The Senate Committee on Health, Education, Labor, and Pensions will please come to order. I think at least one person wants to make a statement regarding this. What we'll do is after we go through this, we will have statements afterwards. I appreciate Mr. Sandlin for appearing before the committee last week. If confirmed, as Deputy Secretary of Labor, Mr. Sondolin will play a crucial role in enacting President Trump's pro worker agenda, empowering workers and creating economic growth worldwide nationwide. His expertise and experience implementing labor policy makes him more than qualified.
Mr. Sandolin committed to support independent workers, allowing them to earn a living and provide for their families in the manner they choose. He was instrumental in creating the independent contractor standard in the first Trump administration, and I hope that the Department of Labor will return to this pro worker policy. He also committed to clarify DOL regulations so workers are protected and employers have legal clarity on what does and does not violate federal labor law. Alongside Secretary designate Chavez de Remer, Mr. Sandolin is ready to work with this Committee to implement a pro American agenda that
secures a better future for all workers. I proudly support his nomination and urge my colleagues to do the same. And with that, I recognize Senator Sanders for his opening statement. Thank you very much, mister chairman, for a wide variety of reasons. I'm strongly opposed, to, president Trump's deputy secretary of labor nominee, Keith Sondling. But more importantly than my views on mister Sondling is the reality that it really doesn't matter who becomes deputy labor secretary. In a few moments,
we will be hearing from president Trump's nominee to be the next commissioner of the Food and Drug Administration, doctor Marty Makary. Truthfully, and all due respect to doctor Makary, it does not matter who the next FDA commissioner is. I think everybody on this committee and the people of America understand who is running the government. And it's not gonna be the secretary of labor. It's not gonna be the secretary of the food and drug administration. With all due respect to president Trump's nominees, the people who the person who is running the government right now is Elon Musk.
Mister Musk has taken it upon himself with the support of president Trump to virtually dismantle the United States government. Yesterday, shockingly, and as a former chairman of the Veterans Committee, I it is outrageous beyond belief. Veterans put their lives on the line to defend our country. Yesterday, we heard that 80,000 employees at the VA are gonna be terminated. Virtually all Americans understand how important Social Security is to the well-being of our seniors. Yesterday,
we learned that they're on the way to get rid of half of Social Security employees at a time when Social Security is now grossly understaffed. Mister Musk has ordered HHS, the Department of Labor, and the Department of Education to fire employees, hand over confidential and sensitive data, and defy judicial orders. Mister chairman, if we are serious about exercising our constitutional responsibilities, which I hope all of us are, it is critical for our committee to hear from the person who is in fact
in charge of the federal government. Yesterday, it was reported that mister Musk met with Republican senators at a private meeting for ninety minutes and plan to do the same with Republican members of the house. That's fine. Washington Post reported mister Moss gave his cell phone number out to Republican senators and promised to improve communications with congressional Republicans. That's fine. But you know what? My constituents in Vermont and constituents all over this country wanna know what the hell is going on with the federal government right now.
And it's not gonna be the assistant the secretary of labor who is going to tell them. So if we are serious, mister chairman, about our oversight responsibilities, we must find out what's going on in the federal government, and the way we do that is bringing mister Musk before this committee. Therefore, mister chairman, I would like to make a motion. I move that pursuant to its authority on the rules twenty five and twenty six of the standing rules of the senate and rule 17 of the rules of procedure of the United States senate senate committee on health, education, labor,
and pensions hereby authorizes an investigation into the actions of The United States Doge Services at agencies within the committee's jurisdiction and pursuant to the same authority, authorizes the chairman to subpoena mister Elon Musk for testimony regarding those actions. I ask for the ayes and nays. We're proceeding with the vote included on the published agenda for this executive session. Unrelated motions will not disrupt the vote that was properly noticed to the committee. Mister chairman, I move to overturn the ruling of the chair that this motion is out of
order. I ask for the ayes and nays. We don't, that is, I'm sorry? We are staying with the published agenda. I will ask the chair, the ranking member, if he wishes to have something included on the published agenda, then bring it beforehand. But we are staying with the published agenda. The clerk will call the roll. Mr. Chair? Yes, sir. Mr. Chairman, the clerk will call the roll. On on on Sonderlin. The clerk will call the roll on Sonderlin. I'm sorry. Senator Paul? Hi. Senator Collins?
So he didn't let you No. He didn't Senator Murkowski? Senator Mullin? Senator Marshall. Senator Scott. Senator Hawley. Senator Tupperville. Senator Banks. Senator Houston. Senator Moody? Aye. Senator Sanders? Nope. Senator Murray? No. Senator Baldwin? No. Senator Murphy? Senator Kane, senator Hasson, senator Hickenlooper, senator Markey, senator Kim, senator Blunt Rochester, senator Alsobrooks, chairman Cassidy. I have 12 ayes, 11 nays. Mister chairman, I have a privilege motion. Yes, sir. I move to adjourn. And I I promised mister Cain the the senator Cain that he could testify.
So can we hold on that? But I think we're through with the business. If if people wish to leave now, they can. I second the motion, actually, to adjourn. Wait. Sir? Yeah. Are you on it? Yeah. So This is to colleagues. The vote is over. But I just want to share a concern, and I'm going to ask my brain, Rebecca Howard, to hand out a QFR answer that Mr. Sonderling provided to the committee. I voted for the labor secretary. I voted yes for the labor secretary. Some of you were here when I asked Mr. Sonderling some questions. He is currently at the agency.
He is the acting chief assistant to the acting Secretary of Labor. So he's been there since January 20. And I asked him the question, how many people have you laid off in the Department of Labor, and how many of those are veterans? Obviously, he didn't know off the top because he hadn't prepped for that question. But I asked who knows that, and he told me the department within the Department of Labor that that knows the human resources questions, and he is in the acting secretary's office. He clearly has interaction with that office. So I asked him the QFR,
which is being distributed to you. Again, he didn't know it's sitting here before me because he hadn't prepared, but I asked a very simple question. How many Department of Labor employees have been fired, furloughed, or placed on administrative leave since 01/20/2025? How many of those were veterans of the United States military? Now this is a question that is within his purview in his current position, and he was prepped for it by me asking him. And then I gave him a QFR, and there is an easy answer to that question, and he knows the answer to the question. He knows the people who will give him the answer to the question.
But his answer to me was a very clear stiff arm of a committee request. The Department of Labor's Office of Assistant Secretary for Management is responsible for all human resource decisions at the department. I have full faith and confidence that the staff in this office is complying with all applicable laws while reviewing executive orders and OPM guidance. He would not answer the question even though this information is within his purview. Now I think it's unacceptable that on a basic simple question like this,
somebody who is here for a nomination will not answer a question tendered by the committee, number one. Number two, I believe he knows the answer to the question, but does not wanna give the committee the information because he's embarrassed about what it would suggest. And the last thing I'll say is why would he be embarrassed about it? His testimony said very plainly that he cares about workforce protections for all employees. And I asked if that included the employees of the Department of Labor, and he said it did. I asked if it included veterans who are working for the federal government.
He said that it did. I think what the answer to this question would show is what public reporting has showed is that veterans are the group that is most disproportionately harmed by the Trump firings, furloughs, and terminations thus far. 30% of the federal workforce is veteran. Thirty percent. It's about 3% of the civilian workforce. In addition to the fact that 30% of the federal workforce is veteran, there has been a decision to lay off probationary employees because probationary employees can't fight back.
Probationary employees are disproportionately veterans because remember, probation isn't you did something wrong, probation is you're new. And new employees in the federal government tend to be young people or career switchers. Every veteran who works for five or ten or twenty five years and then gets a job in the federal government, no matter how valuable their military service. And we've got Virginians with multiple deployments and purple hearts and all kinds of wards. But then when they come into federal civilian service, they're probationary. And so this effort that the Trump administration has undertaken to willy nilly lay folks
off and focus on probationers has hit veterans harder than anyone else. The New York Times has estimated what they can. You know, questions like this don't get answered by folks with the administration, but that Donald Trump has fired at least 6,000 veterans so far, and he's not done. He has fired more veterans than any president in the history of The United States in six weeks, and he's not done. And it's just not acceptable. If I had asked this question of somebody who wasn't at the agency, they would say, I haven't been confirmed. I'm not at the agency yet. I can't give you an answer to the question. I voted for the secretary of labor nominee,
and I was at least open to this nominee when he came before us. But when he has information in his purview about something that not only I care about, but that I think other members would care about, And he refuses to provide it, suggesting, a, that he's stiff arming me and the committee, and, b, that he's probably embarrassed about what the numbers would show. That's the reason I oppose them. And again, the vote is done, but I I would hope that this question of being able to get information on basic factual questions and also caring about the veterans who disproportionately
populate the federal workforce, I would hope that that would be common. Mister chairman? Mister Paul? I make a motion we adjourn. Thank you, Doctor. Macari, for appearing before the committee. The Food and Drug Administration is tasked with overseeing everything from drugs that treat debilitating diseases to safeguards in The U. S. Food supply. While FDA has become a gold standard around the world in safeguarding public health, the agency faces significant challenges. The bureaucracy has led to delays in approving new medicines and devices, restricting patients' access to innovative treatments that can be lifesaving.
As the Trump Administration looks to cut red tape across the federal government, the agency should look at innovative ways to address bottlenecks in the review process. This could include using artificial intelligence and other technologies to improve efficiency and accelerate drug discovery, while ensuring these products are safe for Americans. Another topic of interest is food safety. Americans deserve to know that the food they buy for their families is safe to eat. One place to start should be examining FDA's review process to ensure the safety of ingredients that go into foods.
I know Doctor. McCary is passionate about this issue. I look forward to working with him if he is confirmed. The American people's trust in our public health and science agencies and the products they regulate must be restored. Rebuilding public confidence in medical products like vaccines is especially important as we respond to measles outbreaks and as FDA considers recommendations for vaccines for flu strains ahead of the upcoming flu season. Doctor. MacKari, with his experience as a surgeon and an effective health policy communicator, can help our public health agencies rebuild trust with the American people.
Thank you for appearing before the committee and discussing your vision on how to make America healthy again. Senator Sanders is not here, so Doctor. MacKari, we'll go, to you for your opening statement. Great. Thank you, Senator, Doctor. Cassidy, and, ranking member Sanders, and members of the committee. I'm humbled to be before, you here. I'd like to thank President Trump for his confidence in nominating me to lead the Food and Drug Administration. I'm joined today by my wife, Jessica, my sister, Maria, my brother, Mark, Nora,
Jacoby, Alexander Jacoby, and, my very sacrificial mother and my career role model, my father. My father dedicated his life to the care of children with leukemia, lymphoma, hemophilia, sickle cell disease and then turned his attention to adult hematology. His father, my grandfather, was a pharmacist in a poor Egyptian community and believed in treating everybody equally, especially the most vulnerable among them, a philosophy I've tried to emulate in my career and research.
Even from the African continent, my grandfather looked to the US FDA for trusted guidance. That's because the FDA has a long history of using gold standard science to uphold public safety and help us as clinicians take care of patients when they come to us for help. As a kid, I vividly remember being in the grocery store in our small town with my dad when somebody would stop him, break out in tears and give him a long hug after what I would learn to be a decades long battle with lymphoma.
It happened a few times, and each time it inspired me even more. For twenty two years now, I've had the privilege to walk into the Johns Hopkins Hospital to live out that mission. And each morning as I enter the front door, I pause and look at the nine foot statue of Jesus that stands in the center of the hospital lobby, and I read the sacred text engraved at the base. Come to me all ye who are heavy laden and I will give you rest. I'm grateful to Johns Hopkins for allowing me to have a creative career,
a dual career as both a surgical oncologist and a healthcare public policy researcher. In addition to using FDA approved devices and medications, my research, which has now spanned over 300 scientific peer reviewed articles in the medical literature, has focused on what's actually making a difference in helping people and how healthcare has become too fragmented, too cold and too corporate. My research and subsequent book on price gouging and predatory billing in healthcare turned into
advocacy to demand more transparency in healthcare. President Trump heard the plea and invited me to the White House in his first administration to enact the nation's first executive order to bring down hospital and drug prices through greater transparency. The reform was entirely bipartisan, just as President Trump and Secretary Kennedy's call to make America healthy again by finally addressing the root causes of our child chronic disease epidemic, a message that's resonated with moms across the country regardless of their politics.
A smarter FDA that works for all Americans should be a goal we can all agree on. As a scientist who has spent a career evaluating medical interventions, scientific process. In addition, I also believe that we can use common sense. Doctor. Cassidy, as I have been in the Operating Room, as you would relate as a respected hematologist, it's hard to perform a long sophisticated operation for liver cancer and not ask why our rates of liver cancer tripled in The United States.
We now have a generational opportunity in American healthcare. President Trump and Secretary Kennedy's focus on healthy foods has galvanized a grassroots movement in America. Childhood Obesity is not a willpower problem, and the rise of early onset Alzheimer's is not a genetic cause. We should be and we will be addressing food as it impacts our health. Thanks to the courage of President Trump and Secretary Kennedy, we now have a generational opportunity to usher in radical transparency to facilitate more cures,
meaningful treatments and diagnostics at the FDA to help people take care of their own health. My father told me to write down my observations and my experiences in health care and the research I delved into. Much of the research I did focused on the fundamental question, is what we are doing working? I wrote books to educate the public on medical science and to empower them to live healthier lives. If confirmed, I hope to ensure the FDA holds to the gold standard of trusted science,
transparency, and common sense to rebuild public trust and make America healthy again. Thank you, Mr. Chairman. Thank you, Doctor. Magari. I'll start with questions. In 2021, a few months after President Biden took office, FDA announced it would no longer enforce the in person dispensing requirement for methylpredstone, the drug which obviously is in abortive fashion. Now this is concerning to me. There is a case out of Louisiana which is incredibly egregious in which there was no recognition that the person requesting the drug was not the patient,
but rather someone who was going to, allegedly coerce the person into taking the medication, which would have been evident to a physician should she or he have seen the patient. So, if confirmed, would you reinstate the in person dispensing requirement as well as reporting requirements for adverse events and other complications associated with the drug? Thank you, Senator. And to hear of someone being coerced to take mifepristone is deeply disturbing, and I might even suggest criminal. I have no preconceived plans
on mifepristone policy except to take a solid hard look at the data and to meet with the professional career scientists who have reviewed the data at the FDA and to build an expert coalition to review the ongoing data which is required to be collected as a part of the REMS program, the risk evaluation and mitigation strategy. It is pursuant to the REMS. And so, if we're going to collect data, I believe we should look at it. Last week, the FDA announced it would cancel its annual Vaccines and Related Biologic Products Advisory Committee,
which meets to select anticipated virus strains for next year's flu vaccines. Now, I'm told by people who are familiar that the FDA will make the recommendation and that they will come up with the right decision. But they also say what is lost is the transparency because the open meeting allows a post mortem, if you will, as we say in medicine, a review of last Jira. What went right? What went right? What went wrong and how to make it better? I think one of the laudable things about secretary Kennedy's, positions is he wants more transparency in terms of how the federal government makes medical
decisions as part of restoring that faith. And so frankly, this seemed to kind of go kind of backwards on that. So how will you ensure that advisory committees remain objective, transparent, and still benefiting from the necessary expertise of external experts? Senator, thank you for the question, and I was not involved in that decision. Certainly, we've confirmed once in office. You have my commitment to take a look at it. As you know, that VRBPAC committee, takes a look at guidance and recommendations from international groups,
such as the GIP International Consortium. My understanding is, at least for the last seven or eight years that I've been following that group, we have simply rubber stamped whatever the international GIP Can I stop you for a second? My understanding though since these strains typically begin like in Australia or China, it isn't so much as a rubber stamp but as much as recognizing what are you seeing because that's what's coming to us. So so so just a I think it's more than quibbling to say that that
you're you're learning from them. Your thoughts? Yeah. So, the the American public deserves confidence that scientists are looking at that data from the Southern Hemisphere. It's all reported into a, registry, all the dominant strains, and then picking the most dominant strains that are lighting up in that registry is that process of pick of of really trying to estimate which strain is going to be dominant in The United States. It's not very precise. Some years we don't get it very well, but it's the best we can do with the data we have available at the time. So, the group,
for example, the international GIP group chose to no longer include the influenza B strains a couple of years ago, sounded like a very reasonable decision and Virpac also went along with that recommendation. But I think we're aligned in in that the American public want to have some confidence that, independent scientists are looking at these data. And going back to the transparency, again, it seems what's lost with the open meeting is the transparency. So how is you, FDA how how can you, as FDA commissioner, advocate for that transparency?
Because we want the American people to know. And, obviously, canceling the meeting will kind of shut that door a little bit. Yeah. So, Senator, I was not involved in that decision, but I I accept that. And and again, but but you're ma'am, we're voting for you. So how are you gonna make it happen? I guess that's my question. So I you have my commitment to review, what the committees are doing, how they're being used. As you know, I was, critical when that committee was not convened at all during one of the COVID booster, guidance of decisions by the FDA.
And the FDA career and leadership at the time argued that their advisory and we don't have to convene them, that was repeatedly, throughout the Biden administration. And there may be some value if there's a step that where the efficiencies can be made. But I think with something that's important, something that's critical, something where we want expert opinion, it not only provides some of that wisdom, but it also increases the perception of confidence from the general public, which is Senator Murray. Thank you very much. Thank you for being here today.
Let me follow-up on that. Because last week, I sent you a letter along with some of my colleagues asking you about the FDA's cancellation of that vaccine advisory committee meeting. For everybody's information, this is a meeting that takes place annually for at least thirty years to make recommendations on which influenza strains should be included in the flu vaccines for the upcoming flu season. And for the first time in decades, FDA canceled that meeting with no explanation given, no new date chosen. That is, I believe,
unprecedented and dangerous. And you just referred to it, Doctor. McCary. In 2022, you raised concerns when the FDA was considering not holding a vaccine committee meeting to authorize COVID-nineteen boosters for kids 12 to 15. And at the time, you said it was, quote, unconscionable and undermined the integrity of the FDA standard process to not hold that committee meeting. So if you are confirmed, will you commit to immediately reschedule that FDA vaccine advisory committee meeting to get the
expert views? We need to know those so we can have, the correct vaccine for the upcoming flu season. Thank you, Senator, for the question. And I appreciated our time together, in in meeting ahead of this, hearing. I was not involved in that decision. And what I I would say is you will immediately reconvene it. I will I will immediately reevaluate which, sessions, the leadership of that center, which decisions, which topics, could benefit from So, what we're looking into a reevaluation. This is done every year so we know what flu vaccine to have.
What, what were you, what are you reevaluating? First of all, for the last seven or eight years that I've been following it, they simply adopt verbatim the recommendation of the international GIP group. But I'm not, I was not involved in that decision. I will say that there in my opinion was a huge difference between requiring every 12 year old girl in America to take an eighth COVID booster shot versus rubber stamping a recommendation from the international GIP group, which has done seven out of the last seven years. I I I'm not saying,
that the decision is something I was aware of or involved in, but it's certainly something I will look at if confirmed. Okay. I'm very unclear because the FDA is the gold standard for all of us. And this committee hearing is what has always been what we look to, the FDA look to, the American people look to, to determine what the flu vaccine is. What are you going to look at to make a determination and figure something else out now decades into this? What are you relooking at? Senator, I was not involved in that decision.
I assume you would say, Yes, I will reconfirm it immediately so we can let our public health experts and doctors know what flu to have next fall. As I understand it, the committee members and the scientists at the FDA, the career professional scientists at the FDA, look at the recommendation of the international GFP group, and they say, okay You just told me that you were gonna reevaluate it, and I wanna know what you are reevaluating it on. What are you looking at to make a decision whether to reconvene it? In conjunction with the center director of the biologic center,
I would reevaluate which topics deserve a convening of the advisory committee members on VRBPAC and which may not require a convening. Obviously What would we base your decision on? Well, you can ask the Biden administration that chose not to convene the committee meeting for the COVID vaccine booster. I get that. I understand. But I'm asking you, well, how will we know what flu to take next year vaccine if this committee doesn't reconvene and make their recommendation? Senator, I was not involved in that decision not to convene that group.
I think I thought you'd say, yes, we're going to reconvene. Knows what's coming. Let me just ask you really quick, also following up on a question on, mifepristone, because FDA does play a really critical role in making sure we have safe and effective medications. Contraception and medication abortion have been approved by the FDA for many, many decades based on mountains of high quality evidence and expert scientific judgment. So if you are confirmed, will you commit to upholding the science and evidence based drug approvals for all FDA
approved products, including contraception and medication abortion? Thank you for the question, senator Murray. You have my commitment to come, to, follow the independent scientific review process at the FDA, which is a tried and true process, and that has been around. And so that is my commitment to you, Senator. Okay. Well, I wanna be clear. There have been over a hundred high quality studies over more than two decades backing up the science and safety of mifepristone. Thank you, mister chair. Senator Paul. Congratulations, Doctor. Makary, on your nomination. And, I think one of the most important things we need in government are people who
are open minded. I think closed mindedness, the idea that this is settled and no one will ever if you see data as the FDA and you have to make a decision, are you willing to lead where the data and the facts take you as opposed to your preconceptions? Absolutely, Senator Paul. I think it is part of being a scientist. We need more humility in the medical establishment. You have to be willing to evolve your position as new data comes in. The, people who aren't involved in science think that, you know, they're they're settled science and this is,
you know, it's just all settled. We're just should just all be quiet and submit to whatever settled science is. But you mentioned to me on the way in that yesterday you removed the gallbladder through the laparoscope. I was in medical school and, surgical training, you know, about the time where everybody made a four or five inch V incision to take the gallbladder out and, the older surgeons, the consensus, they ran the surgery departments, they were like, it's, it's malpractice to use these tiny incisions and below the air into the abdomen and do all this,
but it took an overcoming of the consensus. Do you do you remember some of that? It might have been a little after your time, but you remember some of the trans on the larger incision, the small incision, and the resistance of the consensus? Oh, yes, senator. I I can tell you some of the surgeons who trained me said things like big surgeons use big incisions and the bigger the incision, the better. And, you know, without having a big open incision, you can't really see what you're doing. And I would point out that a laparoscope gives you 10 times the magnification, but there's a lot of medical dogma that has contaminated our field,
and I think it's tied to a lack of humility. Ultimately, what makes a great doctor, in my opinion, as I teach my residents, is not how much you know, it's your humility and your willingness to learn as you go from patients. I think some people here also are, not duly impressed enough by what it takes to do the kind of surgery that you do. Now I'm an ophthalmologist, and I do eye surgery, and we do really tiny incisions. But our surgery lasts between five and twenty minutes a lot of times to take the cataract. How long does it take to do you've done whipples, I imagine, which is a surgery on the liver.
How long does a whipple surgery take? What's that? I thought you did Whipples too. So Whipples yeah. I've I've I've done a lot of Whipple operations and islet transplant procedures and then, pioneered a new type of procedure, which is a laparoscopic pancreas islet transplant rotation with hopes that it can someday be used to cure diabetes. It was about eight hours for that operation when we started. We've gotten it down to about four or five hours and we've done some laparoscopic whipples in three hours. With regard to the vaccine committees and they talk about whether they meet or they
don't meet and things, and, there have been, some questions and one of the questions that I've been bringing forward is whether or not there could be a conflict of interest. And one of the things I've asked and you would think it would be universally accepted by everyone without question is you should have to reveal if you get royalties from drug companies. So if you're making a decision on a Pfizer vaccine or a Moderna vaccine, I would think the least of the transparency should be you reveal, you know, if you get royalties from those companies. Do you think we need to evaluate the people on the committees or see whether
they get royalties or see whether or not there are conflict of interest for the people making these decisions? Yes. I do, senator. We need to review the ethics policy because people see things that appear to be a cozy relationship between industry and the regulators that are supposed to be regulating the products. Now I want American companies to thrive. I want life sciences companies to thrive, but we need to call balls and strikes and to keep that independent scientific review process free of any conflicts. So I do think it deserves a look.
And really, I think it would be an area that a lot of people once again think there's a consensus either take all the back COVID vaccines or not. Most of Europe doesn't recommend a COVID vaccine for 12. Almost all the countries don't recommend it for 12, some 18. And it's because they've looked at the risk benefit for for children of the vaccine and some of the possible complications of it. And, it's different, frankly, for older people. And it's like, these are things that we should at least discuss and evaluate Some of the most pro vaccine people when the,
policy came out to give boosters to your six month old said they wouldn't even give it to their 24 year old a booster. You know, remember one of the famous committee members. Two committee members left the vaccine committee because the CDC under Biden politicized the process and overrode the vaccine committee. So to insinuate that somehow there's some brand new thing going on, these are long standing, controversies. And I think that the main thing I'll go back to is in the beginning, we need open mindedness. And I appreciate your willingness to look at the facts,
the data, and not be, overwhelmed by preconceptions. Thank you, Senator. Senator Boland. Thank you, Mr. Chairman. I want to go over a couple of topics that have already been raised and, if we have time, explore one that has not yet. But I want to understand your position on mifepristone because we had an opportunity to speak in my office. And, I thought that you were pretty clear with me during that meeting that you, were aware of the overwhelming scientific conclusion about the safety of this medication and that
you did not think politics should be involved in decisions moving forward. And I understood from our conversation that you intended to stand behind the FDA's longstanding determination. But after our meeting, I don't know if it was you or your minders, but they followed up with my staff and said they felt that you misunderstood my question and wanted to clarify your answer, which by my read implied that you are open to totally reexamining the scientific determination
even with decades of evidence. So I wanna clearly understand your position. As FDA commissioner, will you maintain current access to mifepristone? Yes or no? Senator, I'll be very clear about my position. My position is that of a scientist. As you know, part of the REMS, the risk evaluation mitigation strategy, that was put in, initially by President Clinton in that administration and then modified under, Obama and then again under President Biden, requires ongoing data collection.
So I can't prejudge that data without looking at it. So you're gonna you said something about convening an ongoing panel? I didn't I did not mention To a a previous question was asked. I did not mention a panel. I said I would convene the scientists. They're professional career scientists at the FDA who have reviewed the totality of data on this and are also looking at ongoing data that is being collected. There could be, for example, Senator, a drug drug interaction that may show up on the ongoing data.
So, I I wanna ask, if that's your approach to something that has been approved for now decades, are you gonna do the same with Tylenol? There are a lot of side effects, for daily use, including liver damage. Will you be doing that for Tylenol? As you as you may know, senator, Tylenol does not have a regulation requiring a REMS, a risk evaluation medication. Whether it does or not. I'm asking, are you going to do ongoing surveillance of, the possible side effects for that drug that was approved many years ago?
How about asthma inhalers that have been associated with osteoporosis, opportunistic, lung infections. Are you going to be doing that for those medications? Senator, I will be following the law, and the regulation requires an ongoing immune system. We're going to have a totally different approach to this. I want to get to the, again, a little bit more about what we're talking about with, the influenza vaccine and vaccines in general. As has been said, in this hearing, the advisory committee annual meeting was canceled for, selection of, what strain of of influenza our vaccines,
for this next season would, confront. There have been additional reports that Secretary Kennedy wants to make significant changes to another advisory committee that makes recommendation and provides advice to vaccines, for vaccines. And I worry that this is merely an employ a ploy to install vaccine skeptics on these critical panels. Our advisory committees must maintain scientific integrity and should not be changed for political purposes or to further an agenda.
So, Doctor. McCary, do you intend to remove experts from the vaccine and related biological products advisory committee? Senator, first of all, I'm not familiar with what you're referring to regarding Secretary Kennedy. Secretary Kennedy wants to make America healthy again. With regard to the vaccine VERPAC committee deciding on which flu strain to identify. I was not involved in that decision. But again, just as a reminder I am planning, if confirmed, to remove any experts from the Vaccine and Related Biological Products Advisory Committee?
I have no preconceived plans to rearrange that committee or any committee, I will say, on influenza. Do you commit to maintaining scientific integrity on advisory committees and receiving regular outside expertise, if confirmed? Of course. Okay. Senator sorry. Senator Collins. Thank you, mister chairman. First of all, doctor, I appreciate your willingness to serve and was impressed as a result of our conversation in my office.
Let me ask you you've had a lot of questions about the Vaccine Advisory Committee. Let me just ask you a simple straightforward question, and that is, if you are confirmed, will you reinstate meetings of the committee? The the VRBPAC committee will be meeting if confirmed, and I'm commissioner. Yes. Thank you. In February, we learned that hundreds of probationary employees at FDA were dismissed. And this really concerns me because we need a flow of young new scientists and
researchers, especially since we're seeing retirements and resignations. And ironically, more than half of the FDA employees are funded under various industry user fee agreements. So there is revenue coming into the FDA to pay for these employees. If confirmed, will you, not an outside force, but you, have full authority over FDA staffing decisions?
Senator, I if confirmed as commissioner, you have my commitment that I will do an assessment of the staffing and personnel, at the agency. I have not been involved in any of the decisions, regarding any of the personnel changes, recently. But if confirmed, you have my commitment that I will do an assessment. I just wanna make sure that you're the one doing that assessment. I'm not saying that the staffing level is perfect, and I think it's helpful for a new commissioner to do an assessment, but I want that person to do it.
And it sounds like you are committing to that. Is that correct? I will do an assessment. I commit to that. Yes, senator. One of the best ways to lower the cost of prescription drugs is by promoting more market competition. And one way that we can do this is by making it easier for generic and biosimilar drugs to come to the market. As part of a broader bill that senator Shaheen and I have introduced to help
lower the cost of insulin, we've included a provision to create a new competitive biosimilar pathway and therapy designation at FDA, under which eligible products for which there is inadequate biosimilar competition now could achieve expedited review. I worked with the FDA in the last congress to develop this provision, and I look forward to continuing to push this concept to so that it becomes
law. Do you support the concept of a new expedited pathway for biosimilars to compete, for example, with branded insulin? First of all, senator, you've taken a strong interest in the FDA, and I very much appreciate it. And I really enjoyed our time together. I've learned from you and thank you for your leadership on the diabetes caucus. It's something, of course, very close to my area of medicine. I am a big believer that we need to, figure out a way to get biosimilars,
approved quicker without cutting corners on the scientific review. And it is one of several strategies that the FDA can do to try to alleviate the problems of high drug prices, inadequate competition or underperformance of competition and the drug shortage in The United States. Also, other strategies could include, the way we look at generic drugs, moving medications to over the counter. Does naloxone really need to be a prescription only medication?
Does an EpiPen need to be prescription only? If they can be over the counter and we can feel confident about public safety when, with those products on the shelf at a pharmacy, it would force the companies to put a price on the shelf. And I do believe in price transparency. It will have an effect on the entire marketplace. So thank you, senator. Thank you. And let me just end by saying that I am delighted with your interest in Iloat sell, therapy for individuals with type one. There are clinical trials underway,
and I think that is such an exciting development. Thank you, mister chairman. Thank you, Senator Collins. And now, Senator Hassan. Thank you, mister chair. And, good morning, doctor, and congratulations to you and your family on your nomination. Good morning. Thank you, Senator. President Trump has promised to help lower costs, but prescription drug prices are once again skyrocketing for Granite Staters and all Americans. In 2025, drug makers have increased the list prices of over 500 common medications. Doctor. McCary, when we met,
you and I discussed the importance of increasing generic drug competition. If confirmed, will you work with me to speed the approval of generic drugs at FDA to lower drug costs for patients? Senator, first of all, I very much enjoyed our meeting together. The answer to your question is an emphatic yes. And I would add to that that I would love to work with congress to address the way that patent law has enabled patent thickening, which makes it more difficult for biosimilars and even some generics to come to market because they gotta navigate so many lawsuits and letter the patent law.
Well, and this is something, that, Senator Paul and I have actually been working on and we have something, a bill called the increasing transparency in generic drug applications act, which would allow the FDA to communicate more transparently with generic drug manufacturers in order to make more low cost prescription drugs available for patients. So, the bill would save taxpayers over a billion dollars and has bipartisan bicameral agreement. So I'm going to urge all my colleagues to look at it. I've enjoyed working with Senator Paul and his team on it. Doctor. McCarrie, you and I also,
discussed mifepristone when we met, a medication that has been used for decades in abortion care and miscarriage care. Now during our meeting, you mentioned you weren't familiar with the drug, and I followed up by providing you with decades of the safety data. And you said you're a data guy, you would review it. Have you reviewed the data? And do you agree that mifepristone is safe and effective? Thank you, senator, for sending me that homework to read. And I I did read those articles, including a, and what I was referring to when I said I'm not familiar with it is I have,
and I don't I don't believe I said I was not familiar with it. What I said was I have not reviewed the totality of the data. I am very familiar with mifepristone. And, I did review those studies including two surveys of patients, inquiring about, telemedicine, a 02/2018 National Academy of Medicine review. Right. I'm a member of the National Academy of Medicine, but was not involved in that particular review. Right. But I did review that document. So I shared with you that study, study from the National Academies, where scientists looked at, just so people know, over a hundred studies of medication abortion and found that the literature is clear that
mifepristone is safe and effective. And then, you know, also, we've had the discussion about the REMS process for mifepristone. In 2021, the FDA, looked again based on a citizen petition asking them to review the safety of mifepristone. And I think, you know, just so people get a sense, this is the report back from the FDA about their review and about their modification of the language in the REMS process. And their review, again, was that it is safe and effective. And I think what you're hearing from a lot of us as we ask you questions about this, just,
you know, so the public can understand, there's lots and lots of data here that supports the safety and efficacy of mithopristone and supports its efficacy in its current, under current law and its safety. So I think the concern you're hearing is not about whether you will follow an ongoing REMS process with any medication and look at the most current data. That's what the scientific process is about. The concern is whether you are going to unilaterally overrule the data that currently exists for political purposes and for political reasons.
And that's what we're looking for your reassurance on. You have told us you are an independent scientist. I believe that you have a very distinguished career as a physician. But we need to know that when you say you're an independent scientist, that's really what you mean. And then when the politics get heated around abortion, that you won't abandon that independence. Senator, you have my commitment that once I'm in office, I will do a review of, the data. I have no pre I have no preconceived plans to make changes to the mifepristone
policy, and I do plan to follow the law and the regulation of the REMS to look at ongoing data. It could be that there could be a drug drug interaction that we could identify and ongoing. I understand that. But what I am looking for is an understanding that the current state of science in the process that you have been a participant in throughout your entire career and that others up here have also participated in, that you will follow the science as it is currently developed and not unilaterally overrule scientists because you're under political pressure to do that?
Senator, if you look at my track record, I have never been afraid to speak my honest scientific opinion, and I have no preconceived plans to make changes on that medication. Well, I wish you were hedging a little bit less today. Thank you. Senator Murkowski. Thank you, mister chairman. And, I understand, that the senator from Alabama has, an engagement that she needs to get out to, so I'm going to defer my time to To Florida or Alabama. To flip it afterwards. Florida. Go Gators. But Katie Britt would want me to say roll tide. You'll lose your votes in Florida. But anyway, go ahead.
Thank you, senator Mikulski. I'm so grateful. Thank you. I'm I'm very grateful as the rookie to to be able to question before these senior senators. It's a big deal. So I'm grateful to all of you. Thank you so much. I'm so honored. I am so excited to see you here today. I was incredibly happy with this nomination. When confirmed, I know you're gonna do a great job. I have two issues I wanna cover, and and and they are relevant specifically to the meet the two main roles in my life over the last six years, one as a mother and one as attorney general of Florida. First,
I wanna talk to you about what is going on with the FDA and its bearing its head in the sand about illegal, chemically ridden, extraordinarily high amounts of nicotine, Chinese vapes that are flooding The United States market. In fact, two thirds of the export market from China for these vapes, two thirds of our market here are Chinese vapes coming out of China. So it's unbelievable. They are in flavors like strawberry blow pop, watermelon, sour berry, attracting children, addicting children. We have so many,
thousands and thousands and thousands of pending applications. Most of these things are illegal in The United States right now, but yet somehow China has decided to flood our market with illegal vapes, with The United States market of illegal vapes, and they are benefiting. In fact, in China, they banned flavored vapes. And so all of the manufacturers there of these chemically ridden vapes have now flooded our market and now are addicting our children, much like we're seeing this in in many other ways in harmful substance coming from
China, and they're not doing much about it, fentanyl, etcetera. So whoever comes in as the head of FDA, this is one of your problems you have to address immediately. I know there are a lot of things that you're gonna get questioned about, but these things are all over The United States in convenience stores. They're readily available to children. If you walked in any one right now, you would be able to find them. And and not only are the amounts of nicotine going up and up and up and up, the we don't know what is in these things. And there has been little to nothing done to deal with our pending applications at
the FDA or to enforce those that we know are illegal right now. How would you address this, and what do you plan to do on day one? Well, thank you, senator. I appreciate your passion on this, important issue, and I've appreciated your work as attorney general in Florida on this issue. Maybe it's because you both believe in doing the right thing and because you're a baseball mom that you're interested in this. I first heard about this on the bleachers at a baseball game. I I think there are four, new vaping stores that have popped up in my neighborhood all in the last few
years. I've, not walked into one of them, although perhaps I should to check it out. But, you are absolutely right that, we are being flooded with Chinese products. We have no idea what's in these products, and public health is not even gonna be able to study them, because it takes so long for public health research to catch up. But it's very concerning, and it's it's not right that their banned products are banned in China, and yet they're manufacturing them and sending them into The United States. So there are a few things the FDA can do to try to address this
problem. First of all, the office office of inspections and and and, investigations, has a lot of people with guns, and they do enforcement and raids. And we need, in collaboration with DOJ and other areas of law enforcement, to try to address this problem of illegal products on our market. There was an announcement during the last administration, and I won't get into much of they were gonna once people finally convince them this is out of control and people are getting addicted by the day, there was this big announcement about task force. We're gonna use all the tools available. That's great, and enforcement needs to be key.
Florida had to finally step up and do it ourselves because the federal government would do nothing. But the first key has to be, what do we do with our pending application? How do you clean up FDA's house first? You need to know what the law is before you can enforce it. Let's start there. Please focus on that, and then and then we'll also work with the enforcement measure. And I'd also like to just get a commitment from you as from the Florida, state of Florida, citrus growers, orange growers, that's a big deal to us. There's a regulation in there, an arbitrary regulation amount of sugar content. It needs to be examined with disease and and greening and all the things facing
the citrus industry. That arbitrary regulation, the the oranges aren't producing as much sugar. I can go into it. But while I have your commitment for them to look at that regulation? Things that are set sometimes we need to revisit on how it's affecting, industries across The United States. Will I have your commitment to look at that? Senator, I had my cold pressed freshly squeezed orange juice this morning, and you do have my commitment to look at that. Oh, our orange growers are gonna be so happy to hear that. I will tell them. Thank you so much. Thank you. That was a great murder board that told you to drink the Colts, the, the the orange juice. I'm saying that was really good.
Senator Kim. Thank you, chairman. Doctor, thanks for coming on out. You know, I was looking through your, opening statement. At the very end, you talked about FDA being the gold standard, and you said gold standard of transparency. And I was glad to hear that. I wanted to ask you, you know, in terms of transparency, do you think it's important that we can ensure that there's public comments on actions of agencies and departments, you know, overseeing important aspects of our lives? Senator, first of all, it was good to meet with you, and I enjoyed our conversation. I do believe in civil discourse and have been an advocate for civil discourse,
and coming out of an era of medical establishment censorship. So I do believe in the in the principle. Now there are laws and regulations around public comment periods. And so some in some situations, a public comment period is required by a regulation. I would just suggest here that, you know, this is really important as you know the public very concerned. You're talking about we've had a long conversation about how to restore trust, and I think a big part of that is about involving the public more. I think you saw some of that in terms of the questions regarding, VERPAC and just the need for that type of radical transparency as secretary Kennedy talks
about. Recently, there was an effort, addressing the Richardson waiver. I asked that you look into this if you're confirmed. But I I do think it's important that we maintain public comments, something that so far this HHS has, not abided by and something that's been long standing practice. Another aspect of this is about, transparency and accountability. So I guess I just want to ask you, you know, if we have the sense of nothing to hide, we wanna root out waste, fraud, corruption. Do you support the roles of inspector generals? Senator, I believe in the law and I believe in the process of having inspector generals.
Okay. Well, you know, if you are confirmed, I just urge you to do everything you can to ensure that HHS has an inspector general, has an ability for us to be able to oversee, the accountability and to be able to root out some of the problems that I hope both of us can agree upon. So I just wanna ask for your commitment on that front that you would push to try to have an inspector general there at HHS. Thank you, senator. When it comes to, ethics, you know, I heard you refer about, you know, just concerns you wanna have ethics review in term positions that people might be having, especially involving,
approval of drugs, other things. I guess I I want to just ask you a little bit more, on your boat on your end. It'll it looked like I I come across something that's saying that you were willing to divest from your own, investments that were being perceived potentially as a conflict of interest if you are confirmed in this job. Is that correct? Senator, as as you are aware, the Office of Government Ethics does a comprehensive review of basically everything I own, every stock, every equity, every share. I would describe it as a colonoscopy with a small bowel follow through. It took about four weeks,
and they gave me the option of resigning from some things or maintaining, a role. And and I chose voluntarily to divest and resign from everything. I'd have I applaud that, and I think that that should be the standard, especially for such important jobs. I guess I just wanted to ask you a little bit further here. Would you, would you agree to recuse yourself from matters involving your former clients and employers if that comes before you at the FDA? Senator, what I what I can promise you and commit to is to abide by all
the guidance of the office of government ethics. I understand that, but you just talked about how you voluntarily took steps to be able to divest. You know, that was not something you were required to do, though I do think you should have been. But I guess I just ask you again, would you consider recusing yourself? Because I mean, look, again, if you're making decisions about a previous client of yours, you can see how the general public would react to that in terms of concern about whether or not, you know, you are doing this for the best interest of the people or the best interest of people you know? Senator,
I have signed to agree to recusals as defined by the Office of Government Ethics in any area where they perceived a conflict could occur. And so I have already agreed to, the recusals required by the Office of Government Ethics. One last thing I just wanted to raise, and and this is just something, I I guess I just wanna ask. How are you what is your feeling about, these potential Medicaid cuts that are being reviewed right now in Congress? Senator, as you know, the FDA is not not involved in Medicaid or coverage decisions. I understand that.
I guess the reason I raise is that in your opening remarks, you know, you said I thought it was really powerful. You said that your motto in life has been about treating everyone in the community equally, especially the most vulnerable amongst them. So I I just urge you to just continue to press. You will have a seat at the table if you're confirmed on health care decisions across the administration. Medicaid is essential for the most vulnerable amongst us and treating everyone equally. Your drugs, it's not just about the approval. You'd want to see that get into the hands of Americans,
make sure that they can use and benefit from them. So I do think that you have an interest in preserving Medicaid. Thank you, senator. Senator Murkowski. Thank you, mister chairman. Doctor, welcome. It was, it was a good conversation that we had. I appreciated that. I thank you for the for the encouragement to read that, that provision in your book. So airplane reading for me. Thanks, senator. Sir. I I also want to thank you for the assurance that you gave to senator Collins regarding, the vaccine advisory committee and ensuring that there would be meetings going forward. I think, for for several of us who had had,
I thought, good, substantive conversations with secretary Kennedy, we had received assurances about things like the vaccination committee. So making sure, again, that that kind of very important input goes forward, I think, is important to many of us. So I appreciate that. I wanted to talk to you this morning about an issue that, we discussed in my office, and that is, with regards to ALS. The FDA's accelerated approval pathway has really been important and I think very promising for
treatments for ALS and and some other rare diseases. You have advocated for using common sense alongside reg science in regulatory decisions. So very briefly, how how do we define common sense here as it applies to the to the regulatory decisions of FDA? How do we make sure that ALS patients who, again, are looking at a very, very, very limited time frame, they can't wait for the traditional approval process? There are some emerging measures using digital technologies.
Is this in your realm of common sense? Give me a little bit of, of your view here on on how you how you would like to proceed on these accelerating, approval pathways. Thank you, senator. And I very much enjoyed our time together and talking through a bunch of these issues. We have to customize the regulatory process to the condition that we're trying to be able to offer hope for. So if a condition affects nineteen people in the world as a partial, triplication chromosome fifteen disorder does or a disease that affects fifty two kids in the
world, we cannot require two randomized controlled trials. We have to customize the regulatory process to what we're trying to do if our goal is to try to provide safe and effective therapies. So, I do believe firmly in that approach and I think we can use some common sense to ask some big questions we've never asked before at the FDA. Why does it take ten years for a drug to get approved? Why does a college student who suffers from chronic abdominal pain for years and we
have no idea what's going on, they go to Italy for a summer and they're suddenly cured of their abdominal pain? Why does a peanut allergy medication that's been safe with data for decades get approved in Europe before The United States when nearly ten percent of our population has a food allergy. So, I do think there's a lot of areas where we can ask, does a drug need to be prescription when it could be over the counter? Why are we requiring continuous glucose monitors to have a doctor's prescription when it's good
for people to use these monitors and learn about what they're eating? We don't just wanna limit continuous glucose monitoring to people with diabetes, we wanna prevent diabetes when thirty percent of our nation's children has diabetes or prediabetes or some form of early insulin resistance. Why are we holding these, tools to help people, empower them with knowledge about their health until after they're sick. Same with continuous blood pressure monitoring. Well, and it's as as you point out, why why do we wait? Now there we wanna make sure that there is is that there's a level of
safety. That's the job there through the FDA. But but, again, being able to accelerate these in in ways that are meaningful and and to your point that actually fit with the population that you're speaking to. So know that I'm gonna be pushing you on this, as well as many other advocates out there. I wanna quickly ask you about food ins food safety inspections. State local governments conduct about 60% of food processing facility inspections, 90% of produce safety inspections, a % of retail food inspections.
What has happened is we have seen in the Biden administration, FDA planning to cut funding for state and local food safety programs. This impacts us in in the state of Alaska when it comes to our seafood industry and in other areas. So I'm I'm looking for a commitment from you that under the Trump administration, the FDA is gonna maintain funding for these contracts with state and local governments. They've proven that it's more cost effective, more efficient, and it also is what congress has asked for.
So I'd like to know that you're gonna be supportive in that regard with regards to state and local police. I'm happy to look at that with you, senator. Very good. Thank you, mister chairman. Senator, senator, Blunt Rochester. Thank you, mister chairman. And, thank you so much, doctor McCarley for taking time to meet with me. I found that most parents would do anything to keep their children safe and healthy, which is why we probably see so much intense debate on, the best ways to protect our children. And the FDA has historically, been seen as the authority on reliable information about public health issues related to medical
products, food, tobacco, cosmetics, dietary supplements. However, people are getting their information in many different ways now, in many different places. And we're faced with a growing challenge of opinions, replacing scientific consensus and the proliferation of misinformation and disinformation. Parents need accurate science based information to help make informed decisions for their children. How would you use your position as FDA commissioner to compete with uninformed voices, and to share evidence based consensus driven information that is free from political influence.
Well, thank you, senator, and I enjoyed our time meeting together. I believe very much in empowering people with good information. That's why I've written three best selling books to try to educate people about health. And I do think you can explain to people with humility what we know and what we don't know, and then they're gonna trust us more. Trust in doctors and hospitals is at a crisis right now. It was seventy one percent in 02/2019. Seventy '1 percent of the public trusted us in 02/2019.
Now it's down to 40%. That's a thirty one point drop in my profession. That is a major problem. If we have the cure for pancreatic cancer, but only forty percent of the public is gonna come in and take it because the rest didn't trust us, then that medication is only 40% effective. So I think we fight bad ideas with more ideas. I don't do not believe in censorship of, scientific opinions. I think we need a civil discourse. Unfortunately, we have a, sort of toxic, discourse right now in The United States and the politicalization of immune cells in some
cases. One of my big concerns is that, who those voices are and that they really be robust scientifically trusted, messengers as well. One of the other big issues that we're facing are drug shortages that have reached an all time high threatening access to products that we use every day from IV bags to, lifesaving drugs for cancer. It's particularly concerning for, children's hospitals because of pediatric drugs and supplies that must be formulated to accommodate children's unique needs. Do you agree and this is kind of a yes or no.
This is a yes or no. Do you agree that the FDA should play a leading role in mitigating drug shortages? I love yes and no questions. Good. Can you do it? A leading role they should take a role. I think the problem is much bigger than the FDA. So yes or no, you're, like, not sure if it's a yes or no. I would refer you to my article in JAMA Great. On this topic. And and I I wanna shift to clinical trials as well. You agreed. We talked about the importance of clinical trial diversity. But I wanted an assurance that you will stand up to any Trump administration actions
that conflict with this. So, again, yes or no. Do you believe clinical trial diversity is critically important? That's the easy one. Well, if you're talking about a trial of sickle cell disease, are are are we saying that we need to have white people in a trial sickle cell disease? I believe in common sense, and I believe in clinical trial diversity both. And so I believe if you're gonna make results extrapolated to the general population, you should have results in those populations that you're making recommendations for. That one was an easy one. Do you think it is acceptable for the administration to remove congressionally mandated guidance document
on clinical trial diversity? I'm not familiar with that. Should you be confirmed, will you reinstate and finalize, this document after you look at it, as one of your first actions? Would you take a look at that? Could you commit to looking at that? Yes, senator. Good answer. Will you restore the website for the office of minority health and health equity? I'm not familiar with that website, senator. If there was one and you knew there was one, would you restore the website that would provide information to the American peep people?
I think you're asking me to make a decision on information that I I don't have. So I you have my commitment to take a look at. Any If you if you got the opportunity to review the website and then know that it would help to spread real information, science based information, would you reinstate that website? I I would be happy to review it. I have more questions that I will send, as for the record. But particularly, I'm concerned also about the vaccines for children program and making sure with the you've heard our colleagues talk about the cancellation of the meeting.
This is not just about cost for families, which is huge right now, but it's also about coverage. And so I yield back my time, and, I thank you so much, doctor. Thank you, senator. Thank you very much, senator. Doctor, it's great to see you again. I enjoyed our conversation. Good to see you. Congratulations on your nomination. Thank you. And thank you for your willingness to to to take on this very important role. You've been asked about this several times already, but I just wanna drill down a little bit further. In February, president Clinton's FDA approved a chemical abortion regimen with the drugs mifepressone and also
mifepressomol. Now, the FDA concluded that mifepressone could not be safely used, I'm quoting the FDA there, safely used, could not be, without special measures. It's the FDA's language. And in particular, the FDA mandated that prescribers needed to be licensed physicians who were able to diagnose and treat ectopic pregnancies to accurately determine the gestational age of the baby, and the FDA further required that these drugs be administered and dispensed in person, that there be a day one in person administration of the drug,
a day three in person administration of the second wave of the drug, a day fourteen check-in for complications, and the FDA further emphasized that given the potential risks of these drugs, physicians needed to be able to provide ongoing care. The FDA also said, and I'm quoting now, the percentage of women who considered any particular adverse event as severe ranged from two to thirty five percent, end quote. And the FDA included what's called a black box warning, which you're very familiar with, which remains on the drug. Now those restrictions were largely in place until just a couple of years ago when
the Biden administration, after the United States Supreme Court took up the Dobbs decision, granted cert on it, at that point, the Biden administration decided to eliminate twenty years of in person dispensing requirements for this drug. They didn't cite any any studies that they that they, said were adequate. In fact, the FDA acknowledged that the studies that they looked at did not take into account the new protocols that they were issuing. They just eliminated two decades of in person dispensing requirements. My question to you is, given the FDA's own findings on this drug over two decades,
doesn't it make sense that the FDA returned To the pre political before the political intervention of the Biden administration, the pre political protocol that requires in person dispensing for chemical abortion drugs. Senator, I appreciated our conversation, prior to this hearing. I do think it makes sense to review the totality of data and ongoing data. I know personally of OB doctors who prefer to insist, even though they have the option to prescribe otherwise, but they choose to insist that mifepristone be taken when necessary in their office as
they observe the person taking it. And I think their concern there is that if this drug is, in the wrong hands, it could be used for coercion. And, of course, you're you're familiar with the fact that now it's not merely that there's no requirement that it be ingested in the presence of a a physician. There's no in person dispensing requirement whatsoever. This is what the Biden administration two decades of in person dispensing requirements. The Biden administration eliminated those. Now you've said several times you review the data. You're aware that in 2016, the Obama FDA eliminated the requirement that physicians report adverse events with regard to mifepristone,
aren't you? I believe they limited the data required to fatalities, but not adverse events. Will you put back in place the full reporting requirements that you can have a full range of data to evaluate? Senator, I'm happy to look at that. I do believe in data, and I I don't believe in prejudging data before somebody has taken a look at data, including including future data. Well, let me just say that here's the deal. The FDA's rules were pretty consistent and pretty stable for twenty plus years until suddenly the Dobbs decision appeared on the horizon.
And when that happened, all of a sudden, we got massive changes in the dispensing requirements of this drug. And I'll just point out that over sixty percent of abortions in The United States are now carried out with chemical drugs, with these drugs. They're not they're not done in clinics. They're not done in hospitals. They're done with these drugs without any kind of physician supervision, without any physicians there, if there's a serious adverse event. And I'll also just point out that if the Biden rules are allowed to stand, it doesn't matter what voters in the states, it doesn't matter what this is a serious and very difficult moral issue,
the case of life in abortion. And it won't matter what voters in the states say because the Biden rules say now that bureaucrats can mail in abortion drugs to every single state. No in person dispensing required. It doesn't matter what voters in the state have decided on the issue. It doesn't matter whatsoever. Now if that's allowed to stand, we may as well just go back to making this having the Supreme Court make all the decisions because right now Washington bureaucrats are making all the decisions. Doctors are not involved. They're not in person dispensing. State voters are not involved. And I just wanna register this as extremely concerning to me.
It ought to be concerning to everyone who's concerned about women's safety and also about what I thought was the position of this administration, which is that it ought to be voters in the states and and the the relevant to localities that are deciding this decision. So I know you're familiar with this, doctor. Thank you. I appreciate your commitment to the data. I hope that you'll look at the full range of data, and I hope we can count on you to protect women's health and the health of of the unborn. Thank you, senator. Well, senator Kane, let the record reflect. Even though I have the gavel, I'm gonna stop right now and turn it over to you.
You're recognized, senator. Thank you, senator Hawley. Senator Hawley and I share, a unique perspective. There are two sets of senators who went to the same high school. Chuck Schumer and Bernie Sanders went to James Madison High School in Brooklyn, New York, and Josh and I went to Rockhurst High School in Kansas City. So, just wanted to put that on the record. Doctor McCurry, I loved the opportunity to visit with you. And I I know I know the answer to this question, but I just wanna stress it again. You didn't have anything to do with the layoff of the thousand FDA employees that have been laid off, in the last couple weeks, correct?
That's correct, senator. And do you know anything about the layoffs, for example, who made the decisions or or what groups of people were laid off? I do not, senator. You indicated that when you come into the office, you're gonna do an assessment. And and I suppose based on your experience that if if you look at this going forward, you think personnel policy, including layoff, should be done strategically rather than just kind of willy nilly across the board randomly. Correct? I am open to ideas on making government more efficient. Do you think willy nilly random across the board is a good idea or not
a good idea? Look, I'm a surgeon, so, you know, I'm gonna give you a surgical answer. Okay. That's good. It is a little bit puzzling. The administration has high confidence in you. You're you you've got this hearing right now. They expect you to be confirmed, probably will be based on practice. So the notion that they would lay off a thousand people before you got there is a little bit unusual. And what we're seeing in agencies in the layoffs is that it is willy nilly random. Probationers get laid off because they can't fight back. Probationers are disproportionately veterans. I'm glad you will be a surgeon and and and act like the surgeon should
you be confirmed. Second thing I wanna ask is about user fees, and we chatted a little bit We we agreed that despite the need for reforms at the FDA, that the FDA is sort of the gold standard. I asked you, is there another nation that does this better than us? And you said, no, there wasn't. Even though, again, you've got reforms you'd like to make. Here is a, an issue that's pretty technical, but it's an important one. We talked about tracking adverse events after a drug or medical device is approved. And you indicated that the FDA can do a better job of identifying issues with
problems that are already on the market. It's not all about approval and then it's about post approval tracking. There are many different user fee programs that outline the relationship between the FDA and industry. And for most of the user free programs, except medical device user fee, FDA can use the collected user fee dollars to conduct post marketing surveillance, but the medical device user fee program does not, allow that use of the user fee dollars. Would you agree that the FDA should be able to use the user fees collected on medical devices to do post approval surveillance?
Senator, as as you know, user fees are established by Congress, and I'm more than happy to be a part of the conversation about the best use of those dollars within the agencies. I very much enjoyed our conversation. And as you know, I'm committed to an FDA that delivers more cures for Americans and meaningful treatments. Health care for children. Can I just ask about this? Do you think post approval surveillance is something that's important? I am a big believer in the idea that we should not just turn a blind eye after the FDA approves something. If we do that, we get burned with a million lives lost from oxycodone and oxy OxyContin without any
monitoring. And I do agree with you that making that change would be on congress' shoulders, but I do think it's odd that we don't allow the user fees to be used for post approval surveillance on medical devices when we do in the other areas. And I'd love to work with you on that. On OxyContin, I wanna just close with this one. We're seeing some improvements. Twenty four percent decline in drug overdose for the twelve month period ending in September 2024 compared to previous year. And just yesterday, the NIH released findings of an NIH funded study researching new a new pathway to
address pain issues. But eighty seven thousand Americans died overdosed in the twelve month period. So it's an improvement, but we got so much farther to go. One in four Virginians deal with chronic pain. And one of the issues you and I talked about is, can the FDA not just be in receive mode to get, you know, the the the applications for approvals and approved, can the FDA even be proactive in looking and saying, how come we don't have more non opioid based pain management strategies? The FDA shouldn't be picking a winner among competitors,
but to to look at gaps and try to incentivize or encourage filling those gaps would be smart. Could you share some of your ideas for how we might encourage appropriately the development of innovative strategies to address chronic pain in without using opioids? Thank you, senator. I do believe the FDA should not just be in receive mode, but also partner with industry and facilitate the process and ensure that that the scientific review is independent at the same time without cutting any corners on the independence of that review.
The opioid pain, problem can also be addressed by innovation. More localized treatments. And, and looking at post approval monitoring of devices and Great. Thank you. I look forward to more discussion. Thank you, Senator. Thanks. Coach Summerville? Thank you. Thank you, Mr. Chairman. Thank you, Doctor, for being here. Thank you, coach. To do this. World War II, we had to find ways to feed our troops. We knew nothing about preservatives and canning foods. And ever since then, our food's gone downhill because we have put everything in the world in our food.
Number one, we get kids addicted to it, which we have. We've lost probably a couple of generations because of the obesity and diabetes. I have faith in this generation. I have two kids in this generation coming up that they're looking at their health as a as a future, and they're they're fired up about, you know, nutrition being being being a good part of it. You're rec you familiar with grass, generally recognize safe foods, you know, the chemicals that go into our foods. What's your thoughts on that? What's your thoughts on you as a FDA director,
having the ability to look in this? No, we're not using this chemical in this food. What's your thoughts? Well, first of all, Senator, Coach, I think you have had a perspective on this and been an advocate for healthy foods. And perhaps it's because of your unique position where you've worked with young people for so long. Half of our nation's children are sick. And nobody has really been doing anything meaningful on this front until we have gotten new momentum and enthusiasm from secretary Kennedy and president Trump to finally address the root
causes of these diseases, general body inflammation and generalized insulin resistance. And food has a part of it. Food has a big part of it. When we eat foods with a lot of molecules that do not appear in nature, these are chemicals. These are chemicals that the industry insists are safe, a subset of which are concerning. There's a body of research now that suggests concern with some of these ingredients. We have to look at those ingredients, and you have my commitment to do so if confirmed as FDA commissioner. These chemicals are creating an inflammatory response in the gastrointestinal tract.
And with an altered microbiome lining that GI tract, kids feel sick. It's not an acute inflammatory reaction. It's a chronic, low grade reaction, and they don't feel well. And what are we doing? We are drugging our nation's children at scale. At scale. We have to reassess what we're doing because we're not on a good path right now. Yeah. I grew up in the South. I love fried foods. Okay? We fry everything, including snicker bars and Twinkies. But let me ask you this. I hear a lot about seed oils and, the good and the bad.
Your thoughts? So I think seed oils are a good example of where we could benefit from a consolidation of the scientific research. And I don't think it's any one ingredient in the food supply that's making our nation's children sick with a thirty percent, rate of, insulin resistance and diabetes in American teenagers today. That is a massive signal in the data. And so, I think we have to look at the totality of every single thing in school lunch programs in the diet of our nation's children.
When we're using tax dollars to make purchases of foods that we know make our nation's children sick, we have to reexamine how we're spending those tax dollars. So one thing I would like to work on is a school lunch program for some school districts on a pilot basis to transition to healthier foods. A lot of school districts want to, but they don't know how, and they may not have the funds, so I've been discussing this, with Jay Bhattachary and others in the administration, and I hope that's something we can do. Thank you. Just a few months ago, we had the the former FDA director and asked him about the red dye number
three. And it was a pretty interesting conversation. Red dye number three, we've done studies on it, and we won't allow it in cosmetics, okay, because it causes cancer. But we are allowed to put it in our food. And a little bit confused. I'm a football coach, but I'm not that stupid. You know? You know, put it on your face and put it in your stomach. There's no difference. But he made an interesting statement that we're twenty years behind Europe because Europe doesn't allow it in anything. We're twenty years behind Europe on, looking into red dye three and all the other dyes. What's your thoughts on dyes in this country?
I I agree with you, that it did not make sense that red dye number three was banned in cosmetics but allowed in the food supply. And so, as you know, with two business days left in the Biden administration, there was an announcement to ban Redeye number three in 2027 or 2028. And why that long? We want to kill people for two more years? I mean, I would hope that you would, if you're confirmed, you go in and look at it very quickly and said, why do we want to put our people in harm's way? Thank you. Thank you very much. Senator Hickenlooper.
Thank you, Mr. Chair, and thank you, Doctor. Mercari, for your service. I finally got a chance to look over some of your three books, or probably more than that, but the three books that I was able to chase down, and they each one seemed provocative and full of answers. I will say, as a very, very slow reader, I'm a dyslexic. I do wish you had something like Cliff's notes so that we could get 10 or 15 pages concise and get the essence out of that. I'd be happy to personally summarize them for you, Senator. I think we have witnesses that just heard that. I'm very excited.
I appreciate your courage in taking on a lot of these traditional approaches and being so candid. Let me go through a couple questions. In just a few weeks, roughly 10% of the FDA staff has been laid off. And most of these layoffs were inspectors who looked either at food supply, whether it was safe, safety of medical devices. And yet for the past several years, job vacancies, if you measure them as an indication of anything, but for FDA inspectors, job vacancies have been going up, not down. In other words, we have more unfilled spots, and now all of a sudden we've laid off 10% of the people there.
That chaos and and the understaffing is gonna really present a serious morale issue, which I'm sure you're aware of. I don't know if you have any plans for that, and how are you gonna be able to try and do the best you can to ensure the FDA's gold standard of science if we can't get enough inspectors? Senator, thank you for the question, and I enjoyed our time together in your office. I was not involved in any personnel decisions. That was not a criticism. I was just saying once you get in the job, if if if your if your budget is suddenly diminished and you've got 10% fewer
inspectors and and you already didn't have enough by by the existing measures. I'm not sure how I'm not sure there's an answer for it. Maybe it's an unfair question. Senator, if confirmed, you have my commitment that I will do an assessment within the agency of personnel, and it will be an ongoing assessment to ensure that the scientists and food inspectors have all the resources they need to do their job. Great. Again, that's the certainly the exact place to start. We have a bill, skinny labels, big savings act that helps more generic drugs,
more of that competition come into the market, lower drug costs. Again, with so many of the FDA workers having been fired and laid off, will there be sufficient people at the agency to review generic drug applications? Because that often gets pushed to the bottom of the heap, and yet it has dramatic savings, especially for elderly and people on the lower parts of the people who don't have insurance. So is that FDA is that slow are you worried about a slowdown again due to resources and personnel? Senator, I wanna make sure that the reviewers and the review process is,
done properly without cutting any corners on the scientific independence and done expeditiously. So you do have my commitment that I will, do my best to ensure that that's done as best as possible. Just just to put things in context, if I may, the FDA, has almost 19,000 employees, just over 18,000. That represents a 100 increase since 02/2007. Now I understand there were some, layoffs recently. I understand, some or many were hired back. But I just wanted to let you know that to put things in context,
we have seen a doubling of the agency in terms of number of employees since 02/2007. I I I accept that and was aware of that, but it's a fair point. A lot of talk about measles. Secretary Kennedy recommended the use of cod liver oil as several, one of several things that people could do, and left it to parent parental's discretion as to whether they would get their kids vaccinated, which I think you've got. I agree with that. I think the parents in the end have a right and a responsibility to make that decision for their kids.
But it seemed to me that there could be a stronger those of us who looked at depth and in detail at the facts that this is really a very safe vaccination for ninety nine point nine nine percent of of kids. And it it saves lives, and it prevents huge levels of of very sick kids. Do you think there should be more or will you be willing to be a more enthusiastic supporter of of vaccinations while at the same time recognizing that parents, get the final say? Senator, vaccines save lives.
And I do believe that any child who dies of a vaccine preventable illness is a tragedy in the modern era. The rare times in which some child dies of measles, it is often in the setting of a comorbid condition or severe malnutrition. And perhaps that is the rationale scientifically and physiologically as to why some supplementation, in terms of nutrients may provide a benefit to children who are very sick and hospitalized with measles. Right. And I don't deny that.
Thank you. But I'm getting gaveled. Thank you, Senator. Thank you so much for your service. Thank you, Senator. Yes. Senator Husted. Thank you, Mr. Chairman. I agree to have you before the committee. I, enjoyed, Doctor. McCary, the, conversation we had in in my office, and I wanna just give you a chance to share some thoughts, you know, kinda building on what I'm sure others have asked you. I I am deeply concerned about how much inflationary cost the health care system has created for the American public over the last decade.
And in the twenty first century or in the twenty first century, we talk about inflation around here, the most inflationary cost affecting consumers, businesses, the American public, the American taxpayers' health care costs. We seem to spend more and get worse outcomes. You you look at the fact that from the earliest stages, we have children who are unhealthier, worse diets, more obesity, which lead to problems like diabetes, lower quality of life, lower productivity, as they go through life, higher costs in the health care system that continues to manifest through life,
on all those fronts. And then the government and the tax payers end up paying for all of it through Medicare and Medicaid. It is driving, it is it is driving, us into bankruptcy in some levels and and costing people and families the ability to afford, to live. And so, there are lots of ingredients to that. How do we take cost out of the health care system, whether it is make in making people healthier and making this whole system sustainable for the long run. Well, thank you, Senator Husted.
And, it's good to see the Cavaliers doing great this year. I hope this is their year to win it all. Oh. And I enjoyed our time in your office. We only have one championship in Cleveland. That was when LeBron was there. First of all, you are 100% correct, and this is something I'm very passionate about. Health care costs are spiraling out of control, and it's burdening everyday American businesses and families. It's getting more and more difficult to compete with businesses overseas because of health care
costs. It outpaces inflation. And when we are spending money that we don't have as a country, it drives inflation, and inflation is a backhanded dirty tax on the poor. It doesn't affect the wealthy. It affects the poor. And that's why we've got to address health care spending. We've heard of many different ideas out there, but the the main root issue is the health of the population and it is getting worse. Seventy five percent of adults have some comorbid condition, or diabetes,
or prediabetes, or are overweight, or obese. Three in ten teens now have insulin resistance. That's not good for our future as a country. So thanks to, President Trump and Secretary Kennedy for the first time, we are talking about root causes both on a research basis and in terms of what we can do at every agency. And within the FDA, I do think there are things we can do to help empower people by, facilitating this independent scientific review of devices and other, ways to prevent chronic diseases with continuous glucose monitoring,
continuous blood pressure monitoring, and healthy foods for children. If confirmed, my goals are very clear at the FDA. More cures and meaningful treatments for Americans, including diagnostics, healthy food for children, and rebuilding the public trust. Great. I look forward to working with you on all those issues as I'm sure many of the members of this committee do. One way that we can drive more efficiency and speed to market for things that can improve lives and hopefully lower cost is through technology. I know that, I was involved with the Cleveland Clinic when they got the first quantum computer focused
on healthcare research, and you use things like quantum and AI to drive, discoveries, speed to market with these. Could you talk about how the FDA, under your leadership, would think about those things? Thank you, Senator. I think there's a number of opportunities, with AI right now that we have that we've never had before. We have an incredible opportunity to use AI to help reviewers in the review process, not to replace the human reviews, but to aid them and assist them in the same way that EKGs are read by AI
devices that tell us, normal sinus rhythm at the bottom of the EKG. Now, we still look at the rhythm, but it aids and it may help the efficiency among the reviewers. We can use AI also in drug design and drug development. Now, that's not something the FDA does, but the FDA can help provide data to help train machine learning models to help design, AI systems that can predict toxicities, adverse events, and even cures for some conditions. And finally, AI can be used to as aid with, data monitoring in a post approval setting.
So we don't learn five years after Vioxx is approved that thirty eight thousand Americans died from it. Thank you. Thank you, Mr. Chairman. Thank you, Senator Husted. And now Senator Morkey. Thank you, Mr. Chairman. I'm from Boston, the home of the world champion Boston Celtics. Good luck to the Cavaliers. But, we'll have a little bet in June. You stated that you want to ensure that the FDA holds the gold standard of trusted science and transparency. In order for that to happen, the FDA Commissioner must also uphold the gold standard for trusted science and transparency.
In your financial disclosures, you disclosed that you made over $500,000 from Global Appropriateness Measures, LLC. The client list for that company includes companies that are interested in making money off of the health care system insurance companies, hospital chains, private equity backed companies. So can you tell the committee how much you made from those private equity and venture capital backed companies? Senator, first of all, thank you for the question, and I enjoyed our conversation, prior to this hearing.
I am very proud of my work at Global Appropriateness Measures. The purpose of the endeavor was to lower health care costs for Americans by reducing unnecessary surgery and medications. And so Just for the record, can you just tell us how much you made from, you know, the private equity and venture cap, venture capital backed companies. So I have I have been a shareholder in global appropriateness measures. I am fully divesting. I don't have the exact numbers at my fingertips, but they were all disclosed to the gov office of government ethics, and they are all part of the disclosure,
system. Was it in the millions of dollars or less? Over the period of what over the course of what period of time? Over the period of time you had a relationship with them. There was revenue of that company in the millions of dollars. Yes. And I am one of the shareholders of that company. And I am very proud. The the best way to lower drug prices in The United States are to stop taking drugs we don't need. So I do believe in the appropriateness of care, and that endeavor was designed to create software so we can monitor I appreciate that. We're just looking at the transparency issues.
I'm just trying to help you to be transparent here. So how much were you paid by insurance companies, including Devoted Health Services, an insurance company that primarily sells Medicare Advantage Plans. Yeah. That figure is in the Office of Government Ethics report. I don't have that exact number at my fingertips. And, of course, I in the millions of dollars as well? No. That was, far less. And that I again, I am a shareholder, so I did not, you know, I am one of one of the shareholders of that company. Well, I think the American people do deserve your full transparency about how you might be
influenced by the health care industry, insurance companies, private equity, and venture capital funds, and that's what I'm trying to get at here because All of those reports will be public, senator. They will be public. They're not public at this point. So I'm I'm not in a position to ask you about them, and that's why I'm asking you if you Yeah. Office of Government Ethics releases it at a certain point in time. But, it's not helpful for the confirmation hearing, which is essential in terms of the public understanding, all of the potential, not actual, but potential conflicts of interest that might show up. The FDA is responsible for approving medical devices or drugs that may impact how much
insurance companies pay or what they cover, the same insurance companies that do overcharge, Americans and undercover their care. It will impact hospital costs and private equity. And you're coming into this role with relationships, preexisting, that have a profit interest in the decisions that you will be responsible for making. That's why I'm raising these issues. Will you commit today to not participating in any decisions that would have an impact on known clients of global appropriateness measures during your tenure as FDA Commissioner?
First of all, Senator, I appreciate your enthusiasm on this topic. I am, one of the biggest advocates that was involved in the health insurance industry transparency of the secret negotiated rates. So I'm a big, with you. The, recusals that I will be taking Yes. Are a % in line with the Office of Government Ethics recommendations, which were not to resign from everything, but I chose to resign from everything to ensure a, no appearance of a conflict of interest. That's important for us to hear. And the same thing, will you commit today to not participating in any decisions that would have an impact
on private equity and venture capital investors of those clients as well? Senator, I commit to following the Office of Government Ethics Agreement. Well, again, it's it's just it's just so important for us to understand this going forward, because of obviously the increasing role that those sectors are now playing, and they will be attempting to influence FDA decisions. So that's the reason why I'm raising the questions, and total transparency is absolutely necessary. Thank you, Mr. Chairman. Thank you, Senator. Thank you, senator. Thank you, mister chairman.
On that note, doctor, you've been very transparent, right? I believe so. I mean, talk talk about that process. I mean, the how transparent you have to be to get to this point today. Well, there was a massive disclosure of basically every single share of everything that I own and that process, took a number of weeks And, I would describe it as a, colonoscopy with a small bowel follow through. And everything is out there and basically, will have essentially no privacy when the Office of Government Ethics chooses to release that form. But that's okay. I'm proud of everything that I've done,
and I'm more than happy to acknowledge that I've agreed to divest or resign from everything. And so I, again, was given the option not to resign from everything, and I chose to resign from everything because I want to ensure independence. This is not a job I'm taking to audition for my next job. This is a job I'm doing to serve the American public. I believe in more cures and meaningful treatments, healthy food for children, and rebuilding the public trust. So, senator, I can commit to you that I am absolutely dedicated to that mission, and and I am not there to audition for a future job.
Yeah. I I appreciate that because this is so important. I mean, you you've been nominated for this position because you're incredibly accomplished. Your your background perfectly fits the role that you're about to take, and you bring experiences and success to the table to be the new head of the FDA and and and and change it? Because you've you've talked about this. You mentioned in your testimony that health care has become too fragmented, too cold, and too corporate. Right? I mean, and and and you're gonna go there to shake that up and change that. The the make America healthy again movement that was a big part of giving this
president a a giant mandate with secretary Kennedy and others who are coming to the table, The the role that you're going to play is really important to that, to to to disrupt it. And I think we all we all agree that, I think the American people agree that the medical establishment, often condescending toward the American people, is something that we have to disrupt and change. Can you talk about how you're gonna do that at the FDA? Thank you, senator. And I do agree a % that for the first time ever, President Trump and Secretary Kennedy had moms that were Republican,
Democrat, independent come out and vote because they care deeply about the health of our nation's children. They wanna see healthier food for children. They wanna see an industry, that has, they wanna see an FDA that is independent of corporate influence, but at the same time, working, with partnerships around the country to facilitate, not just be in a receive only mode. So, one of my goals is to ensure that the FDA maintains its scientific integrity and that we can do what we can to contribute to the Make America Healthy Again
spirit. Very good. Clinical and nonclinical testing are both very important parts of FDA's drug approval process. How do we modernize that process, modernize testing? Well, first of all, there are steps in the regulatory process where we can take a look and ask, do we need to use the the same processes that we've been using? Infant formula, for example, has had the same recipe for the last forty years. And so with the exception of selenium,
which was added in 02/2015, for forty years, we're requiring infant formula companies to use a standard recipe that was developed back when the food pyramid was misleading Americans and basically government misinformation. Can we take another look at that? Can we, create other ways in which new products can be brought to market safely? Can we look at real world data from European products? The more competition, the more resiliency in the supply chain and the lower the risk of a shortage in the future. So does an infant formula need to go through the same process as a new
drug, or can we look at real world data and work with the companies to figure out a smarter way that uses both trusted science and common sense, which is a theme I would like, if confirmed. I wanna work with you on that. The FDA is starting to allow patients to choose whether they want prescription drug instructions on paper or digitally. Seems like common sense. But medical device instructions are still required to be on paper. Would you support changing that requirement? Senator, my understanding is that's a requirement set by Congress, and I would be more than happy to work with you and members of Congress
to take a look at that. Do you have an opinion on it? I've heard arguments on both sides. One thing, that people, have raised is that, on one hand, it may be a waste of paper. It's a lot of paper. On the other hand, seniors may not go to a website to look at at the information, so I think there are arguments on both sides. I would welcome the opportunity to work with you on reforming. Thank you. I yield back. Senator Banks, thank you. Senator, also Brooks. Thank you so much, mister chair. Good morning, doctor McCary. Good morning. Good to see you here. You know, I'm gonna just feed off of something my colleague just mentioned some words that I
think are significant. He said the medical establishment is condescending to the American people, and I'd like to offer that, unfortunately, because this administration has been so reckless in the way that it has handled civil servants, I believe they've been very condescending to many of them as well. And they are, for the most part, many of them are my constituents, who work in institutions like John Hopkins and who are serving the people. And many of the, actions of this administration have been quite chaotic and confusing. So I wanna just draw you to a few things. The committee staff raised last week a memo that was,
put out by OPM. And this memo, directed agencies to dramatically reduce staff. And then they reversed themselves. And I'm not sure whether you've seen the latest guidance from OPM this week, which backtracked that directive to fire employees instead said that they should, they clarify by saying that decisions to fire should be left to individual agencies. And so I'd like to just ask you, given this updated guidance, whether we have your assurance here today at this hearing that you will not arbitrarily fire employees, at FDA given the new guidance.
First of all, senator, good to see you, and I enjoyed our conversation. And I'm very proud, to work at Johns Hopkins in the State Of Maryland. And I'm a big believer in the professional career staff at the FDA, which is also located, by and large, most of the employees are in Maryland. And so, you have my promise that if confirmed, I will do my own independent assessment on personnel. I welcome input on efficiencies at the agency. At the same time, I want to make sure that the scientists and food inspectors and staff central to
the core mission of the agency have all the resources they need to do their job well. Thank you. And as you mentioned, there are so many valuable, members. FDA does a tremendous service for our country. They handle, for example, drug safety, as you know. When we think about reviewing medical devices, and you mentioned infant formula, where the men and women who are, designated as the people who would make sure that those items are safe are the ones who've been, terminated. So I would like to know whether you would commit then to rescinding the termination of scientists who were working,
for example, to address the bird flu. Senator, I was not involved in any of those personnel decisions, but if confirmed, I will certainly do an assessment. Okay. You'll go back and look at those those terminations. Happy to, senator. Okay. Thank you. As well as the termination of their individuals in FDA's food, division, the people who keep our food safe. And so you would commit them to going back and looking at those terminations to make, an independent assessment. Of course. Happy to. Okay. And in the same vein, I wonder whether you realize that many of FDA's salaries,
you may already know this, are paid in large not by taxpayers, but by user fees. Are you familiar with that? Yes. I am, senator. And so the concept that the reason to terminate these employees is to save taxpayer dollars is one that's based on a premise that is largely not true since we use the user fees, for many of the salaries. And and that being the case, wonder whether you would commit then to rehiring their 100 employees who were fired from FDA's Tobacco Center, which is 100% funded by user fees. Will you commit to going back in and looking to rehire the 100 who were
terminated? Senator, if an employee has not logged on to their VPN in two years, then I don't wanna rehire that individual. But if there are, people that deserve a look, I, of course, am happy to look at that. Right. We're talking about again, there's a big lie out there that says these civil servants are lazy. They are shiftless. They don't show up. That is by by and large not true. So asking you if you would go back and look at the ones who have been summarily terminated without cause. And your your answer to that has been yes. You will go back and make your own independent assessment. I will do an assessment if confirmed,
senator. Thank you. Thank you. And finally, on Tuesday, Doge made the GSA released a list of over 400 government buildings, that they wanna dispose of, and, many of these are in White Oak Campus, which is in Maryland. One of them is, in a building called Building Number 1. And I wonder whether you're familiar with Building Number 1. I'm I'm not familiar with the numbering of the building, senator. Sorry. Your office would be, and that's one of the buildings that the that Doge has put on the list to close shutter and and close-up. And so, again, just pointing out that many of these decisions are arbitrary,
that they harm the work that we do and harm the American people and just wanted to ask you, if you would be committed to, making decisions that make sense and that do not eliminate the FDA. I believe in common sense and trusted science. And if confirmed, you have my commitment to do an assessment of personnel to look at efficiencies. I welcome the input of any organization, of any individual member of Congress, from the administration and the Doge team as well, to figure out how the government could be more efficient. Thank you so much, doctor. Thank you. Thank you,
senator. Thank you, doctor McCurry. I'd like to submit for the record a Washington Post article referenced by health committee witness and abortion survivor Melissa Melissa Oden regarding a woman who took metopristone twice, including once obtaining it online and taking outside the FDA's ten week indication window. She still delivered her baby. While FDA has conducted safety studies on the product, I'm not aware they've studied any safety outcomes related to a child who might still be born. As a physician, sending women abortion pills without a complete evaluation of the gestation of her pregnancy or
checking for, an ectopic pregnancy is clearly a safety issue. And that's why I would urge Doctor. McCarrey to return to the REMS policy in place during the first Trump administration requiring an in person visit. With that, this concludes our hearing. And I'll just say that I know your family is incredibly proud of you, and I just thank them for being here as well. Believe me, you're on for a ride. So thank you for volunteering along with the doctor. For any senators who wish to ask additional questions, questions for the record will be due tomorrow at 5PM. This concludes the hearing.
Thank you, Mr. Chairman.