    [Senate Hearing 119-28]
    [From the U.S. Government Publishing Office]

                                                          S. Hrg. 119-28

                          NOMINATION OF MARTIN MAKARY
                          TO SERVE AS COMMISSIONER OF
                                 FOOD AND DRUGS
    =======================================================================

                                    HEARING

                                     OF THE

                        COMMITTEE ON HEALTH, EDUCATION,
                              LABOR, AND PENSIONS

                              UNITED STATES SENATE

                        ONE HUNDRED NINETEENTH CONGRESS

                                 FIRST SESSION

                                       ON

               EXAMINING THE NOMINATION OF MARTIN MAKARY, OF VIRGINIA, TO
                BE COMMISSIONER OF FOOD AND DRUGS, DEPARTMENT OF HEALTH
                AND HUMAN SERVICES

                                   __________

                                 MARCH 6, 2025

                                   __________

     Printed for the use of the Committee on Health, Education, Labor, and
                                    Pensions

    [GRAPHIC NOT AVAILABLEIN TIFF FORMAT]

            Available via the World Wide Web: http://www.govinfo.gov

    �                               __________

    �                  U.S. GOVERNMENT PUBLISHING OFFICE
    59-570 PDF                  WASHINGTON : 2026
    =====================================================================

              COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS

                    BILL CASSIDY, M.D., Louisiana, Chairman
    RAND PAUL, M.D., Kentucky            BERNIE SANDERS (I), Vermont,
    SUSAN M. COLLINS, Maine                  Ranking Member
    LISA MURKOWSKI, Alaska               PATTY MURRAY, Washington
    MARKWAYNE MULLIN, Oklahoma           TAMMY BALDWIN, Wisconsin
    ROGER MARSHALL, M.D., Kansas         CHRISTOPHER MURPHY, Connecticut
    TIM SCOTT, South Carolina            TIM KAINE, Virginia
    JOSH HAWLEY, Missouri                MAGGIE HASSAN, New Hampshire
    TOMMY TUBERVILLE, Alabama            JOHN HICKENLOOPER, Colorado
    JIM BANKS, Indiana                   ED MARKEY, Massachusetts
    JON HUSTED, Ohio                     ANDY KIM, New Jersey
    ASHLEY MOODY, Florida                LISA BLUNT ROCHESTER, Delaware
                                         ANGELA ALSOBROOKS, Maryland

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

                                  ----------

                                   STATEMENTS

                            THURSDAY, MARCH 6, 2025

                                                                       Page

                               Committee Members

    Cassidy, Hon. Bill, Chairman, Committee on Health, Education,
      Labor, and Pensions, Opening statement.........................     1

                                   Witnesses

    Makary, Dr., Martin, Arlington, VA...............................     2
        Prepared statement...........................................     3

                              ADDITIONAL MATERIAL

    Statements, articles, publications, letters, etc.
    Cassidy, Hon. Bill
        Washington Post Article......................................    38

                          NOMINATION OF MARTIN MAKARY
                          TO SERVE AS COMMISSIONER OF
                                 FOOD AND DRUGS

                                  ----------

                            Thursday, March 6, 2025

                                           U.S. Senate,
           Committee on Health, Education, Labor, and Pensions,
                                                        Washington, DC.
        The Committee met, pursuant to notice, at 10 a.m., in room
    SD-562, Dirksen Senate Office Building, Hon. Bill Cassidy,
    presiding.

        Present: Senators Cassidy [presiding], Paul, Collins,
    Murkowski, Hawley, Tuberville, Banks, Husted, Moody, Murray,
    Baldwin, Kaine, Hassan, Hickenlooper, Markey, Kim, Blunt
    Rochester, and Alsobrooks.

                      OPENING STATEMENT OF SENATOR CASSIDY

        The Chairman. The Senate Committee on Health Education,
    Labor, and Pensions will please come to order. Thank you, Dr.
    Makary for appearing before the Committee.

        The Food and Drug Administration is tasked with overseeing
    everything from drugs that treat debilitating diseases to
    safeguards in the U.S. food supply. Well, FDA has become a gold
    standard around the world in safeguarding public health, the
    agency faces significant challenges. The bureaucracy has led to
    delays in approving new medicines and devices, restricting
    patients' access to innovative treatments that can be
    lifesaving.

        As the Trump administration looks to cut red tape across
    the Federal Government, the agency should look at innovative
    ways to address bottlenecks in the review process. This could
    include using artificial intelligence and other technologies to
    improve efficiency and accelerate drug discovery while ensuring
    these products are safe for Americans.

        Another topic of interest is food safety. Americans deserve
    to know that the food they buy for their families is safe to
    eat. One place to start should be examining FDA's review
    process to ensure the safety of ingredients that go into foods.
    I know Dr. Makary is passionate about this issue. I look
    forward to working with him if he is confirmed.

        The American people's trust in our public health and
    science agencies and the products they regulate must be
    restored. Rebuilding public confidence in medical products like
    vaccines is especially important as we respond to measles
    outbreaks and as FDA considers recommendations for vaccines for
    flu strains ahead of the upcoming flu season. Dr. Makary with
    his experience as a surgeon and an effective health policy
    communicator, can help our public health agencies rebuild trust
    with the American people.

        Thank you for appearing before the Committee and discussing
    your vision on how to make America healthy again. Senator
    Sanders is not here, so Dr. Makary, we will go to you for your
    opening statement.

             STATEMENT OF DR. MARTIN MAKARY, ARLINGTON, VA

        Dr. Makary. Thank you, Senator Dr. Cassidy, and Ranking
    Member Sanders and Members of the Committee. I'm humbled to be
    before you here.

        I'd like to thank President Trump for his confidence in
    nominating me to lead the Food and Drug Administration. I'm
    joined today by my wife Jessica, my sister Maria, my brother
    Mark, Nora, Alexander Jacoby, and my very sacrificial mother
    and my career role model, my father. My father dedicated his
    life to the care of children with leukemia, lymphoma,
    hemophilia, sickle cell disease, and then turned his attention
    to adult hematology.

        His father, my grandfather, was a pharmacist in a poor
    Egyptian community and believed in treating everybody equally,
    especially the most vulnerable among them--a philosophy I've
    tried to emulate in my career and research. Even from the
    African continent, my grandfather looked to the U.S. FDA for
    trusted guidance. That's because the FDA has a long history of
    using gold standard science to uphold public safety, and help
    us as clinicians take care of patients when they come to us for
    help.

        As a kid, I vividly remember being in the grocery store in
    our small town with my dad, when somebody would stop him, break
    out in tears, and give him a long hug after what I would learn
    to be a decades long battle with lymphoma. It happened a few
    times, and each time it inspired me even more.

        For 22 years now, I've had the privilege to walk into the
    Johns Hopkins Hospital to live out that mission. And each
    morning as I enter the front door, I pause and look at the
    nine-foot statue of Jesus that stands in the center of the
    hospital lobby. And I read the sacred text engraved at the
    base, ``Come to me all ye who are heavy laden and I will give
    you rest.''

        I'm grateful to Johns Hopkins for allowing me to have a
    creative career, a dual career, as both a surgical oncologist
    and a healthcare public policy researcher. In addition to using
    FDA approved devices and medications, my research which has now
    spanned over 300 scientific peer reviewed articles in the
    medical literature, has focused on what's actually making a
    difference in helping people, and how healthcare has become too
    fragmented, too cold, and too corporate.

        My research and subsequent book on price gouging and
    predatory billing in healthcare, turned into advocacy to demand
    more transparency in healthcare. President Trump heard the plea
    and invited me to the White House in his first Administration
    to enact the Nation's first executive order to bring down
    hospital and drug prices through greater transparency.

        The reform was entirely bipartisan-just as President Trump
    and Secretary Kennedy's call to make America Healthy Again by
    finally addressing the root causes of our child chronic disease
    epidemic, a message that's resonated with moms across the
    country, regardless of their politics. A smarter FDA that works
    for all Americans should be a goal we can all agree on.

        As a scientist who has spent a career evaluating medical
    interventions, I believe in the scientific process. In
    addition, I also believe, that we can use common sense, Dr.
    Cassidy, as I have been in the operating room, as you would
    relate, as a respected hematologist, it's hard to perform a
    long-sophisticated operation for liver cancer and not ask why
    are rates of liver cancer tripled in the United States. We now
    have a generational opportunity in American healthcare.

        President Trump and Secretary Kennedy's focus on healthy
    foods has galvanized a grassroots movement in America.
    Childhood obesity is not a willpower problem, and the rise of
    early onset Alzheimer's is not a genetic cause. We should be
    and we will be addressing food, as it impacts our health.

        Thanks to the courage of President Trump and Secretary
    Kennedy, we now have a generational opportunity to usher in
    radical transparency, to facilitate more cures, meaningful
    treatments, and diagnostics at the FDA to help people take care
    of their own health. My father told me to write down my
    observations and my experiences in healthcare and the research
    I delved into. Much of the research I did, focused on the
    fundamental question: is what we are doing working?

        I wrote books to educate the public on medical science, and
    to empower them to live healthier lives. If confirmed, I hope
    to ensure the FDA holds to the gold standard of trusted
    science, transparency, and common sense to rebuild public trust
    and make America healthy again. Thank you, Mr. Chairman.

        [The prepared statement Dr. Makary follows.]
           prepared statement of martin makary

        Thank you and good morning, Chairman [Dr.] Cassidy, Ranking Member
    Sanders, and Members of the Committee.

        I'm humbled to be here before you. I'd like to thank President
    Trump for his confidence in nominating me to lead the Food and Drug
    Administration. I am joined today by my wife, brother, and sister as
    well as my sacrificial mother and my career role model, my father. He
    dedicated his life to the care of children with leukemia, lymphoma,
    hemophilia, sickle cell disease, then turned his focus to adult
    hematology.

        His father was a pharmacist in a poor Egyptian community, and
    believed in treating everyone in the community equally, especially the
    most vulnerable among them--a motto I've tried to live by in my career.

        Even from the African continent, my grandfather looked to the FDA
    for trusted guidance. That's because the FDA has a long history using
    gold standard science to uphold public safety and help us take care of
    people when they come to us for help.

        As a kid, I vividly remember being in a grocery store with my dad,
    when someone stopped to give him a hug after a long battle with
    lymphoma. It happened a few times, and each time it inspired me even
    more.

        For 22 years now I've been privileged to walk into the Johns
    Hopkins Hospital to live out that mission, and each morning as I enter
    the front door, I pause to look at the 9-foot statue of Jesus that
    stands in the hospital lobby and read the sacred text engraved at the
    base, ``Come to me all who are heavily laden, and I will give you
    rest.''

        I'm grateful to Johns Hopkins for allowing me to have a dual career
    as both a surgical oncologist, and a health care researcher.

        In addition to using FDA approved devices and medications, my
    research has focused on patient safety, the Orphan Drug Act, how the
    FDA evaluates devices, opioids, and how health care has become too
    fragmented, too cold, and too corporate. My research on price gouging
    and predatory billing turned into advocacy to call for price
    transparency in health care.

        President Trump heard the plea and invited me to the White House to
    enact the Nation's first executive order to bring down hospital and
    drug prices through greater transparency.

        The reform was entirely bipartisan--just as President Trump and
    Secretary Kennedy's call to Make America Health Again by finally
    addressing the root causes of our childhood chronic disease epidemic
    resonated with Republican, Democrat, and Independent moms across this
    country.

        A smarter FDA that works for all Americans should be a goal we can
    all agree on. As a scientist who has spent a career evaluating medical
    interventions, I believe in the scientific process, but in addition to
    using trusted science, we can also use common sense. Dr. Cassidy is a
    highly respected hepatologist and can tell you: It's hard to perform a
    sophisticated long operation for liver cancer and not ask, ``why have
    rates of liver cancer tripled in the U.S.''?

        We now have a generational opportunity in American health care.
    President Trump and Secretary Kennedy's focus on healthy foods has
    galvanized a grassroots movement in America. Childhood obesity is not a
    willpower problem, and the rise of early onset Alzheimer's is not
    genetic--we should be, and we will be, assessing the foods impacting
    our health.

        Thanks to the courage of President Trump and Secretary Kennedy, we
    now have a generational opportunity to usher in radical transparency
    and to facilitate more cures, meaningful treatments, and diagnostics to
    empower people to take care of their health.

        My father told me to write down my observations about my
    experiences in health care and the research I delved into. Much of the
    research I did research focused on the fundamental question: Is what we
    are doing working? I wrote books to educate people on medical science
    to empower them to live a healthy life. If confirmed, I hope to ensure
    the FDA holds to the gold standard of trusted science, transparency,
    and common sense to rebuild public trust and Make America Healthy
    Again.
                                     ______

        The Chairman. Thank you, Dr. Makary. I'll start with
    questions. In 2021, a few months after President Biden took
    office, FDA announced it would no longer enforce the in-person
    dispensing requirement for Mifepristone, the drug, which
    obviously is an abortion.

        Now, this is concerning to me. There is a case out of
    Louisiana, which is incredibly egregious, in which there was no
    recognition that the person requesting the drug was not the
    patient, but rather someone who was going to allegedly coerce
    the person into taking the medication, which would've been
    evident to a physician should she or he have seen the patient.

        If confirmed, would you reinstate the in-person dispensing
    requirement as well as reporting requirements for adverse
    events and other complications associated with the drug?

        Dr. Makary. Thank you, Senator. And to hear of someone
    being coerced to take Mifepristone is deeply disturbing and I
    might even suggest criminal. I have no preconceived plans on
    Mifepristone policy except to take a solid hard look at the
    data and to meet with the professional career scientists who
    have reviewed the data at the FDA, and to build an expert
    coalition to review the ongoing data, which is required to be
    collected as a part of the REMS program, The Risk Evaluation
    and Mitigation Strategy. It is pursuant to the REMS. And so, if
    we're going to collect data, I believe we should look at it.

        The Chairman. Last week the FDA announced it would cancel
    its annual Vaccines and Related Biologic Products Advisory
    Committee, which meets to select anticipated virus strains for
    next year's flu vaccines.

        Now, I'm told by people who are familiar, that the FDA will
    make the recommendation and that they will come up with the
    right decision. But they also say what is lost is the
    transparency, because the open meeting allows a postmortem, if
    you will, as we say in medicine, a review of last year of what
    went right, what went wrong, and how to make it better.

        I think one of the laudable things about Secretary
    Kennedy's positions is he wants more transparency in terms of
    how the Federal Government makes medical decisions as part of
    restoring that faith and so, frankly, this seems to kind of go
    backward on that. So how will you ensure that advisory
    committees remain objective, transparent, and still benefiting
    from the necessary expertise of external experts?

        Dr. Makary. Senator, thank you for the question, and I was
    not involved in that decision. Certainly, we've confirmed once
    in office, you have my commitment to take a look at it. As you
    know, that VRBPAC committee takes a look at guidance and
    recommendations from international groups such as the GIP
    International Consortium. My understanding is, at least for the
    last seven or 8 years that I've been following that group, we
    have simply rubber stamped whatever the international GIP----

        The Chairman. Can I stop you for a second? My understanding
    though, since these strains typically begin, like in Australia
    or China, it isn't so much as a rubber stamp, but as much as
    recognizing what are you seeing, because that's what's coming
    to us. So, I think it's more than quibbling to say that you're
    learning from them. Your thoughts?

        Dr. Makary. Yes. So, the American public deserves
    confidence that scientists are looking at that data from the
    southern hemisphere. It's all reported into a registry, all the
    dominant strains, and then picking the most dominant strains
    that are lighting up in that registry is that process of really
    trying to estimate which strains are going to be dominant in
    the United States. It's not very precise, some years we don't
    get it very well, but it's the best we can do with the data we
    have available at the time.

        For example, the International GIP group chose to no longer
    include the influenza B strains a couple years ago, sounded
    like a very reasonable decision, and VRBPAC also went along
    with that recommendation. But I think we're aligned in that the
    American public want to have some confidence that independent
    scientists are looking at these data.

        The Chairman. Going back to the transparency again, it
    seems what's lost with the open meeting is the transparency. So
    how can you as FDA commissioner advocate for that transparency?
    Because we want the American people to know, and obviously
    canceling the meeting will kind of shut that door a little bit.

        Dr. Makary. Yes. So, Senator, I was not involved in that
    decision----

        The Chairman. I accept that but we're voting for you. So
    how are you going to make it happen? I guess that's my
    question.

        Dr. Makary. You have my commitment to review what the
    committees are doing, how they're being used--as you know, I
    was critical when that committee was not convened at all during
    one of the Covid booster guidance decisions by the FDA and
    leadership at the time argued that they are advisory, and we
    don't have to convene them, that was repeatedly throughout the
    Biden administration.

        There may be some value if there's a step where the
    efficiencies can be made but I think with something that's
    important, something that's critical, something where we want
    expert opinion, it not only provides some of that wisdom, but
    it also increases the perception of confidence from the general
    public.

        The Chairman. Thank you.

        Senator Murray.

        Senator Murray. Thank you very much. Thank you for, for
    being here today. Let me follow-up on that because last week I
    sent you a letter along with some of my colleagues asking you
    about the FDA's cancellation of that Vaccine Advisory Committee
    meeting.

        For everybody's information, this is a meeting that takes
    place annually, for at least 30 years to make recommendations
    on which influenza strains should be included in the flu
    vaccines for the upcoming flu season. And for the first time in
    decades, FDA canceled that meeting with no explanation given,
    no new date chosen. That is, I believe, unprecedented and
    dangerous and you just referred to it, Dr. Makary.

        In 2022, you raised concerns when the FDA was considering
    not holding a vaccine committee meeting to authorize Covid-19
    boosters for kids 12 to 15, and at the time you said, ``It was
    unconscionable and undermined the integrity of the FDA's
    standard process to not hold that committee meeting.'' So, if
    you are confirmed, will you commit to immediately reschedule
    that FDA Vaccine Advisory Committee meeting to get the expert
    views. We need to know those so we can have the correct vaccine
    for the upcoming flu season.

        Dr. Makary. Thank you, Senator, for the question, and I
    appreciated our time together in meeting ahead of this hearing.
    I was not involved in that decision and what I would say is----

        Senator Murray. I'm just asking you if you'll immediately
    reconvene it.

        Dr. Makary. I will immediately reevaluate which sessions,
    the leadership of that center, which decisions, which topics,
    could benefit from----

        Senator Murray. What goes into a reevaluation? This is done
    every year so we know what flu vaccine to have. What are you
    reevaluating?

        Dr. Makary. First of all, for the last seven or 8 years
    that I've been following it, they simply adopt verbatim the
    recommendation of the international GIP group. But I was not
    involved in that decision. I will say that in my opinion, there
    was a huge difference between requiring every 12-year-old girl
    in America to take an eighth Covid booster shot versus rubber
    stamping a recommendation from the international GIP group,
    which has done seven out of the last 7 years.

        I'm not saying that the decision is something I was aware
    of or involved in, but it's certainly something I will look at,
    if confirmed.

        Senator Murray. Okay. I'm very unclear because the FDA is
    the gold standard for all of us. And this committee hearing is
    what has always been what we look to, the FDA look to, the
    American people look to, to determine what the flu vaccine is.
    What are you going to look at to make a determination and
    figure something else out now decades into this, what are you
    re-looking at?

        Dr. Makary. Senator, I was not involved in that decision,
    but the committee looks at----

        Senator Murray. I understand that. I assumed you would say
    yes, I will reconfirm it immediately so we can let our public
    health experts and doctors know what flu to have next fall.

        Dr. Makary. As I understand it, the committee members and
    the scientists at the FDA, the career professional scientists
    at the FDA, look at the recommendation of the international GIP
    group.

        Senator Murray. I am just asking--you just told me that you
    were going to reevaluate it, and I want to know what you are
    reevaluating it on. What are you looking at to make a decision
    whether to reconvene it?

        Dr. Makary. In conjunction with the Center Director of the
    Biologic Center, I would reevaluate which topics deserve a
    convening of the Advisory Committee members on VRBPAC and which
    may not require a convening, obviously during----

        Senator Murray. What would we base our decision on?

        Dr. Makary. Well, you can ask the Biden administration that
    chose not to convene the committee meeting for the Covid
    vaccine booster.

        Senator Murray. I get that. I understand, but I'm asking
    you, how will we know what flu vaccine to take next year, if
    this committee doesn't reconvene and make their recommendation?

        Dr. Makary. Senator, I was not involved in that decision
    not to convene that group.

        Senator Murray. I just thought you would say yes, we're
    going to reconvene, who knows what's coming. Let me just ask
    you really quick, I am also following-up on a question and on
    mifepristone because FDA does play a really critical role in
    making sure we have safe and effective medications.

        Contraception and medication abortion have been approved by
    the FDA for many, many decades based on mountains of high-
    quality evidence and expert scientific judgments. So, if you
    are confirmed, will you commit to upholding the science and
    evidence-based drug approvals for all FDA approved products,
    including contraception and medication abortion?

        Dr. Makary. Thank you for the question, Senator Murray, you
    have my commitment to follow the independent scientific review
    process at the FDA, which is a tried-and-true process, and that
    has been around. And so that is my commitment to you, Senator.

        Senator Murray. Okay, well, I want to be clear, there have
    been over a hundred high quality studies over more than two
    decades backing up the science and safety of mifepristone.
    Thank you, Mr. Chairman.

        The Chairman. Senator Paul.

        Senator Paul. Congratulations Dr. Makary, on your
    nomination.

        Dr. Makary. Thank you.

        Senator Paul. I think one of the most important things we
    need in government are people who are open-minded. I think
    closed-mindedness, the idea that this is settled and no one
    will ever--If you see data as the FDA and you have to make a
    decision, are you willing to lead where the data and the facts
    take you as opposed to your preconceptions?

        Dr. Makary. Absolutely, Senator Paul. I think it is part of
    being a scientist, we need more humility in the medical
    establishment. You have to be willing to evolve your position
    as new data comes in.

        Senator Paul. The people who aren't involved in science
    think that there's settled science, and this is, it's just all
    settled and we will all be quiet and submit to whatever settled
    science is. But you mentioned to me on the way in that
    yesterday you removed a gallbladder through the laparoscope.

        I was in medical school and surgical training about the
    time where everybody made a four-or five-inch V incision to
    take the gallbladder out. And the older surgeons, the
    consensus, they ran the surgery departments, they were like,
    it's malpractice to use these tiny incisions and blow the air
    into the abdomen and do all this. But it took an overcoming of
    the consensus. Do you remember some of that, it might've been a
    little after your time, but you remember some of the trends
    from the larger incision, the small incision, and the
    resistance of the consensus?

        [Laughter.]

        Dr. Makary. Oh, yes. Senator, I can tell you some of the
    surgeons who trained me said things like, big surgeons used big
    incisions, and the bigger the incision the better. And without
    having a big open incision, you can't really see what you're
    doing. And I would point out that a laparoscope gives you 10
    times the magnification, but there's a lot of medical dogma
    that has contaminated our field, and I think it's tied to a
    lack of humility.

        Ultimately, what makes a great doctor, in my opinion, as I
    teach my residents, is not how much you know, it's your
    humility and your willingness to learn as you go from patients.

        Senator Paul. I think some people here also are not duly
    impressed enough by what it takes to do the kind of surgery
    that you do. Now, I'm an ophthalmologist and I do eye surgery,
    and we do really tiny incisions, but our surgery lasts between
    five and 20 minutes a lot of times to take the cataract. How
    long does it take to do a--you've done Whipples, I imagine,
    which is a surgery on the liver. How long does a Whipple
    surgery take?

        Dr. Makary. Yes, I've done a lot of Whipple operations and
    eyelet transplant procedures, and then pioneered a new type of
    procedure, which is a laparoscopic pancreas eyelet
    transplantation, with hopes that it can someday be used to cure
    diabetes. It was about 8 hours for that operation when we
    started. We've gotten it down to about four or 5 hours, and
    we've done some laparoscopic Whipples in 3 hours.

        Senator Paul. With regard to the vaccine committees, and
    they talk about whether they meet or they don't meet and
    things, there have been some questions, and one of the
    questions that I've been bringing forward is whether or not
    there could be a conflict of interest. And one of the things
    I've asked, and you would think it would be universally
    accepted by everyone without question, is you should have to
    reveal if you get royalties from drug companies.

        If you're making a decision on a Pfizer vaccine or a
    Moderna vaccine, I would think the least of transparency should
    be that you reveal if you get royalties from those companies.
    Do you think we need to evaluate the people on the committees
    or see whether they get royalties or see whether or not there
    are conflict of interest for the people making these decisions?

        Dr. Makary. Yes, I do, Senator. We need to review the
    ethics policy because people see things that appear to be a
    cozy relationship between industry and the regulators that are
    supposed to be regulating the products. Now, I want American
    companies to thrive. I want life sciences companies to thrive,
    but we need to call balls and strikes and to keep that
    independent scientific review process free of any conflicts.
    So, I do think it deserves a look.

        Senator Paul. Really, I think it would be an area that a
    lot of people, once again, think there's a consensus. Either
    take all the Covid vaccines or not. Most of Europe doesn't
    recommend a Covid vaccine for under age 12. Almost all the
    countries don't recommend it for under 12, some under 18. And
    it's because they've looked at the risk benefit for children of
    the vaccine and some of the possible complications of it. And
    it's different, frankly, for older people.

        It's like, these are things that we should at least discuss
    and evaluate. Some of the most pro-vaccine people, when the
    policy came out to give boosters to your 6-month-old said they
    wouldn't even give it to their 24-year-old, a booster.

        You remember one of the famous committee members, two
    committee members left the vaccine committee because the CDC
    under Biden politicized the process and overrode the vaccine
    committee. So, to insinuate that somehow there's some brand-new
    thing going on, these are longstanding controversies. And I
    think that the main thing, I'll go back to, is in the
    beginning, we need open-mindedness. And I appreciate your
    willingness to look at the facts, the data, and not be
    overwhelmed by preconceptions.

        Dr. Makary. Thank you, Senator.

        The Chairman. Senator Baldwin.

        Senator Baldwin. Thank you, Mr. Chairman. Welcome Dr.
    Makary. I want to go over a couple of topics that have already
    been raised, and if we have time explore one that has not yet.
    But I want to understand your position on mifepristone. Because
    we had an opportunity to speak in my office and I thought that
    you were pretty clear with me during that meeting that you were
    aware of the overwhelming scientific conclusion about the
    safety of this medication and that you did not think politics
    should be involved in decisions moving forward. And I
    understood from our conversation that you intended to stand
    behind the FDA's longstanding determination.

        But after our meeting I don't know if it was you or your
    minders, but they followed up with my staff and said they felt
    that you misunderstood my question and wanted to clarify your
    answer. Which by my read, implied that you are open to totally
    reexamining the scientific determination even with decades of
    evidence. So, I want to clearly understand your position as FDA
    commissioner. Will you maintain current access to mifepristone,
    yes, or no?

        Dr. Makary. Senator, I'll be very clear about my position.
    My position is that of a scientist. As you know, part of the
    REMS, the Risk Evaluation Mitigation Strategy, that was put in
    initially by President Clinton in that Administration, and then
    modified under Obama, and then again under President Biden,
    requires ongoing data collection. So, I can't prejudge that
    data without looking at it.

        Senator Baldwin. You're going to--you said something about
    convening an ongoing panel.

        Dr. Makary. I did not mention to----

        Senator Baldwin. A previous question just asked.

        Dr. Makary. I did not mention a panel. I said I would
    convene the scientists, the professional career scientists at
    the FDA, who have reviewed the totality of data on this, and
    are also looking at ongoing data that is being collected. There
    could be, for example Senator, a drug-drug interaction that may
    show up on the ongoing data.

        Senator Baldwin. Okay. So, I want to ask if that's your
    approach to something that has been approved for now decades,
    are you going to do the same with Tylenol?

        There are a lot of side effects for daily use, including
    liver damage. Will you be doing that for Tylenol?

        Dr. Makary. As you may know Senator, Tylenol does not have
    a regulation requiring a REMS, a Risk Evaluation Mitigation
    Strategy.

        Senator Baldwin. I'm not asking whether it does or not. I'm
    asking, are you going to do ongoing surveillance of the
    possible side effects for that drug that was approved many
    years ago? How about asthma inhalers that have been associated
    with osteoporosis, opportunistic lung infections? Are you going
    to be doing that for those medications?

        Dr. Makary. Senator, I will be following the law and the
    regulation requires an ongoing review.

        Senator Baldwin. You have a totally different approach to
    this. I want to get to that again, a little bit more about what
    we're talking about with the influenza vaccine and vaccines in
    general. As has been said in this hearing, the advisory
    committee annual meeting was canceled for selection of what
    strain of influenza our vaccines for this next season would
    confront.

        There have been additional reports that Secretary Kennedy
    wants to make significant changes to another Advisory Committee
    that makes recommendation and provides advice for vaccines. And
    I worry that this is merely a ploy to install vaccine skeptics
    on these critical panels. Our Advisory Committees must maintain
    scientific integrity and should not be changed for political
    purposes or to further an agenda.

        Dr. Makary, do you intend to remove experts from the
    vaccine and related Biological Products Advisory Committee?

        Dr. Makary. Senator, first of all, I'm not familiar with
    what you're referring to regarding Secretary Kennedy. Secretary
    Kennedy wants to make America healthy again. With regard to the
    Vaccine VRBPAC Committee, deciding on which flu strain to
    identify-I was not involved in that decision, but again, just
    as a reminder----

        Senator Baldwin. Are you planning if confirmed to remove
    any experts from the vaccine and related Biological Products
    Advisory Committee?

        Dr. Makary. I have no preconceived plans to rearrange that
    committee or any committee, I will say on influenza that----

        Senator Baldwin. Do you commit to maintaining scientific
    integrity on advisory committees and receiving regular outside
    expertise if confirmed?

        Dr. Makary. Of course.

        Senator Baldwin. Okay.

        The Chairman. Senator Collins.

        Senator Collins. Thank you, Mr. Chairman. First of all,
    Doctor, I appreciate your willingness to serve and was
    impressed as a result of our conversation in my office. Let me
    ask you, you've had a lot of questions about the Vaccine
    Advisory Committee. Let me just ask you a simple,
    straightforward question, and that is, if you are confirmed,
    will you reinstate meetings of the committee?

        Dr. Makary. The VRBPAC Committee will be meeting if
    confirmed and I'm commissioner. Yes.

        Senator Collins. Thank you. In February, we learned that
    hundreds of probationary employees at FDA were dismissed. And
    this really concerns me because we need a flow of young new
    scientists and researchers, especially since we're seeing
    retirements and resignations. And ironically, more than half of
    the FDA employees are funded under various industry user fee
    agreements. So, there is revenue coming into the FDA to pay for
    these employees. If confirmed, will you, not an outside force,
    but you, have full authority over FDA staffing decisions?

        Dr. Makary. Senator if confirmed as commissioner, you have
    my commitment that I will do an assessment of the staffing and
    personnel at the agency. I have not been involved in any of the
    decisions regarding any of the personnel changes recently, but
    if confirmed, you have my commitment that I will do an
    assessment.

        Senator Collins. I just want to make sure that you are the
    one doing that assessment. I'm not saying that the staffing
    level is perfect, and I think it's helpful for a new
    commissioner to do an assessment, but I want that person to do
    it. And it sounds like you are committing to that. Is that
    correct?

        Dr. Makary. I will do an assessment, I commit to that, yes,
    Senator.

        Senator Collins. One of the best ways to lower the cost of
    prescription drugs is by promoting more market competition. And
    one way that we can do this is by making it easier for generic
    and biosimilar drugs to come to the market. As part of a
    broader bill that Senator Shaheen and I have introduced to help
    lower the cost of insulin, we've included a provision to create
    a new competitive biosimilar pathway and therapy designation to
    add FDA, under which eligible products for which there is
    inadequate biosimilar competition now, could achieve expedited
    review.

        I worked with the FDA in the last Congress, to develop this
    provision, and I look forward to continuing to push this
    concept so that it becomes law. Do you support the concept of a
    new expedited pathway for biosimilars to compete, for example,
    with branded insulin?

        Dr. Makary. First of all, Senator you've taken a strong
    interest in the FDA and I very much appreciate it, and I really
    enjoyed our time together. I've learned from you and thank you
    for your leadership on the Diabetes Caucus. It's something, of
    course, very close to my area of medicine.

        I am a big believer that we need to figure out a way to get
    biosimilars approved quicker without cutting corners on the
    scientific review. And it is one of several strategies that the
    FDA can do to try to alleviate the problems of high drug prices
    in inadequate competition or underperformance of competition
    and the drug shortage in the United States.

        Also, other strategies could include the way we look at
    generic drugs, moving medications to over the counter, does
    Naloxone really need to be a prescription only medication? Does
    an EpiPen need to be prescription only? If they can be over the
    counter and we can feel confident about public safety when with
    those products on the shelf at a pharmacy, it would force the
    companies to put a price on the shelf. And I do believe in
    price transparency, it will have an effect on the entire
    marketplace. So, thank you, Senator.

        Senator Collins. Thank you. And let me just end by saying
    that I am delighted with your interest in Islet cell therapy
    for individuals with Type I. There are clinical trials
    underway, and I think that is such an exciting development.
    Thank you, Mr. Chairman.

        Dr. Makary. Thank you, Senator.

        The Chairman. Thank you, Senator Collins.

        Now Senator Hassan.

        Senator Hassan. Thank you, Mr. Chairman. And good morning,
    Doctor, and congratulations to you and your family on your
    nomination.

        Dr. Makary. Good morning. Thank you, Senator.

        Senator Hassan. President Trump has promised to help lower
    costs, but prescription drug prices are once again skyrocketing
    for Granite Staters, and all Americans. In 2025, drug makers
    have increased the list prices of over 500 common medications.
    Dr. Makary, when we met, you and I discussed the importance of
    increasing generic drug competition. If confirmed, will you
    work with me to speed the approval of generic drugs at FDA to
    lower drug costs for patients?

        Dr. Makary. Senator, first of all, I very much enjoyed our
    meeting together. The answer to your question is an emphatic
    yes, and I would add to that, that I would love to work with
    Congress to address the way that patent law has enabled patent
    thickening, which makes it more difficult for biosimilars and
    even some generics to come to market, because they got to
    navigate so many lawsuits and letter of the patent law.

        Senator Hassan. Well, and this is something that Senator
    Paul and I have actually been working on, and we have
    something, a bill called the Increasing Transparency in Generic
    Drug Applications Act, which would allow the FDA to communicate
    more transparently with generic drug manufacturers, in order to
    make more low-cost prescription drugs available for patients.

        The bill would save taxpayers over a billion dollars and
    has bipartisan, bicameral agreement. So, I'm going to urge all
    my colleagues to look at it. I've enjoyed working with Senator
    Paul and his team on it.

        Dr. Makary, you and I also discussed mifepristone when we
    met, a medication that has been used for decades in abortion
    care and miscarriage care. Now, during our meeting, you
    mentioned you weren't familiar with the drug, and I followed up
    by providing you with decades of the safety data and you said
    you're a data guy; you would review it. Have you reviewed the
    data, and do you agree that mifepristone is safe and effective?

        Dr. Makary. Thank you, Senator, for sending me that
    homework to read. And I did read those articles, including--and
    what I was referring to when I said I'm not familiar with it
    is, I don't believe I said I was not familiar with it, what I
    said was, I have not reviewed the totality of the data. I am
    very familiar with mifepristone. And I did review those
    studies, including two surveys of patients inquiring about
    telemedicine, a 2018 National Academy of Medicine Review. I'm a
    member of the National Academy of Medicine, but was not
    involved in that particular review. But I did review that
    document.

        Senator Hassan. I shared with you that study from the
    National Academies where scientists looked at, just so people
    know, over a hundred studies of medication abortion, and found
    that the literature is clear that mifepristone is safe and
    effective.

        Also, we've had the discussion about the REMS process for
    mifepristone. In 2021, the FDA looked again, based on a citizen
    petition asking them to review the safety of mifepristone. And
    I think--just so people get a sense, this is the report back
    from the FDA about their review and about their modification of
    the language in the REMS process. And their review again, was
    that it is safe and effective.

        I think what you're hearing from a lot of us as we ask you
    questions about this, and just so the public can understand,
    there's lots and lots of data here that supports the safety and
    efficacy of mifepristone and supports its efficacy in, under
    current law, and its safety.

        I think the concern you're hearing is not about whether you
    will follow an ongoing REMS process with any medication and
    look at the most current data. That's what the scientific
    process is about. The concern is whether you are going to
    unilaterally overrule the data that currently exists for
    political purposes, and for political reasons, and that's what
    we're looking for your reassurance on.

        You have told us you are an independent scientist, I
    believe that. You have a very distinguished career as a
    physician. But we need to know that when you say you're an
    independent scientist, that's really what you mean. And then
    when the politics get heated around abortion, that you won't
    abandon that independence.

        Dr. Makary. Senator, you have my commitment that once I'm
    in office, I will do a review of the data. I have no
    preconceived plans to make changes to the mifepristone policy.
    And I do plan to follow the law and the regulation of the REMS
    to look at ongoing data. It could be that there could be a
    drug-drug interaction that we could identify on ongoing data.

        Senator Hassan. I understand that. But what I am looking
    for is an understanding that the current state of science, in
    the process that you have been a participant in throughout your
    entire career, and that others up here have also participated
    in, that you will follow the science as it is currently
    developed and not unilaterally overrule scientists because
    you're under political pressure to do that.

        Dr. Makary. Senator, if you look at my track record, I have
    never been afraid to speak my honest scientific opinion, and I
    have no preconceived plans to make changes on that medication.

        Senator Hassan. Well, I wish you were hedging a little bit
    less today. Thank you,

        The Chairman. Senator Murkowski.

        Senator Murkowski. Thank you, Mr. Chairman. And I
    understand that the Senator from Alabama has an engagement that
    she needs to get off to. So, I'm going to defer my time to her
    and go afterwards.

        The Chairman. The Florida, Alabama afterwards.

        Senator Moody. Florida Go Gators! But Katie Britt would
    want me to say, Roll Tide.

        [Laughter.]

        The Chairman. You'll lose your votes in Florida, but
    anyway, go ahead.

        Senator Moody. Thank you, Senator Murkowski, I'm so
    grateful. I'm very grateful as the rookie, to be able to
    question before these senior Senators. It's a big deal. So, I'm
    grateful to all of you. Thank you so much. I'm so honored.

        I am so excited to see you here today, I was incredibly
    happy with this nomination. When confirmed, I know you're going
    to do a great job. I have two issues I want to cover and they
    are relevant specifically to the two main roles in my life over
    the last 6 years: One as a mother and one as Attorney General
    of Florida.

        First, I want to talk to you about what is going on with
    the FDA, and it's burying its head in the sand about illegal,
    chemically ridden, extraordinarily high amounts of nicotine,
    Chinese vapes that are flooding the United States market. In
    fact, two thirds of the export market here are Chinese vapes
    coming out of China. So, it's unbelievable. They are in flavors
    like strawberry, blow pop, watermelon sour berry, attracting
    children, addicting children.

        We have so many thousands and thousands and thousands of
    pending applications, most of these things are illegal in the
    United States right now. But yet, somehow China has decided to
    flood our market with illegal vapes, the United States market
    with illegal vapes. And they're benefiting, in fact, in China,
    they banned flavored vapes. And so, all of the manufacturers
    there of these chemically ridden vapes, have now flooded our
    market, and now are addicting our children. Much like we're
    seeing this in many other ways in harmful substance coming from
    China and they're not doing much about it, fentanyl, ET cetera.

        Whoever comes in as the head of FDA, this is one of your
    problems-you have to address immediately. I know there are a
    lot of things that you're going to get questioned about, but
    these things are all over the United States. In convenience
    stores, they are, readily available to children. If you walked
    in any one right now, you would be able to find them. And not
    only are the amounts of nicotine going up and up and up, we
    don't know what is in these things. And there has been little
    to nothing done to deal with our pending applications at the
    FDA or to enforce those that we know are illegal right now. How
    would you address this and what do you plan to do on day one?

        Dr. Makary. Well, thank you, Senator. I appreciate your
    passion on this important issue, and I've appreciated your work
    as Attorney General in Florida on this issue, and maybe it's
    because you both believe in doing the right thing, and because
    you're a baseball mom that you're interested in this.

        Senator Moody. I first heard about this on the bleachers at
    a baseball game.

        Dr. Makary. I think there are four new vaping stores that
    have popped up in my neighborhood, all in the last few years.
    I've not walked into one of them, although perhaps I should, to
    check it out. But you are absolutely right that we are being
    flooded with Chinese products. We have no idea what's in these
    products and public health is not even going to be able to
    study them because it takes so long for public health research
    to catch up.

        But it's very concerning and it's not right that the
    products are banned in China, and yet they're manufacturing
    them and sending them into the United States. So, there are a
    few things the FDA can do to try to address this problem. First
    of all, the office of inspections and investigations has a lot
    of people with guns and they do enforcement and raids. And we
    need in collaboration with DOJ and other areas of law
    enforcement to try to address this problem of illegal products
    on our market.

        Senator Moody. There was an announcement during the last
    Administration, and I won't get into much--they were going to--
    once people finally convinced them that this is out of control
    and people are getting addicted by the day, there was this big
    announcement about task force, we're going to use all the tools
    available. That's great, and enforcement needs to be key.

        Florida had to finally step up and do it ourselves because
    the Federal Government would do nothing. But the first key has
    to be, what do we do with our pending applications? How do you
    cleanup FDA's house first? You need to know what the law is
    before you can enforce it. Let's start there, please focus on
    that. And then we will also work with the enforcement measure.

        I'd also like to just get a commitment from you as from the
    State of Florida citrus growers, orange growers, that's a big
    deal to us. There's a regulation in there, an arbitrary
    regulation, amount of sugar content. It needs to be examined
    with disease and greening, and all the things facing the citrus
    industry. That arbitrary regulation, the oranges aren't
    producing as much sugar, I can go into it, but do I have your
    commitment for them to look at that regulation? Things that are
    set sometimes we need to revisit on how it's affecting
    industries across the United States. So, do I have your
    commitment to look at that?

        Dr. Makary. Senator, I had my cold press freshly squeezed
    orange juice this morning, and you do have my commitment to
    look at that.

        Senator Moody. Oh, our orange growers are going to be so
    happy to hear that. I will tell them. Thank you so much.

        Dr. Makary. Thank you.

        The Chairman. That was the great mother board that told you
    to drink the orange juice, do you know what I'm saying? That
    was really good.

        Senator Kim.

        [Laughter.]

        Senator Kim. Thank you, Chairman. Doctor, thanks for coming
    on out. I was looking through your opening statement. At the
    very end, you talked about FDA being the gold standard, and you
    said gold standard of transparency, and I was glad to hear
    that. I wanted to ask you in terms of transparency, do you
    think it's important that we can ensure that there's public
    comments on actions of agencies and departments overseeing
    important aspects of our lives?

        Dr. Makary. Senator, first of all, it was good to meet with
    you, and I enjoyed our conversation. I do believe in civil
    discourse and have been an advocate for civil discourse and
    coming out of an era of medical establishment censorship. So, I
    do believe in the principle. Now, there are laws and
    regulations around public comment periods, and in some
    situations, a public comment period is required by a
    regulation.

        Senator Kim. I would just suggest here that this is really
    important, the public, very concerned you were talking about,
    we had a long conversation about how to restore trust. And I
    think a big part of that is about involving the public more, I
    think you saw some of that in terms of the questions regarding
    VRBPAC, and just the need for that type of radical transparency
    as Secretary Kennedy talks about.

        Recently, there was an effort addressing the Richardson
    waiver. I ask that you look into this if you're confirmed, but
    I do think it's important that we maintain public comments,
    something that so far, this HHS has not abided by, and
    something that has been longstanding practice.

        Another aspect of this is about transparency and
    accountability. So, I guess I just wanted to ask you if we have
    this sense of nothing to hide, we want to root out waste,
    fraud, corruption, do you support the roles of Inspector
    Generals?

        Dr. Makary. Senator, I believe in the law, and I believe in
    the process of having Inspector Generals.

        Senator Kim. Okay. Well if you are confirmed, I just urge
    you to do everything you can to ensure that HHS has an
    Inspector General, has an ability for us to be able to oversee
    the accountability and to be able to root out some of the
    problems that I hope both of us can agree upon. So, I just want
    to ask for your commitment on that front that you would push to
    try to have an Inspector General there at HHS.

        Dr. Makary. Thank you, Senator.

        Senator Kim. When it comes to ethics, I heard you refer
    about just concerns, you want to have ethics review in terms of
    positions that people might be having, especially involving
    approval of drugs and other things. I guess I wanted to just
    ask you a little bit more on your end. It looked like I come
    across something that's saying that you were willing to divest
    from your own investments that were being perceived potentially
    as a conflict of interest if you are confirmed in this job, is
    that correct?

        Dr. Makary. Senator, as you are aware, the Office of
    Government Ethics does a comprehensive review of basically
    everything I own, every stock, every equity, every share. I
    would describe it as a colonoscopy with a small bowel follow
    through.

        [Laughter.]

        Dr. Makary. It took about 4 weeks, and they gave me the
    option of resigning from some things, or maintaining a role,
    and I chose voluntarily to divest and resign from everything.

        Senator Kim. I applaud that, and I think that should be the
    standard, especially for such important jobs. I guess I just
    wanted to ask you a little bit further here, would you agree to
    recuse yourself from matters involving your former clients and
    employers, if that comes before you at the FDA?

        Dr. Makary. Senator, what I can promise you and commit to
    is, to abide by all the guidance of the Office of Government
    Ethics----

        Senator Kim. I understand that, but you just talked about
    how you voluntarily took steps to be able to divest. That was
    not something you were required to do, though I do think you
    should have been. But I guess I would just ask you again, would
    you consider recusing yourself? Because I mean, if you're
    making decisions about a previous client of yours, you can see
    how the general public would react to that in terms of concern
    about whether or not you are doing this for the best interest
    of the people or the best interest of people you know?

        Dr. Makary. Senator, I have signed to agree to recusals as
    defined by the Office of Government Ethics in any area where
    they perceived a conflict could occur. And so, I have already
    agreed to the recusals required by the Office of Government
    Ethics.

        Senator Kim. One last thing I just wanted to raise, and
    this is just something I just want to ask, what is you're
    feeling about these potential Medicaid cuts that are being
    reviewed right now in Congress?

        Dr. Makary. Senator, the FDA is not involved in Medicaid or
    coverage decisions.

        Senator Kim. I understand that, I guess the reason I raise
    it is that in your opening remarks you said--I thought it was
    really powerful--you said that your motto in life has been
    about treating everyone in the community equally, especially
    the most vulnerable amongst them.

        I just urge you to just continue to press, you will have a
    seat at the table if you're confirmed on healthcare decisions
    across the Administration and Medicaid is essential for the
    most vulnerable amongst us. And treating everyone equally--your
    drugs, it's not just about the approval, you'd want to see that
    get into the hands of Americans, make sure that they can use
    and benefit from them. So, I do think that you have an interest
    in preserving Medicaid. Thank you.

        The Chairman. Senator Murkowski.

        Senator Murkowski. Thank you, Mr. Chairman. Doctor,
    welcome. It was a good conversation that we had, I appreciated
    that, I thank you for the encouragement to read that provision
    in your book. So, airplane reading for me.

        Dr. Makary. Thank you, Senator.

        Senator Murkowski. I also want to thank you for the
    assurance that you gave to Senator Collins regarding the
    Vaccine Advisory Committee and ensuring that there would be
    meetings going forward. I think for several of us who had, I
    thought good substance conversations with Secretary Kennedy, we
    had received assurances about things like the vaccination
    committee. So, making sure, again, that kind of very important
    input goes forward, I think is important to many of us. So, I
    appreciate that.

        I wanted to talk to you this morning about an issue that we
    discussed in my office, and that is with regards to ALS. The
    FDA's accelerated approval pathway has really been important,
    and I think very promising for treatments for ALS and some
    other rare diseases. You have advocated for using common sense
    alongside science in regulatory decisions. So, very briefly,
    how do we define common sense here as it applies to the
    regulatory decisions of FDA? How do we make sure that ALS
    patients who again, are looking at a very, very, very limited
    timeframe, they can't wait for the traditional approval
    process.

        There are some emerging measures using digital
    technologies, is this in your realm of common sense? Give me a
    little bit of your view here on how you would like to proceed
    on these accelerating approval pathways.

        Dr. Makary. Thank you, Senator and I very much enjoyed our
    time together and talking through a bunch of these issues. We
    have to customize the regulatory process to the condition that
    we're trying to be able to offer hope for. So, if a condition
    affects 19 people in the world, as a partial triplication
    chromosome 15 disorder does, or a disease that affects 52 kids
    in the world, we cannot require two randomized controlled
    trials. We have to customize the regulatory process to what
    we're trying to do, if our goal is to try to provide safe and
    effective therapies.

        I do believe firmly in that approach, and I think we can
    use some common sense to ask some big questions we've never
    asked before at the FDA. Why does it take 10 years for a drug
    to get approved? Why does a college student who suffers from
    chronic abdominal pain for years, and we have no idea what's
    going on, they go to Italy for a summer and they're suddenly
    cured of their abdominal pain. Why does a peanut allergy
    medication that's been safe with data for decades, get approved
    in Europe before the United States when nearly 10 percent of
    our population has a food allergy?

        I do think there's a lot of areas where we can ask, does a
    drug need to be prescription when it could be over the counter?
    Why are we requiring continuous glucose monitors to have a
    doctor's prescription? When it's good for people to use these
    monitors and learn about what they're eating. We don't just
    want to limit continuous glucose monitoring to people with
    diabetes, we want to prevent diabetes when 30 percent of our
    Nation's children has diabetes or pre-diabetes, or some form of
    early insulin resistance. Why are we holding these tools to
    help people empower them with knowledge about their health,
    until after they're sick? Same with continuous blood pressure
    monitoring.

        Senator Murkowski. It's as you point out, why do we wait?
    Now, we want to make sure that there is that level of safety,
    that's the job there through the FDA. But again, being able to
    accelerate these in ways that are meaningful and to your point,
    that actually fit with the population that you're speaking to.
    So, know that I'm going to be pushing you on this as well as
    many other advocates out there.

        Dr. Makary. Thank you.

        Senator Murkowski. I want to quickly ask you about food
    safety inspections. State and local governments conduct about
    60 percent of food processing facility inspections, 90 percent
    of produce safety inspections, a hundred percent of retail food
    inspections. What has happened is we have seen in the Biden
    administration, FDA planning to cut funding for state and local
    food safety programs. This impacts us in the State of Alaska
    when it comes to our seafood industry and in other areas.

        I'm looking for a commitment from you that under the Trump
    administration, the FDA is going to maintain funding for these
    contracts with state and local governments. They've proven that
    it's more cost effective, more efficient, and it also is what
    Congress has asked for. So, I'd like to know that you're going
    to be supportive in that regard with regards to state and local
    food.

        Dr. Makary. I'm happy to look at that with you, Senator.

        Senator Murkowski. Very good. Thank you, Mr. Chairman.

        The Chairman. Senator Blunt Rochester.

        Senator Blunt Rochester. Thank you, Mr. Chairman. And thank
    you so much Dr. Makary for taking time to meet with me. I've
    found that most parents would do anything to keep their
    children safe and healthy, which is why we probably see so much
    intense debate on the best ways to protect our children. And
    the FDA has historically been seen as the authority on reliable
    information about public health issues related to medical
    products, food, tobacco, cosmetics, dietary supplements.
    However, people are getting their information in many different
    ways now, in many different places.

        We're faced with a growing challenge of opinions replacing
    scientific consensus and the proliferation of misinformation
    and disinformation. Parents need accurate science-based
    information to help make informed decisions for their children.
    How would you use your position as FDA commissioner, to compete
    with uninformed voices and to share evidence-based consensus-
    driven information that is free from political influence?

        Dr. Makary. Well, thank you, Senator and I enjoyed our time
    meeting together. I believe very much in empowering people with
    good information, that's why I've written three bestselling
    books to try to educate people about health. And I do think you
    can explain to people with humility what we know and what we
    don't know, and then they're going to trust us more.

        Trust in doctors and hospitals is at a crisis right now. It
    was 71 percent in 2019, 71 percent of the public trusted us in
    2019, now it's down to 40 percent. That's a 31 point drop in my
    profession, that is a major problem. If we have the cure for
    pancreatic cancer, but only 40 percent of the public is going
    to come in and take it because the rest doesn't trust us, then
    that medication is only 40 percent effective.

        I think we fight bad ideas with more ideas. I don't believe
    in censorship of scientific opinions. I think we need a civil
    discourse. Unfortunately, we have a sort of toxic discourse
    right now in the United States and the politicalization of
    immune cells in some cases.

        Senator Blunt Rochester. One of my big concerns is who
    those voices are, and that they really are robust,
    scientifically trusted messengers as well. One of the other big
    issues that we're facing are drug shortages that have reached
    an all-time high, threatening access to products that we use
    every day, from IV bags to lifesaving drugs for cancer.

        It's particularly concerning for children's hospitals
    because of pediatric drugs and supplies that must be formulated
    to accommodate children's unique needs. Do you agree, and this
    is kind of a yes or no, do you agree that the FDA should play a
    leading role in mitigating drug shortages?

        Dr. Makary. I love yes and no questions.

        Senator Blunt Rochester. Good. Can you, do it?

        [Laughter.]

        Dr. Makary. A leading role--they should take a role. I
    think the problem is much bigger than the FDA.

        Senator Blunt Rochester. Yes or no, you're like not sure if
    it's a yes or no.

        Dr. Makary. I would refer you to my article in JAMA on this
    topic.

        Senator Blunt Rochester. I want to shift to clinical trials
    as well. You agreed, we talked about the importance of clinical
    trial diversity, but I want an assurance that you will stand up
    to any Trump administration actions that conflict with this.
    So, again, yes, or no, do you believe clinical trial diversity
    is critically important?

        Senator Blunt Rochester. That's the easy one.

        Dr. Makary. Well, if you're talking about a trial of sickle
    cell disease, are we saying that we need to have white people
    in a trial of sickle cell? I believe in common sense, and I
    believe in clinical trial diversity, both. And so, I believe if
    you're going to make results extrapolated to the general
    population, you should have results in those populations that
    you're making recommendations for.

        Senator Blunt Rochester. That one was an easy one. Do you
    think it is acceptable for the Administration to remove
    congressionally mandated guidance documents on clinical trial
    diversity?

        Dr. Makary. I'm not familiar with that.

        Senator Blunt Rochester. Should you be confirmed, will you
    reinstate and finalize this document after you look at it as
    one of your first actions? Would you take a look at that? Could
    you commit to looking at that?

        Dr. Makary. Yes, Senator.

        Senator Blunt Rochester. Good answer.

        [Laughter.]

        Senator Blunt Rochester. Will you restore the Web site for
    the Office of Minority Health and Health Equity?

        Dr. Makary. I'm not familiar with that Web site, Senator.

        Senator Blunt Rochester. If there was one and you knew
    there was one, would you restore the Web site that would
    provide information to the American people?

        Dr. Makary. I think you're asking me to make a decision on
    information that I don't have. So, you have my commitment to
    take a look at it.

        Senator Blunt Rochester. If you got the opportunity to
    review the Web site, and then know that it would help to spread
    real information, science-based information, would you
    reinstate that Web site?

        Dr. Makary. I would be happy to review it.

        Senator Blunt Rochester. I have more questions that I will
    send for the record, but particularly, I'm concerned also about
    the Vaccines for Children program and making sure with the--
    you've heard our colleagues talk about the cancellation of the
    meeting. This is not just about cost for families, which is
    huge right now, but it's also about coverage. And so, I yield
    back my time and I thank you so much, Doctor.

        Dr. Makary. Thank you, Senator.

        Senator Hawley. Thank you very much, Senator. Doctor, it's
    great to see you again, I enjoyed our conversation.

        Dr. Makary. Good to see you.

        Senator Hawley. Congratulations on your nomination and
    thank you for your willingness to take on this very important
    role. You've been asked about this several times already, but I
    just want to drill down a little bit further.

        In 2000, President Clinton's FDA approved a chemical
    abortion regimen with the drugs mifepristone and also
    misoprostol. Now, the FDA concluded that mifepristone could not
    be safely used, I'm quoting the FDA there, safely used, could
    not be, without special measures, it's the FDA's language. And
    in particular, the FDA mandated that prescribers needed to be
    licensed physicians who were able to diagnose and treat ectopic
    pregnancies to accurately determine the gestational age of the
    baby.

        The FDA further required that these drugs be administered
    and dispensed in person, that there be a day one in-person
    administration of the drug, a day three in-person
    administration of the second wave of the drug, a day 14 check-
    in for complications. And the FDA further emphasized that given
    the potential risks of these drugs, physicians needed to be
    able to provide ongoing care.

        The FDA also said, ``The percentage of women who considered
    any particular adverse event as severe ranged from two to 35
    percent.'' And the FDA included what's called a black box
    warning, which you're very familiar with, which remains on the
    drug.

        Now, those restrictions were largely in place until just a
    couple of years ago, when the Biden administration, after the
    U.S. Supreme Court took up the Dobbs decision, granted cert on
    it. At that point, the Biden administration decided to
    eliminate 20 years of in-person dispensing requirements for
    this drug that didn't cite any studies that they said were
    adequate. That the FDA acknowledged that the studies that they
    looked at did not take into account the new protocols that they
    were issuing. They just eliminated two decades of in-person
    dispensing requirements.

        My question to you is, given the FDA's own findings on this
    drug over two decades, doesn't it make sense that the FDA
    returned to the pre political, before the political
    intervention of the Biden administration, the pre political
    protocol that requires in-person dispensing for chemical
    abortion drugs?

        Dr. Makary. Senator, I appreciated our conversation prior
    to this hearing. I do think it makes sense to review the
    totality of data and ongoing data. I know personally of OB
    doctors who prefer to insist, even though they have the option
    to prescribe otherwise, but they choose to insist that
    mifepristone be taken, when necessary, in their office as they
    observe the person taking it. And I think their concern there
    is that if this drug is in the wrong hands, it could be used
    for coercion.

        Senator Hawley. Of course, you're familiar with the fact
    that now it's not merely that there's no requirement that it be
    ingested in the presence of a physician, there's no in-person
    dispensing requirement whatsoever. This is what the Biden
    administration--two decades of in-person dispensing
    requirements, the Biden administration eliminated those.

        Now, you've said several times, you'll review the data. You
    are aware that in 2016, the Obama FDA eliminated the
    requirement that physicians report adverse events with regard
    to mifepristone, aren't you?

        Dr. Makary. I believe they limited the data required to
    fatalities, but not adverse events.

        Senator Hawley. Will you put back in place the full
    reporting requirements that you can have a full range of data
    to evaluate?

        Dr. Makary. Senator, I'm happy to look at that. I do
    believe in data, and I don't believe in pre-judging data before
    somebody has taken a look at data, including future data.

        Senator Hawley. Well, let me just say that, here's the
    deal. The FDA's rules were pretty consistent and pretty stable
    for 20 plus years, until suddenly the Dobbs decision appeared
    on the horizon. And when that happened, all of a sudden, we got
    massive changes in the dispensing requirements of this drug.

        I'll just point out that over 60 percent of abortions in
    the United States are now carried out with chemical drugs, with
    these drugs. They're not done in clinics; they're not done in
    hospitals, they're done with these drugs, without any kind of
    physician supervision, without any physicians there.

        If there's a serious adverse event--and I'll also just
    point out that if the Biden rules are allowed to stand, it
    doesn't matter what voters in the states, it doesn't matter
    what--this is a serious and very difficult moral issue, the
    case of life and abortion. And it won't matter what voters in
    the states say, because the Biden rules say now that
    bureaucrats can mail in abortion drugs to every single state,
    no in-person dispensing required. It doesn't matter what voters
    in the state have decided on the issue, it doesn't matter
    whatsoever.

        Now, if that's allowed to stand, we may as well just go
    back to having the Supreme Court make all the decisions.
    Because right now, Washington bureaucrats are making all the
    decisions, doctors are not involved. They're not in person
    dispensing, state voters are not involved. And I just want to
    register this is extremely concerning to me. It ought to be
    concerning to everyone who's concerned about women's safety,
    and also about what I thought was the position of this
    Administration, which is that it ought to be voters in the
    states and the relevant localities that are deciding this
    decision.

        I know you're familiar with this, doctor. I appreciate your
    commitment to the data. I hope that you'll look at the full
    range of data, and I hope we can count on you to protect
    women's health and the health of the unborn.

        Dr. Makary. Thank you, Senator.

        Senator Hawley. [Presiding.] Well, Senator Kaine, let the
    record reflect, even though I have the gavel, I'm going to stop
    right now and turn it over to you.

        You're recognized, Senator.

        Senator Kaine. Thank you, Senator Hawley. Senator Hawley
    and I share a unique perspective. There are two sets of
    Senators who went to the same high school. Chuck Schumer and
    Bernie Sanders went to James Madison High School in Brooklyn,
    New York and Josh and I went to Rockhurst High School in Kansas
    City, so I just wanted to put that on the record.

        Dr. Makary, I loved the opportunity to visit with you and I
    know the answer to this question, but I just want to stress it
    again. You didn't have anything to do with the layoff of the
    thousand FDA employees that have been laid off in the last
    couple weeks, correct?

        Dr. Makary. That's correct, Senator.

        Senator Kaine. Do you know anything about the layoffs, for
    example, who made the decisions or what groups of people were
    laid off?

        Dr. Makary. I do not, Senator.

        Senator Kaine. You indicated that when you come into the
    office, you're going to do an assessment. And I suppose based
    on your experience, that if you look at this going forward, you
    think personnel policy, including layoffs, should be done
    strategically rather than just kind of willy nilly across the
    board randomly, correct?

        Dr. Makary. I am open to ideas on making government more
    efficient.

        Senator Kaine. Do you think willy nilly, random across the
    board, is a good idea or not a good idea?

        Dr. Makary. Look, I'm a surgeon, so I'm going to give you a
    surgical answer.

        Senator Kaine. Yes. Okay. That's good. It is a little bit
    puzzling; the Administration has high confidence in you. You've
    got this hearing right now, they expect you to be confirmed,
    probably will be based on practice of the notion that they
    would lay off a thousand people before you got there, is a
    little bit unusual. And what we're seeing in agencies, in the
    layoffs is that it is willy nilly random probationers get laid
    off because they can't fight back. Probationers are
    disproportionately veterans. I'm glad you will be a surgeon and
    act like a surgeon, should you be confirmed.

        Second thing I want to ask is about user fees. And we
    chatted a little bit about this in the office. We agreed that
    despite the need for reforms at the FDA, that the FDA is sort
    of the gold standard. I asked you, is there another nation that
    does this better than us? And you said, no, there wasn't. Even
    though, again, you've got reforms you'd like to make.

        Here is an issue that's pretty technical, but it's an
    important one. We talked about tracking adverse events after a
    drug or medical device is approved. And you indicated that the
    FDA can do a better job of identifying issues with problems
    that are already on the market. It's not all about approval and
    that it's about post-approval tracking.

        There are many different user fee programs that outline the
    relationship between the FDA and industry. And for most of the
    user fee programs except medical device user fee, FDA can use
    the collected user fee dollars to conduct post-marketing
    surveillance. But the medical device user fee program does not
    allow that use of the user fee dollars. Would you agree that
    the FDA should be able to use the user fees collected of
    medical devices to do post-approval surveillance?

        Dr. Makary. Senator user fees are established by Congress,
    and I'm more than happy to be a part of the conversation about
    the best use of those dollars within the agencies. I very much
    enjoyed our conversation, and I'm committed to an FDA that
    delivers more cures for Americans and meaningful treatments,
    healthy food for children----

        Senator Kaine. But can I just ask about this, do you think
    post-approval surveillance is something that's important?

        Dr. Makary. I am a big believer, Okay, in the idea that we
    should not just turn a blind eye after the FDA approves
    something. If we do that, we get burned with a million lives
    lost from Oxycodone and OxyContin without----

        Senator Kaine. That's my next topic. And I do agree with
    you that making that change would be on Congress's shoulders,
    but I do think it's odd that we don't allow the user fees to be
    used for post-approval surveillance on medical devices when we
    do in the other areas. And I'd love to work with you on that.

        On OxyContin, I want to just close with this one. We're
    seeing some improvements: 24 percent decline in drug overdose
    for the 12-month period ending in September, 2024 compared to
    previous year. And just yesterday, the NIH released findings of
    an NIH funded study researching a new pathway to address pain
    issues. But 87,000 Americans died of overdose in the 12-month
    period. So, it's an improvement, but we got so much farther to
    go.

        1 in 4 Virginians deal with chronic pain. And one of the
    issues you and I talked about is, can the FDA not just be in
    receive mode, to get the applications for approvals and
    approve? Can the FDA even be proactive in looking and saying,
    hmm, how come we don't have more non-opioid based pain
    management strategies? The FDA shouldn't be picking a winner
    among competitors, but to look at gaps and try to incentivize
    or encourage filling those gaps would be smart.

        Could you share some of your ideas for how we might
    encourage appropriately, the development of innovative
    strategies to address chronic pain without using opioids?

        Dr. Makary. Thank you, Senator. I do believe the FDA should
    not just be in receive mode, but also partner with industry and
    facilitate the process and ensure that the scientific review is
    independent, at the same time without cutting any corners on
    the independence of that review. The opioid pain problem can
    also be addressed by innovation, more localized treatments, and
    looking at post approval monitoring of devices.

        Senator Kaine. Great and thank you. I look forward to more
    discussion.

        Dr. Makary. Thanks, Senator.

        The Chairman. [Presiding.] Senator Tuberville.

        Senator Tuberville. Thank you, Mr. Chairman. Thank you,
    doctor, for being here.

        Dr. Makary. Thank you, Coach.

        Senator Tuberville. Also for your willingness to do this.
    World War II, we had to find ways to feed our troops. We knew
    nothing about preservatives and canning foods and ever since
    then, our food's going downhill because we have put everything
    in the world, in our food, No. 1, to get kids addicted to it,
    which we have. We've lost probably a couple of generations
    because of the obesity and diabetes.

        I have faith in this generation. I have two kids in this
    generation coming up, that they're looking at their health as a
    future. And they're fired up about nutrition being a good part
    of it.

        Are you familiar with GRASS--generally recognize safe
    foods, the chemicals that go into our foods. What's your
    thoughts on that? What's your thoughts on you as FDA director
    having the ability to look at this and know we're not using
    this chemical in this food. What's your thoughts?

        Dr. Makary. Well, first of all Senator Coach, I think you
    have had a perspective on this and been an advocate for healthy
    foods. And perhaps it's because of your unique position where
    you've worked with young people for so long. Half of our
    Nation's children are sick, and nobody has really been doing
    anything meaningful on this front until we have gotten new
    momentum and enthusiasm from Secretary Kennedy and President
    Trump to finally address the root causes of these diseases:
    General body inflammation and generalized insulin resistance,
    and food is a big part of it.

        When we eat foods with a lot of molecules that do not
    appear in nature, these are chemicals. These are chemicals that
    the industry insists are safe, a subset of which are
    concerning. There's a body of research now that suggests
    concern with some of these ingredients. We have to look at
    those ingredients, and you have my commitment to do so if
    confirmed as FDA commissioner.

        These chemicals are creating an inflammatory response in
    the gastrointestinal tract. And with an altered microbiome
    lining that GI tract, kids feel sick. It's not an acute
    inflammatory reaction, it's a chronic low-grade reaction, and
    they don't feel well. And what are we doing? We are drugging
    our Nation's children at scale. We have to reassess what we're
    doing because we're not on a good path right now.

        Senator Tuberville. I grew up in the South. I love fried
    foods. Okay. We fry everything, including snicker bars and
    Twinkies.

        [Laughter.]

        Senator Tuberville. But let me ask you this, I hear a lot
    about seed oils and the good and the bad, your thoughts?

        Dr. Makary. I think seed oils are a good example of where
    we could benefit from a consolidation of the scientific
    research. And I don't think it's any one ingredient in the food
    supply that's making our Nation's children sick with a 30
    percent rate of insulin resistance and diabetes in American
    teenagers today. That's a massive signal in the data.

        I think we have to look at the totality of every single
    thing in school lunch programs, in the diet of our Nation's
    children. When we're using tax dollars to make purchases of
    foods that we know make our Nation's children sick, we have to
    reexamine how we're spending those tax dollars.

        One thing I would like to work on is a school lunch
    program, for some school districts, on a pilot basis to
    transition to healthier foods. A lot of school districts want
    to, but they don't know how, and they may not have the funds.
    So, I've been discussing this with Jay Bhattacharya and others
    in the Administration, and I hope that's something we can do.

        Senator Tuberville. Thank you. Just a few months ago, we
    had the former FDA director, and I asked him about red dye No.
    3, and it was a pretty interesting conversation. Red dye No. 3,
    we've done studies on it, and we won't allow it in cosmetics,
    Okay? Because it causes cancer, but we are allowed to put it in
    our food and I'm a little bit confused.

        I'm a football coach, but I'm not that stupid. Put it on
    your face and put in your stomach, there's no difference. But
    he made an interesting statement that we're 20 years behind
    Europe, because Europe doesn't allow it in anything. We're 20
    years behind Europe on looking into red dye three and all the
    other dyes. What's your thoughts on dyes in this country?

        Dr. Makary. I agree with you that we--it did not make sense
    that red dye No. 3 was banned in cosmetics, but allowed in the
    food supply. And so, with two business days left in the Biden
    administration, there was an announcement to ban red dye No. 3
    in 2027 or 2028.

        Senator Tuberville. Why that long, we want to kill people
    for two more years. I mean, I would hope that you would, if
    you're confirmed, you go in and look at it very quickly and
    say, why do we want to put our people in harm's way? Thank you,
    Mr. Chairman.

        Dr. Makary. Thank you, coach.

        The Chairman. Senator Hickenlooper.

        Senator Hickenlooper. Thank you, Mr. Chairman and thank
    you, Dr. Makary for your service. I finally got a chance to
    look over some of your three books, or you probably have more
    than that, but the three books that I was able to chase down,
    and they each one seemed provocative and full of answers. I
    will say, as a very, very slow reader, I'm a dyslexic, I do
    wish you had something like Cliff notes so that we could get 10
    or 15 pages concise and get the essence out of that.

        Dr. Makary. I'd be happy to personally summarize them for
    you Senator.

        [Laughter.]

        Senator Hickenlooper. I think we have witnesses that just
    heard that, I'm very excited. I appreciate your courage in
    taking on a lot of these traditional approaches and being so
    candid. Let me go through a couple of questions. In just a few
    weeks, roughly 10 percent of the FDA staff has been laid off.
    And most of these layoffs were inspectors who looked either at
    food supply, whether it was safety of medical devices and yet
    for the past several years, job vacancies, if you measure them
    as an indication of anything, but for FDA inspectors, job
    vacancies have been going up, not down. In other words, we have
    more unfilled spots, and now all of a sudden, we've laid off 10
    percent of the people there.

        That chaos and the understaffing is going to really present
    a serious morale issue, which I'm sure you're aware of. I don't
    know if you have any plans for that. And how are you going to
    be able to try and do the best you can to ensure the FDA's gold
    standard of science if we can't get enough inspectors?

        Dr. Makary. Senator, thank you for the question and I
    enjoyed our time together in your office. I was not involved in
    any personnel decisions.

        Senator Hickenlooper. That was not a criticism. I was just
    saying, once you get in the job, if your budget is suddenly
    diminished and you've got 10 percent fewer inspectors and you
    already didn't have enough by the existing measures, I'm not
    sure there's an answer for it. Maybe it's an unfair question.

        Dr. Makary. Senator, if confirmed, you have my commitment
    that I will do an assessment within the Agency of personnel,
    and it will be an ongoing assessment to ensure that the
    scientists and food inspectors have all the resources they need
    to do their job.

        Senator Hickenlooper. Great. Again, that's certainly the
    exact place to start. We have a bill, Skinny Labels, Big
    Savings Act that helps more generic drugs, more of that
    competition come into the market, lower drug costs.

        Again, with so many of the FDA workers having been fired
    and laid off, will there be sufficient people at the agency to
    review generic drug applications? Because that often gets
    pushed to the bottom of the heap, and yet it has dramatic
    savings, especially for elderly and people on the lower parts,
    the people that don't have insurance. So, are you worried about
    a slowdown, again due to resources and personnel?

        Dr. Makary. Senator, I want to make sure that the reviewers
    and the review process is done properly without cutting any
    corners on the scientific independence and done expeditiously.
    So, you do have my commitment that I will do my best to ensure
    that that's done as best as possible.

        Just to put things in context, if I may. The FDA has almost
    19,000 employees, just over 18,000. That represents a 100
    percent increase since 2007. Now, I understand there were some
    layoffs recently, I understand some or many were hired back,
    but I just wanted to let you know that, to put things in
    context, we have seen a doubling of the agency in terms of
    number of employees since 2007.

        Senator Hickenlooper. Fair point, I accept that and was
    aware of that, but it's a fair point. Lot of talk about
    measles. Secretary Kennedy recommended the use of cod liver oil
    as one of several things that people could do and left it to
    parental discretion as to whether they would get their kids
    vaccinated, which I think you've got--I agree with that.

        I think the parents in the end have a right and a
    responsibility to make that decision for their kids. But it
    seemed to me that there could be a stronger--those of us who
    looked adept and in detail at the facts, that this is really a
    very safe vaccination for 99.99 percent of kids. And it saves
    lives and it prevents huge levels of very sick kids. You think
    there should be more, or will you be willing to be a more
    enthusiastic supporter of vaccinations while at the same time
    recognizing that parents get the final say?

        Dr. Makary. Senator vaccines save lives. And I do believe
    that any child who dies of a vaccine preventable illness is a
    tragedy in the modern era. The rare times in which a child dies
    of measles, it is often in the setting of a comorbid condition
    or severe malnutrition. And perhaps that is the rationale
    scientifically and physiologically as to why some
    supplementation in terms of nutrients may provide a benefit to
    children who are very sick and hospitalized with measles.

        Senator Hickenlooper. Right. And I don't deny that. Thank
    you. But I'm getting gaveled.

        Dr. Makary. Thank you, Senator.

        Senator Hickenlooper. Thank you so much for your service.

        Dr. Makary. Thank you, Senator.

        The Chairman. Senator Husted.

        Senator Husted. Thank you, Mr. Chairman. Great to have you
    before the Committee. I enjoyed Dr. Makary the conversation we
    had in my office. And I want to just give you a chance to share
    some thoughts kind of building on what I'm sure others have
    asked you.

        I am deeply concerned about how much inflationary cost the
    healthcare system has created for the American public over the
    last decade in the 21st century. We talk about inflation around
    here, the most inflationary cost affecting consumers,
    businesses, the American public, the American taxpayer is
    healthcare costs. We seem to spend more, get worse outcomes.

        You look at the fact that from the earliest stages we have
    children who are unhealthier, worse diets, more obesity, which
    lead to problems like diabetes, lower quality of life, lower
    productivity as they go through life, higher costs in the
    healthcare system, that continues to manifest through life on
    all those fronts. And then the government and the taxpayers end
    up paying for all of it through Medicare and Medicaid. It is
    driving us into bankruptcy in some levels and costing people
    and families the ability to afford to live. And so there are
    lots of ingredients to that.

        How do we take cost out of the healthcare system, whether
    it is making people healthier and in making this whole system
    sustainable for the long run.

        Dr. Makary. Well thank you Senator Husted, and it's good to
    see the Cavaliers doing great this year. I hope this is their
    year to win it all. I enjoyed our time in your office.

        Senator Husted. We only have one championship in Cleveland.
    That was when LeBron was there.

        [Laughter.]

        Dr. Makary. First of all, you are a hundred percent
    correct, and this is something I'm very passionate about.
    Healthcare costs are spiraling out of control, and its
    burdening everyday American businesses and families. It's
    getting more and more difficult to compete with businesses
    overseas because of healthcare costs. It outpaces inflation.

        When we are spending money that we don't have as a country,
    it drives inflation and inflation is a backhanded dirty tax on
    the poor. It doesn't affect the wealthy; it affects the poor.
    And that's why we've got to address healthcare spending. We've
    heard of many different ideas out there, but the main root
    issue is the health of the population, and it is getting worse.
    75 percent of adults have some comorbid condition or diabetes
    or pre-diabetes, or are overweight or obese. 3 in 10 teens now
    have insulin resistance, that's not good for our future as a
    country.

        Thanks to President Trump and Secretary Kennedy for the
    first time, we're talking about root causes, both on a research
    basis and in terms of what we can do at every agency. And
    within the FDA, I do think there are things we can do to help
    empower people, by facilitating this independent scientific
    review of devices and other ways to prevent chronic diseases
    with continuous glucose monitoring, continuous blood pressure
    monitoring, and healthy foods for children.

        If confirmed, my goals are very clear at the FDA, more
    cures, and meaningful treatments for Americans, including
    diagnostics, healthy food for children, and rebuilding the
    public trust.

        Senator Husted. Great. I look forward to working with you
    on all those issues, as I'm sure many of the Members of this
    Committee do. One way that we can drive more efficiency and
    speed to market for things that can improve lives and hopefully
    lower costs is through technology. I know that I was involved
    with the Cleveland Clinic when they got the first quantum
    computer focused on healthcare research, and you use things
    like quantum and AI to drive discoveries, speed to market with
    these. Could you talk about how the FDA under your leadership
    would think about those things?

        Dr. Makary. Thank you, Senator. I think there's a number of
    opportunities with AI right now that we have, that we've never
    had before. We have an incredible opportunity to use AI to help
    reviewers in the review process, not to replace the human
    reviews, but to aid them and assist them in the same way that
    EKGs are read by AI devices that tell us normal sinus rhythm at
    the bottom of the EKG. Now, we still look at the rhythm, but it
    aids and it may help the efficiency among the reviewers.

        We can use AI also in drug design and drug development.
    Now, that's not something the FDA does, but the FDA can help
    provide data to help train machine learning models to help
    design AI systems that can predict toxicities, adverse events,
    and even cures for some conditions.

        Finally, AI can be used to aid with data monitoring in a
    post-approval setting. So, we don't learn 5 years after Vioxx
    is approved that 38,000 Americans died from it. Thank you.

        The Chairman. Thank you, Senator Husted.

        Now Senator Markey.

        Senator Markey. Thank you, Mr. Chairman. I'm from Boston,
    the home of the World Champion, Boston Celtics. Good luck to
    the Cavaliers.

        [Laughter.]

        Senator Markey. But we'll have a little bet. You stated
    that you want to ensure that the FDA holds the gold standard of
    trusted science and transparency. In order for that to happen,
    the FDA commissioner must also uphold the gold standard for
    trusted science and transparency.

        In your financial disclosures, you disclosed that you made
    over half a million dollars from Global Appropriateness
    Measures LLC. The client list for that company includes
    companies that are interested in making money off of the
    healthcare system, insurance companies, hospital chains,
    private equity backed companies. So, can you tell the Committee
    how much you made from those private equity and venture capital
    backed companies?

        Dr. Makary. Senator, first of all, thank you for the
    question, and I enjoyed our conversation prior to this hearing.
    I'm very proud of my work at Global Appropriateness Measures.
    The purpose of the endeavor, was to lower healthcare costs for
    Americans by reducing unnecessary surgery and medications----

        Senator Markey. I appreciate that. Just for the record, can
    you just tell us how much you made from the private equity and
    venture capital backed companies?

        Dr. Makary. I have been a shareholder in Global
    Appropriateness Measures. I am fully divesting, I don't have
    the exact numbers at my fingertips, but they were all disclosed
    to the Office of Government Ethics, and they're all part of the
    disclosure system.

        Senator Markey. Was it in the millions of dollars or less?

        Dr. Makary. Over the course of what period of time?

        Senator Markey. Over the period of time that you had a
    relationship with them.

        Dr. Makary. There was revenue of that company in the
    millions of dollars. Yes. And I am one of the shareholders of
    that company, and I am very proud. The best way to lower drug
    prices in the United States are to stop taking drugs we don't
    need. So, I do believe in the appropriateness of care, and that
    endeavor was designed to create software, so we can monitor----

        Senator Markey. I appreciate that. And we're just looking
    at the transparency issue, so I'm just trying to help you to be
    transparent here. So how much were you paid by insurance
    companies, including devoted health services and insurance
    company that primarily sells Medicare Advantage plans?

        Dr. Makary. Yes, that figure is in the Office of Government
    Ethics Report. I don't have that exact number at my fingertips.
    And of course----

        Senator Markey. Was that in the millions of dollars as
    well?

        Dr. Makary. No, that was far less. And again, I'm one of
    the shareholders of that company.

        Senator Markey. Well, I think the American people do
    deserve your full transparency about how you might be
    influenced by the healthcare industry, insurance companies,
    private equity, and venture capital funds. And that's what I'm
    trying to get at here.

        Dr. Makary. Yes, all of those reports will be public
    Senator.

        Senator Markey. They will be public, they're not public at
    this point. So, I'm not in a position to ask you about them.
    And that's why I'm asking you if----

        Dr. Makary. Office of Government Ethics releases it at a
    certain point of time.

        Senator Markey. But it's not helpful for the confirmation
    hearing, which is essential in terms of the public
    understanding, all of the potential, not actual, but potential
    conflicts of interest that might show up. The FDA is
    responsible for approving medical devices or drugs that may
    impact how much insurance companies pay or what they cover. The
    same insurance companies that do overcharge Americans and
    undercover their care. It will impact hospital costs and
    private equity.

        You're coming into this role with relationships
    preexisting, that have a profit interest in the decisions that
    you will be responsible for making. That's why I'm raising
    these issues. Will you commit today to not participating in any
    decisions that would have an impact on known clients of Global
    Appropriateness Measures during your tenure as FDA
    commissioner?

        Dr. Makary. First of all, Senator, I appreciate your
    enthusiasm on this topic. I am one of the biggest advocates
    that was involved in the health insurance industry transparency
    of the secret negotiated rates. So, I'm a big--I'm with you.
    The recusals that I will be taking are a hundred percent in
    line with the Office of Government Ethics recommendations,
    which were not to resign from everything, but I chose to resign
    from everything to ensure no appearance of a conflict of
    interest.

        Senator Markey. That's important for us to hear. And the
    same thing, will you commit today to not participating in any
    decisions that would have an impact on private equity and
    venture capital investors of those clients as well?

        Dr. Makary. Senator, I commit to following the Office of
    Government Ethics Agreement.

        Senator Markey. Well again, it's just so important for us
    to understand this going forward, because of obviously the
    increasing role that those sectors are now playing, and they
    will be attempting to influence FDA decisions. So that's the
    reason why I'm raising the questions and total transparency is
    absolutely necessary. Thank you, Mr. Chairman.

        Dr. Makary. Thank you, Senator.

        The Chairman. Thanks. And I'll note that as you mentioned
    that all your financial records have been with the Office of
    Governor Ethics.

        Senator Banks.

        Senator Banks. Thank you, Mr. Chairman. On that note,
    doctor, you've been very transparent, right?

        Dr. Makary. I believe so.

        Senator Banks. Talk about that process. I mean, how
    transparent you have to be to get to this point today.

        [Laughter.]

        Dr. Makary. Well, there was a massive disclosure of
    basically every single share of everything that I own. And that
    process took a number of weeks and I would describe it as a
    colonoscopy with a small bowel follow through. And everything
    is out there and basically, I will have essentially no privacy
    when the Office of Government Ethics chooses to release that
    form. But that's Okay. I'm proud of everything that I've done,
    and I'm more than happy to acknowledge that I've agreed to
    divest or resign from everything.

        Again, I was given the option not to resign from
    everything, but I chose to resign from everything, because I
    want to ensure independence. This is not a job I'm taking to
    audition for my next job. This is a job I'm doing to serve the
    American public. I believe in more cures and meaningful
    treatments, healthy food for children, and rebuilding the
    public trust. So, Senator, I can commit to you that I am
    absolutely dedicated to that mission, and I am not there to
    audition for a future job.

        Senator Banks. I appreciate that, because this is so
    important. I mean, you've been nominated for this position
    because you're incredibly accomplished, your background
    perfectly fits the role that you're about to take, and you
    bring experiences and success to the table to be the new head
    of the FDA and change it.

        Because you've talked about this, you mentioned in your
    testimony that healthcare has become too fragmented, too cold,
    and too corporate, right? I mean and you're going to go there
    to shake that up and change that. The Make America Healthy
    again movement, that was a big part of giving this President a
    giant mandate with Secretary Kennedy and others who are coming
    to the table, the role that you're going to play is really
    important to that, to disrupt it.

        I think we all agree, that I think the American people
    agree, that the medical establishment is often condescending
    toward the American people, it is something that we have to
    disrupt and change. Can you talk about how you're going to do
    that at the FDA?

        Dr. Makary. Thank you, Senator. And I do agree a hundred
    percent that for the first time ever, President Trump and
    Secretary Kennedy had moms that were Republican, Democrat,
    independent, come out and vote because they care deeply about
    the health of our Nation's children.

        They want to see healthier food for children. They want to
    see an industry that has, they want to see an FDA that is
    independent of corporate influence, but at the same time
    working with partnerships around the country to facilitate, not
    just being a receive only mode. So, one of my goals is to
    ensure that the FDA maintains its scientific integrity and that
    we can do what we can to contribute to the Make America Healthy
    again spirit.

        Senator Banks. Very good. Clinical and nonclinical testing
    are both very important parts of FDA's drug approval process.
    How do we modernize that process? Modernize testing?

        Dr. Makary. Well, first of all, there are steps in the
    regulatory process where we can take a look and ask, do we need
    to use the same processes that we've been using? Infant
    formula, for example, has had the same recipe for the last 40
    years. And so, with the exception of Selenium, which was added
    in 2015, for 40 years we're requiring infant formula companies
    to use a standard recipe that was developed back when the food
    pyramid was misleading Americans and basically government
    misinformation.

        Can we take another look at that? Can we create other ways
    in which new products can be brought to market safely? Can we
    look at real world data from European products? The more
    competition, the more resiliency in the supply chain, and the
    lower the risk of a shortage in the future. So, does infant
    formula need to go through the same process as a new drug? Or
    can we look at real world data and work with the companies to
    figure out a smarter way that uses both trusted science and
    common sense, which is a theme I would like if confirmed.

        Senator Banks. I want to work with you on that. The FDA is
    starting to allow patients to choose whether they want
    prescription drug instructions on paper or digitally, seems
    like common sense. But medical device instructions are still
    required to be on paper. Would you support changing that
    requirement?

        Dr. Makary. Senator, my understanding is that's a
    requirement set by Congress, and I would be more than happy to
    work with you and Members of Congress to take a look at that.

        Senator Banks. Do you have an opinion on it?

        Dr. Makary. I've heard arguments on both sides. One thing
    that people have raised is that, on one hand it may be a waste
    of paper, it's a lot of paper. On the other hand, seniors may
    not go to a Web site to look at the information. So, I think
    there are arguments on both sides. I would welcome the
    opportunity to work with you on reforming.

        Senator Banks. Thank you. I yield back.

        The Chairman. Senator Banks, thank you.

        Senator Alsobrooks.

        Senator Alsobrooks. Thank you so much, Mr. Chairman. Good
    morning, Dr. Makary.

        Dr. Makary. Good morning.

        Senator Alsobrooks. Good to see you here. I'm going to just
    feed off of something my colleague just mentioned, some words
    that I think are significant. He said the medical establishment
    is condescending to the American people. And I'd like to offer
    that, unfortunately because this Administration has been so
    reckless in the way that it has handled civil servants, I
    believe they've been very condescending to many of them as
    well. And they are for the most part, many of them are my
    constituents, who work in institutions like John Hopkins and
    who are serving the people. And many of the actions of this
    Administration have been quite chaotic and confusing.

        I want to just draw you to a few things. The committee
    staff raised last week, a memo that was put out by OPM, and
    this memo directed agencies to dramatically reduce staff and
    then they reversed themselves and I'm not sure whether you've
    seen the latest guidance from OPM this week, which backtracked
    that directive to fire employees, instead said they clarified
    by saying that decisions to fire should be left to individual
    agencies.

        I'd like to just ask you, given this updated guidance,
    whether we have your assurance here today at this hearing, that
    you will not arbitrarily fire employees at FDA, given the new
    guidance.

        Dr. Makary. First of all, Senator, good to see you and I
    enjoyed our conversation. And I'm very proud to work at Johns
    Hopkins in the State of Maryland. And I'm a big believer in the
    professional career staff at the FDA, which is also located by
    and large, most of the employees are in Maryland. And so, you
    have my promise that if confirmed, I will do my own independent
    assessment on personnel.

        I welcome input on efficiencies at the agency, at the same
    time, I want to make sure that the scientists and food
    inspectors and staff central to the core mission of the agency,
    have all the resources they need to do their job well.

        Senator Alsobrooks. Thank you. And as you mentioned, there
    are so many valuable members. FDA does a tremendous service for
    our Country. They handle, for example, drug safety. When we
    think about reviewing medical devices, and you mentioned infant
    formula, where the men and women who are designated as the
    people who would make sure that those items are safe, are the
    ones who've been terminated.

        I would like to know whether you would commit then to
    rescinding the termination of scientists who were working, for
    example, to address the bird flu?

        Dr. Makary. Senator, I was not involved in any of those
    personnel decisions, but if confirmed, I will certainly do an
    assessment.

        Senator Alsobrooks. Okay. You'll go back and look at those
    terminations?

        Dr. Makary. Happy to Senator.

        Senator Alsobrooks. Okay. Thank you. As well as the
    termination of the individuals and FDA's food division, the
    people who keep our food safe. And so, you would commit then to
    going back and looking at those terminations to make an
    independent assessment?

        Dr. Makary. Of course, happy to.

        Senator Alsobrooks. Okay. And in the same vein, I wonder
    whether you realize that many of FDA's salaries, you may
    already know this, are paid in large, not by taxpayers, but by
    user fees. Are you familiar with that?

        Dr. Makary. Yes, I am Senator.

        Senator Alsobrooks. The concept that the reason to
    terminate these employees is to save taxpayer dollars is one
    that's based on a premise that is largely not true. Since we
    use the user fees for many of the salaries, and that being the
    case, I wonder whether you would commit them to rehiring their
    100 employees who were fired from FDA's Tobacco Center, which
    is 100 percent funded by user fees. Will you commit to going
    back and looking to rehire the 100 who were terminated?

        Dr. Makary. Senator, if an employee has not logged onto
    their VPN in 2 years, then I don't want to rehire that
    individual. But if there are people that deserve a look, of
    course, I'm happy to look at that.

        Senator Alsobrooks. Right? We're talking about, again,
    there's a big lie out there that says, these civil servants are
    lazy, they are shiftless, they don't show up. That is by and
    large, not true. So, asking you if you would go back and look
    at the ones who have been summarily terminated without cause,
    and your answer to that has been, yes, you will go back and
    make your own independent assessment.

        Dr. Makary. I will do an assessment if confirmed, Senator.
    Thank you.

        Senator Alsobrooks. Okay. Thank you. And finally on
    Tuesday, DOGE made the GSA release a list of over 400
    government buildings that they want to dispose of. And many of
    these are in White Oak Campus, which is in Maryland. One of
    them is in a building called Building Number One. And I wonder
    whether you're familiar with building Number One?

        Dr. Makary. I'm not familiar with the numbering of the
    building, Senator. I'm sorry.

        Senator Alsobrooks. Well, that's where your office would
    be. And that's one of the buildings that the DOGE has put on
    the list to close shutter and close up. And so, again, just
    pointing out that many of these decisions are arbitrary, that
    they harm the work that we do and harm the American people. And
    just wanted to ask you if you would be committed to making
    decisions that make sense and that do not eliminate the FDA.

        Dr. Makary. I believe in common sense and trusted science.
    And if confirmed, you have my commitment to do an assessment of
    personnel, to look at efficiencies. I welcome the input of any
    organization, of any individual Member of Congress, from the
    Administration, and the DOGE team as well, to figure out how
    the government can be more efficient.

        Senator Alsobrooks. Thank you so much, doctor.

        Dr. Makary. Thank you, Senator.

        The Chairman. Thank you, Dr. Makary.

        I'd like to submit for the record a Washington Post article
    referenced by a HELP Committee witness, an abortion survivor,
    Melissa Ohden, regarding a woman who took mifepristone twice,
    including once obtaining it online and taken outside the FDA's
    10-week indication window. She still delivered her baby. While
    FDA has conducted safety studies on the product, I'm not aware
    that they've studied any safety outcomes related to a child who
    might still be born.

        As a physician, sending women abortion pills without a
    complete evaluation of the gestation of her pregnancy or
    checking for an ectopic pregnancy is clearly a safety issue.
    And that's why I would urge Dr. Makary to return the REMS
    policy in place during the first Trump administration,
    requiring an in-person visit.

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

        The Chairman. With that, this concludes our hearing. And
    I'll just say that I know your family's incredibly proud of
    you, and I just thank them for being here as well. Believe me,
    you're on for a ride. So, thank you for volunteering. For any
    Senators who wish to ask additional questions, questions for
    the record will be due tomorrow at 5 p.m. This concludes the
    hearing.

                              ADDITIONAL MATERIAL
    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT

        [Whereupon, at 11:47 a.m., the hearing was adjourned.]