drug because of its price?

        b. Do you acknowledge that the Administration does not have the 
        legal authority to use march-in rights to lower drug prices?

    Answer 1. March-in authority is a powerful tool designed to ensure 
that the benefits of the American taxpayer's investment in research and 
development are reasonably available to the public. It is my 
understanding that there is a whole-of-government effort to develop a 
march-in implementation framework that will consider how different 
factors, including price, impact these decisions. I look forward to 
seeing this framework, and if confirmed, I will follow both the letter 
and the spirit of the law.

    Question 2. To build capacity in biomedical research across the 
entire United States, NIH uses the Institutional Development Award 
(IDeA) program, which is vital to Kansas and institutions like the 
University of Kansas and its medical center, as well as specific 
initiatives like the Centers of Biomedical Research Excellence (COBRE) 
and IDeA Networks of Biomedical Research Excellence (INBRE). What do 
you see as the most important benefits and successes of the IDeA 
program thus far?

        a. Despite the program targeting half of the country, IDeA's 
        budget is only around 0.9 percent of the overall NIH budget. If 
        Congress were to prioritize more funding specifically for IDeA, 
        how would you, as NIH Director, look to expand the program?

        b. Do you support increasing the IDeA program's participation 
        beyond the currently available mechanisms, to programs such as 
        those supporting biomedical research facilities, 
        instrumentation, and training?

    Answer 2. If confirmed as NIH Director, I look forward to expanding 
that program not only by partnering with the outstanding academic 
institutions within the IDeA states as they grow out their educational 
and research outreach programs, but also for programs that we have that 
are national infrastructure, such as the National Clinical Trials 
Network and other infrastructure that literally goes down into 
individual communities. I view increasing the IDeA program's 
participation as one way we can engage more of the American people in 
the research that we conduct, and I think it would be very positive.

    Question 3. First launched in 2015, the All of Us Precision 
Medicine Initiative has the potential to transform medicine and health 
care by providing an in-depth look at how genes, lifestyles, and 
environments impact human health. How will NIH continue to prioritize 
precision medicine and engagement with all communities--from urban 
centers to rural areas across the country--to advance precision 
medicine to enhance patient care among different patient populations?

    Answer 3. The All of Us Research Program is an ambitious effort to 
gather data over time from 1 million or more people living in the 
United States, with the ultimate goal of accelerating research and 
improving health. Unlike research studies that are focused on a 
specific disease or population, All of Us will serve as a national 
research resource to inform thousands of studies, covering a wide 
variety of health conditions. Researchers will use data from the 
program to learn more about how individual differences in lifestyle, 
environment, and biological makeup can influence health and disease. I 
fully support this program, and affirm its commitment to delivering 
results that benefit all people, in all communities.
                           senator tuberville
    Question 1. The NIH funded a study recently about the ``Psycho-
social Functioning in Transgender Youth After 2 Years of Hormones.'' 
According to the letter NIH sent to Ranking Member Cassidy and me, the 
``research seeks to understand physical and psycho-social effects of 
medical intervention to evaluate the effectiveness of existing medical 
treatments already in use among transgender youth.'' Two young people 
committed suicide who were part of this study.

        a. If you are confirmed, how will you make sure nothing like 
        that happens again on your watch?

        b. Has the NIH funded research--through this study, or others--
        that might tell us the long-term impacts of puberty blockers, 
        hormone therapies, surgeries, or other alterations on an 
        individual's bones or muscles?

        c. Specifically, how those interventions might alter an 
        individual's bones or muscles to make them stronger or weaker?

        d. Given the interest in society today around this issue, do 
        you think that's something the NIH should consider in a future 
        study--safely, of course?

        e. How will you undertake future studies?

    Answer 1. Like you, I share deep concern over the mental health of 
young people, particularly those in the LGBTQ+ community who face 
unique challenges. The study you reference was not funded by NCI. If 
confirmed, I will ensure that NIH takes seriously the protection of 
participants in NIH-funded clinical research while also better 
understanding the impact of medical treatment in transgender youth.

    Question 2. The NIH used to be a universally respected non-
political organization before COVID. But that trust has been broken, 
especially in rural parts of the country like Alabama. People in these 
parts of the country in particular have lost confidence in our public 
health institutions. They feel totally overlooked.

        a. What would you do as NIH Director to help gain back some of 
        that trust, especially among rural populations?

    Answer 2. NIH is the steward of our Nation's medical and behavioral 
research, and I am committed to ensuring that NIH continues to be a 
force of innovation and discovery. To do that, we need to rebuild trust 
in science and engage with the American people transparently and 
consistently in our efforts. No. 1, I believe deeply in the doctor-
patient relationship. A patient comes and puts their life and their 
health in the hands of their doctors. Anything that we can do to 
strengthen the doctor-patient relationship is something that we should 
fully pursue where possible. Second, I believe that patients are valued 
and full participants in the research and science. A strong researcher-
patient relationship engenders great trust in the process if it's done 
in a respectful and appropriate way.

    Question 3. In your past job as a cancer researcher and in your 
current job as the head of the National Cancer Institute, you've had 
hands-on experience with the kind of groundbreaking drugs and therapies 
that have changed the outcomes for so many patients and families. This 
Administration has made curing cancer a huge priority, which I support. 
They--and our Chairman--also talk a lot about lowering drug prices.

        a. In your experience, would these breakthrough therapies and 
        drugs have ever been possible without substantial research and 
        investment from pharmaceutical companies?

    Answer 3. Industry can play a critical role in helping develop 
drugs and their partnership can be paramount in helping drive 
innovation. But I believe it is also imperative that NIH-funded 
research must be conducted in a manner that ensures a fair return on 
the taxpayer investments.

    Question 4. Setting aside any speculation about suspected origins 
of the COVID virus, I think we can all agree that the NIH has a lot to 
do to regain the trust of the public--both in the U.S. and 
internationally.

        a. As head of the NIH, how would you ensure that taxpayer 
        dollars don't go toward funding dangerous research--like gain 
        of function--in countries of concern?

    Answer 4. If confirmed as NIH Director, I am committed to adhering 
to all relevant oversight policies and protocols for programs that 
engage in enhanced potential pandemic pathogen research, to make sure 
that they are conducted safely.

    Question 5. Do you regret signing a letter in May 2020 urging 
governments to implement mask mandates ``in all public places'' and 
``public buildings''?

    Answer 5. If confirmed as NIH Director, my responsibility would be 
to bring forth the data for public health officials and policymakers to 
make informed decisions about public health. Having reviewed the data 
myself, I appreciate the benefits of masking and slowing the spread of 
COVID-19, especially in the early days of the pandemic.

    Question 6. The aforementioned May 2020 letter that you signed 
states that ``laws appear to be highly effective at increasing 
compliance and slowing or stopping the spread of COVID-19.'' Given this 
statement, do you support the following mandates imposed by the Biden 
administration:

        a. The vaccine mandate imposed through the Occupational Safety 
        and Health Administration, which was blocked by the Supreme 
        Court in January 2022?

        b. The vaccine mandate imposed by the Department of Defense 
        issued in August 2021, which Congress voted to rescind in the 
        fiscal year 2023 NDAA?

        c. The vaccine mandate imposed by the Center for Medicare and 
        Medicaid Services issued in November 2021 requirement?

    Answer 6. While NIH helps to support research on vaccines, 
therapeutics, and diagnostics regarding COVID-19 and other threats, we 
do not make the decision on whether to recommend or mandate use of any 
vaccine.

    Question 7. Please describe your role as Chair of the National 
Cancer Institute's Equity Council.

    Answer 7. The council is comprised of a diverse group of leaders 
from across NCI with a passion and commitment to: ensuring that NCI has 
a robust research portfolio to effectively address cancer disparities; 
nurturing a workforce at all career levels that is representative of 
all the people we serve; and cultivating and ensuring that a community 
at NCI that is diverse in thought and representation, including at 
leadership levels across the institute. As chair, I am responsible for 
helping guide the agenda of the council to best achieve our mission.

    Question 8. Please describe any materials that the council has 
endorsed related to diversity, equity, and inclusion.

    Answer 8. NCI makes information about equity, diversity, and 
inclusion available on its website. This includes publicly available 
content such as blogs focused on health disparities research, and 
presentations focused on equity, inclusion, and diversity from NCI 
leadership and program staff, as well as NCI-supported researchers.

    Question 9. The NIH has funded a number of troubling projects in 
the recent past. Please comment if you think that it is appropriate to 
continue to fund this research and if not, how you would ensure it does 
not continue:

        a. According to media reports, the NIH spent more than $8 
        million on a research study that pays gay and transgender boys 
        as young as 13 hundreds of dollars to report their sexual 
        behavior on a mobile app, all without parental permission. NIH-
        funded researchers at Columbia University offer up to $275 to 
        gay and transgender boys, between the ages of 13 and 18, to 
        document their sexual activity on MyPEEPS Mobile, including 
        whether they have ``condomless anal sex.'' \2\
---------------------------------------------------------------------------
    \2\  https://freebeacon.com/latest-news/taxpayer-funded-study-pays-
gay-minors-to-report-sexual-activity-without-parental-permission/.

        b. According to media reports, between 2016 and 2020, NIH 
        awarded approximately $1.5 million to Pitt for a project 
        related to the GenitoUrinary Developmental Molecular Anatomy 
        Project (GUDMAP) program to provide the scientific and medical 
        community tools to study ``congenital diseases of the 
        genitourinary tract (kidneys, bladder, ureter, uretha)'' by 
        obtaining such organs from aborted babies for research. \3\
---------------------------------------------------------------------------
    \3\  https://www.foxnews.com/politics/congress-letter-biden-admin-
pittsburgh-fetal-tissue-research.

          FOIA documents from NIH indicate that University of 
        Pittsburg may have been altering abortion procedures solely to 
---------------------------------------------------------------------------
        obtain fetal tissue, which is illegal under 42 USC 289g-1.

          The reports show that university researchers may have 
        caused the death of the children by harvesting organs from 
        babies who were old enough to live outside the womb.

    Answer 9. As the current NCI Director, I am not familiar with the 
projects that you listed and cannot speak to their appropriateness.

    Question 10. Previously, you sat on the board of Natera, which has 
drawn attention from the New York Times for promoting prenatal tests 
for various diseases, which apparently have a False Positive Rate of 85 
percent or higher. Tragically, these false positives prompt many 
parents to abort their unborn child.

        a. Were you ever aware of the high false positive rate for 
        neonatal tests?

        b. If so, when were you made aware?

        c. Did you ever exercise oversight of the prenatal tests?

    Answer 10. The article that I believe you are referring to had this 
incorrect test accuracy claim removed. The Natera test is accurate in 
>99 percent of cases.
                             senator mullin
    Question 1. If confirmed, would you maintain the current policy of 
the NIH that allows taxpayer dollars to fund research on the effects of 
gender transition procedures on youth? If so, would you allow NIH to 
fund studies on procedures such as sterilizing surgeries, cross-sex 
hormones, or puberty blockers in minors?

    Answer 1. Transgender children and adolescents are a distinctly 
understudied population in the United States. If confirmed, I will 
ensure that NIH takes seriously the protection of participants in NIH-
funded clinical research while also better understanding the impact of 
medical treatment in transgender youth.

    Question 2. The NIH gave almost half a million dollars to fund a 
study published in 2023 called ``Psychosocial Functioning in 
Transgender Youth after 2 Years of Hormones.'' The study evaluated the 
impact of gender transition procedures on youth, and two of the study 
participants tragically committed suicide. Do you think it was ethical 
for the NIH to fund a study evaluating gender transition procedures 
that led to these outcomes?

    Answer 2. Transgender children and adolescents are a distinctly 
understudied population in the United States. If confirmed, I will 
ensure that NIH takes seriously the protection of participants in NIH-
funded clinical research while also better understanding the impact of 
medical treatment in transgender youth.

    Question 3. If confirmed, would you maintain the Biden 
administration's current policy that permits NIH research using fetal 
tissues that are derived from abortions?

    Answer 3. Fetal tissue research is critical to our understanding of 
a variety of diseases. I recognize and appreciate the great sensitivity 
and passionate feelings of many people on the issue of fetal tissue 
research, and I want to be respectful of that. As I shared before the 
Committee, it is my belief that my job is to serve everyone, including 
the communities who care deeply about how fetal tissue is used. As NIH 
Director, it is my responsibility to follow the laws of the land in 
every aspect and ensure that while we work to achieve the maximal good 
for people, we do so in a way that follows our principles of review and 
oversight of fetal tissue. As NIH Director, I would ensure full 
compliance and inclusion of the review boards when considering the use 
of fetal tissue.

    Question 4. In 42 U.S. Code Sec.  289g-2(a), the law prohibits a 
person from knowingly acquiring, receiving, or transferring any human 
fetal tissue ``for valuable consideration if the transfer affects 
interstate commerce.'' Would you say that it is a violation of the law 
for abortion and tissue procurement entities to profit off of the 
remains of aborted children?

    Answer 4. If confirmed NIH Director, I am committed to following 
all applicable laws related to human fetal tissue.

    Question 5. Should the NIH be conducting research using the fetal 
tissue remains of unborn children who were aborted at 24 weeks 
gestation or later?

    Answer 5. Fetal tissue research is critical to our understanding of 
a variety of diseases. If confirmed, I will ensure we are continuing to 
follow existing policies and statutory requirements on fetal tissue 
research.

    Question 6. What guidelines are in place to ensure that the fetal 
tissue from unborn children used in NIH funded research is not coming 
from illegal abortions that could occur in pro-life states like 
Oklahoma?

    Answer 6. Fetal tissue research is critical to our understanding of 
a variety of diseases. If confirmed, I will ensure we are continuing to 
follow existing policies and statutory requirements on fetal tissue 
research.

    Question 7. According to the Office of Director congressional 
Justification Fiscal Year (FY) 2024, ``NIH has long prioritized 
supporting a safe and respectful workplace, free from harassment and 
discrimination, wherever NIH-funded research is conducted.'' Over the 
past several years, however, there have been concerns raised over NIH's 
handling of sexual harassment complaints involving scientists funded 
through NIH. In one particularly troubling case involving an NIH-funded 
scientist at San Diego Biomedical Research Institute, it appears that 
NIH failed to stop ``pass the harasser.'' If confirmed, will you commit 
to answer all congressional requests concerning the NIH's handling of 
sexual harassment complaints and will you commit to working with 
lawmakers to address these concerns?

    Answer 7. Over the past several years, NIH has taken many 
substantive actions within the scope of NIH's grant authorities to 
address harassment and discrimination in NIH extramural biomedical 
science, including the development and implementation of policies and 
processes. I appreciate Congress' continued interest and support as the 
agency works toward ensuring safe and respectful workplaces, free from 
harassment and discrimination, wherever NIH-funded research is 
conducted. I commit to working with you on this important issue.
                              senator budd
    Question 1. As an oncologist, what opportunities do you see for 
more targeted research on rare and orphan diseases including non-cancer 
genetic disorders and prion-based illnesses?

    Answer 1. At NCI, the Center for Cancer Research (CCR) has a 
mandate to confront the special challenges presented by rare cancers 
and diseases as well cancers that may be predominant in medically 
underserved populations. In many cases, the knowledge CCR's 
investigators gain from studying and treating rare cancers and related 
diseases provides them with insights into the mechanisms that underlie 
other more common malignancies. CCR, working with the NIH Clinical 
Center, brings together patients from around the world who share rare 
disease diagnoses. If confirmed, I look forward to working with you to 
expand this work.

    Question 2. How can we best leverage interagency cooperative 
efforts, similar to those used in the fight against cancer, against 
other rare diseases? Is NIH appropriately structured or are there 
institutional hurdles that currently prevent us from maximizing the 
return on moneys spent on biomedical research in the United States? And 
if so and confirmed, how would work to address these hurdles?

    Answer 2. NIH's collaborative efforts with other HHS agencies are 
vital to transforming fundamental scientific and technical information 
into effective, knowledge-based approaches that advance the health and 
safety of the public, such as disease treatments, preventive 
interventions, protective health policies and regulations, and public 
health campaigns. In turn, the information provided by other HHS 
agencies on public health needs informs the policies and priorities of 
NIH-funded research. Recent cooperative efforts include ending the 
pandemic, tackling health disparities, and strengthening behavioral 
health. If confirmed, I look forward to working with my colleagues 
across HHS and the U.S. Government to do even more to improve the 
health of the American people.

    Question 3. If confirmed to serve as the next NIH Director, what 
specific actions will you take to continue advancing the science behind 
prion-based illnesses such as Creutzfeldt-Jacob Disease (CJD), and 
ensure that NIH does not miss opportunities to advance our 
understanding of rare diseases that share biochemical pathways with 
other diseases? How will you ensure that the patient voice is equally 
leveraged across NIH, including with respect to intra and extramural 
biomedical, clinical, and translational research for rare diseases? How 
do you plan on collaborating with your colleagues across HHS, including 
those at FDA, so that the learnings from this NIH work might also be 
applied in their endeavors on behalf of patients?

    Answer 3. NIH supports dozens of studies on Creutzfeldt-Jakob 
disease (CJD) and other prion diseases such as transmissible spongiform 
encephalopathy. NIH's collaborative efforts with other HHS agencies as 
well as across government are vital to transforming fundamental 
scientific and technical information into effective, knowledge-based 
approaches that advance the health including rare disease treatments. 
If confirmed, I look forward to working with patients and their 
families as well my colleagues across HHS and the U.S. Government to 
advance scientific understanding to improve the health of the American 
people.
                                 ______
                                 

    [Whereupon, at 12:30 p.m., the hearing was adjourned.]

                                    [all]