S.Hrg.119-28

1[Senate Hearing 119-28]2[From the U.S. Government Publishing Office]34                                                      S. Hrg. 119-2856                      NOMINATION OF MARTIN MAKARY7                      TO SERVE AS COMMISSIONER OF8                             FOOD AND DRUGS9=======================================================================1011                                HEARING1213                                 OF THE1415                    COMMITTEE ON HEALTH, EDUCATION,16                          LABOR, AND PENSIONS1718                          UNITED STATES SENATE1920                    ONE HUNDRED NINETEENTH CONGRESS2122                             FIRST SESSION2324                                   ON2526           EXAMINING THE NOMINATION OF MARTIN MAKARY, OF VIRGINIA, TO27            BE COMMISSIONER OF FOOD AND DRUGS, DEPARTMENT OF HEALTH28            AND HUMAN SERVICES2930                               __________3132                             MARCH 6, 20253334                               __________3536 Printed for the use of the Committee on Health, Education, Labor, and37                                Pensions3839[GRAPHIC NOT AVAILABLEIN TIFF FORMAT]4041        Available via the World Wide Web: http://www.govinfo.gov4243�                               __________4445�                  U.S. GOVERNMENT PUBLISHING OFFICE4659-570 PDF                  WASHINGTON : 202647=====================================================================4849          COMMITTEE ON HEALTH, EDUCATION, LABOR, AND PENSIONS5051                BILL CASSIDY, M.D., Louisiana, Chairman52RAND PAUL, M.D., Kentucky            BERNIE SANDERS (I), Vermont,53SUSAN M. COLLINS, Maine                  Ranking Member54LISA MURKOWSKI, Alaska               PATTY MURRAY, Washington55MARKWAYNE MULLIN, Oklahoma           TAMMY BALDWIN, Wisconsin56ROGER MARSHALL, M.D., Kansas         CHRISTOPHER MURPHY, Connecticut57TIM SCOTT, South Carolina            TIM KAINE, Virginia58JOSH HAWLEY, Missouri                MAGGIE HASSAN, New Hampshire59TOMMY TUBERVILLE, Alabama            JOHN HICKENLOOPER, Colorado60JIM BANKS, Indiana                   ED MARKEY, Massachusetts61JON HUSTED, Ohio                     ANDY KIM, New Jersey62ASHLEY MOODY, Florida                LISA BLUNT ROCHESTER, Delaware63                                     ANGELA ALSOBROOKS, Maryland6465                Amanda Lincoln, Majority Staff Director66           Danielle Janowski, Majority Deputy Staff Director67                Warren Gunnels, Minority Staff Director68              Bill Dauster, Minority Deputy Staff Director69                            C O N T E N T S7071                              ----------7273                               STATEMENTS7475                        THURSDAY, MARCH 6, 20257677                                                                   Page7879                           Committee Members8081Cassidy, Hon. Bill, Chairman, Committee on Health, Education,82  Labor, and Pensions, Opening statement.........................     18384                               Witnesses8586Makary, Dr., Martin, Arlington, VA...............................     287    Prepared statement...........................................     38889                          ADDITIONAL MATERIAL9091Statements, articles, publications, letters, etc.92Cassidy, Hon. Bill93    Washington Post Article......................................    389495                      NOMINATION OF MARTIN MAKARY96                      TO SERVE AS COMMISSIONER OF97                             FOOD AND DRUGS9899                              ----------100101                        Thursday, March 6, 2025102103                                       U.S. Senate,104       Committee on Health, Education, Labor, and Pensions,105                                                    Washington, DC.106    The Committee met, pursuant to notice, at 10 a.m., in room107SD-562, Dirksen Senate Office Building, Hon. Bill Cassidy,108presiding.109110    Present: Senators Cassidy [presiding], Paul, Collins,111Murkowski, Hawley, Tuberville, Banks, Husted, Moody, Murray,112Baldwin, Kaine, Hassan, Hickenlooper, Markey, Kim, Blunt113Rochester, and Alsobrooks.114115                  OPENING STATEMENT OF SENATOR CASSIDY116117    The Chairman. The Senate Committee on Health Education,118Labor, and Pensions will please come to order. Thank you, Dr.119Makary for appearing before the Committee.120121    The Food and Drug Administration is tasked with overseeing122everything from drugs that treat debilitating diseases to123safeguards in the U.S. food supply. Well, FDA has become a gold124standard around the world in safeguarding public health, the125agency faces significant challenges. The bureaucracy has led to126delays in approving new medicines and devices, restricting127patients' access to innovative treatments that can be128lifesaving.129130    As the Trump administration looks to cut red tape across131the Federal Government, the agency should look at innovative132ways to address bottlenecks in the review process. This could133include using artificial intelligence and other technologies to134improve efficiency and accelerate drug discovery while ensuring135these products are safe for Americans.136137    Another topic of interest is food safety. Americans deserve138to know that the food they buy for their families is safe to139eat. One place to start should be examining FDA's review140process to ensure the safety of ingredients that go into foods.141I know Dr. Makary is passionate about this issue. I look142forward to working with him if he is confirmed.143144    The American people's trust in our public health and145science agencies and the products they regulate must be146restored. Rebuilding public confidence in medical products like147vaccines is especially important as we respond to measles148outbreaks and as FDA considers recommendations for vaccines for149flu strains ahead of the upcoming flu season. Dr. Makary with150his experience as a surgeon and an effective health policy151communicator, can help our public health agencies rebuild trust152with the American people.153154    Thank you for appearing before the Committee and discussing155your vision on how to make America healthy again. Senator156Sanders is not here, so Dr. Makary, we will go to you for your157opening statement.158159         STATEMENT OF DR. MARTIN MAKARY, ARLINGTON, VA160161    Dr. Makary. Thank you, Senator Dr. Cassidy, and Ranking162Member Sanders and Members of the Committee. I'm humbled to be163before you here.164165    I'd like to thank President Trump for his confidence in166nominating me to lead the Food and Drug Administration. I'm167joined today by my wife Jessica, my sister Maria, my brother168Mark, Nora, Alexander Jacoby, and my very sacrificial mother169and my career role model, my father. My father dedicated his170life to the care of children with leukemia, lymphoma,171hemophilia, sickle cell disease, and then turned his attention172to adult hematology.173174    His father, my grandfather, was a pharmacist in a poor175Egyptian community and believed in treating everybody equally,176especially the most vulnerable among them--a philosophy I've177tried to emulate in my career and research. Even from the178African continent, my grandfather looked to the U.S. FDA for179trusted guidance. That's because the FDA has a long history of180using gold standard science to uphold public safety, and help181us as clinicians take care of patients when they come to us for182help.183184    As a kid, I vividly remember being in the grocery store in185our small town with my dad, when somebody would stop him, break186out in tears, and give him a long hug after what I would learn187to be a decades long battle with lymphoma. It happened a few188times, and each time it inspired me even more.189190    For 22 years now, I've had the privilege to walk into the191Johns Hopkins Hospital to live out that mission. And each192morning as I enter the front door, I pause and look at the193nine-foot statue of Jesus that stands in the center of the194hospital lobby. And I read the sacred text engraved at the195base, ``Come to me all ye who are heavy laden and I will give196you rest.''197198    I'm grateful to Johns Hopkins for allowing me to have a199creative career, a dual career, as both a surgical oncologist200and a healthcare public policy researcher. In addition to using201FDA approved devices and medications, my research which has now202spanned over 300 scientific peer reviewed articles in the203medical literature, has focused on what's actually making a204difference in helping people, and how healthcare has become too205fragmented, too cold, and too corporate.206207    My research and subsequent book on price gouging and208predatory billing in healthcare, turned into advocacy to demand209more transparency in healthcare. President Trump heard the plea210and invited me to the White House in his first Administration211to enact the Nation's first executive order to bring down212hospital and drug prices through greater transparency.213214    The reform was entirely bipartisan-just as President Trump215and Secretary Kennedy's call to make America Healthy Again by216finally addressing the root causes of our child chronic disease217epidemic, a message that's resonated with moms across the218country, regardless of their politics. A smarter FDA that works219for all Americans should be a goal we can all agree on.220221    As a scientist who has spent a career evaluating medical222interventions, I believe in the scientific process. In223addition, I also believe, that we can use common sense, Dr.224Cassidy, as I have been in the operating room, as you would225relate, as a respected hematologist, it's hard to perform a226long-sophisticated operation for liver cancer and not ask why227are rates of liver cancer tripled in the United States. We now228have a generational opportunity in American healthcare.229230    President Trump and Secretary Kennedy's focus on healthy231foods has galvanized a grassroots movement in America.232Childhood obesity is not a willpower problem, and the rise of233early onset Alzheimer's is not a genetic cause. We should be234and we will be addressing food, as it impacts our health.235236    Thanks to the courage of President Trump and Secretary237Kennedy, we now have a generational opportunity to usher in238radical transparency, to facilitate more cures, meaningful239treatments, and diagnostics at the FDA to help people take care240of their own health. My father told me to write down my241observations and my experiences in healthcare and the research242I delved into. Much of the research I did, focused on the243fundamental question: is what we are doing working?244245    I wrote books to educate the public on medical science, and246to empower them to live healthier lives. If confirmed, I hope247to ensure the FDA holds to the gold standard of trusted248science, transparency, and common sense to rebuild public trust249and make America healthy again. Thank you, Mr. Chairman.250251    [The prepared statement Dr. Makary follows.]252       prepared statement of martin makary253254    Thank you and good morning, Chairman [Dr.] Cassidy, Ranking Member255Sanders, and Members of the Committee.256257    I'm humbled to be here before you. I'd like to thank President258Trump for his confidence in nominating me to lead the Food and Drug259Administration. I am joined today by my wife, brother, and sister as260well as my sacrificial mother and my career role model, my father. He261dedicated his life to the care of children with leukemia, lymphoma,262hemophilia, sickle cell disease, then turned his focus to adult263hematology.264265    His father was a pharmacist in a poor Egyptian community, and266believed in treating everyone in the community equally, especially the267most vulnerable among them--a motto I've tried to live by in my career.268269    Even from the African continent, my grandfather looked to the FDA270for trusted guidance. That's because the FDA has a long history using271gold standard science to uphold public safety and help us take care of272people when they come to us for help.273274    As a kid, I vividly remember being in a grocery store with my dad,275when someone stopped to give him a hug after a long battle with276lymphoma. It happened a few times, and each time it inspired me even277more.278279    For 22 years now I've been privileged to walk into the Johns280Hopkins Hospital to live out that mission, and each morning as I enter281the front door, I pause to look at the 9-foot statue of Jesus that282stands in the hospital lobby and read the sacred text engraved at the283base, ``Come to me all who are heavily laden, and I will give you284rest.''285286    I'm grateful to Johns Hopkins for allowing me to have a dual career287as both a surgical oncologist, and a health care researcher.288289    In addition to using FDA approved devices and medications, my290research has focused on patient safety, the Orphan Drug Act, how the291FDA evaluates devices, opioids, and how health care has become too292fragmented, too cold, and too corporate. My research on price gouging293and predatory billing turned into advocacy to call for price294transparency in health care.295296    President Trump heard the plea and invited me to the White House to297enact the Nation's first executive order to bring down hospital and298drug prices through greater transparency.299300    The reform was entirely bipartisan--just as President Trump and301Secretary Kennedy's call to Make America Health Again by finally302addressing the root causes of our childhood chronic disease epidemic303resonated with Republican, Democrat, and Independent moms across this304country.305306    A smarter FDA that works for all Americans should be a goal we can307all agree on. As a scientist who has spent a career evaluating medical308interventions, I believe in the scientific process, but in addition to309using trusted science, we can also use common sense. Dr. Cassidy is a310highly respected hepatologist and can tell you: It's hard to perform a311sophisticated long operation for liver cancer and not ask, ``why have312rates of liver cancer tripled in the U.S.''?313314    We now have a generational opportunity in American health care.315President Trump and Secretary Kennedy's focus on healthy foods has316galvanized a grassroots movement in America. Childhood obesity is not a317willpower problem, and the rise of early onset Alzheimer's is not318genetic--we should be, and we will be, assessing the foods impacting319our health.320321    Thanks to the courage of President Trump and Secretary Kennedy, we322now have a generational opportunity to usher in radical transparency323and to facilitate more cures, meaningful treatments, and diagnostics to324empower people to take care of their health.325326    My father told me to write down my observations about my327experiences in health care and the research I delved into. Much of the328research I did research focused on the fundamental question: Is what we329are doing working? I wrote books to educate people on medical science330to empower them to live a healthy life. If confirmed, I hope to ensure331the FDA holds to the gold standard of trusted science, transparency,332and common sense to rebuild public trust and Make America Healthy333Again.334                                 ______335336    The Chairman. Thank you, Dr. Makary. I'll start with337questions. In 2021, a few months after President Biden took338office, FDA announced it would no longer enforce the in-person339dispensing requirement for Mifepristone, the drug, which340obviously is an abortion.341342    Now, this is concerning to me. There is a case out of343Louisiana, which is incredibly egregious, in which there was no344recognition that the person requesting the drug was not the345patient, but rather someone who was going to allegedly coerce346the person into taking the medication, which would've been347evident to a physician should she or he have seen the patient.348349    If confirmed, would you reinstate the in-person dispensing350requirement as well as reporting requirements for adverse351events and other complications associated with the drug?352353    Dr. Makary. Thank you, Senator. And to hear of someone354being coerced to take Mifepristone is deeply disturbing and I355might even suggest criminal. I have no preconceived plans on356Mifepristone policy except to take a solid hard look at the357data and to meet with the professional career scientists who358have reviewed the data at the FDA, and to build an expert359coalition to review the ongoing data, which is required to be360collected as a part of the REMS program, The Risk Evaluation361and Mitigation Strategy. It is pursuant to the REMS. And so, if362we're going to collect data, I believe we should look at it.363364    The Chairman. Last week the FDA announced it would cancel365its annual Vaccines and Related Biologic Products Advisory366Committee, which meets to select anticipated virus strains for367next year's flu vaccines.368369    Now, I'm told by people who are familiar, that the FDA will370make the recommendation and that they will come up with the371right decision. But they also say what is lost is the372transparency, because the open meeting allows a postmortem, if373you will, as we say in medicine, a review of last year of what374went right, what went wrong, and how to make it better.375376    I think one of the laudable things about Secretary377Kennedy's positions is he wants more transparency in terms of378how the Federal Government makes medical decisions as part of379restoring that faith and so, frankly, this seems to kind of go380backward on that. So how will you ensure that advisory381committees remain objective, transparent, and still benefiting382from the necessary expertise of external experts?383384    Dr. Makary. Senator, thank you for the question, and I was385not involved in that decision. Certainly, we've confirmed once386in office, you have my commitment to take a look at it. As you387know, that VRBPAC committee takes a look at guidance and388recommendations from international groups such as the GIP389International Consortium. My understanding is, at least for the390last seven or 8 years that I've been following that group, we391have simply rubber stamped whatever the international GIP----392393    The Chairman. Can I stop you for a second? My understanding394though, since these strains typically begin, like in Australia395or China, it isn't so much as a rubber stamp, but as much as396recognizing what are you seeing, because that's what's coming397to us. So, I think it's more than quibbling to say that you're398learning from them. Your thoughts?399400    Dr. Makary. Yes. So, the American public deserves401confidence that scientists are looking at that data from the402southern hemisphere. It's all reported into a registry, all the403dominant strains, and then picking the most dominant strains404that are lighting up in that registry is that process of really405trying to estimate which strains are going to be dominant in406the United States. It's not very precise, some years we don't407get it very well, but it's the best we can do with the data we408have available at the time.409410    For example, the International GIP group chose to no longer411include the influenza B strains a couple years ago, sounded412like a very reasonable decision, and VRBPAC also went along413with that recommendation. But I think we're aligned in that the414American public want to have some confidence that independent415scientists are looking at these data.416417    The Chairman. Going back to the transparency again, it418seems what's lost with the open meeting is the transparency. So419how can you as FDA commissioner advocate for that transparency?420Because we want the American people to know, and obviously421canceling the meeting will kind of shut that door a little bit.422423    Dr. Makary. Yes. So, Senator, I was not involved in that424decision----425426    The Chairman. I accept that but we're voting for you. So427how are you going to make it happen? I guess that's my428question.429430    Dr. Makary. You have my commitment to review what the431committees are doing, how they're being used--as you know, I432was critical when that committee was not convened at all during433one of the Covid booster guidance decisions by the FDA and434leadership at the time argued that they are advisory, and we435don't have to convene them, that was repeatedly throughout the436Biden administration.437438    There may be some value if there's a step where the439efficiencies can be made but I think with something that's440important, something that's critical, something where we want441expert opinion, it not only provides some of that wisdom, but442it also increases the perception of confidence from the general443public.444445    The Chairman. Thank you.446447    Senator Murray.448449    Senator Murray. Thank you very much. Thank you for, for450being here today. Let me follow-up on that because last week I451sent you a letter along with some of my colleagues asking you452about the FDA's cancellation of that Vaccine Advisory Committee453meeting.454455    For everybody's information, this is a meeting that takes456place annually, for at least 30 years to make recommendations457on which influenza strains should be included in the flu458vaccines for the upcoming flu season. And for the first time in459decades, FDA canceled that meeting with no explanation given,460no new date chosen. That is, I believe, unprecedented and461dangerous and you just referred to it, Dr. Makary.462463    In 2022, you raised concerns when the FDA was considering464not holding a vaccine committee meeting to authorize Covid-19465boosters for kids 12 to 15, and at the time you said, ``It was466unconscionable and undermined the integrity of the FDA's467standard process to not hold that committee meeting.'' So, if468you are confirmed, will you commit to immediately reschedule469that FDA Vaccine Advisory Committee meeting to get the expert470views. We need to know those so we can have the correct vaccine471for the upcoming flu season.472473    Dr. Makary. Thank you, Senator, for the question, and I474appreciated our time together in meeting ahead of this hearing.475I was not involved in that decision and what I would say is----476477    Senator Murray. I'm just asking you if you'll immediately478reconvene it.479480    Dr. Makary. I will immediately reevaluate which sessions,481the leadership of that center, which decisions, which topics,482could benefit from----483484    Senator Murray. What goes into a reevaluation? This is done485every year so we know what flu vaccine to have. What are you486reevaluating?487488    Dr. Makary. First of all, for the last seven or 8 years489that I've been following it, they simply adopt verbatim the490recommendation of the international GIP group. But I was not491involved in that decision. I will say that in my opinion, there492was a huge difference between requiring every 12-year-old girl493in America to take an eighth Covid booster shot versus rubber494stamping a recommendation from the international GIP group,495which has done seven out of the last 7 years.496497    I'm not saying that the decision is something I was aware498of or involved in, but it's certainly something I will look at,499if confirmed.500501    Senator Murray. Okay. I'm very unclear because the FDA is502the gold standard for all of us. And this committee hearing is503what has always been what we look to, the FDA look to, the504American people look to, to determine what the flu vaccine is.505What are you going to look at to make a determination and506figure something else out now decades into this, what are you507re-looking at?508509    Dr. Makary. Senator, I was not involved in that decision,510but the committee looks at----511512    Senator Murray. I understand that. I assumed you would say513yes, I will reconfirm it immediately so we can let our public514health experts and doctors know what flu to have next fall.515516    Dr. Makary. As I understand it, the committee members and517the scientists at the FDA, the career professional scientists518at the FDA, look at the recommendation of the international GIP519group.520521    Senator Murray. I am just asking--you just told me that you522were going to reevaluate it, and I want to know what you are523reevaluating it on. What are you looking at to make a decision524whether to reconvene it?525526    Dr. Makary. In conjunction with the Center Director of the527Biologic Center, I would reevaluate which topics deserve a528convening of the Advisory Committee members on VRBPAC and which529may not require a convening, obviously during----530531    Senator Murray. What would we base our decision on?532533    Dr. Makary. Well, you can ask the Biden administration that534chose not to convene the committee meeting for the Covid535vaccine booster.536537    Senator Murray. I get that. I understand, but I'm asking538you, how will we know what flu vaccine to take next year, if539this committee doesn't reconvene and make their recommendation?540541    Dr. Makary. Senator, I was not involved in that decision542not to convene that group.543544    Senator Murray. I just thought you would say yes, we're545going to reconvene, who knows what's coming. Let me just ask546you really quick, I am also following-up on a question and on547mifepristone because FDA does play a really critical role in548making sure we have safe and effective medications.549550    Contraception and medication abortion have been approved by551the FDA for many, many decades based on mountains of high-552quality evidence and expert scientific judgments. So, if you553are confirmed, will you commit to upholding the science and554evidence-based drug approvals for all FDA approved products,555including contraception and medication abortion?556557    Dr. Makary. Thank you for the question, Senator Murray, you558have my commitment to follow the independent scientific review559process at the FDA, which is a tried-and-true process, and that560has been around. And so that is my commitment to you, Senator.561562    Senator Murray. Okay, well, I want to be clear, there have563been over a hundred high quality studies over more than two564decades backing up the science and safety of mifepristone.565Thank you, Mr. Chairman.566567    The Chairman. Senator Paul.568569    Senator Paul. Congratulations Dr. Makary, on your570nomination.571572    Dr. Makary. Thank you.573574    Senator Paul. I think one of the most important things we575need in government are people who are open-minded. I think576closed-mindedness, the idea that this is settled and no one577will ever--If you see data as the FDA and you have to make a578decision, are you willing to lead where the data and the facts579take you as opposed to your preconceptions?580581    Dr. Makary. Absolutely, Senator Paul. I think it is part of582being a scientist, we need more humility in the medical583establishment. You have to be willing to evolve your position584as new data comes in.585586    Senator Paul. The people who aren't involved in science587think that there's settled science, and this is, it's just all588settled and we will all be quiet and submit to whatever settled589science is. But you mentioned to me on the way in that590yesterday you removed a gallbladder through the laparoscope.591592    I was in medical school and surgical training about the593time where everybody made a four-or five-inch V incision to594take the gallbladder out. And the older surgeons, the595consensus, they ran the surgery departments, they were like,596it's malpractice to use these tiny incisions and blow the air597into the abdomen and do all this. But it took an overcoming of598the consensus. Do you remember some of that, it might've been a599little after your time, but you remember some of the trends600from the larger incision, the small incision, and the601resistance of the consensus?602603    [Laughter.]604605    Dr. Makary. Oh, yes. Senator, I can tell you some of the606surgeons who trained me said things like, big surgeons used big607incisions, and the bigger the incision the better. And without608having a big open incision, you can't really see what you're609doing. And I would point out that a laparoscope gives you 10610times the magnification, but there's a lot of medical dogma611that has contaminated our field, and I think it's tied to a612lack of humility.613614    Ultimately, what makes a great doctor, in my opinion, as I615teach my residents, is not how much you know, it's your616humility and your willingness to learn as you go from patients.617618    Senator Paul. I think some people here also are not duly619impressed enough by what it takes to do the kind of surgery620that you do. Now, I'm an ophthalmologist and I do eye surgery,621and we do really tiny incisions, but our surgery lasts between622five and 20 minutes a lot of times to take the cataract. How623long does it take to do a--you've done Whipples, I imagine,624which is a surgery on the liver. How long does a Whipple625surgery take?626627    Dr. Makary. Yes, I've done a lot of Whipple operations and628eyelet transplant procedures, and then pioneered a new type of629procedure, which is a laparoscopic pancreas eyelet630transplantation, with hopes that it can someday be used to cure631diabetes. It was about 8 hours for that operation when we632started. We've gotten it down to about four or 5 hours, and633we've done some laparoscopic Whipples in 3 hours.634635    Senator Paul. With regard to the vaccine committees, and636they talk about whether they meet or they don't meet and637things, there have been some questions, and one of the638questions that I've been bringing forward is whether or not639there could be a conflict of interest. And one of the things640I've asked, and you would think it would be universally641accepted by everyone without question, is you should have to642reveal if you get royalties from drug companies.643644    If you're making a decision on a Pfizer vaccine or a645Moderna vaccine, I would think the least of transparency should646be that you reveal if you get royalties from those companies.647Do you think we need to evaluate the people on the committees648or see whether they get royalties or see whether or not there649are conflict of interest for the people making these decisions?650651    Dr. Makary. Yes, I do, Senator. We need to review the652ethics policy because people see things that appear to be a653cozy relationship between industry and the regulators that are654supposed to be regulating the products. Now, I want American655companies to thrive. I want life sciences companies to thrive,656but we need to call balls and strikes and to keep that657independent scientific review process free of any conflicts.658So, I do think it deserves a look.659660    Senator Paul. Really, I think it would be an area that a661lot of people, once again, think there's a consensus. Either662take all the Covid vaccines or not. Most of Europe doesn't663recommend a Covid vaccine for under age 12. Almost all the664countries don't recommend it for under 12, some under 18. And665it's because they've looked at the risk benefit for children of666the vaccine and some of the possible complications of it. And667it's different, frankly, for older people.668669    It's like, these are things that we should at least discuss670and evaluate. Some of the most pro-vaccine people, when the671policy came out to give boosters to your 6-month-old said they672wouldn't even give it to their 24-year-old, a booster.673674    You remember one of the famous committee members, two675committee members left the vaccine committee because the CDC676under Biden politicized the process and overrode the vaccine677committee. So, to insinuate that somehow there's some brand-new678thing going on, these are longstanding controversies. And I679think that the main thing, I'll go back to, is in the680beginning, we need open-mindedness. And I appreciate your681willingness to look at the facts, the data, and not be682overwhelmed by preconceptions.683684    Dr. Makary. Thank you, Senator.685686    The Chairman. Senator Baldwin.687688    Senator Baldwin. Thank you, Mr. Chairman. Welcome Dr.689Makary. I want to go over a couple of topics that have already690been raised, and if we have time explore one that has not yet.691But I want to understand your position on mifepristone. Because692we had an opportunity to speak in my office and I thought that693you were pretty clear with me during that meeting that you were694aware of the overwhelming scientific conclusion about the695safety of this medication and that you did not think politics696should be involved in decisions moving forward. And I697understood from our conversation that you intended to stand698behind the FDA's longstanding determination.699700    But after our meeting I don't know if it was you or your701minders, but they followed up with my staff and said they felt702that you misunderstood my question and wanted to clarify your703answer. Which by my read, implied that you are open to totally704reexamining the scientific determination even with decades of705evidence. So, I want to clearly understand your position as FDA706commissioner. Will you maintain current access to mifepristone,707yes, or no?708709    Dr. Makary. Senator, I'll be very clear about my position.710My position is that of a scientist. As you know, part of the711REMS, the Risk Evaluation Mitigation Strategy, that was put in712initially by President Clinton in that Administration, and then713modified under Obama, and then again under President Biden,714requires ongoing data collection. So, I can't prejudge that715data without looking at it.716717    Senator Baldwin. You're going to--you said something about718convening an ongoing panel.719720    Dr. Makary. I did not mention to----721722    Senator Baldwin. A previous question just asked.723724    Dr. Makary. I did not mention a panel. I said I would725convene the scientists, the professional career scientists at726the FDA, who have reviewed the totality of data on this, and727are also looking at ongoing data that is being collected. There728could be, for example Senator, a drug-drug interaction that may729show up on the ongoing data.730731    Senator Baldwin. Okay. So, I want to ask if that's your732approach to something that has been approved for now decades,733are you going to do the same with Tylenol?734735    There are a lot of side effects for daily use, including736liver damage. Will you be doing that for Tylenol?737738    Dr. Makary. As you may know Senator, Tylenol does not have739a regulation requiring a REMS, a Risk Evaluation Mitigation740Strategy.741742    Senator Baldwin. I'm not asking whether it does or not. I'm743asking, are you going to do ongoing surveillance of the744possible side effects for that drug that was approved many745years ago? How about asthma inhalers that have been associated746with osteoporosis, opportunistic lung infections? Are you going747to be doing that for those medications?748749    Dr. Makary. Senator, I will be following the law and the750regulation requires an ongoing review.751752    Senator Baldwin. You have a totally different approach to753this. I want to get to that again, a little bit more about what754we're talking about with the influenza vaccine and vaccines in755general. As has been said in this hearing, the advisory756committee annual meeting was canceled for selection of what757strain of influenza our vaccines for this next season would758confront.759760    There have been additional reports that Secretary Kennedy761wants to make significant changes to another Advisory Committee762that makes recommendation and provides advice for vaccines. And763I worry that this is merely a ploy to install vaccine skeptics764on these critical panels. Our Advisory Committees must maintain765scientific integrity and should not be changed for political766purposes or to further an agenda.767768    Dr. Makary, do you intend to remove experts from the769vaccine and related Biological Products Advisory Committee?770771    Dr. Makary. Senator, first of all, I'm not familiar with772what you're referring to regarding Secretary Kennedy. Secretary773Kennedy wants to make America healthy again. With regard to the774Vaccine VRBPAC Committee, deciding on which flu strain to775identify-I was not involved in that decision, but again, just776as a reminder----777778    Senator Baldwin. Are you planning if confirmed to remove779any experts from the vaccine and related Biological Products780Advisory Committee?781782    Dr. Makary. I have no preconceived plans to rearrange that783committee or any committee, I will say on influenza that----784785    Senator Baldwin. Do you commit to maintaining scientific786integrity on advisory committees and receiving regular outside787expertise if confirmed?788789    Dr. Makary. Of course.790791    Senator Baldwin. Okay.792793    The Chairman. Senator Collins.794795    Senator Collins. Thank you, Mr. Chairman. First of all,796Doctor, I appreciate your willingness to serve and was797impressed as a result of our conversation in my office. Let me798ask you, you've had a lot of questions about the Vaccine799Advisory Committee. Let me just ask you a simple,800straightforward question, and that is, if you are confirmed,801will you reinstate meetings of the committee?802803    Dr. Makary. The VRBPAC Committee will be meeting if804confirmed and I'm commissioner. Yes.805806    Senator Collins. Thank you. In February, we learned that807hundreds of probationary employees at FDA were dismissed. And808this really concerns me because we need a flow of young new809scientists and researchers, especially since we're seeing810retirements and resignations. And ironically, more than half of811the FDA employees are funded under various industry user fee812agreements. So, there is revenue coming into the FDA to pay for813these employees. If confirmed, will you, not an outside force,814but you, have full authority over FDA staffing decisions?815816    Dr. Makary. Senator if confirmed as commissioner, you have817my commitment that I will do an assessment of the staffing and818personnel at the agency. I have not been involved in any of the819decisions regarding any of the personnel changes recently, but820if confirmed, you have my commitment that I will do an821assessment.822823    Senator Collins. I just want to make sure that you are the824one doing that assessment. I'm not saying that the staffing825level is perfect, and I think it's helpful for a new826commissioner to do an assessment, but I want that person to do827it. And it sounds like you are committing to that. Is that828correct?829830    Dr. Makary. I will do an assessment, I commit to that, yes,831Senator.832833    Senator Collins. One of the best ways to lower the cost of834prescription drugs is by promoting more market competition. And835one way that we can do this is by making it easier for generic836and biosimilar drugs to come to the market. As part of a837broader bill that Senator Shaheen and I have introduced to help838lower the cost of insulin, we've included a provision to create839a new competitive biosimilar pathway and therapy designation to840add FDA, under which eligible products for which there is841inadequate biosimilar competition now, could achieve expedited842review.843844    I worked with the FDA in the last Congress, to develop this845provision, and I look forward to continuing to push this846concept so that it becomes law. Do you support the concept of a847new expedited pathway for biosimilars to compete, for example,848with branded insulin?849850    Dr. Makary. First of all, Senator you've taken a strong851interest in the FDA and I very much appreciate it, and I really852enjoyed our time together. I've learned from you and thank you853for your leadership on the Diabetes Caucus. It's something, of854course, very close to my area of medicine.855856    I am a big believer that we need to figure out a way to get857biosimilars approved quicker without cutting corners on the858scientific review. And it is one of several strategies that the859FDA can do to try to alleviate the problems of high drug prices860in inadequate competition or underperformance of competition861and the drug shortage in the United States.862863    Also, other strategies could include the way we look at864generic drugs, moving medications to over the counter, does865Naloxone really need to be a prescription only medication? Does866an EpiPen need to be prescription only? If they can be over the867counter and we can feel confident about public safety when with868those products on the shelf at a pharmacy, it would force the869companies to put a price on the shelf. And I do believe in870price transparency, it will have an effect on the entire871marketplace. So, thank you, Senator.872873    Senator Collins. Thank you. And let me just end by saying874that I am delighted with your interest in Islet cell therapy875for individuals with Type I. There are clinical trials876underway, and I think that is such an exciting development.877Thank you, Mr. Chairman.878879    Dr. Makary. Thank you, Senator.880881    The Chairman. Thank you, Senator Collins.882883    Now Senator Hassan.884885    Senator Hassan. Thank you, Mr. Chairman. And good morning,886Doctor, and congratulations to you and your family on your887nomination.888889    Dr. Makary. Good morning. Thank you, Senator.890891    Senator Hassan. President Trump has promised to help lower892costs, but prescription drug prices are once again skyrocketing893for Granite Staters, and all Americans. In 2025, drug makers894have increased the list prices of over 500 common medications.895Dr. Makary, when we met, you and I discussed the importance of896increasing generic drug competition. If confirmed, will you897work with me to speed the approval of generic drugs at FDA to898lower drug costs for patients?899900    Dr. Makary. Senator, first of all, I very much enjoyed our901meeting together. The answer to your question is an emphatic902yes, and I would add to that, that I would love to work with903Congress to address the way that patent law has enabled patent904thickening, which makes it more difficult for biosimilars and905even some generics to come to market, because they got to906navigate so many lawsuits and letter of the patent law.907908    Senator Hassan. Well, and this is something that Senator909Paul and I have actually been working on, and we have910something, a bill called the Increasing Transparency in Generic911Drug Applications Act, which would allow the FDA to communicate912more transparently with generic drug manufacturers, in order to913make more low-cost prescription drugs available for patients.914915    The bill would save taxpayers over a billion dollars and916has bipartisan, bicameral agreement. So, I'm going to urge all917my colleagues to look at it. I've enjoyed working with Senator918Paul and his team on it.919920    Dr. Makary, you and I also discussed mifepristone when we921met, a medication that has been used for decades in abortion922care and miscarriage care. Now, during our meeting, you923mentioned you weren't familiar with the drug, and I followed up924by providing you with decades of the safety data and you said925you're a data guy; you would review it. Have you reviewed the926data, and do you agree that mifepristone is safe and effective?927928    Dr. Makary. Thank you, Senator, for sending me that929homework to read. And I did read those articles, including--and930what I was referring to when I said I'm not familiar with it931is, I don't believe I said I was not familiar with it, what I932said was, I have not reviewed the totality of the data. I am933very familiar with mifepristone. And I did review those934studies, including two surveys of patients inquiring about935telemedicine, a 2018 National Academy of Medicine Review. I'm a936member of the National Academy of Medicine, but was not937involved in that particular review. But I did review that938document.939940    Senator Hassan. I shared with you that study from the941National Academies where scientists looked at, just so people942know, over a hundred studies of medication abortion, and found943that the literature is clear that mifepristone is safe and944effective.945946    Also, we've had the discussion about the REMS process for947mifepristone. In 2021, the FDA looked again, based on a citizen948petition asking them to review the safety of mifepristone. And949I think--just so people get a sense, this is the report back950from the FDA about their review and about their modification of951the language in the REMS process. And their review again, was952that it is safe and effective.953954    I think what you're hearing from a lot of us as we ask you955questions about this, and just so the public can understand,956there's lots and lots of data here that supports the safety and957efficacy of mifepristone and supports its efficacy in, under958current law, and its safety.959960    I think the concern you're hearing is not about whether you961will follow an ongoing REMS process with any medication and962look at the most current data. That's what the scientific963process is about. The concern is whether you are going to964unilaterally overrule the data that currently exists for965political purposes, and for political reasons, and that's what966we're looking for your reassurance on.967968    You have told us you are an independent scientist, I969believe that. You have a very distinguished career as a970physician. But we need to know that when you say you're an971independent scientist, that's really what you mean. And then972when the politics get heated around abortion, that you won't973abandon that independence.974975    Dr. Makary. Senator, you have my commitment that once I'm976in office, I will do a review of the data. I have no977preconceived plans to make changes to the mifepristone policy.978And I do plan to follow the law and the regulation of the REMS979to look at ongoing data. It could be that there could be a980drug-drug interaction that we could identify on ongoing data.981982    Senator Hassan. I understand that. But what I am looking983for is an understanding that the current state of science, in984the process that you have been a participant in throughout your985entire career, and that others up here have also participated986in, that you will follow the science as it is currently987developed and not unilaterally overrule scientists because988you're under political pressure to do that.989990    Dr. Makary. Senator, if you look at my track record, I have991never been afraid to speak my honest scientific opinion, and I992have no preconceived plans to make changes on that medication.993994    Senator Hassan. Well, I wish you were hedging a little bit995less today. Thank you,996997    The Chairman. Senator Murkowski.998999    Senator Murkowski. Thank you, Mr. Chairman. And I1000understand that the Senator from Alabama has an engagement that1001she needs to get off to. So, I'm going to defer my time to her1002and go afterwards.10031004    The Chairman. The Florida, Alabama afterwards.10051006    Senator Moody. Florida Go Gators! But Katie Britt would1007want me to say, Roll Tide.10081009    [Laughter.]10101011    The Chairman. You'll lose your votes in Florida, but1012anyway, go ahead.10131014    Senator Moody. Thank you, Senator Murkowski, I'm so1015grateful. I'm very grateful as the rookie, to be able to1016question before these senior Senators. It's a big deal. So, I'm1017grateful to all of you. Thank you so much. I'm so honored.10181019    I am so excited to see you here today, I was incredibly1020happy with this nomination. When confirmed, I know you're going1021to do a great job. I have two issues I want to cover and they1022are relevant specifically to the two main roles in my life over1023the last 6 years: One as a mother and one as Attorney General1024of Florida.10251026    First, I want to talk to you about what is going on with1027the FDA, and it's burying its head in the sand about illegal,1028chemically ridden, extraordinarily high amounts of nicotine,1029Chinese vapes that are flooding the United States market. In1030fact, two thirds of the export market here are Chinese vapes1031coming out of China. So, it's unbelievable. They are in flavors1032like strawberry, blow pop, watermelon sour berry, attracting1033children, addicting children.10341035    We have so many thousands and thousands and thousands of1036pending applications, most of these things are illegal in the1037United States right now. But yet, somehow China has decided to1038flood our market with illegal vapes, the United States market1039with illegal vapes. And they're benefiting, in fact, in China,1040they banned flavored vapes. And so, all of the manufacturers1041there of these chemically ridden vapes, have now flooded our1042market, and now are addicting our children. Much like we're1043seeing this in many other ways in harmful substance coming from1044China and they're not doing much about it, fentanyl, ET cetera.10451046    Whoever comes in as the head of FDA, this is one of your1047problems-you have to address immediately. I know there are a1048lot of things that you're going to get questioned about, but1049these things are all over the United States. In convenience1050stores, they are, readily available to children. If you walked1051in any one right now, you would be able to find them. And not1052only are the amounts of nicotine going up and up and up, we1053don't know what is in these things. And there has been little1054to nothing done to deal with our pending applications at the1055FDA or to enforce those that we know are illegal right now. How1056would you address this and what do you plan to do on day one?10571058    Dr. Makary. Well, thank you, Senator. I appreciate your1059passion on this important issue, and I've appreciated your work1060as Attorney General in Florida on this issue, and maybe it's1061because you both believe in doing the right thing, and because1062you're a baseball mom that you're interested in this.10631064    Senator Moody. I first heard about this on the bleachers at1065a baseball game.10661067    Dr. Makary. I think there are four new vaping stores that1068have popped up in my neighborhood, all in the last few years.1069I've not walked into one of them, although perhaps I should, to1070check it out. But you are absolutely right that we are being1071flooded with Chinese products. We have no idea what's in these1072products and public health is not even going to be able to1073study them because it takes so long for public health research1074to catch up.10751076    But it's very concerning and it's not right that the1077products are banned in China, and yet they're manufacturing1078them and sending them into the United States. So, there are a1079few things the FDA can do to try to address this problem. First1080of all, the office of inspections and investigations has a lot1081of people with guns and they do enforcement and raids. And we1082need in collaboration with DOJ and other areas of law1083enforcement to try to address this problem of illegal products1084on our market.10851086    Senator Moody. There was an announcement during the last1087Administration, and I won't get into much--they were going to--1088once people finally convinced them that this is out of control1089and people are getting addicted by the day, there was this big1090announcement about task force, we're going to use all the tools1091available. That's great, and enforcement needs to be key.10921093    Florida had to finally step up and do it ourselves because1094the Federal Government would do nothing. But the first key has1095to be, what do we do with our pending applications? How do you1096cleanup FDA's house first? You need to know what the law is1097before you can enforce it. Let's start there, please focus on1098that. And then we will also work with the enforcement measure.10991100    I'd also like to just get a commitment from you as from the1101State of Florida citrus growers, orange growers, that's a big1102deal to us. There's a regulation in there, an arbitrary1103regulation, amount of sugar content. It needs to be examined1104with disease and greening, and all the things facing the citrus1105industry. That arbitrary regulation, the oranges aren't1106producing as much sugar, I can go into it, but do I have your1107commitment for them to look at that regulation? Things that are1108set sometimes we need to revisit on how it's affecting1109industries across the United States. So, do I have your1110commitment to look at that?11111112    Dr. Makary. Senator, I had my cold press freshly squeezed1113orange juice this morning, and you do have my commitment to1114look at that.11151116    Senator Moody. Oh, our orange growers are going to be so1117happy to hear that. I will tell them. Thank you so much.11181119    Dr. Makary. Thank you.11201121    The Chairman. That was the great mother board that told you1122to drink the orange juice, do you know what I'm saying? That1123was really good.11241125    Senator Kim.11261127    [Laughter.]11281129    Senator Kim. Thank you, Chairman. Doctor, thanks for coming1130on out. I was looking through your opening statement. At the1131very end, you talked about FDA being the gold standard, and you1132said gold standard of transparency, and I was glad to hear1133that. I wanted to ask you in terms of transparency, do you1134think it's important that we can ensure that there's public1135comments on actions of agencies and departments overseeing1136important aspects of our lives?11371138    Dr. Makary. Senator, first of all, it was good to meet with1139you, and I enjoyed our conversation. I do believe in civil1140discourse and have been an advocate for civil discourse and1141coming out of an era of medical establishment censorship. So, I1142do believe in the principle. Now, there are laws and1143regulations around public comment periods, and in some1144situations, a public comment period is required by a1145regulation.11461147    Senator Kim. I would just suggest here that this is really1148important, the public, very concerned you were talking about,1149we had a long conversation about how to restore trust. And I1150think a big part of that is about involving the public more, I1151think you saw some of that in terms of the questions regarding1152VRBPAC, and just the need for that type of radical transparency1153as Secretary Kennedy talks about.11541155    Recently, there was an effort addressing the Richardson1156waiver. I ask that you look into this if you're confirmed, but1157I do think it's important that we maintain public comments,1158something that so far, this HHS has not abided by, and1159something that has been longstanding practice.11601161    Another aspect of this is about transparency and1162accountability. So, I guess I just wanted to ask you if we have1163this sense of nothing to hide, we want to root out waste,1164fraud, corruption, do you support the roles of Inspector1165Generals?11661167    Dr. Makary. Senator, I believe in the law, and I believe in1168the process of having Inspector Generals.11691170    Senator Kim. Okay. Well if you are confirmed, I just urge1171you to do everything you can to ensure that HHS has an1172Inspector General, has an ability for us to be able to oversee1173the accountability and to be able to root out some of the1174problems that I hope both of us can agree upon. So, I just want1175to ask for your commitment on that front that you would push to1176try to have an Inspector General there at HHS.11771178    Dr. Makary. Thank you, Senator.11791180    Senator Kim. When it comes to ethics, I heard you refer1181about just concerns, you want to have ethics review in terms of1182positions that people might be having, especially involving1183approval of drugs and other things. I guess I wanted to just1184ask you a little bit more on your end. It looked like I come1185across something that's saying that you were willing to divest1186from your own investments that were being perceived potentially1187as a conflict of interest if you are confirmed in this job, is1188that correct?11891190    Dr. Makary. Senator, as you are aware, the Office of1191Government Ethics does a comprehensive review of basically1192everything I own, every stock, every equity, every share. I1193would describe it as a colonoscopy with a small bowel follow1194through.11951196    [Laughter.]11971198    Dr. Makary. It took about 4 weeks, and they gave me the1199option of resigning from some things, or maintaining a role,1200and I chose voluntarily to divest and resign from everything.12011202    Senator Kim. I applaud that, and I think that should be the1203standard, especially for such important jobs. I guess I just1204wanted to ask you a little bit further here, would you agree to1205recuse yourself from matters involving your former clients and1206employers, if that comes before you at the FDA?12071208    Dr. Makary. Senator, what I can promise you and commit to1209is, to abide by all the guidance of the Office of Government1210Ethics----12111212    Senator Kim. I understand that, but you just talked about1213how you voluntarily took steps to be able to divest. That was1214not something you were required to do, though I do think you1215should have been. But I guess I would just ask you again, would1216you consider recusing yourself? Because I mean, if you're1217making decisions about a previous client of yours, you can see1218how the general public would react to that in terms of concern1219about whether or not you are doing this for the best interest1220of the people or the best interest of people you know?12211222    Dr. Makary. Senator, I have signed to agree to recusals as1223defined by the Office of Government Ethics in any area where1224they perceived a conflict could occur. And so, I have already1225agreed to the recusals required by the Office of Government1226Ethics.12271228    Senator Kim. One last thing I just wanted to raise, and1229this is just something I just want to ask, what is you're1230feeling about these potential Medicaid cuts that are being1231reviewed right now in Congress?12321233    Dr. Makary. Senator, the FDA is not involved in Medicaid or1234coverage decisions.12351236    Senator Kim. I understand that, I guess the reason I raise1237it is that in your opening remarks you said--I thought it was1238really powerful--you said that your motto in life has been1239about treating everyone in the community equally, especially1240the most vulnerable amongst them.12411242    I just urge you to just continue to press, you will have a1243seat at the table if you're confirmed on healthcare decisions1244across the Administration and Medicaid is essential for the1245most vulnerable amongst us. And treating everyone equally--your1246drugs, it's not just about the approval, you'd want to see that1247get into the hands of Americans, make sure that they can use1248and benefit from them. So, I do think that you have an interest1249in preserving Medicaid. Thank you.12501251    The Chairman. Senator Murkowski.12521253    Senator Murkowski. Thank you, Mr. Chairman. Doctor,1254welcome. It was a good conversation that we had, I appreciated1255that, I thank you for the encouragement to read that provision1256in your book. So, airplane reading for me.12571258    Dr. Makary. Thank you, Senator.12591260    Senator Murkowski. I also want to thank you for the1261assurance that you gave to Senator Collins regarding the1262Vaccine Advisory Committee and ensuring that there would be1263meetings going forward. I think for several of us who had, I1264thought good substance conversations with Secretary Kennedy, we1265had received assurances about things like the vaccination1266committee. So, making sure, again, that kind of very important1267input goes forward, I think is important to many of us. So, I1268appreciate that.12691270    I wanted to talk to you this morning about an issue that we1271discussed in my office, and that is with regards to ALS. The1272FDA's accelerated approval pathway has really been important,1273and I think very promising for treatments for ALS and some1274other rare diseases. You have advocated for using common sense1275alongside science in regulatory decisions. So, very briefly,1276how do we define common sense here as it applies to the1277regulatory decisions of FDA? How do we make sure that ALS1278patients who again, are looking at a very, very, very limited1279timeframe, they can't wait for the traditional approval1280process.12811282    There are some emerging measures using digital1283technologies, is this in your realm of common sense? Give me a1284little bit of your view here on how you would like to proceed1285on these accelerating approval pathways.12861287    Dr. Makary. Thank you, Senator and I very much enjoyed our1288time together and talking through a bunch of these issues. We1289have to customize the regulatory process to the condition that1290we're trying to be able to offer hope for. So, if a condition1291affects 19 people in the world, as a partial triplication1292chromosome 15 disorder does, or a disease that affects 52 kids1293in the world, we cannot require two randomized controlled1294trials. We have to customize the regulatory process to what1295we're trying to do, if our goal is to try to provide safe and1296effective therapies.12971298    I do believe firmly in that approach, and I think we can1299use some common sense to ask some big questions we've never1300asked before at the FDA. Why does it take 10 years for a drug1301to get approved? Why does a college student who suffers from1302chronic abdominal pain for years, and we have no idea what's1303going on, they go to Italy for a summer and they're suddenly1304cured of their abdominal pain. Why does a peanut allergy1305medication that's been safe with data for decades, get approved1306in Europe before the United States when nearly 10 percent of1307our population has a food allergy?13081309    I do think there's a lot of areas where we can ask, does a1310drug need to be prescription when it could be over the counter?1311Why are we requiring continuous glucose monitors to have a1312doctor's prescription? When it's good for people to use these1313monitors and learn about what they're eating. We don't just1314want to limit continuous glucose monitoring to people with1315diabetes, we want to prevent diabetes when 30 percent of our1316Nation's children has diabetes or pre-diabetes, or some form of1317early insulin resistance. Why are we holding these tools to1318help people empower them with knowledge about their health,1319until after they're sick? Same with continuous blood pressure1320monitoring.13211322    Senator Murkowski. It's as you point out, why do we wait?1323Now, we want to make sure that there is that level of safety,1324that's the job there through the FDA. But again, being able to1325accelerate these in ways that are meaningful and to your point,1326that actually fit with the population that you're speaking to.1327So, know that I'm going to be pushing you on this as well as1328many other advocates out there.13291330    Dr. Makary. Thank you.13311332    Senator Murkowski. I want to quickly ask you about food1333safety inspections. State and local governments conduct about133460 percent of food processing facility inspections, 90 percent1335of produce safety inspections, a hundred percent of retail food1336inspections. What has happened is we have seen in the Biden1337administration, FDA planning to cut funding for state and local1338food safety programs. This impacts us in the State of Alaska1339when it comes to our seafood industry and in other areas.13401341    I'm looking for a commitment from you that under the Trump1342administration, the FDA is going to maintain funding for these1343contracts with state and local governments. They've proven that1344it's more cost effective, more efficient, and it also is what1345Congress has asked for. So, I'd like to know that you're going1346to be supportive in that regard with regards to state and local1347food.13481349    Dr. Makary. I'm happy to look at that with you, Senator.13501351    Senator Murkowski. Very good. Thank you, Mr. Chairman.13521353    The Chairman. Senator Blunt Rochester.13541355    Senator Blunt Rochester. Thank you, Mr. Chairman. And thank1356you so much Dr. Makary for taking time to meet with me. I've1357found that most parents would do anything to keep their1358children safe and healthy, which is why we probably see so much1359intense debate on the best ways to protect our children. And1360the FDA has historically been seen as the authority on reliable1361information about public health issues related to medical1362products, food, tobacco, cosmetics, dietary supplements.1363However, people are getting their information in many different1364ways now, in many different places.13651366    We're faced with a growing challenge of opinions replacing1367scientific consensus and the proliferation of misinformation1368and disinformation. Parents need accurate science-based1369information to help make informed decisions for their children.1370How would you use your position as FDA commissioner, to compete1371with uninformed voices and to share evidence-based consensus-1372driven information that is free from political influence?13731374    Dr. Makary. Well, thank you, Senator and I enjoyed our time1375meeting together. I believe very much in empowering people with1376good information, that's why I've written three bestselling1377books to try to educate people about health. And I do think you1378can explain to people with humility what we know and what we1379don't know, and then they're going to trust us more.13801381    Trust in doctors and hospitals is at a crisis right now. It1382was 71 percent in 2019, 71 percent of the public trusted us in13832019, now it's down to 40 percent. That's a 31 point drop in my1384profession, that is a major problem. If we have the cure for1385pancreatic cancer, but only 40 percent of the public is going1386to come in and take it because the rest doesn't trust us, then1387that medication is only 40 percent effective.13881389    I think we fight bad ideas with more ideas. I don't believe1390in censorship of scientific opinions. I think we need a civil1391discourse. Unfortunately, we have a sort of toxic discourse1392right now in the United States and the politicalization of1393immune cells in some cases.13941395    Senator Blunt Rochester. One of my big concerns is who1396those voices are, and that they really are robust,1397scientifically trusted messengers as well. One of the other big1398issues that we're facing are drug shortages that have reached1399an all-time high, threatening access to products that we use1400every day, from IV bags to lifesaving drugs for cancer.14011402    It's particularly concerning for children's hospitals1403because of pediatric drugs and supplies that must be formulated1404to accommodate children's unique needs. Do you agree, and this1405is kind of a yes or no, do you agree that the FDA should play a1406leading role in mitigating drug shortages?14071408    Dr. Makary. I love yes and no questions.14091410    Senator Blunt Rochester. Good. Can you, do it?14111412    [Laughter.]14131414    Dr. Makary. A leading role--they should take a role. I1415think the problem is much bigger than the FDA.14161417    Senator Blunt Rochester. Yes or no, you're like not sure if1418it's a yes or no.14191420    Dr. Makary. I would refer you to my article in JAMA on this1421topic.14221423    Senator Blunt Rochester. I want to shift to clinical trials1424as well. You agreed, we talked about the importance of clinical1425trial diversity, but I want an assurance that you will stand up1426to any Trump administration actions that conflict with this.1427So, again, yes, or no, do you believe clinical trial diversity1428is critically important?14291430    Senator Blunt Rochester. That's the easy one.14311432    Dr. Makary. Well, if you're talking about a trial of sickle1433cell disease, are we saying that we need to have white people1434in a trial of sickle cell? I believe in common sense, and I1435believe in clinical trial diversity, both. And so, I believe if1436you're going to make results extrapolated to the general1437population, you should have results in those populations that1438you're making recommendations for.14391440    Senator Blunt Rochester. That one was an easy one. Do you1441think it is acceptable for the Administration to remove1442congressionally mandated guidance documents on clinical trial1443diversity?14441445    Dr. Makary. I'm not familiar with that.14461447    Senator Blunt Rochester. Should you be confirmed, will you1448reinstate and finalize this document after you look at it as1449one of your first actions? Would you take a look at that? Could1450you commit to looking at that?14511452    Dr. Makary. Yes, Senator.14531454    Senator Blunt Rochester. Good answer.14551456    [Laughter.]14571458    Senator Blunt Rochester. Will you restore the Web site for1459the Office of Minority Health and Health Equity?14601461    Dr. Makary. I'm not familiar with that Web site, Senator.14621463    Senator Blunt Rochester. If there was one and you knew1464there was one, would you restore the Web site that would1465provide information to the American people?14661467    Dr. Makary. I think you're asking me to make a decision on1468information that I don't have. So, you have my commitment to1469take a look at it.14701471    Senator Blunt Rochester. If you got the opportunity to1472review the Web site, and then know that it would help to spread1473real information, science-based information, would you1474reinstate that Web site?14751476    Dr. Makary. I would be happy to review it.14771478    Senator Blunt Rochester. I have more questions that I will1479send for the record, but particularly, I'm concerned also about1480the Vaccines for Children program and making sure with the--1481you've heard our colleagues talk about the cancellation of the1482meeting. This is not just about cost for families, which is1483huge right now, but it's also about coverage. And so, I yield1484back my time and I thank you so much, Doctor.14851486    Dr. Makary. Thank you, Senator.14871488    Senator Hawley. Thank you very much, Senator. Doctor, it's1489great to see you again, I enjoyed our conversation.14901491    Dr. Makary. Good to see you.14921493    Senator Hawley. Congratulations on your nomination and1494thank you for your willingness to take on this very important1495role. You've been asked about this several times already, but I1496just want to drill down a little bit further.14971498    In 2000, President Clinton's FDA approved a chemical1499abortion regimen with the drugs mifepristone and also1500misoprostol. Now, the FDA concluded that mifepristone could not1501be safely used, I'm quoting the FDA there, safely used, could1502not be, without special measures, it's the FDA's language. And1503in particular, the FDA mandated that prescribers needed to be1504licensed physicians who were able to diagnose and treat ectopic1505pregnancies to accurately determine the gestational age of the1506baby.15071508    The FDA further required that these drugs be administered1509and dispensed in person, that there be a day one in-person1510administration of the drug, a day three in-person1511administration of the second wave of the drug, a day 14 check-1512in for complications. And the FDA further emphasized that given1513the potential risks of these drugs, physicians needed to be1514able to provide ongoing care.15151516    The FDA also said, ``The percentage of women who considered1517any particular adverse event as severe ranged from two to 351518percent.'' And the FDA included what's called a black box1519warning, which you're very familiar with, which remains on the1520drug.15211522    Now, those restrictions were largely in place until just a1523couple of years ago, when the Biden administration, after the1524U.S. Supreme Court took up the Dobbs decision, granted cert on1525it. At that point, the Biden administration decided to1526eliminate 20 years of in-person dispensing requirements for1527this drug that didn't cite any studies that they said were1528adequate. That the FDA acknowledged that the studies that they1529looked at did not take into account the new protocols that they1530were issuing. They just eliminated two decades of in-person1531dispensing requirements.15321533    My question to you is, given the FDA's own findings on this1534drug over two decades, doesn't it make sense that the FDA1535returned to the pre political, before the political1536intervention of the Biden administration, the pre political1537protocol that requires in-person dispensing for chemical1538abortion drugs?15391540    Dr. Makary. Senator, I appreciated our conversation prior1541to this hearing. I do think it makes sense to review the1542totality of data and ongoing data. I know personally of OB1543doctors who prefer to insist, even though they have the option1544to prescribe otherwise, but they choose to insist that1545mifepristone be taken, when necessary, in their office as they1546observe the person taking it. And I think their concern there1547is that if this drug is in the wrong hands, it could be used1548for coercion.15491550    Senator Hawley. Of course, you're familiar with the fact1551that now it's not merely that there's no requirement that it be1552ingested in the presence of a physician, there's no in-person1553dispensing requirement whatsoever. This is what the Biden1554administration--two decades of in-person dispensing1555requirements, the Biden administration eliminated those.15561557    Now, you've said several times, you'll review the data. You1558are aware that in 2016, the Obama FDA eliminated the1559requirement that physicians report adverse events with regard1560to mifepristone, aren't you?15611562    Dr. Makary. I believe they limited the data required to1563fatalities, but not adverse events.15641565    Senator Hawley. Will you put back in place the full1566reporting requirements that you can have a full range of data1567to evaluate?15681569    Dr. Makary. Senator, I'm happy to look at that. I do1570believe in data, and I don't believe in pre-judging data before1571somebody has taken a look at data, including future data.15721573    Senator Hawley. Well, let me just say that, here's the1574deal. The FDA's rules were pretty consistent and pretty stable1575for 20 plus years, until suddenly the Dobbs decision appeared1576on the horizon. And when that happened, all of a sudden, we got1577massive changes in the dispensing requirements of this drug.15781579    I'll just point out that over 60 percent of abortions in1580the United States are now carried out with chemical drugs, with1581these drugs. They're not done in clinics; they're not done in1582hospitals, they're done with these drugs, without any kind of1583physician supervision, without any physicians there.15841585    If there's a serious adverse event--and I'll also just1586point out that if the Biden rules are allowed to stand, it1587doesn't matter what voters in the states, it doesn't matter1588what--this is a serious and very difficult moral issue, the1589case of life and abortion. And it won't matter what voters in1590the states say, because the Biden rules say now that1591bureaucrats can mail in abortion drugs to every single state,1592no in-person dispensing required. It doesn't matter what voters1593in the state have decided on the issue, it doesn't matter1594whatsoever.15951596    Now, if that's allowed to stand, we may as well just go1597back to having the Supreme Court make all the decisions.1598Because right now, Washington bureaucrats are making all the1599decisions, doctors are not involved. They're not in person1600dispensing, state voters are not involved. And I just want to1601register this is extremely concerning to me. It ought to be1602concerning to everyone who's concerned about women's safety,1603and also about what I thought was the position of this1604Administration, which is that it ought to be voters in the1605states and the relevant localities that are deciding this1606decision.16071608    I know you're familiar with this, doctor. I appreciate your1609commitment to the data. I hope that you'll look at the full1610range of data, and I hope we can count on you to protect1611women's health and the health of the unborn.16121613    Dr. Makary. Thank you, Senator.16141615    Senator Hawley. [Presiding.] Well, Senator Kaine, let the1616record reflect, even though I have the gavel, I'm going to stop1617right now and turn it over to you.16181619    You're recognized, Senator.16201621    Senator Kaine. Thank you, Senator Hawley. Senator Hawley1622and I share a unique perspective. There are two sets of1623Senators who went to the same high school. Chuck Schumer and1624Bernie Sanders went to James Madison High School in Brooklyn,1625New York and Josh and I went to Rockhurst High School in Kansas1626City, so I just wanted to put that on the record.16271628    Dr. Makary, I loved the opportunity to visit with you and I1629know the answer to this question, but I just want to stress it1630again. You didn't have anything to do with the layoff of the1631thousand FDA employees that have been laid off in the last1632couple weeks, correct?16331634    Dr. Makary. That's correct, Senator.16351636    Senator Kaine. Do you know anything about the layoffs, for1637example, who made the decisions or what groups of people were1638laid off?16391640    Dr. Makary. I do not, Senator.16411642    Senator Kaine. You indicated that when you come into the1643office, you're going to do an assessment. And I suppose based1644on your experience, that if you look at this going forward, you1645think personnel policy, including layoffs, should be done1646strategically rather than just kind of willy nilly across the1647board randomly, correct?16481649    Dr. Makary. I am open to ideas on making government more1650efficient.16511652    Senator Kaine. Do you think willy nilly, random across the1653board, is a good idea or not a good idea?16541655    Dr. Makary. Look, I'm a surgeon, so I'm going to give you a1656surgical answer.16571658    Senator Kaine. Yes. Okay. That's good. It is a little bit1659puzzling; the Administration has high confidence in you. You've1660got this hearing right now, they expect you to be confirmed,1661probably will be based on practice of the notion that they1662would lay off a thousand people before you got there, is a1663little bit unusual. And what we're seeing in agencies, in the1664layoffs is that it is willy nilly random probationers get laid1665off because they can't fight back. Probationers are1666disproportionately veterans. I'm glad you will be a surgeon and1667act like a surgeon, should you be confirmed.16681669    Second thing I want to ask is about user fees. And we1670chatted a little bit about this in the office. We agreed that1671despite the need for reforms at the FDA, that the FDA is sort1672of the gold standard. I asked you, is there another nation that1673does this better than us? And you said, no, there wasn't. Even1674though, again, you've got reforms you'd like to make.16751676    Here is an issue that's pretty technical, but it's an1677important one. We talked about tracking adverse events after a1678drug or medical device is approved. And you indicated that the1679FDA can do a better job of identifying issues with problems1680that are already on the market. It's not all about approval and1681that it's about post-approval tracking.16821683    There are many different user fee programs that outline the1684relationship between the FDA and industry. And for most of the1685user fee programs except medical device user fee, FDA can use1686the collected user fee dollars to conduct post-marketing1687surveillance. But the medical device user fee program does not1688allow that use of the user fee dollars. Would you agree that1689the FDA should be able to use the user fees collected of1690medical devices to do post-approval surveillance?16911692    Dr. Makary. Senator user fees are established by Congress,1693and I'm more than happy to be a part of the conversation about1694the best use of those dollars within the agencies. I very much1695enjoyed our conversation, and I'm committed to an FDA that1696delivers more cures for Americans and meaningful treatments,1697healthy food for children----16981699    Senator Kaine. But can I just ask about this, do you think1700post-approval surveillance is something that's important?17011702    Dr. Makary. I am a big believer, Okay, in the idea that we1703should not just turn a blind eye after the FDA approves1704something. If we do that, we get burned with a million lives1705lost from Oxycodone and OxyContin without----17061707    Senator Kaine. That's my next topic. And I do agree with1708you that making that change would be on Congress's shoulders,1709but I do think it's odd that we don't allow the user fees to be1710used for post-approval surveillance on medical devices when we1711do in the other areas. And I'd love to work with you on that.17121713    On OxyContin, I want to just close with this one. We're1714seeing some improvements: 24 percent decline in drug overdose1715for the 12-month period ending in September, 2024 compared to1716previous year. And just yesterday, the NIH released findings of1717an NIH funded study researching a new pathway to address pain1718issues. But 87,000 Americans died of overdose in the 12-month1719period. So, it's an improvement, but we got so much farther to1720go.17211722    1 in 4 Virginians deal with chronic pain. And one of the1723issues you and I talked about is, can the FDA not just be in1724receive mode, to get the applications for approvals and1725approve? Can the FDA even be proactive in looking and saying,1726hmm, how come we don't have more non-opioid based pain1727management strategies? The FDA shouldn't be picking a winner1728among competitors, but to look at gaps and try to incentivize1729or encourage filling those gaps would be smart.17301731    Could you share some of your ideas for how we might1732encourage appropriately, the development of innovative1733strategies to address chronic pain without using opioids?17341735    Dr. Makary. Thank you, Senator. I do believe the FDA should1736not just be in receive mode, but also partner with industry and1737facilitate the process and ensure that the scientific review is1738independent, at the same time without cutting any corners on1739the independence of that review. The opioid pain problem can1740also be addressed by innovation, more localized treatments, and1741looking at post approval monitoring of devices.17421743    Senator Kaine. Great and thank you. I look forward to more1744discussion.17451746    Dr. Makary. Thanks, Senator.17471748    The Chairman. [Presiding.] Senator Tuberville.17491750    Senator Tuberville. Thank you, Mr. Chairman. Thank you,1751doctor, for being here.17521753    Dr. Makary. Thank you, Coach.17541755    Senator Tuberville. Also for your willingness to do this.1756World War II, we had to find ways to feed our troops. We knew1757nothing about preservatives and canning foods and ever since1758then, our food's going downhill because we have put everything1759in the world, in our food, No. 1, to get kids addicted to it,1760which we have. We've lost probably a couple of generations1761because of the obesity and diabetes.17621763    I have faith in this generation. I have two kids in this1764generation coming up, that they're looking at their health as a1765future. And they're fired up about nutrition being a good part1766of it.17671768    Are you familiar with GRASS--generally recognize safe1769foods, the chemicals that go into our foods. What's your1770thoughts on that? What's your thoughts on you as FDA director1771having the ability to look at this and know we're not using1772this chemical in this food. What's your thoughts?17731774    Dr. Makary. Well, first of all Senator Coach, I think you1775have had a perspective on this and been an advocate for healthy1776foods. And perhaps it's because of your unique position where1777you've worked with young people for so long. Half of our1778Nation's children are sick, and nobody has really been doing1779anything meaningful on this front until we have gotten new1780momentum and enthusiasm from Secretary Kennedy and President1781Trump to finally address the root causes of these diseases:1782General body inflammation and generalized insulin resistance,1783and food is a big part of it.17841785    When we eat foods with a lot of molecules that do not1786appear in nature, these are chemicals. These are chemicals that1787the industry insists are safe, a subset of which are1788concerning. There's a body of research now that suggests1789concern with some of these ingredients. We have to look at1790those ingredients, and you have my commitment to do so if1791confirmed as FDA commissioner.17921793    These chemicals are creating an inflammatory response in1794the gastrointestinal tract. And with an altered microbiome1795lining that GI tract, kids feel sick. It's not an acute1796inflammatory reaction, it's a chronic low-grade reaction, and1797they don't feel well. And what are we doing? We are drugging1798our Nation's children at scale. We have to reassess what we're1799doing because we're not on a good path right now.18001801    Senator Tuberville. I grew up in the South. I love fried1802foods. Okay. We fry everything, including snicker bars and1803Twinkies.18041805    [Laughter.]18061807    Senator Tuberville. But let me ask you this, I hear a lot1808about seed oils and the good and the bad, your thoughts?18091810    Dr. Makary. I think seed oils are a good example of where1811we could benefit from a consolidation of the scientific1812research. And I don't think it's any one ingredient in the food1813supply that's making our Nation's children sick with a 301814percent rate of insulin resistance and diabetes in American1815teenagers today. That's a massive signal in the data.18161817    I think we have to look at the totality of every single1818thing in school lunch programs, in the diet of our Nation's1819children. When we're using tax dollars to make purchases of1820foods that we know make our Nation's children sick, we have to1821reexamine how we're spending those tax dollars.18221823    One thing I would like to work on is a school lunch1824program, for some school districts, on a pilot basis to1825transition to healthier foods. A lot of school districts want1826to, but they don't know how, and they may not have the funds.1827So, I've been discussing this with Jay Bhattacharya and others1828in the Administration, and I hope that's something we can do.18291830    Senator Tuberville. Thank you. Just a few months ago, we1831had the former FDA director, and I asked him about red dye No.18323, and it was a pretty interesting conversation. Red dye No. 3,1833we've done studies on it, and we won't allow it in cosmetics,1834Okay? Because it causes cancer, but we are allowed to put it in1835our food and I'm a little bit confused.18361837    I'm a football coach, but I'm not that stupid. Put it on1838your face and put in your stomach, there's no difference. But1839he made an interesting statement that we're 20 years behind1840Europe, because Europe doesn't allow it in anything. We're 201841years behind Europe on looking into red dye three and all the1842other dyes. What's your thoughts on dyes in this country?18431844    Dr. Makary. I agree with you that we--it did not make sense1845that red dye No. 3 was banned in cosmetics, but allowed in the1846food supply. And so, with two business days left in the Biden1847administration, there was an announcement to ban red dye No. 31848in 2027 or 2028.18491850    Senator Tuberville. Why that long, we want to kill people1851for two more years. I mean, I would hope that you would, if1852you're confirmed, you go in and look at it very quickly and1853say, why do we want to put our people in harm's way? Thank you,1854Mr. Chairman.18551856    Dr. Makary. Thank you, coach.18571858    The Chairman. Senator Hickenlooper.18591860    Senator Hickenlooper. Thank you, Mr. Chairman and thank1861you, Dr. Makary for your service. I finally got a chance to1862look over some of your three books, or you probably have more1863than that, but the three books that I was able to chase down,1864and they each one seemed provocative and full of answers. I1865will say, as a very, very slow reader, I'm a dyslexic, I do1866wish you had something like Cliff notes so that we could get 101867or 15 pages concise and get the essence out of that.18681869    Dr. Makary. I'd be happy to personally summarize them for1870you Senator.18711872    [Laughter.]18731874    Senator Hickenlooper. I think we have witnesses that just1875heard that, I'm very excited. I appreciate your courage in1876taking on a lot of these traditional approaches and being so1877candid. Let me go through a couple of questions. In just a few1878weeks, roughly 10 percent of the FDA staff has been laid off.1879And most of these layoffs were inspectors who looked either at1880food supply, whether it was safety of medical devices and yet1881for the past several years, job vacancies, if you measure them1882as an indication of anything, but for FDA inspectors, job1883vacancies have been going up, not down. In other words, we have1884more unfilled spots, and now all of a sudden, we've laid off 101885percent of the people there.18861887    That chaos and the understaffing is going to really present1888a serious morale issue, which I'm sure you're aware of. I don't1889know if you have any plans for that. And how are you going to1890be able to try and do the best you can to ensure the FDA's gold1891standard of science if we can't get enough inspectors?18921893    Dr. Makary. Senator, thank you for the question and I1894enjoyed our time together in your office. I was not involved in1895any personnel decisions.18961897    Senator Hickenlooper. That was not a criticism. I was just1898saying, once you get in the job, if your budget is suddenly1899diminished and you've got 10 percent fewer inspectors and you1900already didn't have enough by the existing measures, I'm not1901sure there's an answer for it. Maybe it's an unfair question.19021903    Dr. Makary. Senator, if confirmed, you have my commitment1904that I will do an assessment within the Agency of personnel,1905and it will be an ongoing assessment to ensure that the1906scientists and food inspectors have all the resources they need1907to do their job.19081909    Senator Hickenlooper. Great. Again, that's certainly the1910exact place to start. We have a bill, Skinny Labels, Big1911Savings Act that helps more generic drugs, more of that1912competition come into the market, lower drug costs.19131914    Again, with so many of the FDA workers having been fired1915and laid off, will there be sufficient people at the agency to1916review generic drug applications? Because that often gets1917pushed to the bottom of the heap, and yet it has dramatic1918savings, especially for elderly and people on the lower parts,1919the people that don't have insurance. So, are you worried about1920a slowdown, again due to resources and personnel?19211922    Dr. Makary. Senator, I want to make sure that the reviewers1923and the review process is done properly without cutting any1924corners on the scientific independence and done expeditiously.1925So, you do have my commitment that I will do my best to ensure1926that that's done as best as possible.19271928    Just to put things in context, if I may. The FDA has almost192919,000 employees, just over 18,000. That represents a 1001930percent increase since 2007. Now, I understand there were some1931layoffs recently, I understand some or many were hired back,1932but I just wanted to let you know that, to put things in1933context, we have seen a doubling of the agency in terms of1934number of employees since 2007.19351936    Senator Hickenlooper. Fair point, I accept that and was1937aware of that, but it's a fair point. Lot of talk about1938measles. Secretary Kennedy recommended the use of cod liver oil1939as one of several things that people could do and left it to1940parental discretion as to whether they would get their kids1941vaccinated, which I think you've got--I agree with that.19421943    I think the parents in the end have a right and a1944responsibility to make that decision for their kids. But it1945seemed to me that there could be a stronger--those of us who1946looked adept and in detail at the facts, that this is really a1947very safe vaccination for 99.99 percent of kids. And it saves1948lives and it prevents huge levels of very sick kids. You think1949there should be more, or will you be willing to be a more1950enthusiastic supporter of vaccinations while at the same time1951recognizing that parents get the final say?19521953    Dr. Makary. Senator vaccines save lives. And I do believe1954that any child who dies of a vaccine preventable illness is a1955tragedy in the modern era. The rare times in which a child dies1956of measles, it is often in the setting of a comorbid condition1957or severe malnutrition. And perhaps that is the rationale1958scientifically and physiologically as to why some1959supplementation in terms of nutrients may provide a benefit to1960children who are very sick and hospitalized with measles.19611962    Senator Hickenlooper. Right. And I don't deny that. Thank1963you. But I'm getting gaveled.19641965    Dr. Makary. Thank you, Senator.19661967    Senator Hickenlooper. Thank you so much for your service.19681969    Dr. Makary. Thank you, Senator.19701971    The Chairman. Senator Husted.19721973    Senator Husted. Thank you, Mr. Chairman. Great to have you1974before the Committee. I enjoyed Dr. Makary the conversation we1975had in my office. And I want to just give you a chance to share1976some thoughts kind of building on what I'm sure others have1977asked you.19781979    I am deeply concerned about how much inflationary cost the1980healthcare system has created for the American public over the1981last decade in the 21st century. We talk about inflation around1982here, the most inflationary cost affecting consumers,1983businesses, the American public, the American taxpayer is1984healthcare costs. We seem to spend more, get worse outcomes.19851986    You look at the fact that from the earliest stages we have1987children who are unhealthier, worse diets, more obesity, which1988lead to problems like diabetes, lower quality of life, lower1989productivity as they go through life, higher costs in the1990healthcare system, that continues to manifest through life on1991all those fronts. And then the government and the taxpayers end1992up paying for all of it through Medicare and Medicaid. It is1993driving us into bankruptcy in some levels and costing people1994and families the ability to afford to live. And so there are1995lots of ingredients to that.19961997    How do we take cost out of the healthcare system, whether1998it is making people healthier and in making this whole system1999sustainable for the long run.20002001    Dr. Makary. Well thank you Senator Husted, and it's good to2002see the Cavaliers doing great this year. I hope this is their2003year to win it all. I enjoyed our time in your office.20042005    Senator Husted. We only have one championship in Cleveland.2006That was when LeBron was there.20072008    [Laughter.]20092010    Dr. Makary. First of all, you are a hundred percent2011correct, and this is something I'm very passionate about.2012Healthcare costs are spiraling out of control, and its2013burdening everyday American businesses and families. It's2014getting more and more difficult to compete with businesses2015overseas because of healthcare costs. It outpaces inflation.20162017    When we are spending money that we don't have as a country,2018it drives inflation and inflation is a backhanded dirty tax on2019the poor. It doesn't affect the wealthy; it affects the poor.2020And that's why we've got to address healthcare spending. We've2021heard of many different ideas out there, but the main root2022issue is the health of the population, and it is getting worse.202375 percent of adults have some comorbid condition or diabetes2024or pre-diabetes, or are overweight or obese. 3 in 10 teens now2025have insulin resistance, that's not good for our future as a2026country.20272028    Thanks to President Trump and Secretary Kennedy for the2029first time, we're talking about root causes, both on a research2030basis and in terms of what we can do at every agency. And2031within the FDA, I do think there are things we can do to help2032empower people, by facilitating this independent scientific2033review of devices and other ways to prevent chronic diseases2034with continuous glucose monitoring, continuous blood pressure2035monitoring, and healthy foods for children.20362037    If confirmed, my goals are very clear at the FDA, more2038cures, and meaningful treatments for Americans, including2039diagnostics, healthy food for children, and rebuilding the2040public trust.20412042    Senator Husted. Great. I look forward to working with you2043on all those issues, as I'm sure many of the Members of this2044Committee do. One way that we can drive more efficiency and2045speed to market for things that can improve lives and hopefully2046lower costs is through technology. I know that I was involved2047with the Cleveland Clinic when they got the first quantum2048computer focused on healthcare research, and you use things2049like quantum and AI to drive discoveries, speed to market with2050these. Could you talk about how the FDA under your leadership2051would think about those things?20522053    Dr. Makary. Thank you, Senator. I think there's a number of2054opportunities with AI right now that we have, that we've never2055had before. We have an incredible opportunity to use AI to help2056reviewers in the review process, not to replace the human2057reviews, but to aid them and assist them in the same way that2058EKGs are read by AI devices that tell us normal sinus rhythm at2059the bottom of the EKG. Now, we still look at the rhythm, but it2060aids and it may help the efficiency among the reviewers.20612062    We can use AI also in drug design and drug development.2063Now, that's not something the FDA does, but the FDA can help2064provide data to help train machine learning models to help2065design AI systems that can predict toxicities, adverse events,2066and even cures for some conditions.20672068    Finally, AI can be used to aid with data monitoring in a2069post-approval setting. So, we don't learn 5 years after Vioxx2070is approved that 38,000 Americans died from it. Thank you.20712072    The Chairman. Thank you, Senator Husted.20732074    Now Senator Markey.20752076    Senator Markey. Thank you, Mr. Chairman. I'm from Boston,2077the home of the World Champion, Boston Celtics. Good luck to2078the Cavaliers.20792080    [Laughter.]20812082    Senator Markey. But we'll have a little bet. You stated2083that you want to ensure that the FDA holds the gold standard of2084trusted science and transparency. In order for that to happen,2085the FDA commissioner must also uphold the gold standard for2086trusted science and transparency.20872088    In your financial disclosures, you disclosed that you made2089over half a million dollars from Global Appropriateness2090Measures LLC. The client list for that company includes2091companies that are interested in making money off of the2092healthcare system, insurance companies, hospital chains,2093private equity backed companies. So, can you tell the Committee2094how much you made from those private equity and venture capital2095backed companies?20962097    Dr. Makary. Senator, first of all, thank you for the2098question, and I enjoyed our conversation prior to this hearing.2099I'm very proud of my work at Global Appropriateness Measures.2100The purpose of the endeavor, was to lower healthcare costs for2101Americans by reducing unnecessary surgery and medications----21022103    Senator Markey. I appreciate that. Just for the record, can2104you just tell us how much you made from the private equity and2105venture capital backed companies?21062107    Dr. Makary. I have been a shareholder in Global2108Appropriateness Measures. I am fully divesting, I don't have2109the exact numbers at my fingertips, but they were all disclosed2110to the Office of Government Ethics, and they're all part of the2111disclosure system.21122113    Senator Markey. Was it in the millions of dollars or less?21142115    Dr. Makary. Over the course of what period of time?21162117    Senator Markey. Over the period of time that you had a2118relationship with them.21192120    Dr. Makary. There was revenue of that company in the2121millions of dollars. Yes. And I am one of the shareholders of2122that company, and I am very proud. The best way to lower drug2123prices in the United States are to stop taking drugs we don't2124need. So, I do believe in the appropriateness of care, and that2125endeavor was designed to create software, so we can monitor----21262127    Senator Markey. I appreciate that. And we're just looking2128at the transparency issue, so I'm just trying to help you to be2129transparent here. So how much were you paid by insurance2130companies, including devoted health services and insurance2131company that primarily sells Medicare Advantage plans?21322133    Dr. Makary. Yes, that figure is in the Office of Government2134Ethics Report. I don't have that exact number at my fingertips.2135And of course----21362137    Senator Markey. Was that in the millions of dollars as2138well?21392140    Dr. Makary. No, that was far less. And again, I'm one of2141the shareholders of that company.21422143    Senator Markey. Well, I think the American people do2144deserve your full transparency about how you might be2145influenced by the healthcare industry, insurance companies,2146private equity, and venture capital funds. And that's what I'm2147trying to get at here.21482149    Dr. Makary. Yes, all of those reports will be public2150Senator.21512152    Senator Markey. They will be public, they're not public at2153this point. So, I'm not in a position to ask you about them.2154And that's why I'm asking you if----21552156    Dr. Makary. Office of Government Ethics releases it at a2157certain point of time.21582159    Senator Markey. But it's not helpful for the confirmation2160hearing, which is essential in terms of the public2161understanding, all of the potential, not actual, but potential2162conflicts of interest that might show up. The FDA is2163responsible for approving medical devices or drugs that may2164impact how much insurance companies pay or what they cover. The2165same insurance companies that do overcharge Americans and2166undercover their care. It will impact hospital costs and2167private equity.21682169    You're coming into this role with relationships2170preexisting, that have a profit interest in the decisions that2171you will be responsible for making. That's why I'm raising2172these issues. Will you commit today to not participating in any2173decisions that would have an impact on known clients of Global2174Appropriateness Measures during your tenure as FDA2175commissioner?21762177    Dr. Makary. First of all, Senator, I appreciate your2178enthusiasm on this topic. I am one of the biggest advocates2179that was involved in the health insurance industry transparency2180of the secret negotiated rates. So, I'm a big--I'm with you.2181The recusals that I will be taking are a hundred percent in2182line with the Office of Government Ethics recommendations,2183which were not to resign from everything, but I chose to resign2184from everything to ensure no appearance of a conflict of2185interest.21862187    Senator Markey. That's important for us to hear. And the2188same thing, will you commit today to not participating in any2189decisions that would have an impact on private equity and2190venture capital investors of those clients as well?21912192    Dr. Makary. Senator, I commit to following the Office of2193Government Ethics Agreement.21942195    Senator Markey. Well again, it's just so important for us2196to understand this going forward, because of obviously the2197increasing role that those sectors are now playing, and they2198will be attempting to influence FDA decisions. So that's the2199reason why I'm raising the questions and total transparency is2200absolutely necessary. Thank you, Mr. Chairman.22012202    Dr. Makary. Thank you, Senator.22032204    The Chairman. Thanks. And I'll note that as you mentioned2205that all your financial records have been with the Office of2206Governor Ethics.22072208    Senator Banks.22092210    Senator Banks. Thank you, Mr. Chairman. On that note,2211doctor, you've been very transparent, right?22122213    Dr. Makary. I believe so.22142215    Senator Banks. Talk about that process. I mean, how2216transparent you have to be to get to this point today.22172218    [Laughter.]22192220    Dr. Makary. Well, there was a massive disclosure of2221basically every single share of everything that I own. And that2222process took a number of weeks and I would describe it as a2223colonoscopy with a small bowel follow through. And everything2224is out there and basically, I will have essentially no privacy2225when the Office of Government Ethics chooses to release that2226form. But that's Okay. I'm proud of everything that I've done,2227and I'm more than happy to acknowledge that I've agreed to2228divest or resign from everything.22292230    Again, I was given the option not to resign from2231everything, but I chose to resign from everything, because I2232want to ensure independence. This is not a job I'm taking to2233audition for my next job. This is a job I'm doing to serve the2234American public. I believe in more cures and meaningful2235treatments, healthy food for children, and rebuilding the2236public trust. So, Senator, I can commit to you that I am2237absolutely dedicated to that mission, and I am not there to2238audition for a future job.22392240    Senator Banks. I appreciate that, because this is so2241important. I mean, you've been nominated for this position2242because you're incredibly accomplished, your background2243perfectly fits the role that you're about to take, and you2244bring experiences and success to the table to be the new head2245of the FDA and change it.22462247    Because you've talked about this, you mentioned in your2248testimony that healthcare has become too fragmented, too cold,2249and too corporate, right? I mean and you're going to go there2250to shake that up and change that. The Make America Healthy2251again movement, that was a big part of giving this President a2252giant mandate with Secretary Kennedy and others who are coming2253to the table, the role that you're going to play is really2254important to that, to disrupt it.22552256    I think we all agree, that I think the American people2257agree, that the medical establishment is often condescending2258toward the American people, it is something that we have to2259disrupt and change. Can you talk about how you're going to do2260that at the FDA?22612262    Dr. Makary. Thank you, Senator. And I do agree a hundred2263percent that for the first time ever, President Trump and2264Secretary Kennedy had moms that were Republican, Democrat,2265independent, come out and vote because they care deeply about2266the health of our Nation's children.22672268    They want to see healthier food for children. They want to2269see an industry that has, they want to see an FDA that is2270independent of corporate influence, but at the same time2271working with partnerships around the country to facilitate, not2272just being a receive only mode. So, one of my goals is to2273ensure that the FDA maintains its scientific integrity and that2274we can do what we can to contribute to the Make America Healthy2275again spirit.22762277    Senator Banks. Very good. Clinical and nonclinical testing2278are both very important parts of FDA's drug approval process.2279How do we modernize that process? Modernize testing?22802281    Dr. Makary. Well, first of all, there are steps in the2282regulatory process where we can take a look and ask, do we need2283to use the same processes that we've been using? Infant2284formula, for example, has had the same recipe for the last 402285years. And so, with the exception of Selenium, which was added2286in 2015, for 40 years we're requiring infant formula companies2287to use a standard recipe that was developed back when the food2288pyramid was misleading Americans and basically government2289misinformation.22902291    Can we take another look at that? Can we create other ways2292in which new products can be brought to market safely? Can we2293look at real world data from European products? The more2294competition, the more resiliency in the supply chain, and the2295lower the risk of a shortage in the future. So, does infant2296formula need to go through the same process as a new drug? Or2297can we look at real world data and work with the companies to2298figure out a smarter way that uses both trusted science and2299common sense, which is a theme I would like if confirmed.23002301    Senator Banks. I want to work with you on that. The FDA is2302starting to allow patients to choose whether they want2303prescription drug instructions on paper or digitally, seems2304like common sense. But medical device instructions are still2305required to be on paper. Would you support changing that2306requirement?23072308    Dr. Makary. Senator, my understanding is that's a2309requirement set by Congress, and I would be more than happy to2310work with you and Members of Congress to take a look at that.23112312    Senator Banks. Do you have an opinion on it?23132314    Dr. Makary. I've heard arguments on both sides. One thing2315that people have raised is that, on one hand it may be a waste2316of paper, it's a lot of paper. On the other hand, seniors may2317not go to a Web site to look at the information. So, I think2318there are arguments on both sides. I would welcome the2319opportunity to work with you on reforming.23202321    Senator Banks. Thank you. I yield back.23222323    The Chairman. Senator Banks, thank you.23242325    Senator Alsobrooks.23262327    Senator Alsobrooks. Thank you so much, Mr. Chairman. Good2328morning, Dr. Makary.23292330    Dr. Makary. Good morning.23312332    Senator Alsobrooks. Good to see you here. I'm going to just2333feed off of something my colleague just mentioned, some words2334that I think are significant. He said the medical establishment2335is condescending to the American people. And I'd like to offer2336that, unfortunately because this Administration has been so2337reckless in the way that it has handled civil servants, I2338believe they've been very condescending to many of them as2339well. And they are for the most part, many of them are my2340constituents, who work in institutions like John Hopkins and2341who are serving the people. And many of the actions of this2342Administration have been quite chaotic and confusing.23432344    I want to just draw you to a few things. The committee2345staff raised last week, a memo that was put out by OPM, and2346this memo directed agencies to dramatically reduce staff and2347then they reversed themselves and I'm not sure whether you've2348seen the latest guidance from OPM this week, which backtracked2349that directive to fire employees, instead said they clarified2350by saying that decisions to fire should be left to individual2351agencies.23522353    I'd like to just ask you, given this updated guidance,2354whether we have your assurance here today at this hearing, that2355you will not arbitrarily fire employees at FDA, given the new2356guidance.23572358    Dr. Makary. First of all, Senator, good to see you and I2359enjoyed our conversation. And I'm very proud to work at Johns2360Hopkins in the State of Maryland. And I'm a big believer in the2361professional career staff at the FDA, which is also located by2362and large, most of the employees are in Maryland. And so, you2363have my promise that if confirmed, I will do my own independent2364assessment on personnel.23652366    I welcome input on efficiencies at the agency, at the same2367time, I want to make sure that the scientists and food2368inspectors and staff central to the core mission of the agency,2369have all the resources they need to do their job well.23702371    Senator Alsobrooks. Thank you. And as you mentioned, there2372are so many valuable members. FDA does a tremendous service for2373our Country. They handle, for example, drug safety. When we2374think about reviewing medical devices, and you mentioned infant2375formula, where the men and women who are designated as the2376people who would make sure that those items are safe, are the2377ones who've been terminated.23782379    I would like to know whether you would commit then to2380rescinding the termination of scientists who were working, for2381example, to address the bird flu?23822383    Dr. Makary. Senator, I was not involved in any of those2384personnel decisions, but if confirmed, I will certainly do an2385assessment.23862387    Senator Alsobrooks. Okay. You'll go back and look at those2388terminations?23892390    Dr. Makary. Happy to Senator.23912392    Senator Alsobrooks. Okay. Thank you. As well as the2393termination of the individuals and FDA's food division, the2394people who keep our food safe. And so, you would commit then to2395going back and looking at those terminations to make an2396independent assessment?23972398    Dr. Makary. Of course, happy to.23992400    Senator Alsobrooks. Okay. And in the same vein, I wonder2401whether you realize that many of FDA's salaries, you may2402already know this, are paid in large, not by taxpayers, but by2403user fees. Are you familiar with that?24042405    Dr. Makary. Yes, I am Senator.24062407    Senator Alsobrooks. The concept that the reason to2408terminate these employees is to save taxpayer dollars is one2409that's based on a premise that is largely not true. Since we2410use the user fees for many of the salaries, and that being the2411case, I wonder whether you would commit them to rehiring their2412100 employees who were fired from FDA's Tobacco Center, which2413is 100 percent funded by user fees. Will you commit to going2414back and looking to rehire the 100 who were terminated?24152416    Dr. Makary. Senator, if an employee has not logged onto2417their VPN in 2 years, then I don't want to rehire that2418individual. But if there are people that deserve a look, of2419course, I'm happy to look at that.24202421    Senator Alsobrooks. Right? We're talking about, again,2422there's a big lie out there that says, these civil servants are2423lazy, they are shiftless, they don't show up. That is by and2424large, not true. So, asking you if you would go back and look2425at the ones who have been summarily terminated without cause,2426and your answer to that has been, yes, you will go back and2427make your own independent assessment.24282429    Dr. Makary. I will do an assessment if confirmed, Senator.2430Thank you.24312432    Senator Alsobrooks. Okay. Thank you. And finally on2433Tuesday, DOGE made the GSA release a list of over 4002434government buildings that they want to dispose of. And many of2435these are in White Oak Campus, which is in Maryland. One of2436them is in a building called Building Number One. And I wonder2437whether you're familiar with building Number One?24382439    Dr. Makary. I'm not familiar with the numbering of the2440building, Senator. I'm sorry.24412442    Senator Alsobrooks. Well, that's where your office would2443be. And that's one of the buildings that the DOGE has put on2444the list to close shutter and close up. And so, again, just2445pointing out that many of these decisions are arbitrary, that2446they harm the work that we do and harm the American people. And2447just wanted to ask you if you would be committed to making2448decisions that make sense and that do not eliminate the FDA.24492450    Dr. Makary. I believe in common sense and trusted science.2451And if confirmed, you have my commitment to do an assessment of2452personnel, to look at efficiencies. I welcome the input of any2453organization, of any individual Member of Congress, from the2454Administration, and the DOGE team as well, to figure out how2455the government can be more efficient.24562457    Senator Alsobrooks. Thank you so much, doctor.24582459    Dr. Makary. Thank you, Senator.24602461    The Chairman. Thank you, Dr. Makary.24622463    I'd like to submit for the record a Washington Post article2464referenced by a HELP Committee witness, an abortion survivor,2465Melissa Ohden, regarding a woman who took mifepristone twice,2466including once obtaining it online and taken outside the FDA's246710-week indication window. She still delivered her baby. While2468FDA has conducted safety studies on the product, I'm not aware2469that they've studied any safety outcomes related to a child who2470might still be born.24712472    As a physician, sending women abortion pills without a2473complete evaluation of the gestation of her pregnancy or2474checking for an ectopic pregnancy is clearly a safety issue.2475And that's why I would urge Dr. Makary to return the REMS2476policy in place during the first Trump administration,2477requiring an in-person visit.24782479    [The following information can be found on page 38 in2480Additional Material:]24812482    The Chairman. With that, this concludes our hearing. And2483I'll just say that I know your family's incredibly proud of2484you, and I just thank them for being here as well. Believe me,2485you're on for a ride. So, thank you for volunteering. For any2486Senators who wish to ask additional questions, questions for2487the record will be due tomorrow at 5 p.m. This concludes the2488hearing.24892490                          ADDITIONAL MATERIAL2491[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT24922493    [Whereupon, at 11:47 a.m., the hearing was adjourned.]24942495