Senate Health, Education, Labor, and Pensions: Hearings to examine the nomination of Heidi Overton

The Senate Committee on Health, Education, Labor, and Pensions will still come to order. We are waiting for a quorum, but we will start with opening statements. The nominees we are considering today have the qualifications and the integrity necessary to do the job. America needs a Surgeon General who makes decisions rooted in science, a leader who gives families clear medical guidance and works to restore public trust in health institutions. With years of proven experience as a physician and a medical contributor, Dr. Sapphire is ready to take on this challenge.

Dr. Westlake will also be a great addition to the Department of Health and Human Services as Assistant Secretary for Mental Health and Substance Use. He has over two decades of clinical experience in community emergency medicine and has been a champion for mental health and substance use disorder policy, including spearheading the Wisconsin model for my HALT Fentanyl Act signed into law last year by President Trump. I'm confident that he will continue to be successful in this space. I will also be supporting Ms. Lazar to be the Assistant Secretary for Aging at HHS. She is more than qualified.

Ms. Lazar has been performing the duties of the Assistant Secretary for more than a year now and cares deeply for older Americans. She also helped lead the same organization during Trump One. I intend to support the health nominees before me today, but I'm deeply concerned deeply concerned by reports over the weekend that the president considered giving OMB a direct role in individual NIH grant decisions. Politicians who have zero medical experience or background should have zero role in deciding which NIH grants get funded. I hope to see the White House agree and decide against politicizing the approval process.

Scientific research, the health of our country depends upon being driven by evidence and not by politics. As for Ms. Sweat and Mr. Ralph, they're committed to protecting workers' rights as they help settle disputes, ensuring that trains and planes keep running. I look forward to working with them. The committee is also considering the No Aid for Ghost Students Act.

According to the U.S. Government Accountability Office, The federal government loses an estimated $233 to $521 billion to fraud every year. Money coming out of the pockets of people in Louisiana, out of the people of Kentucky and Vermont, and all of us. That's just wasted. These fraudsters, fraudsters known as ghost students, are using stolen or fake identities to submit FAFSA applications and to take federal student aid money. This legislation stops those fraudsters, fraudsters, ensuring the aid goes to students in need.

I appreciate the works of Senators Moody, Hassan, and Tuberville. With that, I recognize Senator Sanders. Thank you, Mr. Chairman. Today we are voting— never ends.

Today we're voting on 3 of President Trump's nominees for the Department of Health and Human Services. I will be voting against all of them. In my view, we need public health officials at the HHS who will have the courage to stand up for science and not simply act as a rubber stamp for Secretary Kennedy's dangerous anti-vaccine agenda and his unacceptable war on science. After carefully reviewing the records of these nominees, I do not believe that they will be able to do that. Uh, Dr. Nicole Saphire, President Trump's nominee to be Surgeon General has questioned the need for hepatitis B vaccinations at birth at a time when the scientific data has been clear.

Hepatitis B vaccine has successfully reduced the number of babies and young people, young children infected by this virus from 20,000 a year to fewer than 20. She inappropriately criticized the American Academy of Pediatrics when it pushed back against changes to the vaccine schedule recommended by Secretary Kennedy's handpicked advisors. Mr. Chairman, we need a Surgeon General who will tell parents the truth about vaccines, not someone who misleads the public by stating that, quote, there have been children who have died from the MMR vaccine, end quote, during the worst measles outbreak in more than 30 years. We need a Surgeon General who will stand on the side of parents, not Big Tobacco, by speaking out against the Trump administration's outrageous decision to approve the new fruit-flavored e-cigarettes, which she has refused to do. We need a Surgeon General who will stand up for science and the truth, not conspiracy theories and misinformation.

Dr. Safire is not that person. I'm also opposed to President Trump's nominees to the National Mediation Board that we are considering today. The National Mediation Board coordinates labor-management relations within the U.S. railroad and airline industries. Workers in those industries cannot strike without approval from this board. Last year, President Trump fired board member Deidre, Deidre Hamilton, who the Senate confirmed to the board in 2023.

Ms. Hamilton was a champion for workers' rights and an attorney for the Association of Flight Attendants, before she joined the board. This committee should not accept the president firing a board member who was confirmed by the Senate and replacing her with a pick approved by the airline industry. Finally, Mr. Chairman, we are also considering the so-called No Aid for Ghost Students Act. The proponents of this bill tell us that they want to combat fraud. I think there's nobody on this committee who disagrees with that goal.

However, I'm afraid that this bill, as currently written, will make it harder for working-class Americans, incarcerated students, homeless students, and students who lack access to the internet from receiving the Pell Grants and financial aid they desperately need. That is why this legislation is strongly opposed by the American Federation of Teachers and over a dozen other groups representing millions of students and teachers throughout the country. As currently written, this bill could deny aid to legitimate students It could enable the Trump administration to politically target students and colleges who disagree with them. And it leaves students who are wrongfully denied aid limited recourse to receive the financial assistance that they are entitled to. Further, this bill does nothing to address the very real affordability crisis students are facing in this country today.

In America right now, hundreds of thousands of bright young people are not going to college, not because they are unqualified, but because they cannot afford it. Unfortunately, President Trump's so-called big beautiful bill has made a bad situation even worse by making the largest cut to higher education in American history. The result: the average college graduate is now forced to pay $4,000 more each and every year on their student loan payments, about $244 a month. In my view, that must change. That is why I'll be offering an amendment to reverse these devastating cuts to higher education and restore access to federal financial aid for millions of students.

And further, in America today, an increasing number of seniors— this is really quite unbelievable— are in danger of having their Social Security checks garnished to pay back student loans they took out decades ago. How absurd is that? In the richest country in the history of the world, no senior should have their Social Security payments taken away from them to pay back student debt. This is especially true when seniors throughout the country already cannot afford the skyrocketing prices of healthcare, prescription drugs, and housing. And that is why I'll be offering an amendment to prohibit the federal government from garnishing the Social Security checks of seniors and people with disabilities to pay back student debt.

Thank you, Mr. Chairman. We're still waiting for Senator Murkowski. So in the interest of time, members should stay here, but we'll proceed to the consideration of the No Aid for Ghost Students Act of 2026. And then when Senator Murkowski arrives, we will then go into the elect— the vote for the nominees. Okay.

For the awareness of all senators and staff, we intend to vote on amendments as they are raised, but we'll hold the vote on final passage of the bill until the end of the session. We'll keep members and staff updated on the timing of the vote on final passage. As a reminder, when discussing an amendment, please identify which amendment you are discussing by its name and Number. I will now begin consideration of S.4428, the No Aid for Ghost Students Act. I thank Senator Moody and her co-lead, Senator Hassan, for their leadership on this issue.

The bill has undergone extensive bipartisan negotiations, stakeholder engagement, and multiple rounds of technical feedback from the administration. Federal student aid has seen an alarming increase in fraudulent applications in recent years. We must ensure taxpayer dollars go towards the students who need them, not the scammers and fraudsters. Every stolen or lost dollar could have helped another student achieve their educational dream. And frankly, when the public hears about it, undermines their faith in these sorts of programs.

There's more at stake than even the hundreds of billions of dollars. We have a manager's amendment, S4428. I move to adopt the manager's amendment in the nature of a substitute and have it considered original text for the purpose of further amendments. All those in favor, please say aye. Aye.

All opposed, say nay. The ayes have it. The motion's agreed to. I'm now going to ask Senator Moody to offer her amendments, as she is the lead author on the bill. Senator Moody.

Thank you, Chairman Cassidy. I don't think it's lost on anyone that America has a fraud problem. We see it every single day. And I commend you, Chairman and Senator Hassan, for the extensive work you have both done. To help bring this important bipartisan legislation before the committee today.

It's simple that if we're going to dedicate taxpayers to helping students pursue an education, we need to make sure that that money that we dedicate goes to students and not fraudsters. Ghost students, as they are called, which are not real students, it's just fraudsters posing as students to try and get taxpayer dollars. Ghost students have stolen billions in student aid, and that deprives American students the assistance Congress has provided for them. Them. The Trump administration has established an effective system right now that quickly screens applications for markers of suspicion, and it briefly holds payments to applicants that are flagged as highly suspicious, and it requires them to prove their identity before the funds go out.

I can tell you, as a former prosecutor, as a former attorney general, once the funds go out, it is incredibly hard to ever get them back. So the American taxpayers are out that money, and we're just— we cannot then go to rightfully deserving students. The No Aid for Ghost Students Act, which we're considering right now, will protect students and taxpayers from fraud by codifying the system and providing additional guardrails to protect students, actual students that are seeking help. This is easy, straightforward, We've sought bipartisan input all the way up until today, and I urge all of my colleagues to vote in favor of this bill to protect students and frauds and, and protect them against fraudsters that are trying to take money that is available to them. So thank you so much, Mr. Chairman.

Does anyone else wish to comment upon this amendment or on the bill in general? Senator Hassan. Mr. Chairman, thank you. And I want to also thank Senator Moody for her leadership here and support the amendment that she and I have just, uh, bringing forward, which makes a technical, uh, grammar, uh, correction to the bill. But let me speak to the substance for a second if I could.

While Congress and the Department of Education have worked for years to prevent financial aid fraud, criminals have become increasingly sophisticated with their tactics, armed with the power of AI, technological advancements, and stolen identities that they've gotten on the dark web. This bipartisan bill seeks to better protect our financial aid system from identity theft that is harming everyday individuals, straining colleges, and stealing aid from those who need it most. And I do want to point out that this is not just about protecting colleges and the overall student body and the financial aid system. Every single day, people across the country are targeted by financial aid fraudsters, and we have to act now to protect those people. For example, a financial aid administrator at a school in my state recently detected suspicious activity when reviewing financial aid disbursements and found that a fraudster had stolen the identity of an individual who was not enrolled at the college in order to obtain financial aid.

The individual whose identity was stolen is severely disabled and nonverbal, and his mother had no idea that his identity had been used to steal more than $7,000 in financial aid. In another case, A financial aid administrator was contacted by an individual who saw student loans on her credit report, even though she had never attended that New Hampshire school and had never applied for student loans of any kind. In this case, fraudsters had stolen nearly $6,500 in federal student loans using her identity. Stories like this exist in every one of our states, and we have a role and responsibility to help schools protect financial aid, but also to protect people from having their identities stolen. Because the work it takes for a disabled nonverbal person to reclaim their identity and qualify, for instance, for other benefits is significant.

So this is a really important bill. It has safeguards in place to address some of the concerns that colleagues on my side of the aisle have raised, and I hope very much that people will support it. Thank you, Mr. Chair. Senator Hassan, Chairman's privilege is Senator Moody.

Senator Sanders raised the issue that this could keep people who are lower income or rural or others from being able to access student aid. Can you please address that concern? Go ahead. Yes, I will do that. In fact, I— we would not have put this bill up and worked on it together or put this bill up if it wasn't to protect genuine students that are making application.

This bill is to protect against when an application comes up, they're reviewing that, and you may have a purported student out of Tampa, Florida with an IP address in Africa. Like, these are things that we— you can briefly hold, make sure the funds don't go out to a ghost student, just to confirm the identity of the person making application. There are simple fixes that we can make in our laws right now that would save billions in taxpayer money. This is one of them. So unless the person that we fear may lose access to a loan has an IP address in Romania or North Korea or Africa—.

That was one of the— that's an example that I was giving you. And that this would only— and again, briefly, they can, they can do these very quickly. It's not like you're holding these days or weeks. They hold it for a moment, they confirm identity. Sometimes they can do it online with the applicant.

And it— we were very specific that it's the ones that are marked as highly suspicious. Okay. And does—. And I would just add that fraudsters target the most vulnerable low-income students because these are the people who are less able to have fewer tools to protect their credit and their identity. And so we have guardrails in the bill to ensure that the Education Department is held accountable through public reporting.

We have roles for the Department's Office of Inspector General and the GAO in monitoring this system. It's also endorsed by the American Association of Community Colleges, the Association of Community College Trustees, the American Council on Education, and the Center for Higher Education Policy and Practice at Southern New Hampshire University. If there's no objection, I move to adopt this by voice vote. The, the amendment. The amendment.

All those in favor, please say aye. Aye. All those opposed, say nay. The amendment is adopted. Do senators— do any members wish to offer amendments?

Senator Sanders. Thank you, Mr. Chairman. I call up Sanders Amendment Number 1. This amendment is simple and it's straightforward. It would simply prohibit the federal government from garnishing the Social Security checks of seniors and people with disabilities to pay back student loans many of them took out decades ago.

You know, when we talk about student loans, we kind of think we're talking about young people in their 20s or 30s. I've had a meeting with people who are grandparents who are still paying back their student loans. Uh, and as a result of Trump's recent decisions, the amount that they're paying back has gone up very significantly. Mr. Chairman, in America today, More than 1 in 3 seniors with student loans are reliant on their Social Security checks to make ends meet. Half of seniors who had a Social Security check garnished as a result of unpaid student debt skipped a doctor's visit or could not obtain the prescription drugs they needed because they cannot afford it.

I mean, in the richest country in the history of the world, no senior should have their Social Security payments taken away from them to pay back student debt. And I urge my colleagues to support this amendment. I understand the ranking member's concern, but I want to point out this amendment doesn't have a score or technical assistance. Would you consider offering and withdrawing? And I will agree to work with you on this and to, get it done.

Well, I thank you for the offer, but I think, What it tries to do is, is pretty clear, Mr. Chairman.

It is incomprehensible that when so many seniors are struggling today to stay alive, when half of seniors, older people in this country don't have money saved for their retirement, you don't garnish their Social Security because they can't afford to pay back a student debt that they incurred decades before. I think it speaks to itself, and I would like a vote on this amendment. And then let me say for the record, I agree, um, Social Security checks being garnished to repay— garnished being to repay student loans is something that we should all be concerned about. But I'll point out it's not happening. In June 2025, the Trump administration indefinitely paused garnishment of student Social Security checks.

But that said, under our system, this amendment would score and there has been no pay-for presented. Perhaps most importantly, Senate Republicans have already taken steps to mitigate the possibility of Social Security garnishment through reforms made in the Working Families Tax Cuts Act. And the folks who are theoretically most likely to have their Social Security check garnished to repay student loans are elderly parents and grandparents who took out Parent PLUS loans. That's why Senate Republicans capped Parent PLUS loans at $65K per student. This new limit ensuring parents and grandparents cannot borrow into excess, putting themselves into a situation that could lead to garnishment.

I will move to table this amendment and encourage colleagues to do the same. The clerk shall call the roll. Senator Paul. Aye. Senator Collins.

No. Senator Murkowski. She's an aye by proxy. Senator Marshall. Aye.

Senator Scott. Aye. Senator Hawley. Aye. Senator Tuberville.

Aye. Senator Banks. Senator Houston. Aye. Senator Moody.

Aye. Senator Armstrong. Aye. Senator Sanders. No.

Senator Murray. No. Senator Baldwin. No. Senator Murphy.

No. Senator Kaine. No by proxy. Senator Hassan. Senator Hickenlooper.

No by proxy. Senator Markey. No by proxy. Senator Kim. No by proxy.

Senator Blunt Rochester. Senator Ulster Brooks. No by proxy. Chairman Cassidy. Aye.

I have 11 ayes, 12 nays.

Okay. Is there anybody who wishes to comment upon the amendment?

Okay, seeing none, we'll now vote on the adoption of the amendment. I shall be voting no. The clerk shall call the roll. Senator Paul. No.

Senator Collins. Aye. Senator Murkowski. She is no by proxy. Senator Marshall.

Senator Scott. Senator Hawley. Senator Tuberville. Senator Banks. Senator Houston.

No. Senator Moody. No. Senator Armstrong. No.

Senator Sanders. Aye. Senator Murray. Aye. Senator Baldwin.

Aye. Senator Murphy. Aye. Senator Kaine. Aye by proxy.

Senator Hassan. Aye. Senator Hickenlooper. Aye by proxy. Senator Markey.

Aye by proxy. Senator Kim. Aye by proxy. Senator Blunt Rochester. Aye.

Senator Ulster Brooks. Aye by proxy. Chairman Cassidy. Aye. No, no, I'm sorry, I'm sorry.

No, no, I'm sorry. No. Okay, I have 12 ayes, 11 nays. Okay, the amendment passes. Now, with the absence of a score— Yes, sir.

And just so that I can understand how this works, because I don't, if, uh, If we have to be present for the ayes to win, do they not have to be present for the ayes to win?

No, not for amendments. And noes on passage can be done by proxy. But ayes on passage cannot be done by proxy if you need a majority. Okay, got it. Okay.

Well, darn. Thank you.

Thank you, Senator Scott.

Okay. So we're not going to vote on this today. We'll continue to work on it. Given that we don't have a score on this, we shall not vote on the bill today, and we shall continue to work on this to hopefully get it into a condition where we can prevent $300 to $500 billion in fraud per year from going out the door because of people with IP addresses in Romania and Africa and North Korea. Filing fraudulent claims.

So we still don't have Murkowski. She's still en route. So I think we might just have to wait.

Do we have any sense of how far she is? 5 To 10 minutes.

Hold just a minute. We're obviously waiting for Senator Murkowski. Let me just make one more call to find out how far she is. She was in Nome the last I heard.

We could do an off-the-floor vote on those issues.

Everybody's got a tight schedule. And so what we'll do is recess the hearing and we'll meet off the floor, subject to the call of the chair. And we'll meet off the floor at a later vote in order to pass the nominees that we have before us. That'll be an en bloc vote. As I understand, Senator Sanders, you've agreed to an en bloc vote for those folks.

So it'll be a rapid vote. But I thank everybody for their indulgence. And then remember that we'll have a hearing for Senator— excuse me, for Dr. Heidi Overton after this. To be the next FDA commissioner. But we'll take a 5-minute break.

Okay. Thank you.

Please record anyone that was present for the first part of this meeting as being present for this part of the meeting. So thank you, Dr. Overton, for appearing before the committee and for your service to our nation. I appreciate your conversations over the past month. The United States has led the world in life-saving medical discoveries, accounting for 40% of the world's biotech-related patents for drugs. Because of the FDA's review process, we produce twice as many novel chemical or biological products as European countries.

But we are losing that advantage. Regulatory uncertainty and outdated frameworks at FDA stifle American innovation and push developers overseas including the Communist China, where there is a more streamlined regulatory environment. Yes, in some cases China is cutting corners and ethical boundaries, but that does not change our responsibility to make the United States a more attractive place for clinical trials to be conducted. I recently released proposals to eliminate unnecessary barriers in the FDA approval process for different products while ensuring that the gold standard of review is maintained. This should be a top priority of any future commissioner in close coordination with Congress.

Our next FDA commissioner must have the vision and drive to ensure continued American biomedical leadership. This would be a commissioner with a vision for reform, who knows how to get buy-in across the agency to embrace change, and whom the American people can trust to make product approval decisions based on unbiased, sound science. Unfortunately, politicalization and misinformation severely damaged the credibility of FDA and HHS. Last week, HHS Deputy Secretary nominee Chris Klump spoke passionately about the need to differentiate the scientific process from policy decisions to prevent political interference from blurring those lines. I mentioned in the previous markup about reports that the president considered giving OMB a direct role in individual NIH decisions.

I said then, and I repeat, these decisions must be made by people who understand science, not politicians. I hope to see the White House decide against politicizing the approval process. The next FDA commissioner must prevent politics and political prejudice from influencing regulatory decisions if there is no substantiating scientific evidence to support. In particular, the agency has failed to follow the science and act when it comes to the dangerous chemical abortion drug that kills innocent babies and can harm mothers. But these safety concerns are common sense.

For the example, the abortion drug is only approved for up to 10 weeks gestation and should not be taken when the mother is at risk for ectopic pregnancy. How do you check for an ectopic pregnancy without an inpatient ultrasound? You cannot. Dr. Marshall made the point during our hearing on this that you really can't know the gestational, gestational age without an in-person scan. He had particular credibility as an obstetrician.

And how can we know the frequencies of these complications without the requirement that the doctor prescribing report an adverse event? This is something the next FDA commissioner needs to take action on. Beyond policy changes, FDA is in desperate need of stability. It needs strong leadership, someone who is radically honest with the American people and promotes science over ideology. Dr. Overton, you're a medical doctor.

Of course, I— that resonates with me. You've seen patients. You have a deep understanding of the healthcare system and health policy. But I have concerns. You are behind the president in the Oval Office when he signed an executive order to break up the vaccine schedule into more doses, completely ignoring the reality of families today struggling to make life affordable.

This doesn't just inconvenience them by making them spend more money by taking time off to take the child to the physician. That's point number one. Point number two is the order is based on zero scientific evidence. At the same time, the President called the MMR vaccine quite lethal. There ain't no scientific evidence for that.

And by the way, this comes as we see Americans dying from measles for the first time in decades. I can see that with my own eyes. To say the vaccine is quite lethal will discourage some from being vaccinated, yet the scientific evidence says that getting vaccinated practically eliminates The risk of getting measles, of being hospitalized, of transmitting the infections to other people. It's not just about your body. It's about the person you infect who may get hospitalized, who may die, and perhaps even that individual themselves dying.

That's the risk in being unvaccinated. That's what the scientific evidence shows. When Dr. Safire, the president's Surgeon General nominee, was asked before this committee if the MMR vaccine is lethal, She said no, unequivocally. I admire that the vaccine is safe and effective. I will ask you that question today, Dr. Overton.

This committee needs to know whether you'll be radically honest, whether you will use your authority to stand up for sound science and protect children's health, that you will unequivocally say that the MMR vaccine in its current formulation is safe. It is not lethal. You also need to ensure that uninformed ideologies do not influence FDA's decision on whether to approve individual products, even if the president is pressuring. This is something you will need to answer to get the committee's support. I will note the secretary of HHS, Secretary Kennedy, gave me guarantees.

Later, he did not keep those. I asked him why not. He said that the president had told him to do something, and as opposed to keep his promise to me, to this committee, by extension the American people, he had to do what the president told him to do. We can argue that ethics system, but that's his ethics system. I need to know your ethics system.

With that, I yield to Senator Sanders. Well, thank you very much, Mr. Chairman. Uh, today we'll be considering President Trump's nominee to be the commissioner of the Food and Drug Administration, Dr. Heidi Overton. Uh, the FDA was established by Congress to regulate prescription drugs and the food that we eat, among many other things. According to the FDA's website, its mission is to, quote, make medical products more effective, safer, and more affordable.

More affordable. Uh, in my view, the FDA is failing that very important responsibility.

In America today, despite what President Trump has told us, we continue to pay by far the highest prices in the world for prescription drugs, in some cases 10 times more than the people in other nations. While, while 10 top drug companies made over $100 billion in profits last year and paid their CEOs exorbitant compensation packages. One out of four Americans cannot afford to pay for the medicine they need, and thousands of families face financial ruin as they pay prices that they cannot afford for the prescription drugs that keep them alive. Major companies make $100 billion in profits, CEOs get huge compensation packages, and people die or go into financial bankruptcy because they can't afford the medicine that they need. In my view, we need a commissioner of the FDA who is prepared to take on the greed of the pharmaceutical industry and use every tool at his or her disposal to substantially lower the outrageous cost of prescription drugs in our country.

That's not all. For decades, Congress and the FDA have allowed large corporations to make huge profits by enticing children and adults to consume ultra-processed food and beverages loaded up with sugar, salt, and saturated fat. It's an issue this committee has looked at time and time again. There is growing evidence that these foods are deliberately designed, deliberately designed by these companies to be addictive, similar to cigarettes and alcohol, and lead to a higher risk of Type 2 diabetes. Bottom line, much of the food that we as Americans are now consuming are making us unhealthy and are contributing to the fact that our life expectancy is lower than many other wealthy countries.

And that is unacceptable. In my view, we need an FDA commissioner who is prepared to take on not only the pharmaceutical industry, but the food and beverage industry to protect our kids, and all of our people from the twin epidemics of obesity and diabetes. Further, the FDA commissioner is responsible for maintaining the safety of the American food supply. Yet it seems like every day there's a new food product being recalled due to contamination. Under the Trump administration, our country has experienced an unprecedented, unprecedented number of outbreaks of foodborne illnesses linked to healthy foods like lettuce, eggs, and blueberries.

At the same time, the number of food facility inspections conducted overseas by FDA is down by more than 35% compared to 2019. How can we expect to make America healthy again when we have to worry about the safety of the food we eat? Dr. Overton, based on the work you've done to advance this administration's agenda, I have serious concerns about your nomination to be commissioner. Thank you very much, Mr. Chairman. Dr. Hagerty— Senator Hagerty will now introduce, and he'll answer the question of why a guy from Tennessee is introducing somebody from New Mexico.

So I look forward to that explanation. Senator Hagerty. We actually share a distinction in common. We were both White House fellows. You both what?

We were both White House fellows. I must say I was at a different point in time than Dr. Overton, a little bit earlier, but it's my honor to be here today. Thank you for having me, and I'm very pleased to introduce Dr. Heidi Overton to serve as the commissioner of the FDA. The FDA is charged with protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, cosmetics, and the nation's food supply. FDA's gold standard for science helps ensure American patients have access to safe, effective, and innovative treatments.

However, China has significantly advanced its domestic biotechnology— biotechnology industry and drug development ecosystem, drawing investment and volume away from the United States at an accelerating pace. To maintain our national lead, we must ensure that the United States maintains its competitive advantage, which starts with ensuring that the FDA has stable yet ambitious leadership. I'm confident that Dr. Overton is that leader. Dr. Overton currently serves as Deputy Assistant to the President for Domestic Policy at the White House, where she plays a significant role in the administration's healthcare policy agenda. She was selected to be a White House Fellow, as I mentioned, distinction that I share with her, um, in the Office of American Innovation and the Domestic Policy Council.

In that role, she advised senior administration officials on healthcare policy and worked with HHS and CMS to to develop and execute major healthcare initiatives. She received her MD from the University of New Mexico and her PhD in clinical investigation from the Johns Hopkins Bloomberg School of Public Health. She previously completed a surgical oncology research fellowship at Johns Hopkins and trained as a general surgery resident, caring directly for patients and performing 300 surgical cases. In announcing her nomination, President Trump stated that the FDA needs Dr. Overton's leadership to, quote, ensure that the U.S. remains the world leader for scientific discovery and for cures. She's committed to implementing this go-fast culture that President Trump refers to, one that will maintain American dominance in pharmaceutical innovation by reducing regulatory burdens and strengthening critical processes.

Dr. Overton is the leader that FDA needs at this consequential moment for the future of American biosecurity. I'm pleased to support President Trump's nomination and look forward to Dr. Overton's swift confirmation. Thank you. Thank you, Senator Hagerty. I shall be open to questions.

And as an outset, I want to again praise— I again praise Dr. Safire when she came. Some come and give equivocal answers that give a backdoor to later saying, oh no, I left— I didn't— I didn't tell somebody what wasn't true. What's up? Oh, I'm sorry. Your statement.

I'm geared up. You make your statement, then I'll make my statement.

Thank you, Chairman Cassidy, Ranking Member Sanders, and members of the Senate HELP Committee. Thank you for the opportunity to appear before you today. It is an honor to be considered for the position of Commissioner of Food and Drugs. I would like to thank President Trump and Secretary Kennedy for entrusting me with this opportunity to serve the country. I am deeply honored.

First and foremost, I thank my Lord and Savior Jesus Christ for every blessing and opportunity in my life. Matthew 5:16 and Colossians 3:23 have been my life verses since I was a child, and I sincerely hope to exemplify these principles today and always. I want to recognize and honor my incredible family, my parents, Bill and Natalie Overton behind me, my sister and her family, Alyssa, Nathan, and Chloe Joy Hatala, 2 years old at the end there. Every part of my success belongs to them. Their lives of service, especially my dad's service as a pastor and my mom's as a nurse, is my inspiration.

I would also like to thank the abundance of friends, mentors, colleagues who have supported me, many from the Four Corners area and traveled here to be, be with us today. Throughout my life and career, I have experienced seemingly intractable health system failures firsthand, and it has been my motivation to be part of the solution. From seeing disparate health outcomes in the tribal communities surrounding my hometown of Gallup, New Mexico, to 2 years of surgical training in inner city Baltimore, to the White House during COVID and to my own personal health journey managing adult onset type 1 diabetes, I have seen system failures detract from the ability of patients to benefit from the world-leading innovation and medical discoveries available in America. These experiences culminated in a medical degree from the University of New Mexico a doctorate of public health and clinical investigation from the Johns Hopkins Bloomberg School of Public Health, a White House fellowship, and board certification in general public health and preventive medicine. I have served on the boards of the University and Hospital of UNM.

I contributed to writing clinical guidelines to address the role of surgical overprescribing during the opioid crisis, and I served in key roles in the COVID response in testing and vaccine prioritization. If confirmed as Commissioner of Food and Drugs, I will immediately set my focus to restoring the primacy of American innovation while furthering the core missions of advancing national security, increasing access to affordable treatments, and promoting public health. President Trump's direction for me in this role, should I be confirmed, is to go fast. Slow and prohibitive requirements for cutting-edge therapies at the FDA means investment is increasingly flowing to China, who has found ways to do things faster and cheaper. As Chairman Cassidy highlighted in his recent report, China has surpassed the United States as a top venue for clinical trials.

This should give pause to every American and to those who serve on their behalf. When we lose this advantage, we lose our health security. And when we lose our health security, we lose everything. This problem is not partisan. We must reverse this trend.

My message to the committee today is that time is certainly of the essence. We can protect America's global leadership in biotechnology, but we have to act fast. The FDA has begun work on this through Operation Trialblazer. If I have the privilege of being confirmed, I will work with the dedicated career professionals to make sure every aspect of clinical trials and drug development is optimized. This will not only bring development back to the United States, It will bring cures to patients faster.

If confirmed, I will work to ensure every talented person at the agency shares the goal of making the FDA the agency of the possible rather than the impossible. The recent rapid approval of a new treatment for pancreatic cancer is one example. This should be the norm for the FDA so that all Americans get early access to the best care. It is important to remember, remember that food is also a critical part of the Food and Drug Administration's name. And we must continue the revolutionary steps to improve food safety, quality, and transparency.

Finally, the FDA must remain at the front lines of promoting public health and safety. From continuing to tackle the opioid crisis and the new dangers of synthetic 7OH, to protecting children from illicit foreign vapes containing dangerous chemicals, to safeguarding infant formula and ensuring robust food outbreak response systems, the FDA must remain vigilant and ready to execute. In closing, I am confident that I have the clinical, research, and policy background in this critical moment to drive real reform, along with the proven ability to manage complex interagency processes to achieve meaningful outcomes for the American people. The talented career scientists and regulators at the FDA deserve leadership who will empower them to tackle these issues head-on for the purpose of securing a stronger America. If I have the privilege of being confirmed, I am committed to working with this committee and with all stakeholders to ensure FDA meets this generational opportunity to continue leading the world in innovation while furthering the core missions of advancing national security, increasing access to affordable treatments, and promoting public health.

Thank you for your consideration. I look forward to your questions. Dr. Overton, I shall start. As I started to say earlier, please be unequivocal in your answers. As scripture says, let your yay be yay and your nay be nay.

You were standing behind President Trump when he called the MMR vaccine potentially quite lethal. Is the MMR vaccine safe and effective?

Senator Cassidy, as a physician, I appreciated our conversations and thank you for doing this hearing so quickly and have had the privilege of taking care of patients. Yay, yay, nay, nay. Share that. Is the MMR vaccine lethal is your question. I have— the MMR vaccine is not lethal.

It is safe and effective. Yes, Senator, the MMR vaccine is safe and effective. Do you— so you disagree with the president on that? Senator, if confirmed as FDA commissioner, my role would be individual product determinations and what the law requires for statutory standards of safety and efficacy. The MMR vaccine is currently licensed and approved by the FDA.

It is safe and effective, and it is our best tool right now in the public health response to the measles outbreak. It is 97% effective in stopping transmission of the virus after 2 doses. Are there any vaccines on the US market right now which are unsafe? Senator, every vaccine on the US market right now are safe and effective according to the FDA. As FDA commissioner, what would you do if inaccurate information about the safety of an FDA vaccine FDA-approved vaccine was being communicated to the American people.

Senator, thank you for the opportunity to address this. The, the role of the FDA commissioner is very clearly defined in statute and has requirements for individual product safety and efficacy determinations. If I'm confirmed as commissioner of Food and Drugs, my commitment will be to make sure that Americans know the status of every product that is approved by the FDA that have met those requirements that are laid out as safe and effective. But if someone is alleging something is not safe when FDA has approved it as safe, what would be your role? Yeah, Senator, I think right now my recommendation to the American people, as I said before, is the nominee for the commissioner of Food and Drugs is that the MMR vaccine is safe and effective.

Except that I'm giving you a not so theoretical when someone is saying things alleging that the FDA was wrong in approving a drug as safe? What would be— let's assume that someone is your boss. What is your role? Thank you, Senator. I think the, I think the role of FDA commissioner, if confirmed, and what I would do in this role is to communicate and use my scientific training and my clinical background to describe what is currently known.

And what is currently known is that the vaccines that have been approved by the FDA FDA have met the standards for safety and efficacy. FDA has a robust post-market safety review system, and I would communicate that any time that any product needs further safety review, that is appropriate for the FDA to do. Right now, every vaccine that is on the market has been determined to be safe and effective. There's ongoing review. And I'm sorry to interrupt.

I just have just 2 minutes left. Yes, sir. What role should the White House our Health and Human Services officials who are not part of the FDA play in deciding whether FDA should approve a product? Thank you, Senator Cassidy. If I'm confirmed as FDA commissioner, my, my role, my commitment would be to follow exactly the statutory standards for safety and efficacy review of every individual product.

That role, as the statute outlines, is vested in the Commissioner of Food and Drugs. And so policy priorities can be set by the President and are set by the President. Individual product reviews and determination are— should be according to statute under the purview of the FDA. It would take the recommendations of the career experts who are reviewing that. Most individual product determination decisions are made at the career center level, and that is how the reliance on the expertise for each individual product is made, and that is what is appropriate.

Let me now say what I said in my opening statement. The Secretary gave me guarantees, by extension this committee, our Congress, and the American people. He later backtracked on those. He said he had to because the President told him to do something different. If you give us— and that's your problem.

That's your problem. You are trustworthy, it seems. Had other people with whom we thought guarantees coming from the White House and the secretary would be kept, and they weren't. If the president asks you to do something that goes against those guarantees you give us today, what will you do? Yeah, Senator, thank you for the opportunity to address this directly.

I've had the privilege of working for the president in the first term and again for a year and a half. What I know is that he is driven by outcomes and he wants the best possible solution for the American—. I'm almost out of time. I'm out of time. That's not my question.

If he asks you to do something which goes against the guarantee you've made to these American people through us, what will you do? Senator, I've had robust discussions with the president. I would give him my best advice and I would follow the statutory requirements for the role of FDA commissioners— the commissioner regarding individual product determinations for safety and efficacy. And that would be what would guide every decision if confirmed to this role. I'm out of time.

Senator Sanders.

Thank you, Mr. Chairman, and thank you for your line of questioning. I think, Dr. Overton, the concerns that Senator Cassidy raised are concerns that many of us have.

We have a president who, in my view, does not particularly believe in the rule of law, wants to get things done. And if people do not obey his wishes, He deals with that. And what I think the committee wants to know is whether you are going to have the courage to stand up to somebody who lies all of the time, who does not particularly believe in science. So that is the question. Will you have the courage to stand up to President Trump?

Senator Sanders, thank you for the opportunity to be here today, and thank you for your opening comments on the high cost of prescription drug prices and the urgency that we have to address those.

Answer the question, please, Doctor. Yes. And to your question of— Senator, I have worked for the president for a long time now and earned his trust because I have been part of robust discussions to bring him the best advice. And my job would be to follow the law and execute what is required of the Commissioner of Food and Drugs, which is individual product decisions based on safety and efficacy standards. All right.

Let me ask you— let me ask you a question a little bit beyond your job description that you for the job you're applying for here. The United States is the only major country on Earth not to guarantee healthcare to all people as a human right. There are studies that tens of thousands of people in this country die because they don't get to a doctor when they should because they can't afford it. Do you happen to believe that healthcare is a human right that should be available to every man, woman, and child in our country? Senator Thank you for the question.

My experience as a clinician and the patients that I've taken care of from rural New Mexico to Johns Hopkins Hospital has been a privilege. And every— having access to that healthcare is so important. The importance for us is to be able to deliver that healthcare and to execute the responsibilities that are vested from Congress into the agency. Doctor, you're not answering the question. It's not a complicated question.

I live 50 miles away from the Canadian border. Somehow everybody in that country can go to a doctor. Everybody is covered throughout Europe. Everybody is covered. We spend twice as much per capita on healthcare, and we got 85 million who are uninsured or underinsured.

Is healthcare a human right? And you will work with us to make sure that every American has healthcare because it is a human right. Senator, it has been my privilege to, to be able to take care of patients and to make sure that they have access to the best care possible and to deliver that care. And if confirmed—. I don't have a lot of time, Doctor, but I'm gathering that you do not think that healthcare is a human right.

Let me ask you this. President Trump has claimed in his State of the Union address that he took prescription drugs from the highest price in the entire world to the lowest. Wow. The American people are so excited to know now that we pay the lowest prices in the world for prescription drugs. What do you think?

Was the president telling the truth? Do we pay the lowest prices in the world for prescription drugs? Do we pay the highest prices in the world?

Senator, lowering drug costs is something that we share, and there have been— there has been immense progress, especially on individual products. Right now, 89% of branded drugs have signed agreements to lower their prices and make that available directly. We pay the lowest prices in the The president said it. He's, he's your boss. He just told us, you know, you're going to stand up to him.

So he just said we pay the lowest prices in the world for prescription drugs. It's true or it's not true. Is it true, Senator? We have seen—. Is it true that we pay the lowest prices in the world for prescription drugs?

As President Trump has said. So, Senator, the results that we have seen for the American people from the most favored nation policies have dropped prices. And right now, CPI says that for the first time in 60 years, prescription drug prices have gone down by 3%. Yeah, which may have something to do with the legislation that we passed several years ago. Uh, let me ask you this.

Um, as you are aware that we have an obesity epidemic in the United States. Uh, and, um, since the 1970s, the situation has gotten so bad that 1 out of every 5 kids in America is now obese. More than 35 million Americans have type 2 diabetes. That's over 10% of our population. Earlier this year, this committee passed legislation to require strong warning labels on ultra-processed food and to ban junk food ads targeted to kids.

No ads on TV for junk food targeted to kids. Do you support that legislation? Senator, I support the goal of getting the best information to the American people and addressing the childhood obesity epidemic. It is It's terrible that only 20% of our youth are eligible for the military because of their health status. We— I support, like I said in my opening statement, increased food quality, transparency, and safety.

And that is—. Should we ban TV ads? Should we ban TV ads that advertise junk food to kids, which is what the legislation here did? Senator, here today to talk about my nomination for the Food and Drug Administration, and appreciate the question. I know we're out of time, but happy to continue answering.

Okay, thank you very much.

Senator Cassidy has asked me to chair in his absence, so I'm very pleased to call upon myself for the, the questions here. Uh, Doctor, first of all, let me say that I enjoyed our in-depth discussion in my office. I still have a number of concerns that I want to raise with you today. One is actions that the FDA recently took concerning flavored nicotine products. As I explained to you, Senator Dick Durbin and I have worked for years on smoking-related issues.

When youth use e-cigarettes, nearly 90% are choosing flavored products. Yet in August, the FDA authorized several new flavored nicotine pouches and vapes, including flavors like blueberry and mango and citrus and autumn spice, cappuccino and cool mint. These new approvals, in my judgment, jeopardize the recent progress that's been made in reducing the number of youth who use e-cigarettes and become addicted to nicotine. FDA justified these approvals by saying that these products give more options to adults. However, we know that the demographic really driving consumption of favored flavored vapes are young people.

It's 90% are more likely to choose flavored products. The previous commissioner of the FDA strongly disagreed with this decision, but apparently was overruled. What is your position on FDA's approval of more flavored vaping products?

Senator, thank you, and, and thank you for the, the amount of time in our discussion on type 1 diabetes and your leadership in that, that I've personally benefited from greatly. Thank you. Specific to your question on on flavored vapes. I would first like to propose that there is 100% agreement from this administration that we must protect kids from illegal substances and from vapes and from flavored vapes. We saw some of that progress.

President Trump signed Tobacco 21 into law last administration, and the, the drop now at the lowest amount of 5% is still too many. From a peak of 27% to 5%, still too many. So number one, we have to protect kids, and we agree with that. Number 2, there is the regulation and the law on the books that the FDA has to abide by, which is looking at appropriate— the standard of appropriate for the protection of the public health. That decision on flavored vapes was recommended by the careers because they believed that standard was met because adults— so many adults are using flavors preferentially.

The Journal of Harm Reduction lays out that those who quit smoking because of vapes used flavored vapes. So this is a, a robust discussion, but I would want to work with you that if that standard is not appropriate, we should work on statutes to fix that because we have to protect kids, number one. And the other big problem for the FDA is the flood of illicit vapes on the market. The FDA asked for more authority in its congressional justification this year to have more authority to better enforce against those products. And those are things I would hope to work with you on because we do agree on protecting kids.

Thank you. I think this was a terrible decision by FDA. I agree with the former commissioner that it should not have occurred. I want to turn to a different issue, and that is how slow the FDA is despite Congress providing expedited path pathways in improving drugs for rare diseases for which there are no options. And I think of ALS, where there's very little that can be done.

I think of ataxia. I think of Wolfram syndrome, pediatric syndrome. There are many. What will you do to help expedite the approval of promising drugs that have been shown to be safe, but where it's very difficult to do large clinical trials because there are so few people who have these rare diseases. But right now, they have nothing to help them.

Yes, Senator, this is a key priority and something that under the new leadership of the center directors at the FDA, they have started to make progress. There are good policies underway. For example, the plausible mechanisms pathway, but not just N of 1. We should think about N of 5, N of 20, and of 20. And those cases where having the flexibility and the risk-based review determinations for those situations like we talked about, where people are willing to take more risk in these scenarios, should be formalized into policy.

Chairman Cassidy highlighted the review lottery in cases like this. It's very important that there is best practices across reviewers, that is coming from the direction of the, the center leaders who right now are saying frontier science doesn't matter if it's not accessible to patients. So I would want to use all of the statutory authority we can right now at the FDA, if I'm confirmed, to expedite that, and where there are any barriers, to come to you and work with you on ways to further provide that clarity. But I believe there's a lot we can do right now to help these patients. Thank you.

Senator Murray. Thank you very much. Dr. Overton, do you agree with the FDA approval of mifepristone, which means the agency deems it safe and effective? Senator, thank you for the question. I look forward to getting to meet with you next week and talk in more detail.

Mifepristone was approved by the FDA as having met its safety and efficacy standard. No, my question— I know what the FDA has done. I asked if, if you agree with the FDA that it's safe and effective. Senator, as the nominee for, for the Commissioner of Food and Drugs, my job would be to abide by the statutory standards set out for safety and efficacy. And when a product is before the agency and has met those standards, I would agree with, with the statutory standards of safety and efficacy.

So you do believe it's safe? I believe it has. I know that it has met the safety and efficacy standard according to the FDA review. Well, just— well, despite what FDA says and despite what decades of science says, you actually published an article 3 years ago that incorrectly described medication abortion as dangerous to women. The fact that you would blatantly contradict decades of high-quality scientific evidence and millions of patients use it is alarming to me.

So that's why I asked you that question. You have stated in an article that you believe it is dangerous. So I asked you, do you believe it is safe today? And you're not answering my question. Senator, thank you to— for the opportunity to discuss this directly.

I have always been driven by data and information and used the clinical training and the research training that I have in, in everything that I have written specific to that publication in '23 was at a time after a change was made at the FDA and how that medication was accessed. And I think it's very important for the FDA in its post-market review, like with every medication, especially those medications that have a risk evaluation mitigation strategy—. I hear you changing your answer now, saying you don't think it is safe. And it's— the FDA agreed that this was safe and effective 26 years ago. And from my— where I come from, I really believe that our FDA needs people who will put science first.

The FDA has said this is safe, and we need somebody in FDA who's going to be there to make sure that this is done by science base. So that's where I come from. Let me change really quickly. I am— I'm almost out of time. As you know, this summer Americans have had to deal with lettuce that causes explosive diarrhea.

There's been an outbreak recalling millions of eggs. Frozen blueberries were contaminated with E. coli. Multiple recalls of infant formula. And the list goes on. What happened this summer just— it cannot happen again.

And coincidentally, all of this happened after Trump and Doge pushed out and fired more than 4,600 people at the FDA. And now the agency, I hear, is trying to scramble to rehire about 3,500 people. That is nearly a 17% reduction in just a year and a half for a workforce whose job it is to keep our food and our medicines safe. Can you tell us how many people currently work at the Human Foods Program at FDA right now? Senator, thank you for the question.

Having not, not been at the agency right now, I don't know the exact staffing numbers of that center. I know there are about 16,000 employees currently. And I know that the FDA, as publicly reported, is hiring to have the best people in the best positions to be able to deliver on the core mission. Food safety is one of those. And there are a lot of things that we can do and work together on.

And— Well, let me just tell— yeah, let me just tell you, because this is really important. The office has approximately 1,700 employees, which is still 13% fewer than they had at the start of 2025. So that is deeply disturbing. So I want you to be aware of that, and I want you to focus on that. And I want to ask you, are you currently aware which part of the FDA's Human Foods Program monitors those kind of outbreaks and foodborne illnesses?

Do you know what it's called?

I think no. Within the, within the Center of Human Foods. Yeah, well, I'll tell you, it's the Food Safety and Inspection Center, I believe. Well, it's the Coordinated Outbreak Risk and Evaluation Network. It's called the CORE Network.

I think that's really important that you focus on that and know that and make sure that it is fully staffed. It is absolutely incredibly important to people's safe— safety, and I think everyone right now is very concerned. Thank you. About what's been happening, and I see a direct correlation to the reduction of staff that has been there. Finally, and I just have a minute, a few seconds left, last year the Trump administration falsely labeled birth control as abortion.

Do you agree that, say, an IUD is an abortion patient. Senator, if I have the privilege of being confirmed, first off, I commit to working with you on the food safety pillars that are critically important. We did ask in the congressional justification for more foreign facility user fees to be able to have more of those inspections and specifically address the problems that were raised. I appreciate that, but I wanted to know if you agree that an IUD is an abortion patient. Senator, thank you for the question.

If I'm confirmed as FDA commissioner, I'll be fully briefed on all their prior decisions and make determinations according to the standards of safety and efficacy?

Well, I don't think you answered the question. Look, I, I think it is outrageous and should be deeply alarming to all Americans right now that the prospect of an FDA commissioner who doesn't know that birth control is not an abortion is deeply concerning to me. Thank you, Mr. Chairman.

Congratulations, Dr. Overton. Thanks for being here today. I'm sure my colleagues across the aisle will have or will ask you a lot of questions, whether you agree with President Trump or not. I know as a senator, sometimes I say things less artfully than I could, but I think focusing on sound bites misses the biggest, bigger picture about you. You've got the experience, the expertise, to lead the FDA, even if some of your background may not seem like the traditional path to this position.

And I want to start with the issue today of, uh, illicit vapes. Okay, we need an FDA Center for Tobacco Products that is efficient, predictable, and able to meet its statutory timelines. Dr. Overton, what steps would you take to improve the FDA's tobacco review process and provide manufacturers with more regulatory clarity.

Thank you, Senator, and thank you for the great conversation that we had and for the encouragement there. I will just note for the committee that my background is very similar, in fact, to a former FDA commissioner who is known to have a very successful tenure and wrote an op-ed with another former commissioner in support of my nomination. So I'd be excited to bring the energy and the ability to solve these complex problems Elicit vapes is one of those problems that we need to solve. I want to work with this committee to make sure that we are doing that in the right way. Number one, we have to protect kids as the first step.

Number two, getting more approvals and— sorry, excuse me— more authorizations for products that have met the standards at the FDA is critical to being able to have a legal, robust market. Right now, part of the problem— and Senator Moody and I discussed this— hi, Senator. To have— there was an immense backlog at the FDA when the Trump administration first came in. They have been— there was up to 27 million applications in PMTA. There have been— it's been immense work to streamline that.

I think there was 310,000 applications that are pending right now, or that were pending in May. They are down to about 100,000. There have been 48 products that were authorized for use. And I think having that robust legal framework is critical in order to get legal approved market products to the people that use them for smoking cessation while having the strongest protections available to keep them out of the hands of kids, which we all agree on, and being able to do proper enforcement with the other law enforcement agencies. DOJ, DHS all have a critical role, and if I'm confirmed, I would work with them to make sure the enforcement is just as strong as we work to fix the backlog that we inherited from the previous administration.

Do you support category-specific product standards for ENDS, nicotine pouch products? And how would you approach developing those standards? Thank you, Senator. I think if I'm confirmed to the role, my first step would be getting a full and complete briefing from the Center for Tobacco Products on exactly that question. I think we do have to have regulatory clarity and certainty to be able to get products that are legal and are helping adults stop smoking and do that in a way that is protecting kids with, again, appropriate input from this committee on how to best do that in accordance with the standard of appropriate for the protection of public health.

So there's streamlining reviews, there is working with, um, with the companies that have applications in front to make sure that they are submitting data and accurately assessing how to meet that standard. But I would want to get briefed fully by the center if I'm confirmed. Thank you. We, uh, we also need to make sure legal tobacco products aren't being undercut by illicit and unauthorized products, including products coming from foreign manufacturers. How would you work with agencies like HSI and DOJ, as well as state and local authorities, to strengthen these policies?

Yes, Senator, thank you. That, that is something that is of critical importance for the agency. There was a request in the, in the congressional proposal this year to have more authorities for better enforcement at the borders and better coordination with the other agencies on knowing what products are coming in. Often they are mislabeled. They are, and we know they are targeted towards kids, video games and candies and other products.

And so that interagency coordination and the experience that I bring from having run very big interagency processes right now would be used on day one to increase our abilities to enforce appropriately. Thank you. Thank you, Mr. Chairman.

Thank you. Let me also correct something for the record. Chairman— excuse me, Senator Murray said that Mifepristone had been shown to be safe and effective. And I will point out it was approved under more stringent safety requirements than are currently in effect, and a post-market safety study is ongoing. I'll let my own remarks as regards the absence of ultrasounds to establish gestational age and ectopic pregnancy as in of themselves indicating what I mean.

Next, we'll go to Senator Murphy.

Thank you very much. Mr. Chairman, um, listen, I share the chairman's concern about this dramatic reduction in faith in the FDA that has happened over the past year, and the reason is simple: people don't believe that science has anything to do with some of the decision-making and that it's all about politics. Here's an example. Um, on April 30th, it's a Thursday afternoon, um, Reynolds, one of the biggest tobacco companies in the country, makes an $8 million donation to the president. Two days later, on Saturday, um, because of that donation, they have lunch with the president, and they tell him that they want a change in FDA rules, especially regarding flavored vapes.

The president calls the FDA commissioner, he calls the Secretary of HHS, and three days later, on Tuesday, new guidance is issued that paves the way to the sale of flavored vapes. That is not a coincidence. Right? That is the definition of political interference in FDA decision-making. Thursday, a donation is made.

Saturday, a meeting with the president. The same day, a call to the FDA commissioner. And 3 days later, 3 days later, the FDA changes the rules. Extraordinary. And 4 days after that, the FDA commissioner resigns, either in protest or because he was fired because of his disagreement with this decision.

I heard you say that your commitment is to science being the guiding marker for decisions made at FDA. So let me talk to you about one of the ways that science has been undermined, and that is the eradication of the advisory board system. So since President Trump came into office, 27% of all advisory boards have been eliminated, and of those that remain, there have been 72% fewer meetings. The Tobacco Advisory Board had no specific meeting and no vote on this specific policy, because if they had had a vote, they would have voted against this. And that's in part why the FDA commissioner resigned.

And so, so long as these advisory boards, which are authorized by Congress, are attacked, eliminated, and restricted from meeting, you are not going to rebound the public's support for independent FDA decision-making. So let me ask you specifically, will you commit to restarting the advisory boards that have been disbanded under this president?

Senator, thank you for, for the question, and hope to have the opportunity to meet and discuss things in, in more detail. I think specific to your question, I will note that since FDA has had a number of advisory committees meeting, and I think they are extremely valuable from everything that I know about the FDA, if I'm confirmed as commissioner, they are a critical part of, of the role of the FDA. Okay, I get it, but you've done a pretty good job of avoiding answering questions so far. So will you commit— it's yes or no— will you commit to restarting the committees that have been disbanded? Senator, if I'm confirmed as FDA commissioner, advisory committees will meet at the FDA.

I have to look at specifically all of the ones that you're— that might be disbanded to what you're asking. But they're the ones that I'm familiar with, like the Vaccine-Related Biologic Product Advisory Committee has been meeting. They've been making recommendations. Those recommendations have been used to— as normal process. And I would continue that direction.

It's critical to get there. Will you at least commit to ceasing the campaign of disbanding committees? Will you keep the committees that exist today, or are you open to, uh, shutting down more advisory committees? Senator, if I'm confirmed as FDA Commissioner, advisory committees will be a critical part, and I—. Can you commit to us that you will not shut down any additional advisory committees?

Senator, my goal would be to not shut down any advisory committees, but to look at all of them to make sure they're fulfilling their highest purpose, getting the best experts on, providing recommendations. They are a key part of the administrative record of the FDA, and the FDA does rely on that. I hear you. That would be a huge part of, of my role if confirmed. I think it's, it's, I think it's careful wording that your goal will be to not shut down advisory committees.

That's not a commitment. Finally, do you see anything wrong with the chain of events that I just articulated for you? I mean, that's an extraordinary story. An $8 million donation. Two days later, a meeting of those donors with the president.

An immediate phone call to the FDA to change the rules. Four days later, the rules are changed. And four days after that, the FDA commissioner resigns. Do you have any opinion as to whether that's the way that you want the FDA to work? Senator, I reject the framing of that question.

I will say, having worked for the president for a year and a half, in this role, I know that he is committed to the best possible outcomes for Americans, and he wants his team to ensure that that is what is being delivered. So you don't see any connection between the donation, the president's meeting, and 4 days later, the standards being changed?

Mr. Chair, Senator, again, I reject the framing of that question. I think the president is aware that that adults are using vapes to quit smoking. And that has been his direction, is to get the best outcome for the American people in every decision that is made. If I'm confirmed as commissioner, that will be my, that will be my commitment.

Okay. Senator Moody.

Thank you, Chairman Cassidy. Dr. Overton, thank you for joining us. And to your family and friends that are here to support you, sometimes these hearings are harder on them. So thank you for being here with our Mr. Secretary, Mr. Secretary, Mr. Secretary, Mr. Secretary, Mr. Secretary, we had some— a good meeting, a long meeting, and I appreciate you stepping up to take on this important position. I think we are at a time when Americans are becoming more conscious of their health, and I wouldn't be surprised if Americans across the country are watching this hearing right now that probably thought 5 years ago they would never be watching a Senate confirmation hearing.

I think you come in at a very important time, and we expect high performance from whoever takes on this role.

We are also in the era of drug discovery and pharmaceutical innovation, and you will play a key role in all of that. And I want to ask you a few questions in a moment about some right-to-try laws, but I want to first follow up, and I didn't want to do this focus on this too much, but a lot of my colleagues have been talking about something that's been very important to me as a mother of a kid still in school, kids watching young people as Attorney General become more and more addicted to vapes. A lot of these coming in illegally from foreign countries, especially China. We don't know what is in them. In fact, A large percentage of our market in vaping, I would say 85% of the US market, um, of vapes, illicit nicotine products, are illegally smuggled in from China.

We know that they're specifically designed to be attractive to kids, and we know this because they often have games on them. It's not hard to tell who they're trying to market to. So will you commit— and I know you've answered some questions and a lot of my colleagues, and I'm glad because this was one of the first questions I asked at the last hearing for the same position— will you commit to targeting illegal Chinese vapes for strong regulatory action? Senator, thank you for the question. Yes, I will commit to ensuring that the enforcement And, and that FDA is working closely with its other law enforcement agencies to ensure that we are enforcing the law and protecting against illegal—.

Okay, so you're, you're saying closely with some of the agencies that do seizures, and we're trying to make sure we give them more power to do that. But within your power, as at the FDA, will you commit to examining regulations currently in place and making sure that we are modifying them as necessary to prohibit, crack down on illicit Chinese vapes? Yes, if I'm confirmed to this role, that would be a top priority. It's a critical part of the pillars in order to ensure that we are protecting kids. We are getting legal products to the adults that are using them to stop smoking, and we are cracking down on illicit products that are affecting children especially, but should not be on our market.

So yes, that would be—. Is it your opinion right now that as, as the regs are set up, um, that if someone files an application that is a vape product, is the application on file enough to allow the current sale of the product? Thank you, Senator. This, this question in context of the market that exists right now where there are products that, that adults are using to stop smoking, it is critical to fix that pipeline, to have regulations in law. Is there right now, if someone files an application and it's pending with you, can they continue to sell even though it hasn't been approved?

Senator, I believe as, as the guidance is currently written, there is a low risk. And for products that have a complete application, it can't be just one note like the $27 million that came in and $26 million were kicked out because they were not even appropriate applications to the FDA. So they should—. Yes. If someone files an application, they can sell, right?

I think until we have— I think we have to fix It's the broad— my commitment is—. I'm just trying to find out what the law is. The law is a yes. I'll get to the next question, right? Is that a yes?

Because I just think it's important that everybody understands that. Right now, we had millions that were pending, right? And so presumably they could have sold until we kicked them out, which is why bringing that down was so important. Because you had millions and millions just filed, no idea what's in them, no idea where they come from, no idea what they contain. But we had regs that allowed them to be sold, right?

Yes. So you've kicked it down now to a couple hundred thousand. Efficiency, I'm hearing, is top of mind for many of my colleagues. And now you're seeing why efficiency is so important. Yes.

Because you're allowing these things to be sold and we don't know what's in them. Right. So do you commit to me to not only addressing that regulation, if that has indeed allowed products that are harmful to be on the market, do you commit to addressing that if necessary? Yes, Senator, I commit to addressing that to find the right solution for this problem. It's critically important.

Thank you so much. Senator Baldwin, with an apology because she was supposed to go before Senator Murphy. And so I apologize. Thank you, Mr. Chairman. Dr. Overton, the FDA commissioner should make sure that products on the grocery shelf are labeled accurately, including products in the dairy aisle.

I have asked past FDA commissioners to take a common sense approach laid out by my bipartisan Dairy Pride Act. And so far, they have failed utterly to do the job. If confirmed, will you rescind FDA's current guidance and enforce existing standards of identity to stop imitation products from using dairy names. Thank you, Senator, and I enjoyed our conversation on this topic in particular and your passion, your leadership on it. And I think it is critically important that Americans have transparency in their labels.

As we discussed, this is something I would absolutely commit to going and looking at and, and figuring out the right policy solution so that the guidance from the agency has accurate, transparent information for Americans. So you'd absolutely have my commitment to go and to look at that and to work with you on getting that right. It is, it is important that Americans know what is in their food, and the standards of identity are, are a key tool to that. Thank you. Uh, mifepristone has been FDA approved for nearly 25 years.

More than 100 peer-reviewed Robust clinical studies have confirmed its safety. 99% Of patients who took the abortion pill had no complications. FDA's update to the mifepristone risk evaluation and mitigation strategy, otherwise known as REMS, and product label in 2016, 2021, and 2023 all reaffirmed the drug's safety and improved its accessibility for the American people. For each update, the drug went through rigorous scientific review, and it's been proven to be even safer than many low-risk drugs prescribed for other purposes. Dr. Overton, do you believe mifepristone is safe and effective?

Senator, thank you for the question, opportunity to discuss this. The mifepristone has been approved by the FDA with the appropriate risk evaluation mitigation strategies, so it has met the safety and efficacy determinations of the FDA for those standards. The REMS did change, as you outlined, and the current safety review that is happening at the FDA is taking an internal study and look at safety after the last REM change. So you can't answer the question, Dr. Overton, do you believe mifepristone is safe and effective? Senator, according to FDA standards, the drug is safe and effective as labeled today with the appropriate risk evaluation mitigation strategy.

But on that leads me to my next question. Do you believe the label for mifepristone needs to be changed? Yes or no? Senator, I can't prejudge the determination of a safety review that is currently ongoing. Um, the former FDA commissioner used his position at the agency to proactively request that the drug companies submit new applications to change the label for acetaminophen also known as Tylenol.

This was based on the administration's belief that Tylenol may cause autism, something that has no scientific backing. If confirmed, would you use your position to pressure any company to change their label? Yes or no? Senator, if I'm confirmed as Commissioner of Food and Drugs, I will be guided by the science and the best evidence that is available. And ensure that labels accurately reflect what is known about a medication?

I haven't been encouraged by what I've seen, but I urge you to indeed follow the well-established science on safety and efficacy of mifepristone. The FDA cannot be basing its decisions on political whims of any secretary, including Secretary Kennedy. Um, I want to go back to the topic of flavored vapes and youth tobacco use. In 2019, at Children's Hospital of Wisconsin, they found the first cases of what was then a mysterious illness linked to vaping. Since then, I've urged the FDA to take stronger action against e-cigarette companies that use tricks to attract children.

One reason these products are so popular is because they come in sweet, trendy flavors like root beer float or cotton candy. In fact, a recent study showed that 95% of Wisconsin middle schoolers said they wouldn't use an e-cigarette if it didn't have a flavor. This is why I was deeply concerned to learn earlier this year that the FDA approved two more of these popular vape flavors. Dr. Overton, are you aware that flavored vapes are very popular with teens? Senator, thank you.

And I agree that it is critical and a core priority for us to protect kids from these products. They should not have— we should not have nicotine in the hands of kids. I am aware of data on flavored vapes and their usages. Okay. So do you believe that this information about flavored vapes being popular should be considered in future approvals?

Since I was gathering wool and it's gone a minute over, I'll ask just to wrap that up and do that for a QFR, please. All right. I will submit that as a question for the record. Thank you, Dr. Overton. Thank you, Senator Banks.

Thank you, Mr. Chairman. Dr. Overton, You agree that China is dominating clinical drug trials, uh, which is concerning because often the standards in those trials are far less safe and effective there than what— how they are applied in the United States. If confirmed, what will you do to make inspections of clinical trials more safe and effective in China and other countries and make sure that good clinical practice is always being followed? Yeah, thank you, Senator. This is a core priority.

If I'm confirmed, this is something that we have to address. We have seen progress from the agency recently. Um, they were acting directors of time, now many of them permanent. The agency leadership who published together a document saying all data must have good clinical practices— it was an initial notification that the FDA will be requiring that. If I'm confirmed, going in and making sure that policy is as strong as it can be, enforceable and communicated well so that our companies— and ultimately our goal is that these products should be developed and manufactured here in America.

We want to make it easier for that to happen, and we want to be very strict in places that are not doing that right now and are currently stealing away much of our biotechnology. You agree that we're not doing nearly enough right now, but on your watch, we're going to, we're going to make it a top priority. Senator, I think there is a lot more to do, and I'd be committed to doing that. Absolutely. Under Dr. McCary's leadership, the FDA gave conflicting answers about mifepristone's safety study and reinstating the in-person dispensing requirement.

I'm, I'm disappointed that the FDA has removed so many guardrails, uh, from this dangerous drug which carries the strongest black box warning. Uh, can you tell us when that safety study will be completed, and will you commit to accelerating the safety study in the interest of, of women's safety? Thank you, Senator Banks. If I have the privilege of being confirmed, this will be something that would immediately be on my desk. As I understand, the FDA has an update due to the court on October 7th of the process that it is in, and, and it is a process update.

Again, this is the Louisiana case that the FDA must owe an update. So I'm not currently involved in the details of the study, but if I'm confirmed, I'd immediately get briefed and be updated on the process and be able to give better answers on the estimated timelines of when that review will be completed. The commitment would be that, that study has to be done in the most durable scientific way possible and, and the results communicated transparently. We'll note it is not just the Louisiana court case that is waiting for that update to the court. There's another case from Hawaii that has asked the FDA to remove the REMS altogether.

And they are also looking for an update from the safety study. So if I'm confirmed as commissioner, my job would be to use all of the clinical and the research training that I have to make sure that that study is well designed. It is—. The analysis is, is appropriate, it's adjusted appropriately, and the results can be transparently shared so that all Americans have an opportunity to know what exactly is in those findings. As you know, the FDA commissioner has invested investigatory authority.

Is it in the public interest to investigate companies that dispense abortion drugs and mislead women about their risk? Thank you, Senator. I think every drug that has been approved by the FDA has robust post-market review and enforcement. If there are issues identified, and especially when there is a REMS on a medication, the manufacturers have to abide by the law. The committee— this committee published a report recently that highlighted some potential concerns from those manufacturers in regards to meeting the current REMS, not related to the ongoing safety study.

So if I'm confirmed as commissioner, I would be committed to making sure that every company is following the law regarding the requirements, especially when a drug necessitates a REMS on the medication. I want to work with you on reforming the GRAS standard as well. The mandatory ingredient notification rule that Secretary Kennedy announced last month was a big step forward. Does the FDA have enough resources to do all the ingredient safety evaluations, and how can Congress help you provide better and more resources? Thank you, Senator.

To my understanding, the, the agency would need more resources in its human foods program to properly be able to do all of those mandatory notifications. I know there are proposals in Congress. There are some that I believe the FDA has given technical feedback to work on this problem together, and I think it is, it is critically important that we get it right. The FDA has the—. So you'll get back with us on what else—.

Resources. Last question: several states have passed their own food ingredient bans and labeling requirements. Do you think many states have adequate personnel and expertise to review food ingredients and determine safety, which has traditionally been the FDA's job? Thank you, Senator. I think there has been a lot of progress in the states.

I think it is important that we have—. Mr. Chair, if I may answer.

I think it is very important that when certain thresholds are met across states, there are times that it is appropriate to consider a national standard, a strong national standard to have uniformity. Historically across the FDA and EPA, there have been cases when there is kind of a threshold met that a number of states states have done something on an issue that is appropriate then for the federal regulatory body to look at having a strong national standard. Thank you. Thank you. Senator Hassen.

Well, thank you, Chair Cassidy, and I thank you and the ranking member for this hearing. Uh, congratulations, Dr. Overton, to you and your family, and thank you for your willingness to serve your country. Uh, I just want to start by level setting a little bit here. Um, mifepristone safety studies show that it is in 99.8% of medication abortions using mifepristone, uh, there are no serious adverse events. And you know what?

Recent studies on telehealth use of mifepristone has the exact same statistic— about 6,000 women studied in the United States, in 20 states and Washington, D.C. It has been approved for telehealth in the United Kingdom, in Canada, in Scotland. So I just want to level set with that. Before turning to other issues, I want to ask you a simple question, Doctor. If directed by the president to take action that would break the law, would you follow the law or follow the president's directive?

Senator Hassan, thank you. I appreciate the opportunity to meet and share, especially the patient stories and the person. I appreciate that. Our time is limited. Yes or no?

Senator, I will follow the law if I'm confirmed as FDA commissioner. Thank you. Do you think it's possible for the president to ever be wrong about something?

Senator, as I've shared here before, I've had the privilege of working for the president for over a year and a half and have had robust discussions with him, along with all of his advisors. Is it possible for him to be wrong? Is it possible for him to be wrong? Senator, it is the president who sets the policy directions, but he works with all of his advisors to get the best information. My experience has been he wants to make the best decision and the best—.

I appreciate this. I have limited time, so I'm going to stop I was asking you about whether the President of the United States could be wrong because I want to talk about a specific comment the President recently made. You were standing right behind President Trump at an August 10th press conference when he talked about the combined measles, mumps, and rubella vaccine that is given to children to protect from these diseases. The President said of the combined vaccines that, quote, together there could be a possibility they're quite lethal, close quote. Close quote.

Do you believe that the combined measles, mumps, and rubella vaccine is possibly quite lethal? Senator, the MMR vaccine is safe and effective. It is our best current tool to combat the measles outbreak that is happening. Right. So the president said that the combined measles and mumps vaccine could kill children who receive it.

So was the president wrong when he suggested that the combined measles, mumps, and rubella vaccine may be lethal? Senator, the president asks questions and wants the best outcomes for the American people right now. As he said recently in the Oval Office, the MMR vaccine, every American should get it. It is the best tool that we have. Let me, let me get to why I'm going down this line.

This is an important issue because the American people need a leader at the FDA who is able to say that the president is wrong when he is. Especially when it comes to medicine for kids. So I'll ask you again, was the president wrong when he suggested— I don't care what he has said recently, but when he suggested that the combined measles and mumps vaccine may be lethal to children, was he wrong? Senator, the MMR vaccine is safe and effective. It is the best tool that we have in the current measles outbreak.

Well, thank you. Every American that's unvaccinated should get it. I wish it wasn't so difficult for members of the administration to just plainly I can only say that the president's wrong. And it's really concerning to me that you are equivocating on it here. He was wrong about that.

In September of last year, during your time advising President Trump, he gave a press conference claiming that Tylenol causes autism in children. He stated the following about women's use of Tylenol during pregnancy. Quote, I want to say it like it is. Don't take Tylenol. Don't take it.

If you just can't, I mean, it's fight like hell not to take it. So do you believe that Tylenol causes autism and that women should fight like hell not to take Tylenol during pregnancy? Senator, I have not seen any causal evidence that Tylenol causes autism. The Tylenol label, as I understand it, recommends that pregnant women talk to their doctor, which, as a physician and as someone that has taken care—. But was the president wrong?

The president said Tylenol is linked to autism and that women should not take it during pregnancy. Was he wrong when he said that? Yes or no? Senator, there is no current evidence of a causal link between Tylenol and autism. Was he wrong when he told women not to take Tylenol during pregnancy?

Of course, because a high fever during pregnancy, which Tylenol could ameliorate, is also highly dangerous for women. So was he wrong? Yes or no? Senator, if I'm confirmed as FDA commissioner, I will communicate what is known about the medications. Right now, the label says pregnant women should talk to their doctor.

About medicines. That's not what the— that's not what the president said. Look, my time is limited and I'm going down this path because I am really concerned that if an FDA commissioner will not tell the American public that the president is wrong about something, that poses a real threat to our health. Last comment, if I may, Mr. Chair.

Dr. Overton wrote an article in 2023 saying Mifepristone was dangerous. I believe you should recuse yourself from any studies and make sure that career scientists conduct them at the FDA concerning mifepristone safety, especially with regard to telehealth. Thank you.

We're out of time and we got to vote. So, Senator Murkowski. Thank you, Mr. Chairman. I will stick to my time. Dr. Arvinton, thank you for being here.

Thank you for the conversation. I want to continue with the discussion about mifepristone. As you and I shared in, in my office, this is a drug that is FDA approved, has been in use for well over two decades now. I believe Senator Hassan has, has provided some statistics for the, for the committee in terms of the efficacy. I do understand what is happening within the process right now as it is being reviewed, but my concern is, as I have shared, that there was political pressure, that there is political pressure to to revisit the approval status of certain products.

And I think we're seeing this with, with mifepristone that have already gone through the scientific review process, have been shown to be safe and effective. As I mentioned, we are— we're going to be in a very challenging position in a very rural state like Alaska when, if, if in fact the move to require in-person dispensing of the medication as opposed to telehealth appointments is the direction. You have effectively taken about 80% of our state and put them in a really challenging— excuse me, 80% of the communities in the state and put them in a very challenging position in terms of access to providers, access to to this FDA-approved drug. So I can go down this same rabbit trail and probably get the exact same very specific technical responses that you have provided the committee, but know that this is something that I'm very concerned about, and I am concerned about the political pressure that does come to bear on the scientific review process when you have directives that are said This is an area that we want to revisit and find a reason. Now, I'm not going to ask you to respond to that.

What I would like to do is to move my questions over to food safety issues right now.

We rely a lot on probably the healthiest of proteins out there, and that's Salmon, vital part of the diet in our economy and in our communities. As the FDA is assessing levels of PFAS and seafood, I would like your commitment to ensure that any public communications are science-based, they're balanced, they avoid creating unnecessary fear that could misinform consumers about health risks. Yes, Senator, thank you. And thank you for the time discussing Alaska and, and especially our shared passion for the tribal communities. Yes, if I'm confirmed, I'd commit to making sure that every food safety review is to the highest standard and communication about it is accurate.

We need that. Um, uh, I have had, uh, many conversations with previous FDA commissioners regarding the importance also of labeling. Uh, I am not a fan of genetically engineered salmon. I think that Mother Nature has done a mighty fine job. And we need to label that as such, but I would ask for your commitment to ensure again that consumers are able to make informed decisions when they're purchasing a product like salmon, uh, whether it is wild-caught or whether it is genetically engineered.

And my goal is to make sure they're not choosing the genetically engineered, but I just need your commitment on the labeling. Yes, Senator, I will work with you to have accurate labeling, and I know the America First Seafood Strategy is is still in works by the administration. And I believe that, that this is, this is a top priority that's shared by the administration of getting that right and making sure labels like Senator Baldwin labels are accurate and informed, informed to the American people. Last question, and this is on food safety inspections. As you know, the state and the local governments conduct about 60% of food processing facility inspections in Alaska, like, like others.

We perform— our DEC performs food safety inspection, permitting, and enforcement work under contract for FDA and has for many years. There's been efforts to cut funding for the state and food— local food safety programs, and we're told, and we believe this, that FDA says that they cannot as cost-effectively replace the state's DEC food inspectors We got some challenging geographic conditions in Alaska, but in other places as well. So I just need your commitment that FDA will maintain funding for these contracts with state and local governments because we need to have not only a good inspection system, but one that is cost effective and obeys or follows the will of Congress. Yes, Senator, I will work with you on that and ensure that that is— we are following the law, getting the best resources to Alaska. I know the FDA asked for form facility fees, but also better state sharing with state and local partners in food inspection.

So yes, it's my commitment. It'd be a high priority to get that right. Thank you. Thank you, Mr. Chairman. Thank you.

Senator Lisa Blunt Rochester.

Thank you, Chair Cassidy, and congratulations, Dr. Overton, on your nomination to be the commissioner of the Food and Drug Administration. Dr. Overton, you were standing in the Oval Office when the President signed the executive order calling for the reduction of the number of universally recommended childhood vaccines and splitting the MMR vaccine into 3 separate shots. It's been reported that you provided a list of options to the President, and so obviously you think these were, were good options, correct?

Senator, thank you. I enjoyed our meeting and getting to talk to you about our shared passion for public health and your public service. My—. Yes, it's just a yes or no. You think these are good options, the splitting of the MMR vaccine as well as recommending your recommendation for reducing the number of childhood vaccines?

My job in my current role is to take the president's directive, provide options to him. But you provided options. You wouldn't have provided bad options, right? With an interagency process that is—. Would you have provided him bad options?

Senator, these are— again, the current job is to take a request and to deliver something that the president has requested. It's just a simple question. I—. This I thought was the easy question. You provided him what you thought in your expertise were good, sound recommendations.

Senator, I have worked to always bring my clinical background. I'm going to assume that's a yes. And I'm going to just ask, what scientific evidence did you personally review that shows giving measles, mumps, and rubella as 3 separate vaccines is safer or more effective than the combined MMR? Senator, again, my current role is a policy coordination process for agency input and advice. Did you personally review any scientific evidence is basically the question.

Senator, if I'm confirmed as FDA commissioner, which is what I'm here to talk to you about today—. I'm asking a question of what you did to help inform the president before he made the decision. I guess the other question I would have is currently, are the separate single antigen measles, mumps, or rubella vaccines commercially available in the United States? Senator, there are no commercially available monovalent vaccines for that. Okay, so, so they don't exist.

Um, the President gave you a directive, as you said, to go fast, but vaccine manufacturers have indicated that developing, trialing, and obtaining FDA approval for new single disease vaccines could take up to a decade. In light of that, what would be your implementation timeline knowing that it could take a decade to even implement something like this? Yes, Senator, if I'm confirmed as FDA commissioner and companies would submit an application, they would be reviewed as appropriate to the safety and standard, um, safety and efficacy standards. And if they meet that, an individual product would be approved. But it is up to the companies to submit an application to the FDA.

That would be the role. So in— as commissioner, in making the recommendation to the president to do something like this, we didn't take into account the science or the timeline, it sounds like. The president has also proposed giving babies microdosed vaccines at roughly 20% of the current dose. So wouldn't that mean that they'd have to have 5 times the amount of shots, as well as the parents would have to visit 5 times with their child, as well as who pays for that? Is it insurers who pay for it?

Is it Is it the parents who pay for it? Is that— or is it the taxpayers who pay for it? Just kind of getting into the how does this actually happen? Yeah, Senator, thank you for the question. The president is aware and he has talked about recently, he knows that companies would need to submit an application to the FDA, that this would take time.

I believe that he is solving for feedback he has gotten of parents wanting an additional option on the market. It is not taking anything away. The current MMR vaccine is safe and effective, is our best tool. And right now people should get that. I think the challenge I'm having here is that the administration is saying they want people to do less shots, but then they're telling them to here's a do more shots and is not based on science.

And I'm really concerned about that. And he also claimed, I think it was in that press conference, that vaccination the size of a bottle of soda are poured into little child. He's seen vaccines poured into a child's body the size of a soda bottle. Do we have that much vaccine that goes into a child's body like a 20-ounce soda, even a mini? I don't think so.

Would you say, Doctor? Senator, I would say right now in the products licensed by the FDA are safe and effective. They are given—. And they're not the size of a— of a soda bottle either. I'm really concerned, as I shared, about the science piece, the implementation piece, and ultimately the fact that we're in the middle of a 3-decade measles outbreak, the largest in 3 decades.

And so I, you know, we heard the comments before. We hope that you will use science if you're confirmed. And we hope that you will stand up if the information is incorrect or wrong, because people's lives are on the line. Thank you. I yield back.

Thank you very much. Thank you, Senator. Senator Cassidy has left me with the gavel, which is a frightening prospect, isn't it, Senator Kaine? But I won't take more than 10 or 15 minutes. No, I'm just kidding.

Dr. Overton, it's great. It's great to see you. I enjoyed our conversation the other day. Congratulations on your nomination. I just want to ask you about something.

I want to start with something you said to Senator Baldwin a little bit earlier. I just want to make sure I understand what you're, what you're saying. This is on the topic of the abortion drug, which is now causing abortion numbers in this country, as you know, to be higher than when Roe v. Wade was still the law of the land. Over 1 million abortions committed last year in my state of Missouri, where we have tight restrictions on the abortion drug. Those restrictions are being completely overridden by pharmaceutical companies that are mailing in the drug.

Without Missouri permission, in fact, in contravention of Missouri law. So this is something— and my state's gone to court to stop that. So this is something that is very directly personal to the state of Missouri and to me. You said in response to Senator Baldwin, mifepristone has been approved by the FDA with the appropriate risk evaluation mitigation strategies. It has met the safety and efficacy determinations of the FDA.

You went on and said, according to FDA standards, the drug is safe and effective as labeled today. Do I have that right? I'm just reading a transcript. I just want to make sure I've got that correct. That—.

That— yes, that was a discussion of the current labeling of, of the drug. Okay. I'm confused by this, though, because that's not the FDA's position in court. Senator, the—. The—.

Right now there is an ongoing safety review that is being done to assess if the risk evaluation mitigation strategy is appropriate. But the FDA— this is very important— the FDA's position in court is that they will not defend— they are not defending the merits of the REMS that the Biden administration put into place, that they have admitted in court that those REMS were not— are not safe and effective, that they were not done according to FDA standards. That's the official position of the Food and Drug Administration in court. In Louisiana and also in the case that my state has brought. So I want to get to the bottom of this.

I want to be sure that the FDA is not changing its position. I think it's going to be news to the court. So are you saying that the FDA's position is now that the drug is safe and effective and appropriately labeled? Senator, I would say when talking about the risk evaluation mitigation strategy, specifically the REMS, it is— there is an ongoing safety review after a REMS was changed. It is appropriate to be doing the safety review because the FDA has not done an internal updated recent safety analysis.

But what— to connect what I was saying before, right now there has not— there has not been a change to the label. That safety study is ongoing and very important. Women's health and women's safety is a critical piece of this. So there is no change in position. The FDA does need to do that safety study to look at the internal data that has not been looked at since a REMS change was made.

I agree with all of that. I mean, I think that the safety study is absolutely vital. It's long overdue. The fact that this drug sends 1 in 10 women— more than that, more than 1 in 10 women who take it to the hospital with a life-threatening condition. That's what the data shows.

That's extraordinary. The label on the drug that these pharma companies put on it doesn't disclose any of that. And no wonder, because many of these pharma companies are overseas. They're based in the Caymans. They're making billions of dollars by lying to women about the dangers of this drug.

I think all of that's indisputable. I just want to be real clear, though, because it matters a lot. The FDA is not defending the merits of the Biden administration's REMS in court. The FDA's position is they admit in court that the REMS were not appropriately put into place. I'm talking about Joe Biden's rollback of any safety procedures.

As you know, there are no safety protocols left on this drug. It used to be that if you If you wanted to get the drug, you had to get a screening for an ectopic pregnancy, which is important. You had to see a physician. That physician had to be able to admit the woman to a hospital if needed for her health. The Biden administration got rid of all of that, and the FDA in court has said, we don't defend any of that.

We admit that that was— that that's a huge problem. I just want to be sure that that's your position. Is that your position? Senator, my position is that if confirmed, the ongoing safety review is a critical piece for the FDA because there has not been an internal safety review since that change was made. It significantly changed how the medication was prescribed so that the FDA's current position is accurate and aligned with mine.

Okay, let me, let me try this a different way. Both your predecessor, Dr. McCary, and the, the secretary, Secretary Kennedy, have said, and I quote now, that the Biden REM suffered from a lack of adequate consideration and also of safety risk testing. Do you agree with that? I think it— my view, it is critical that the FDA complete that safety analysis. But do you agree with that?

That's your predecessor, that's Dr. McCary and the secretary, that the Biden REM suffered from a lack of adequate consideration and safety risk testing. As I understand how part of how the Biden administration's decision was made, it relied a lot on external evidence, and since that time happened, there has not been an updated internal safety analysis from the FDA that I think is critical so that Americans know what happened. So it— that is, if confirmed, the most urgent thing that I would go and get briefed on and updated on the status of that safety review to reach the best decision for Americans. All right. If I don't stop now, then everybody else is going to say, Josh, you know, you're abusing the gavel.

So I'm going to— and I don't want that. So I'm going to have some more questions for you on this subject because this is so important. Dr. Overton, thank you for being here. And is— okay, Senator Ossoff Brooks, you are recognized. Thank you so much, uh, and thank you, Dr. Overton.

Good afternoon. Thank you for, uh, for being here. Uh, you know, in another series of these crackpot conspiracy theories of this administration, the Environmental Protection Agency just launched a drinking water study that will test for birth control, mifepristone, and emergency contraception. And so the first question is Do you have any reason to believe that birth control contaminates our drinking water in our country?

Thank you, Senator. If confirmed as FDA commissioner, my job will be to work within the FDA statutory requirements for individual review, individual product review for safety and efficacy determination. What the EPA— I think to your question— is outside of the jurisdiction of the FDA. FDA. I think it is important for all agencies to answer questions that American people might have.

Yeah, I mean, well, actually, so you're, you're a medical doctor, so I'm sure you're well-versed in these issues. Do you have any reason to believe that, that taking birth control is— that women are contaminating our drinking water in our country by taking birth control? Senator, thank you for the question. If, if confirmed as FDA Commissioner, I will work within what the FDA is required to do for individual product reviews of safety and of those applications, post-market review, and of those individual products. But this is also a part of what the FDA is required to do.

And in fact, the FDA is required— it requires pharmaceutical companies to submit an environmental assessment, and that assessment is a part of an approval process. And the FDA Center for Drug Evaluation and Research looks at data. And so this is a part of what you will be tasked with doing as leading the FDA. And so I'm just asking you, you know, whether this is an issue that you believe the American people should— should— is this something you are concerned about? Senator, I think, I think as I've understood from the American people and polling and questions, they, they want transparency in the ingredients of every part of drinking water, food supply, and that's a critical function of public health.

And the EPA and the FDA have different roles EPA is looking at the entire water supply. FDA is looking at individual product determinations and environmental impact in that case. But if I'm confirmed, I will get briefed fully on the science by the career experts and ask them this question. Well, it's already been studied. I mean, it's the fact birth control has been approved for over 65 years now, and the FDA has thoroughly studied it.

The data exists. And so they're, you know, this is just another effort, I believe, by this administration to, um, to seek out, uh, answers to things that are not problems. This is another conspiracy theory, which is the reason that I'm asking it. Um, I also want to take you back to another area of concern, and it is that as a senior advisor to the president— I know you answered some questions about this— um, you helped to lead an interagency process and make recommendations on health policy, and one of the huge issues, of course, of interest would be big tobacco. And I want to know whether or not you know how much money big tobacco has contributed to the president's Super PAC inauguration or to his ballroom.

Senator, those are not questions that I— those are not things that I'm familiar with. Well, I know you've been a senior adviser to his, but the answer is $20 million. And whether you know as well, do you know how much the president owns in tobacco stocks? I think these are questions the American people deserve to know. Well, the answer is $1.64 million the president owns in Philip Morris and, and holds Altria Investments.

And then based on the numbers that I just gave, would you say that the president then has a vested personal financial interest in the success of the tobacco industry? Is that a fair statement? Sir, I reject the framing of that. The president's interest is in the best outcomes for the American people. He is here to serve in that capacity.

But you acknowledge that he's an investor then in the— in big tobacco. I mean, he's earned $1.64 million in Philip Morris and in Holz Investments. And I would say that that would give you a financial interest in it. But let me go further and clarify a timeline that is of interest. The president met with some folks at his golf course on May 2nd.

And it's no coincidence, I would say, that just a few days later, on May 5th, the FDA authorized the sale of flavored e-cigarettes. On May 8th, we saw that FDA rolled back enforcement of unauthorized vapes. And then we know that the former FDA commissioner, who was very against all of this, was fired on the 12th. So these things don't feel like coincidences to me. Does it feel that way to you, Senator?

If I'm confirmed as Commissioner of Food and Drugs, my job will be to uphold the law and abide by the statutory standards for the appropriate protection of the public health that is required for all reviews regarding vapes. And, and in the case of flavored vapes, I will note it was the career officials who made a recommendation that those products that were, that were authorized by the FDA met that standard. But you can acknowledge, and this is my last, that the, that timeline I just gave you would raise eyebrows for some people. You can understand why that would be a troubling timeline, uh, you know, if your boss met with these folks and then suddenly the approvals came. Thank you.

Further? Thank you.

Thank you, Mr. Chair, and thanks to Dr. Overton. Um, a comment, because that is not a question because it's already been put on the record, but I just want to point it out, and that is in 2026 compared to 2025, there has been FDA reports of foodborne outbreaks 16 times the reported cases from 2025. So we've seen this 16x increase in FDA reports about foodborne outbreak-related illnesses. At the same time, at the same time, um, the reports are that the number of food inspectors employed by the federal government is at the lowest since 2005.

The head of the human foods program at FDA quit early last year because of indiscriminate layoffs of technical experts. And Dr. Overton, should you be confirmed, you would walk into an FDA that has lost 4,500 staff members since the beginning of the administration, which is about 20% of its workforce. You will have your hands full if you're confirmed. Dramatic increases in foodborne illness and We're not talking about measles and all the other things, but dramatic increases in foodborne illness, dramatic shrinking in staff, including the resignation of some of the key technical experts in this space. That is an important thing for us to contemplate.

I'm not going to ask you about it. You didn't do the layoffs. Others did the layoffs. I want to ask you about this. There was an article that was published last night in the Wall Street Journal that I would like to introduce in the record.

And it— here's the title: U.S. regulators plan major move to Speed Authorization of Vapes, Tobacco Pouches from the Wall Street Journal, September 23, 2026. I'd like to introduce it into the record just to read a couple of sections. The Trump administration is planning to smooth the way for more tobacco products such as flavored vapes to legally enter the market by changing the rules to speed up the authorization process, people familiar with the matter said. The Food and Drug Administration is expected to announce in coming days that it will revisit a 2021 rule that outlined requirements for new tobacco applications. That 2021 rule was done by Trump term one administration.

It was proposed by President Trump in his first term. It was only finalized after President Biden, uh, became president, but the rule that the administration is contemplating changing, if this is accurate, would be backtracking on a Trump term one priority. During Trump term one, this committee, for example, passed the law raising the age of federal tobacco products from 18 to 21, got it out of committee, went to President Trump's desk. He signed it. I was the co-sponsor with Senator McConnell.

So what are you aware of about the Trump administration plan to smooth the way for more tobacco products. Senator, thank you. And thank you for the great discussion we had and for your leadership on that, on Tobacco 21. Like I've said before, it is a key priority that we all agree on, that nicotine should be kept out of the hands of kids and that we have to have the proper enforcement strategies to do that. And so thank you again for your leadership on that.

I, I am not aware of that decision-making since I've been nominated to the role. I've not been involved in that. And what's your current position? Senator, currently a deputy assistant to the president for domestic policy. For domestic policy.

So you're telling me you have no awareness in your current position as a domestic policy advisor at the White House of Trump administration discussions about planning to smooth the way for more tobacco products such as flavored vapes? Senator, since the time of my nomination, I've not been involved in those discussions. What I do know that the overarching goals of administration—. I'm not asking kids. Listen, I'm not asking whether you've been involved in them.

I didn't ask that. Are you aware— I mean, we're talking to you as an FDA director. This report says within days the FDA is, is, is putting out a rule to roll back advances made during Trump term one. You're a domestic policy advisor. I know you're not assuming the duties of the FDA administrator until you get confirmed, but Your testimony here today is you are completely unaware of any of the discussions that are going on right now within the Trump administration about rolling back tobacco regulation.

Senator, I'm not involved in those discussions. I didn't ask—. I didn't ask— What I can say is that—. Dr. Overton, now come on, don't play games with me. I didn't ask whether you were involved in them.

I asked, are you aware that this matter, that that bears directly on the position to which you've been nominated, and which is at least in sort of the subject matter bailiwick you currently operate. Are you aware of discussions that is going on about whether the FDA will roll back tobacco safety regulations? And that's an easy— you're either aware of them or you're not.

Thank you, Senator. You know, I'm not involved in those conversations. The, the administration wants to protect kids wants to have legal pathways to authorized vapes. Let the record reflect that the witness refused to answer the question. I yield.

Senator Markey.

Thank you, Mr. Chairman. Dr. Overton, thank you for meeting with me earlier this week. What was your role in the executive order President Trump signed last month regarding childhood vaccine recommendations. Senator Markey, thank you. I enjoyed our meeting and your length of public service, and thank you for taking the time.

In my current role, I serve as an advisor to the president. If he makes a request, I run interagency processes, get feedback from all the agency experts, present options to the president for his decision. Okay, so last month, the America First Policy Institute, where you served in a leadership role said that you were, quote, critical in the president's executive order to deliver gold standard childhood vaccine recommendations and, quote, modernize the childhood vaccine schedule. So it doesn't sound like you were just part of the process. Um, you stood beside the president, uh, when he signed that executive order calling for splitting up the measles, mumps, rubella, or MMR vaccine, and called it, and called it, quote, a historic day and an historic action.

And at the signing, the president said, quote, we want it in 3 separate vaccinations given at separate times. Together, there could be a possibility they're quite lethal, and separately, it looks like they are not at all lethal. So, Dr. Overton, we've heard you and other members of the administration repeatedly champion gold standard science. At that signing, you told the country, quote, take a look at this scientific assessment. And for more than 50 years, the FDA, the agency you want to run, has found the combined MMR vaccine safe and effective.

You have said today that it is safe and effective. Minutes after the president suggested it could be quite lethal, you had the microphone. You didn't correct him. Instead, you said parents should have, quote, the option to separate them out. So why didn't you correct the president at that moment so that the correct science was understood by American parents.

Senator, thank you. And I think again, for the committee and for what the president has said recently, the MMR vaccine is safe and effective, is our best tool for those that are unvaccinated to get in the current measles outbreak. And I, I do believe that what the president is responding to is providing additional options. He—. There is very clear to not take anything away, to keep that vaccine available It is the best tool that we have.

Any— anything new to the market would take time to develop, but that, that option was for the president's decision, and he, he wanted to provide an option to Americans that right now are getting zero vaccinations after COVID. Trust plummeted, and they want to make sure— he wants to provide an additional option while saying that it is safe and effective. You thanked the president for correcting the wrong of Americans not having a scientific assessment of this vaccine, which you have called safe and effective. So when the FDA science and the president's erroneous scientific claims conflict, as they did that day, which, which one will you defend? Senator, I will use my clinical training, my research experience, and, and the career expertise that is at the agency to get their input on and to take a review of all of the scientific determin— determinations for individual products that have been determined to be safe and effective.

That's the role of the FDA commissioner. You had a chance last month and you didn't take it to correct the president and his dissemination of erroneous medical recommendations. So why should we expect you to stand up to the president as FDA commissioner? Senator, I believe the president is responding to wanting to give options to people that are currently getting zero vaccinations. And as he has said, the MMR is not lethal.

But what he said was— what he said was false. What he said was false. He said it was lethal. And he said that with you standing right next to him. You did not correct him when he said that.

Senator, the MMR vaccine is safe and effective. Every American that is unvaccinated should get it. It is the most effective tool that we have. The president has said that now. He said it recently in the Oval Office.

And that is important. That is what— if I'm confirmed, that is what I would do in the role, is to make sure that Americans know that is currently the best available tool. It is safe and effective, right? But it is not lethal. As FDA commissioner, we have to have faith in you that you will stand up for the science.

And my faith in you was undermined at that moment because the consequence of that is fewer children not being vaccinated. In our country right now. The president has cast a shadow over the efficacy, safety of these vaccines, and I, I don't have confidence that you will stand up to the president where it's necessary. Thank you, Mr. Chairman. Thank you.

Uh, I wish to enter letters of, in support of Dr. Overton's nomination into the record, and it will be done without objection. I want to compliment the mom and the grandmom of that little baby right there who has been incredibly well-behaved. I wish you could teach that to my grandchildren. And for any senator wishing to ask additional questions, questions for the record will be due 5 PM Friday, September 25th. Dr. Overton, I thank you for coming here, and I thank you for your willingness to serve our country and for the service you've already done.

And I thank your family for being here to support you. Thank you. The committee stands adjourned.