Senators question Heidi Overton in confirmation hearing for FDA commissioner

[0:00] developers overseas, including the Communist China, where there is a more streamlined regulatory environment. [0:06] Yes, in some cases China is cutting corners and ethical boundaries, [0:10] but that does not change our responsibility to make the United States a more attractive place for [0:17] clinical trials to be conducted. I recently released proposals to eliminate unnecessary barriers in the FDA approval process for different products, [0:25] 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. [0:34] Our next FDA commissioner must have the vision and drive to ensure continued American biomedical leadership. [0:41] This would be a commissioner with a vision for reform, who knows how to get buy-in across the agency to embrace change, [0:48] and whom the American people can trust to make product approval decisions based on unbiased sound science. [0:54] Unfortunately, politicalization and misinformation severely damaged the credibility of FDA and HHS. [1:02] Last week, HHS Deputy Secretary nominee Chris Klump spoke passionately about the need to differentiate the scientific process from policy decisions, [1:12] to prevent political interference from blurring those lines. [1:14] I mentioned in the previous markup about reports that the president considered giving OMB a direct role in individual NIH decisions, [1:24] I said then and I repeat, these decisions must be made by people who understand science, not politicians. [1:32] I hope to see the White House decide against politicizing the approval process. [1:36] The next FDA commissioner must prevent politics and political prejudice from influencing regulatory decisions if there is no substantiating scientific evidence to support. [1:47] 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. [1:57] 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. [2:07] How do you check for an ectopic pregnancy without an inpatient ultrasound? [2:13] You cannot. [2:14] Dr. Marshall made the point during our hearing on this that you really can't know the gestational age without an in-person scan. [2:23] He had particular credibility as an obstetrician. [2:27] And how can we know the frequencies of these complications without the requirement that the doctor prescribing report an adverse event? [2:35] This is something the next FDA commissioner needs to take action on. [2:41] Beyond policy changes, FDA is in desperate need of stability. [2:44] It needs strong leadership, someone who is radically honest with the American people and promotes science over ideology. [2:52] Dr. Overton, you're a medical doctor. [2:55] Of course, I'm that resonates with me. [2:57] You've seen patients. [2:58] You have a deep understanding of the health care system and health policy. [3:03] But I have concerns. [3:05] You were behind the president in the Oval Office when he signed an executive order to break up the vaccine schedule into more doses, [3:12] completely ignoring the reality of families today struggling to make life affordable. [3:17] This doesn't just inconvenience them by making them spend more money by taking time off to take the child to the physician. [3:26] That's point number one. [3:28] Point number two is the order is based on zero scientific evidence. [3:33] At the same time, the president called the MMR vaccine quite lethal. [3:37] There ain't no scientific evidence for that. [3:41] And by the way, this comes as we see Americans dying from measles for the first time in decades. [3:49] I can see that with my own eyes. [3:51] To say the vaccine is quite lethal will discourage some from being vaccinated. [3:56] Yet the scientific evidence says that getting vaccinated practically eliminates the risk of getting measles, [4:02] of being hospitalized, of transmitting the infections to other people. [4:06] It's not just about your body. [4:08] It's about the person you infect who may get hospitalized, who may die, [4:12] and perhaps even that individual themselves dying. [4:15] That's the risk of being unvaccinated. [4:18] That's what the scientific evidence shows. [4:20] When Dr. Sapphire, the president's surgeon general nominee, was asked before this committee [4:25] if the MMR vaccine is lethal, she said no. [4:29] Unequivocally, I admire that. [4:31] The vaccine is safe and effective. [4:33] I will ask you that question today. [4:36] Dr. Overton, this committee needs to know whether you'll be radically honest. [4:40] Whether you will use your authority to stand up for sound science and protect children's health. [4:47] That you will unequivocally say that the MMR vaccine, in its current formulation, is safe. [4:53] It is not lethal. [4:54] You'll also need to ensure that uninformed ideologies do not influence FDA's decision [5:00] on whether to approve individual products, even if the president is pressuring. [5:05] This is something you will need to answer to get the committee's support. [5:09] I will note, the Secretary of HHS, Secretary Kennedy, gave me guarantees. [5:14] Later, he did not keep those. [5:16] I asked him why not. [5:18] He said that the president had told him to do something. [5:21] And as opposed to keep his promise to me, to this committee, by extension to the American people, [5:26] he had to do what the president told him to do. [5:29] We can argue that ethics system, but that's his ethics system. [5:33] I need to know your ethics system. [5:35] With that, I yield to Senator Sanders. [5:38] Well, thank you very much, Mr. Chairman. [5:42] Today, we'll be considering President Trump's nominee to be the Commissioner of the Food and Drug [5:47] Administration, Dr. Heidi Overton. [5:50] The FDA was established by Congress to regulate prescription drugs and the food that we eat, [5:55] among many other things. [5:57] According to the FDA's website, its mission is to, quote, [6:01] make medical products more effective, safer, and more affordable, more affordable. [6:07] In my view, the FDA is failing that very important responsibility. [6:12] In America today, despite what President Trump has told us, we continue to pay by far the highest prices [6:21] in the world for prescription drugs. [6:24] In some cases, 10 times more than the people in other nations. [6:29] While 10 top drug companies made over $100 billion in profits last year and pay their CEOs exorbitant [6:39] compensation packages, one out of four Americans cannot afford to pay for the medicine they need, [6:47] and thousands of families face financial ruin as they pay prices that they cannot afford for the [6:52] prescription drugs that keep them alive. Major companies make $100 billion in profits. [7:00] CEOs get huge compensation packages, and people die or go into financial bankruptcy [7:06] because they can't afford the medicine that they need. [7:10] In my view, we need a Commissioner of the FDA who is prepared to take on the greed of the pharmaceutical [7:16] industry and use every tool at his or her disposal to substantially lower the outrageous cost of [7:23] prescription drugs in our country. That's not all. For decades, Congress and the FDA have allowed [7:29] large corporations to make huge profits by enticing children and adults to consume ultra-processed food [7:38] and beverages loaded up with sugar, salt, and saturated fat. It's an issue this committee has [7:45] looked at time and time again. There is growing evidence that these foods are deliberately designed, [7:51] deliberately designed by these companies to be addictive, similar to cigarettes and alcohol, [7:57] and lead to a higher risk of type 2 diabetes. Bottom line, much of the food that we as Americans [8:04] are now consuming are making us unhealthy and are contributing to the fact that our life expectancy [8:10] is lower than many other wealthy countries, and that is unacceptable. In my view, [8:16] we need an FDA Commissioner who is prepared to take on not only the pharmaceutical industry, [8:22] but the food and beverage industry to protect our kids and all of our people from the twin [8:29] epidemics of obesity and diabetes. Further, the FDA Commissioner is responsible for maintaining [8:36] the safety of the American food supply, yet it seems like every day there's a new food product [8:41] being recalled due to contamination. Under the Trump administration, our country has experienced an [8:47] unprecedented number of outbreaks of foodborne illnesses linked to healthy foods like lettuce, [8:54] eggs, and blueberries. At the same time, the number of food facility inspections conducted overseas [9:01] by FDA is down by more than 35 percent compared to 2019. How can we expect to make America healthy again, [9:08] when we have to worry about the safety of the food we eat? Dr. Overton, based on the work you've done [9:15] to advance this administration's agenda, I have serious concerns about your nomination to be [9:20] commissioned. Thank you very much, Mr. Chairman. Dr. Hagerty, Senator Hagerty will now introduce, [9:29] and he'll answer the question of why a guy from Tennessee is introducing somebody from New Mexico, [9:34] so I look forward to that explanation. Senator Hagerty. We actually share a distinction in common. [9:41] We were both White House Fellows. You both what? We were both White House Fellows. I must say I was [9:47] at a different point in time and then Dr. Overton a little bit earlier, but it's my honor to be here [9:52] today. Thank you for having me, and I'm very pleased to introduce Dr. Heidi Overton to serve as the [9:57] Commissioner of the FDA. The FDA is charged with protecting public health by ensuring the safety, [10:02] efficacy, and security of human and veterinary drugs, biological products, medical devices, [10:07] cosmetics, and the nation's food supply. FDA's gold standard for science helps ensure American [10:12] patients have access to safe, effective, and innovative treatments. However, China has [10:17] significantly advanced its domestic biotechnology industry and drug development ecosystem, drawing [10:25] investment and volume away from the United States at an accelerating pace. To maintain our national [10:30] lead, we must ensure that the United States maintains its competitive advantage, which starts [10:35] with ensuring that the FDA has stable yet ambitious leadership. I'm confident that Dr. Overton is that [10:42] leader. Dr. Overton currently serves as Deputy Assistant to the President for Domestic Policy at the White House, [10:48] where she plays a significant role in the administration's health care policy agenda. [10:53] She was selected to be a White House Fellow, as I mentioned a distinction that I share with her, [10:56] in the Office of American Innovation and the Domestic Policy Council. In that role, [11:02] she advised senior administration officials on health care policy and worked with HHS and CMS to [11:07] develop and execute major health care initiatives. She received her MD from the University of New Mexico [11:13] and her PhD in clinical investigation from the Johns Hopkins Bloomberg School of Public Health. [11:18] She previously completed a surgical oncology research fellowship at Johns Hopkins and trained as a [11:23] general surgery resident, caring directly for patients and performing 300 surgical cases. [11:31] In announcing her nomination, President Trump stated that the FDA needs Dr. Overton's leadership to, [11:36] quote, ensure that the U.S. remains the world leader for scientific discovery and for cures. [11:42] She's committed to implementing this go-fast culture that President Trump prefers to, [11:46] one that will maintain American dominance in pharmaceutical innovation by reducing regulatory [11:51] burdens and strengthening critical processes. Dr. Overton is the leader that FDA needs at this [11:56] consequential moment for the future of American biosecurity. I'm pleased to support President [12:01] Trump's nomination and look forward to Dr. Overton's swift confirmation. Thank you. [12:06] Thank you, Senator Haggerty. I shall be on the questions. And as an outset, I want to again praise, [12:18] I again praise Dr. Sapphire when she came. Some come and give equivocal answers that give a back door to [12:24] later saying, oh no, I left, I didn't, I didn't tell something what wasn't true. Oh, I'm sorry, [12:33] your statement. I'm geared up. You make your statement, then I'll make my statement. [12:41] Thank you, Chairman Cassidy, Ranking Member Sanders, and members of the Senate Help Committee, [12:45] thank you for the opportunity to appear before you today. It is an honor to be considered for the [12:50] position of Commissioner of Food and Drugs. I would like to thank President Trump and Secretary Kennedy [12:55] for entrusting me with this opportunity to serve the country. I am deeply honored. [12:59] First and foremost, I thank my Lord and Savior, Jesus Christ, for every blessing and opportunity [13:04] in my life. Matthew 5.16 and Colossians 3.23 have been my life verses since I was a child, [13:10] and I sincerely hope to exemplify these principles today and always. I want to recognize and honor [13:16] my incredible family, my parents, Bill and Natalie Overton behind me, my sister and her family, [13:22] Alyssa, Nathan, and Chloe Joy Hatala, two years old at the end there. Every part of my success belongs to [13:28] them. Their lives of service, especially my dad's service as a pastor and my mom's as a nurse, [13:33] is my inspiration. I would also like to thank the abundance of friends, mentors, colleagues who have [13:38] supported me, many from the Four Corners area who have traveled here to be with us today. [13:44] Throughout my life and career, I have experienced seemingly intractable health system failures [13:48] firsthand, and it has been my motivation to be part of the solution. From seeing disparate health [13:53] outcomes in the tribal communities surrounding my hometown of Gallup, New Mexico, to two years of [13:58] surgical training in inner-city Baltimore, to the White House during COVID, and to my own personal [14:03] health journey managing adult onset type 1 diabetes, I have seen system failures detract from the ability [14:10] of patients to benefit from the world-leading innovation and medical discoveries available in [14:15] America. These experiences culminated in a medical degree from the University of New Mexico, [14:20] a doctorate of Public Health and Clinical Investigation from the Johns Hopkins Bloomberg School of Public [14:25] Health, a White House Fellowship, and board certification in general, public health and [14:30] preventive medicine. I have served on the boards of the University and Hospital of UNM. I contributed to [14:36] writing clinical guidelines to address the role of surgical overprescribing during the opioid crisis, [14:41] and I served in key roles in the COVID response and testing and vaccine prioritization. [14:45] If confirmed as Commissioner of Food and Drugs, I will immediately set my focus to restoring the [14:51] primacy of American innovation while furthering the core missions of advancing national security, [14:57] increasing access to affordable treatments, and promoting public health. President Trump's direction [15:02] for me in this role, should I be confirmed, is to go fast. Slow and prohibitive requirements for [15:08] cutting-edge therapies at the FDA means investment is increasingly flowing to China, who has found ways to do [15:14] things faster and cheaper. As Chairman Cassidy highlighted in his recent report, China has [15:19] surpassed the United States as a top venue for clinical trials. This should give pause to every [15:24] American and to those who serve on their behalf. When we lose this advantage, we lose our health [15:29] security. And when we lose our health security, we lose everything. This problem is not partisan. We must [15:37] reverse this trend. My message to the committee today is that time is certainly of the essence. We can protect [15:44] America's global leadership in biotechnology, but we have to act fast. The FDA has begun work on this [15:49] through Operation Trial Blazer. If I have the privilege of being confirmed, I will work with the [15:54] dedicated career professionals to make sure every aspect of clinical trials and drug development is [16:00] optimized. This will not only bring development back to the United States, it will bring cures to patients [16:05] faster. If confirmed, I will work to ensure every talented person at the agency shares the goal of making the [16:12] FDA the agency of the possible rather than the impossible. The recent rapid approval of a new [16:18] treatment for pancreatic cancer is one example. This should be the norm for the FDA so that all Americans [16:23] get early access to the best care. It is important to remember that food is also a critical part of the [16:29] Food and Drug Administration's name, and we must continue the revolutionary steps to improve food [16:34] safety, quality, and transparency. Finally, the FDA must remain at the front lines of promoting public health and [16:40] safety. From continuing to tackle the opioid crisis and the new dangers of synthetic 7-OH to protecting [16:46] children from illicit foreign vapes containing dangerous chemicals to safeguarding infant formula and [16:51] ensuring robust food outbreak response systems, the FDA must remain vigilant and ready to execute. [16:58] In closing, I am confident that I have the clinical research and policy background in this critical [17:04] moment to drive real reform along with the proven ability to manage complex interagency processes to [17:09] achieve meaningful outcomes for the American people. The talented career scientists and regulators at [17:15] the FDA deserve leadership who will empower them to tackle these issues head-on for the purpose of [17:19] securing a stronger America. If I have the privilege of being confirmed, I am committed to working with [17:25] this committee and with all stakeholders to ensure FDA meets this generational opportunity to continue [17:31] leading the world in innovation while furthering the core missions of advancing national security, [17:36] increasing access to affordable treatments, and promoting public health. Thank you for your [17:40] consideration. I look forward to your questions. Dr. Overton, I shall start. As I started to say earlier, [17:47] please be unequivocal in your answers. As scripture says, let your yea be yea and your nay be yea. [17:53] Nay. You were standing behind President Trump when he called the MMR vaccine potentially quite lethal. [17:58] Is the MMR vaccine safe and effective? Senator Cassidy, as a physician, I appreciated our conversations and thank you for [18:08] doing this hearing so quickly and have had the privilege of taking care of patients and I know that [18:13] you share that. Is the MMR vaccine lethal is your question. I have the MMR vaccine is not lethal. [18:19] Is it safe and effective? Yes, Senator. The MMR vaccine is safe and effective. [18:24] Do you so you disagree with the president on that? Senator, if confirmed as FDA commissioner, [18:30] my role would be individual product determinations and what the law requires for statutory standards of [18:35] safety and efficacy. The MMR vaccine is currently licensed and approved by the FDA. It is safe and [18:40] effective and it is our best tool right now in the public health response to the measles outbreak. [18:45] It is 97 percent effective in stopping transmission of the virus after two doses. Are there any vaccines [18:52] on the U.S. market right now which are unsafe? Senator, every vaccine on the U.S. market right now are safe [18:59] and effective according to the FDA. As FDA commissioner, what would you do if inaccurate [19:05] information about the safety of an FDA vaccine, FDA approved vaccine was being communicated to the [19:13] American people? Senator, thank you for the opportunity to address this. The the role of the FDA commissioner [19:19] is very clearly defined in statute and has requirements for individual product safety and efficacy [19:25] determinations. If I'm confirmed as commissioner of food and drugs, my commitment will be to make sure [19:30] that Americans know the status of every product that is approved by the FDA that have met those [19:36] requirements that are laid out as safe and effective. But if someone is alleging something is not safe [19:42] when FDA has approved it as safe, what would be your role? Senator, I think right now my recommendation [19:51] to the American people, as I said before you as a nominee for the commissioner of food and drugs, [19:55] is that the MMR vaccine is safe and effective. I accept that, but I'm giving you a not so theoretical. [20:01] When someone is saying things alleging that the FDA was wrong in approving a drug as safe, [20:09] what would be, and let's assume that that someone is your boss. What is your role? Thank you, Senator. I think the, [20:17] I think the role of FDA commissioner has confirmed, and what I would do in this role is to communicate [20:23] and use my scientific training and my clinical background to describe what is currently known. [20:28] And what is currently known is that the vaccines that have been approved by the FDA have met the standards [20:33] for safety and efficacy. FDA has a robust post-market safety review system, and I would communicate that [20:40] any time that any product needs further safety review, that is appropriate for the FDA to do. Right now, [20:47] every vaccine that is on the market has been determined to be safe and effective, and there's [20:51] ongoing review. And I'm sorry to interrupt. I just have just two minutes left. Yes, sir. [20:56] What role should the White House or health and human services officials who are not part of the FDA [21:03] play in deciding whether FDA should approve a product? Thank you, Senator Cassidy. [21:11] If I'm confirmed as FDA commissioner, my role, my commitment would be to follow exactly the statutory [21:16] standards for safety and efficacy review of every individual product. That role, as the statute [21:22] outlines, is vested in the Commissioner of Food and Drugs. And so policy priorities can be set by the [21:28] President and are set by the President. Individual product reviews and determination are, should be, [21:35] according to statute, under the purview of the FDA. I would take the recommendations of the career [21:40] experts who are reviewing that. Most individual product determination decisions are made at the [21:44] career center level, and that is how the reliance on the expertise for each individual product is made, [21:53] and that is what is appropriate. Let me now say what I said in my opening statement. The Secretary gave me [22:00] guarantees by extension this committee, our Congress, and the American people. He later backtracked on those. [22:08] He said he had to because the President told him to do something different. If you give us, and that's [22:13] your problem, that's your problem. You are trustworthy, it seems. Other people with whom we thought [22:20] guarantees coming from the White House and the Secretary would be kept, and they weren't. If the [22:25] President asks you to do something that goes against those guarantees you give us today, what will you do? [22:33] Yeah, Senator, thank you for the opportunity to address this directly. I've had the privilege of working for [22:38] the President in the first term, and again for a year and a half. What I know is that he is driven by [22:43] outcomes, and he wants the best possible solution for the American people. I'm almost out of time, [22:46] I'm out of time. That's not my question. If he asks you to do something which goes against the guarantee [22:52] you've made to these American people through us, what will you do? Senator, I've had robust discussions [22:58] with the President. I would give him my best advice, and I would follow the statutory requirements for the [23:04] role of FDA Commissioners regarding individual product determinations for safety and efficacy, [23:10] and that would be what would guide every decision if confirmed to this role. I'm out of time. Senator [23:15] Sanders. Thank you, Mr. Chairman, and thank you for your line of questioning. I think, Dr. Overton, [23:23] the concerns that Senator Cassidy raised are concerns that many of us have. We have a President who, [23:31] in my view, does not particularly believe in the rule of law, wants to get things done, [23:37] and if people do not obey his wishes, he deals with that. And what I think the committee wants to [23:46] know is whether you are going to have the courage to stand up to somebody who lies all of the time, [23:50] who does not particularly believe in science. So that is the question. Will you have the courage to [23:59] stand up to President Trump? Senator Sanders, thank you for the opportunity to be here today, [24:07] and thank you for your opening comments on the high cost of prescription drug prices and the urgency [24:12] that we have to address those actions. Answer the question, please, Doctor. Yes, and to your [24:16] question, Senator, I have worked for the President for a long time now and earned his trust because [24:21] I have been part of robust discussions to bring him the best advice, and my job would be to follow [24:26] the law and execute what is required of the Commissioner of Food and Drugs, his individual product [24:32] decisions based on safety and efficacy standards. All right, let me ask you, let me ask you a question a [24:37] little bit beyond your job description for the job you're applying for here. The United States is the [24:44] only major country on earth not to guarantee healthcare to all people is a human right. There [24:50] are studies that tens of thousands of people in this country die because they don't get to a doctor [24:54] when they should because they can't afford it. Do you happen to believe that healthcare is a human right [25:01] that should be available to every man, woman, and child in our country? Senator, thank you for the question. [25:07] My experience as a clinician and the patients that I've taken care of from rural New Mexico to [25:12] Johns Hopkins Hospital has been a privilege, and having access to that healthcare is so important. [25:20] The importance for us is to be able to deliver that healthcare and to execute the responsibilities [25:25] that are vested from Congress into the agency and the FDA. Doctor, you're not answering the question. [25:31] It's not a complicated question. I live 50 miles away from the Canadian border, [25:35] somehow. Everybody in the country can go to a doctor. Everybody is covered. Throughout Europe, [25:40] everybody is covered. We spend twice as much per capita on healthcare, and we've got 85 million [25:45] who are uninsured or unrecharged. Is healthcare a human right? And you will work with us to make sure [25:51] that every American has healthcare because it is a human right. Senator, it has been, again, [25:57] my privilege to be able to take care of patients and to make sure that they have access to the best care [26:03] possible and to deliver that care. I don't have a lot of time, but I'm gathering that you do not [26:10] think that healthcare is a human right. Let me ask you this. President Trump has claimed in his [26:17] State of the Union address that he took prescription drugs from the highest price in the entire world [26:23] to the lowest. Wow. The American people are so excited to know now that we pay the lowest prices in [26:30] the world for prescription drugs. What do you think? Is President telling the truth? Do we pay the lowest [26:35] prices in the world for prescription drugs? Do we pay the highest prices in the world? Senator, [26:42] lowering drug costs is something that we share, and there have been, there has been immense progress, [26:47] especially on individual products. Right now, 89 percent of branded drugs have signed agreements to [26:53] lower their prices and make that available directly to the mayor. Do we pay the lowest prices? The [26:57] President said it. He's your boss. He just told us, you know, you're going to stand up to him. So he just [27:03] said, we pay the lowest prices in the world for prescription drugs. It's true or it's not true. Is it [27:08] true? Senator, we have seen- Is it true that we pay the lowest prices in the world for prescription drugs, [27:14] as President Trump has said? So, Senator, the results that we have seen for the American people from the [27:22] most favored nation policies have dropped prices, and right now, CPI says that for the first time in 60 years, [27:28] prescription drug prices have gone down by three percent. Yeah, which may have something to do [27:32] with the legislation that we passed several years ago. Let me ask you this. As you are aware that [27:39] we have an obesity epidemic in the United States, and since the 1970s, the situation has gotten so bad [27:49] that one out of every five kids in America is now obese. More than 35 million Americans have type 2 [27:55] diabetes. That's over 10 percent of our population. Earlier this year, this committee passed legislation [28:03] to require strong warning labels on ultra-processed food and to ban junk food ads targeted to kids. [28:11] No ads on TV for junk food targeted to kids. Do you support that legislation? Senator, I support the goal [28:18] of getting the best information to the American people and addressing the childhood obesity epidemic. [28:23] It is terrible that only 20 percent of our youth are eligible for the military because of their health [28:28] status. I support, like I said in my opening statement, increased food quality, transparency, [28:35] and safety, and that is very important. Should we ban TV ads that advertise junk food to kids, [28:42] which is what the legislation here did? Senator, I'm here today to talk about my nomination for [28:48] Food and Drug Administration, and I appreciate the question. I know we're out of time, [28:52] but happy to continue answering. Okay, thank you very much. Senator Cassidy has asked me to chair [29:03] in his absence, so I'm very pleased to call upon myself for the questions here. Doctor, first of all, [29:15] let me say that I enjoyed our in-depth discussion in my office. I still have a number of concerns that I [29:26] want to raise with you today. One is actions that the FDA recently took concerning flavored nicotine [29:38] products. As I explained to you, Senator Dick Durbin and I have worked for years on smoking-related issues. [29:49] When youth use e-cigarettes, nearly 90% are choosing flavored products. Yet in August, the FDA authorized [30:04] several new flavored nicotine pouches and vapes, including flavors like blueberry, mango, and citrus, [30:15] and autumn spice, cappuccino, and cool mint. These new approvals, in my judgment, jeopardize the recent [30:26] progress that's been made in reducing the number of youth who use e-cigarettes and become addicted to [30:34] nicotine. FDA justified these approvals by saying that these products give more options to adults. However, [30:44] we know that the demographic really driving consumption of favored flavored vapes are young [30:53] people. It's 90% are more likely to choose flavored products. The previous commissioner of the FDA [31:06] strongly disagreed with this decision, but apparently was overruled. What is your position [31:15] on FDA's approval of more flavored vaping products? Senator, thank you, and thank you for the [31:27] the amount of time in our discussion on type 1 diabetes and your leadership in that that I've [31:30] personally benefited from greatly. Thank you. Specific to your question on on flavored vapes, I would [31:37] first like to propose that there is a 100% agreement from this administration that we must protect kids [31:43] from illegal substances and from vapes and from flavored vapes. We saw some of that progress. President [31:48] Trump signed Tobacco 21 into law last administration, and the drop now at the lowest amount of 5% is [31:55] 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. [32:03] Number two, there is the regulation and the law on the books that the FDA has to abide by, which is looking at [32:09] appropriate, the standard of appropriate for the protection of the public health. That decision on [32:14] flavored vapes was recommended by the careers because they believe that standard was met because [32:19] adults, so many adults are using flavors preferentially. The Journal of Harm Reduction lays out that those who [32:26] quit smoking because of vapes used flavored vapes. So this is a robust discussion, but I would want to work [32:32] with the FDA that if that standard is not appropriate, we should work on statutes to fix that because we have to [32:37] protect kids number one. And the other big problem for the FDA is the flood of illicit vapes on the market. [32:44] The FDA asked for more authority in its congressional justification this year to have more authority to [32:49] better enforce against those products. And those are things I would hope to work with you on because we do agree on protecting kids. [32:56] Thank you. I think this was a terrible decision by FDA. I agree with the former commissioner that it should [33:04] not have occurred. I want to turn to a different issue and that is how slow the FDA is despite Congress [33:16] providing expedited pathways in approving drugs for rare diseases for which there are no [33:27] options. And I think of ALS where there's very little that can be done. I think of ataxia. I think of Wolfram [33:37] syndrome, pediatric syndrome. There are many. What will you do to help expedite the approval of promising drugs [33:51] that have been shown to be safe. But where there's it's very difficult to do large clinical trials because there are so few people who have [34:03] these rare diseases. But right now they have nothing to help them. [34:11] Senator, this is a key priority and something that under the the new leadership of the center [34:16] directors at the FDA, they have started to make progress. There are good policies underway. For [34:21] example, the plausible mechanisms pathway, but not just N of one. We should think about N of five, [34:26] N of 20 and of 20 and of 20 and those cases where having the flexibility and the risk-based review [34:32] determinations for those situations like we talked about where people are willing to take more risk in [34:37] these scenarios should be formalized into policy. Chairman Cassidy highlighted the review lottery in [34:43] cases like this. It's very important that there is best practices across reviewers that is coming from the [34:48] direction of the center leaders who right now are saying frontier science doesn't matter if it's not [34:54] accessible to patients. So I would want to use all of the statutory authority we can right now at the FDA if [35:01] I'm confirmed to expedite that and where there are any barriers to come to you and work with you on ways to [35:06] further provide that clarity. But I believe there's a lot we can do right now to help these patients. [35:11] Thank you. Senator Murray. Thank you very much. Dr. Overton, do you agree with the FDA [35:19] approval of mifepristone which means the agency deems it safe and effective? Senator, thank you for the [35:27] question. I look forward to getting to meet with you next week and talk in more detail. [35:32] Mifepristone was approved by the FDA as having met its safety and efficacy standard. No, my question, [35:40] I know what the FDA has done. I asked if if you agree with the FDA that it's safe and effective. [35:47] Senator, as the nominee for for the Commissioner of Food and Drugs, [35:51] my job would be to abide by the statutory standards set out for safety and efficacy. [35:56] And when a product is before the agency and has met those standards, [36:00] I would agree with with the statutory standards of safety and efficacy. So you do believe it's safe? [36:06] I believe it has. I know that it has met the safety and efficacy standard according to the FDA review. [36:13] Well, just well, despite what FDA says and despite what decades of science says, [36:19] you actually published an article three years ago that incorrectly described medication abortion [36:25] as dangerous to women. The fact that you would blatantly contradict decades of high quality [36:31] scientific evidence and millions of patients use it is alarming to me. So that's why I asked you that [36:36] question. You have stated in an article that you believe it is dangerous. So I asked you, [36:42] do you believe it is safe today? And you're not answering my question. [36:45] Senator, thank you for the opportunity to discuss this directly. I have always been driven by data [36:53] and information and used the clinical training and the research training that I have in everything [36:59] that I have written. Specific to that publication in 23 was at a time after a change was made at the FDA [37:07] and how that medication was accessed. And I think it's very important for the FDA in its post-market review, [37:13] like with every medication, especially those medications that have a risk evaluation mitigation strategy. [37:18] Well, I hear you changing your answer and now saying you don't think it is safe. [37:23] The FDA agreed that this was safe and effective 26 years ago. And from where I come from, [37:30] I really believe that our FDA needs people who have put science first. The FDA has said this is safe, [37:36] and we need someone in FDA who's going to be there to make sure that this is done by science base. So [37:43] that's where I come from. Let me change really quickly. I'm almost out of time. As you know, [37:50] this summer Americans have had to deal with lettuce that causes explosive diarrhea. There's been an [37:55] outbreak recalling millions of eggs, frozen blueberries were contaminated with E. coli, multiple recalls of [38:01] infant formula and the list goes on. What happened this summer just, it cannot happen again. And [38:08] coincidentally, all of this happened after Trump and Doge pushed out and fired more than 4,600 people [38:14] at the FDA. And now the agency I hear is trying to scramble to rehire about 3,500 people. That is nearly [38:22] a 17% reduction in just a year and a half for a workforce whose job it is to keep our food and our [38:29] medicines safe. Can you tell us how many people currently work at the human foods program at FDA [38:36] right now? Senator, thank you for the question. Having not been at the agency right now, I don't [38:42] know the exact staffing numbers of that center. I know there are about 16,000 employees currently. [38:47] And I know that the FDA, as publicly reported, is hiring to have the best people in the best [38:52] positions to be able to deliver on the core mission. Food safety is one of those. And there are a lot of [38:59] things that we can do and work together on. And well, let me just tell you, let me just tell you, [39:04] because it's really important. The office has approximately 1,700 employees, which is still 13% [39:12] fewer than they had at the start of 2025. So that is deeply disturbing. So I want you to be aware of [39:19] that. And I want you to focus on that. And I wanted to ask you, are you currently aware which part of the [39:24] FDA's human foods program monitors those kinds of outbreaks and foodborne illnesses? Do you know [39:29] what it's called? No. Within the center of human foods? Well, I'll tell you. It's the safety and [39:36] inspection center, I believe. Well, it's the coordinated outbreak risk and evaluation network. [39:41] It's called the core network. I think that's really important that you focus on that and know that and [39:46] make sure that it is fully staffed. It is absolutely incredibly important to people's safety. And I think [39:52] everyone right now is very concerned about what's been happening. And I see a direct correlation to [39:57] the reduction of staff that has been there. Finally, and I just have a minute, a few seconds left. [40:05] Last year, the Trump administration falsely labeled birth control as abortion. Do you agree that, [40:10] say, an IUD is an abortion patient? If I have the privilege of being confirmed, first off, I commit to [40:17] working with you on the food safety pillars are critically important. We did ask in the congressional [40:21] justification for more foreign facility user fees to be able to have more of those inspections and [40:28] specifically address the problems that were raised. I appreciate that. But I wanted to know if you [40:32] agree that an IUD is an abortion patient. Senator, thank you for the question. If I'm confirmed as FDA [40:37] commissioner, I'll be fully briefed on all their prior decisions and make determinations according to [40:42] the standards of safety and efficacy. Well, I don't think you answered the question. Look, I think it is [40:50] outrageous and should be deeply alarming to all Americans right now that the prospect of an FDA [40:56] commissioner who doesn't know that birth control is not an abortion is deeply concerning to me. [41:02] Thank you, Mr. Chairman. Congratulations, Dr. Overton. Thanks for being here today. I'm sure my colleagues [41:11] across the aisle will or will ask you a lot of questions whether you agree with President Trump or [41:17] not. I know as a senator, sometimes I say things less artfully than I could, but I think focusing on [41:24] sound bites misses the biggest bigger picture about you. You've got the experience, the expertise to lead [41:34] the FDA, even if some of your background may not seem like the traditional path to this position. And I [41:40] want to start with the issue today of illicit vapes, okay? We need an FDA center for the tobacco products [41:49] that is efficient, predictable, and able to meet its statutory timelines. Dr. Overton, what steps would you [41:56] take to improve the FDA's tobacco review process and provide manufacturers with more regulatory clarity? [42:04] Thank you, Senator, and thank you for the great conversation that we had and for the encouragement there. [42:10] I will just note for the committee that my background is very similar, in fact, to a former FDA commissioner [42:15] who is known to have a very successful tenure and wrote an op-ed with another former commissioner in [42:20] support of my nomination. So I'd be excited to bring the energy and the ability to solve these complex [42:25] problems. Illicit vapes is one of those problems that we need to solve. I want to work with this [42:30] committee to make sure that we are doing that in the right way. Number one, we have to protect kids as the [42:36] first step. Number two, getting more approvals and, sorry, excuse me, more authorizations for products [42:43] that have met the standards at the FDA is critical to being able to have a legal robust market. Right [42:49] now, part of the problem, and Senator Moody and I discussed this, hi, Senator, to have, there was an [42:54] immense backlog at the FDA when the Trump administration first came in. They have been, there was up to 27 [43:01] million applications in PMTA. There have been, it's been immense work to streamline that. There was 310,000 [43:09] applications that are pending right now, or that were pending in May. They're down to about 100,000. [43:15] There have been 48 products that were authorized for use. And I think having that robust legal framework [43:22] is critical in order to get legal approved market products to the people that use them for smoking [43:28] cessation while having the strongest protections available to keep them out of the hands of kids, [43:33] which we all agree on, and being able to do proper enforcement with the other law enforcement agencies, [43:39] DOJ, DHS, all have a critical role. And if I'm confirmed, I would work with them to make sure the [43:44] enforcement is just as strong as we work to fix the backlog that we inherited from the previous [43:50] administration. Do you support category-specific product standards for ends of nicotine pouch products, [43:58] and how would you approach developing those standards? Thank you, Senator. I think if I'm [44:04] confirmed to the role, my first step would be getting a full and complete briefing from the [44:09] Center for Tobacco Products on exactly that question. I think we do have to have regulatory clarity and [44:15] certainty to be able to get products that are legal and are helping adults stop smoking and do that in a [44:21] way that is protecting kids with, again, appropriate input from this committee on how to best do that in [44:28] accordance with the standard appropriate for the protection of public health. So there's streamlining [44:33] reviews. There is working with the companies that have applications in front to make sure that they are [44:40] submitting data and accurately assessing how to meet that standard. But I would want to get brief [44:46] fully by the Center if I'm confirmed. Thank you. We also need to make sure legal tobacco products aren't [44:53] being undercut by illicit and unauthorized products, including products coming from foreign manufacturers. [45:01] How would you work with agencies like HSI and DOJ as well as state and local authorities to strengthen [45:06] these policies? Yes, Senator. Thank you. That is something that is of critical importance for the agency. [45:12] There was a request in the congressional proposal this year to have more authorities for better enforcement [45:18] at the borders and better coordination with the other agencies on knowing what products are coming in. [45:23] Often they are mislabeled. They are and we know they are targeted towards kids video games and candies and [45:30] other products. And so that interagency coordination and the experience that I bring from having run very [45:37] big interagency processes right now would be used on day one to increase our abilities to enforce appropriately. [45:43] Thank you. Thank you. Thank you, Mr. Chairman. Thank you. Let me also correct something for the record. [45:53] Chairman, excuse me, Senator Murray said that Miefer-Prestone [45:58] was shown to be safe and effective. And I will point out it was approved under more [46:03] stringent safety requirements than are currently in effect. And a post-market safety study is ongoing. [46:09] I'll let my own remarks as regards the absence of ultrasounds to establish gestational age [46:16] and ectopic pregnancy as in of themselves indicating what I mean. Next, we'll go to Senator Murphy. [46:22] Senator Murphy- Thank you very much, Mr. Chairman. Listen, I share the chairman's concern [46:30] about this dramatic reduction in faith in the FDA that has happened over the past year. And the reason [46:36] is simple. People don't believe that science has anything to do with some of the decision making and [46:41] that it's all about politics. Here's an example. On April 30th, it's a Thursday afternoon. Reynolds, [46:49] one of the biggest tobacco companies in the country, makes an eight million dollar donation to the [46:53] president. Two days later on Saturday, because of that donation, they have lunch with the president and [46:58] they tell him that they want a change in FDA rules, especially regarding flavored vapes. The president [47:05] calls the FDA commissioner. He calls the secretary of HHS. And three days later on Tuesday, new guidance [47:13] is issued that paves the way to the sale of flavored vapes. That is not a coincidence, right? That is the [47:21] definition of political interference in FDA decision making. Thursday, a donation is made. Saturday, [47:29] a meeting with the president. The same day, a call to the FDA commissioner. And three days later, [47:35] three days later, the FDA changes the rules. Extraordinary. And four days after that, the FDA [47:41] commissioner resigns, either in protest or because he was fired because of his disagreement with this [47:47] decision. I heard you say that your commitment is to science being the guiding marker for decisions [47:58] made at FDA. So let me talk to you about one of the ways that science has been undermined. And that [48:06] is the eradication of the advisory board system. So since President Trump came into office, 27% of all [48:14] advisory boards have been eliminated. And of those that remain, there have been 72% fewer meetings. [48:21] The tobacco advisory board had no specific meeting and no vote on this specific policy, [48:27] because if they had had a vote, they would have voted against this. And that's in part why the FDA [48:32] commissioner resigned. And so, so long as these advisory boards, which are authorized by Congress, [48:39] are attacked, eliminated, and restricted from meeting, you are not going to rebound the public's [48:47] support for independent FDA decision making. So let me ask you specifically, will you commit to restarting [48:58] the advisory boards that have been disbanded under this president? Senator, thank you for the question [49:08] and I hope to have the opportunity to meet and discuss things in more detail. I think specific to your [49:13] question. I will note that since FDA has had a number of advisory committees meeting, and I think [49:20] they're, they are extremely valuable from everything that I know about the FDA. If I'm confirmed as [49:25] commissioner, they are a critical part of, of the role of the FDA. Okay, I get it, but you've done a [49:30] pretty good job of avoiding answering questions so far. So will you commit, it's yes or no, will you commit [49:35] to restarting the committees that have been disbanded? Senator, if I'm confirmed as FDA commissioner, [49:41] advisory committees will meet at the FDA. I have to look at specifically all of the ones that you're, [49:45] that might be disbanded to, to what you're asking, but they're the ones that I'm familiar with, like [49:50] the vaccine related biologic product advisory committee has been meeting. They've been making [49:54] recommendations. Those recommendations have been used to as, as normal process, and I would continue [50:00] that direction. It's critical to get there. Will you at least commit to ceasing the campaign of [50:06] disbanding committees? Will you keep the committees that exist today? Or are you open to, uh, to shutting [50:14] down more advisory committees? Senator, if I'm confirmed as FDA commissioner, advisory committees [50:20] will be a critical part. And I, can you commit to us that you will not shut down any additional [50:25] advisory committees? Senator, my, my goal would be to not shut down any advisory committees, but to look at [50:31] all of them to make sure they're fulfilling their highest purpose, getting the best experts on, [50:37] providing recommendations. They are key part of the administrative record of the FDA and the FDA does [50:41] rely on that. So yes, that would be a huge part of, of my role of confirmed. I think it's, it's, I think [50:47] it's careful wording that your goal will be to not shut down advisory committees. That's not a commitment. [50:52] Finally, do you see anything wrong with the chain of events that I just articulated for you? I mean, [50:58] that's an extraordinary story. An $8 million donation, two days later, a meeting of those [51:06] donors with the president, an immediate phone call to the FDA to change the rules. Four days later, [51:12] the rules are changed. And four days after that, the FDA commissioner resigns. Do you have any opinion [51:19] as to whether that's the way that you want the FDA to work? Senator, I reject the framing of that [51:27] question. I will say, having worked for the president for a year and a half in this role, [51:31] I know that he is committed to the best possible outcomes for Americans. And he wants his team to [51:36] ensure that that is what is being delivered. So you don't see any connection between [51:40] the donation, the president's meeting, and four days later, the standards being changed. [51:49] Mr. Chair, Senator, again, I reject the framing of that question. I think the president [51:54] is aware that adults are using vapes to quit smoking. And that has been his direction, [52:00] is to get the best outcome for the American people in every decision that is made. If I'm [52:04] confirmed as commissioner, that will be my commitment. Okay. Senator Moody. [52:13] Thank you, Chairman Cassidy. Dr. Overton, thank you for joining us. And to your family and friends that [52:17] are here to support you. Sometimes these hearings are harder on them. So thank you for being here with our [52:22] nominee. We had a good meeting, a long meeting. And I appreciate you stepping up to take on this [52:30] important position. I think we are at a time when Americans are becoming more conscious of their [52:36] health. And I wouldn't be surprised if Americans across the country are watching this hearing right [52:42] now that probably thought five years ago they would never be watching a Senate confirmation hearing. So [52:47] I think you come in at a very important time. And we expect high performance from whoever takes on this [52:55] role. We are also in the era of drug discovery and pharmaceutical innovation. And you will play a key [53:04] role in all of that. And I want to ask you a few questions in a moment about some right to try laws. But [53:10] 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 [53:17] have been talking about something that's been very important to me as a mother. I have a kid still in [53:23] school. Kids watching young people as Attorney General become more and more addicted to vapes. A lot [53:32] of these coming in illegally from foreign countries, especially China. We don't know what is in them. In fact, [53:40] a large percentage of our market in vaping, I would say 85% of the US market of vapes, illicit nicotine [53:53] products are illegally smuggled in from China. We know that they're specifically designed to be [53:59] attractive to kids. And we know this because they often have games on them. It's not hard to tell who [54:07] they're trying to market to. So will you commit and I know you've answered some questions and a lot [54:13] of my colleagues and I'm glad because this was one of the first questions I asked at the last [54:18] hearing for the same position. Will you commit to targeting illegal Chinese vapes for strong regulatory [54:25] action? Senator, thank you for the question. Yes, I will commit to ensuring that the enforcement [54:33] and that FDA is working closely with its other law enforcement agencies to ensure that we are enforcing [54:39] the law and protecting against illegal. Okay, so you're you're sitting closely with some of the [54:43] agencies that do seizures and we're trying to make sure we give them more power to do that. [54:47] But within your power as at the FDA, will you commit to examining regulations currently in place [54:54] and making sure that we are modifying them as necessary to prohibit crack down on illicit Chinese vapes? [55:02] Yes, if I'm confirming this role, that will be a top priority. It's a critical part of the pillars [55:06] in order to ensure that we are protecting kids. We are getting legal products to the adults that are [55:11] using them to stop smoking and we are cracking down on illicit products that are affecting children [55:17] especially but should not be on our market. So yes, that was your opinion right now that as as the regs are [55:23] set up and that if someone files an application that is a vape product, is the application on file [55:32] enough to allow the current sale of the product? Thank you, Senator. This this question in context [55:39] of the market that exists right now where there are products that that adults are using to stop smoking, [55:47] it is critical to fix that pipeline to have regulations. Is there right now if someone files [55:53] an application and it's pending with you, can they continue to sell even though it hasn't been approved? [55:58] Senator, I believe as as the guidance is currently written, there is a low risk and for products that [56:04] have a complete application. It can't be just one note like the 27 million that came in and 26 million [56:10] were kicked out because they were not even appropriate application to the FDA. So they should say yes if [56:16] someone files an application they can sell right? I think until we I think we have to fix the broad [56:21] 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 [56:25] question right? Is that a yes? Because I just think it's important that everybody understands that. [56:30] Right now we had millions that were pending right and so presumably they could have sold until we [56:35] kicked them out which is why bringing that down was so important because you had millions and millions [56:40] just filed no idea what's in them, no idea where they come from, no idea what they contain but we had [56:45] regs that allowed them to be sold right? Yes. So you've kicked it down now to a couple hundred thousand. [56:50] Efficiency I'm hearing is top of mind for many of my colleagues and now you're seeing why efficiency [56:56] is so important. Yes. Because you're allowing these things to be sold and we don't know what's in them [57:01] right? So do you commit to me to not only addressing that regulation if that has indeed allowed products [57:10] that are harmful to be on the market do you commit to addressing that if necessary? Yes Senator I commit to [57:16] addressing that to find the right solution for this problem it's critically important. Thank you so much. [57:20] Senator Baldwin with an apology because she was supposed to go before Senator Murphy and so I apologize. [57:28] Thank you Mr. Chairman. Dr. Overton the FDA commissioner should make sure that products on the grocery [57:39] shelf are labeled accurately including products in the dairy aisle. I have asked past FDA commissioners [57:49] to take a common sense approach laid out by my bipartisan Dairy Pride Act and so far they have [57:58] failed utterly to do the job. If confirmed will you rescind FDA's current guidance and enforce existing [58:10] standards of identity to stop imitation products from using dairy names? Thank you Senator and I enjoyed our [58:19] conversation and this topic in particular and your passion your leadership on it and I think it is [58:23] critically important that Americans have transparency in their labels. As we discussed this is something [58:28] I would absolutely commit to going and looking at and and figuring out the right policy solution so that [58:34] the guidance from the agency has accurate transparent information for Americans. So you'd absolutely have [58:41] 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 [58:47] what is in their food and the standards of identity are a key tool to that. Thank you. Mifepristone has been [58:55] FDA approved for nearly 25 years. More than 100 peer-reviewed robust clinical studies have confirmed [59:04] its safety. 99% of patients who took the abortion pill had no complications. FDA's update to the [59:14] 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. [59:36] For each update the drug went through rigorous scientific review and it's been proven to be even safer than many [59:44] low-risk drugs prescribed for other purposes. Dr. Overton do you believe Mifepristone is safe and effective? [59:53] Senator, thank you for the question opportunity to discuss this. The Mifepristone has been approved by the FDA [1:00:02] with the appropriate risk evaluation mitigation strategies so it has met the safety and efficacy [1:00:07] determinations of the FDA for those standards. The REMS did change as you outlined and the current safety [1:00:15] review that is happening at the FDA is taking an internal study and look at safety after the last REM change. [1:00:25] So you can't answer the question Dr. Overton do you believe Mifepristone is safe and effective? [1:00:33] Senator, according to FDA standards the drug is safe and effective as labeled today with the appropriate risk evaluation mitigation strategy. [1:00:43] Dr. That leads me to my next question. Do you believe the label for Mifepristone needs to be changed? Yes or no? [1:00:52] Senator, I can't prejudge the determination of a safety review that is currently ongoing. [1:00:58] Dr. The former FDA commissioner used his position at the agency to proactively request that the drug companies submit new [1:01:09] applications to change the label for acetaminophen, also known as Tylenol. This was based on the [1:01:16] administration's belief that Tylenol may cause autism, something that has no scientific backing. If confirmed, [1:01:26] would you use your position to pressure any company to change their label? Yes or no? [1:01:33] Senator, if I'm confirmed as commissioner of food and drugs, I will be guided by the science and the best [1:01:37] evidence that is available and ensure that labels accurately reflect what is known about a medication. [1:01:47] I haven't been encouraged by what I've seen but I urge you to indeed follow the well-established [1:01:54] science on safety and efficacy of Mifepristone. The FDA cannot be basing its decisions on [1:02:02] political whims of any secretary including Secretary Kennedy. [1:02:07] Dr. I want to go back to the topic of flavored vapes and youth tobacco use. In 2019, [1:02:17] at Children's Hospital of Wisconsin, they found the first cases of what was then a mysterious illness [1:02:26] linked to vaping. Since then, I've urged the FDA to take stronger action against e-cigarette companies that use [1:02:34] tricks to attract children. One reason these products are so popular is because they come in sweet, [1:02:42] trendy flavors like root beer float or cotton candy. In fact, a recent study showed that 95 percent of [1:02:52] Wisconsin middle schoolers said they wouldn't use an e-cigarette if it didn't have a flavor. This is why I was [1:03:02] deeply concerned to learn earlier this year that the FDA approved two more of these popular vape flavors. [1:03:10] Dr. Overton, are you aware that flavored vapes are very popular with teens? [1:03:16] Ms. Senator, thank you and I agree that it is critical and a core priority for us to protect kids from [1:03:23] these products. They should not have, we should not have nicotine in the hands of kids. [1:03:27] Dr. Overton, I am aware of data on flavored vapes and their usages. [1:03:30] Dr. Okay, so do you believe that this information about flavored vapes being popular should be [1:03:38] considered in future approvals? Dr. I'm going to ask just to wrap that up and do that for QFR, please. [1:03:46] Dr. All right, I will submit that as a question for the record. Thank you, Dr. Overton. [1:03:50] Dr. Thank you. [1:03:50] Dr. Senator Banks. [1:03:51] Dr. Thank you, Mr. Chairman. Dr. Overton, [1:03:53] Dr. Chairman, you agree that China is dominating clinical drug trials, which is concerning because [1:04:00] often the standards and those trials are far less safe and effective there than what, how they are [1:04:06] applied in the United States. If confirmed, what will you do to make inspections of clinical trials [1:04:11] more safe and effective in China and other countries and make sure that good clinical practice is always [1:04:18] being followed? Dr. Yeah, thank you, Senator. This is a core priority. If I'm confirmed, this is something [1:04:23] that we have to address. We have seen progress from the agency recently. They were acting directors [1:04:29] of time, now many of them permanent. The agency leadership who published together a document saying [1:04:35] all data must have good clinical practices, it was an initial notification that the FDA will be [1:04:41] requiring that. If I'm confirmed, going in and making sure that policy is as strong as it can be, [1:04:47] enforceable, and communicated well so that our companies, and ultimately our goal is that these products [1:04:52] should be developed and manufactured here in America. We want to make it easier for that to happen, [1:04:57] and we want to be very strict in places that are not doing that right now, and are currently [1:05:01] stealing away much of our biotechnology. You agree that we're not doing nearly enough right now, [1:05:06] but on your watch, we're going to make it a top priority. Senator, I think there is a lot more to do, [1:05:10] and I'd be committed to doing that, absolutely. Under Dr. McCary's leadership, the FDA gave conflicting [1:05:16] answers about Mifepristone's safety study and reinstating the in-person dispensing requirement. [1:05:23] I'm disappointed that the FDA has removed so many guard rails from this dangerous drug which carries [1:05:30] the strongest black box warning. Can you tell us when that safety study will be completed, and will [1:05:36] you commit to accelerating the safety study in the interest of women's safety? Thank you, Senator Banks. [1:05:42] If I have the privilege of being confirmed, this will be something that would immediately be on my [1:05:48] desk, because I understand the FDA has an update due to the court on October 7th of the process that it [1:05:54] is in, and it is a process update. Again, this is the Louisiana case that the FDA must owe an update, [1:06:02] so I'm not currently involved in the details of the study, but if I'm confirmed, I would immediately get [1:06:06] briefed and be updated on the process and be able to give better answers on the estimated timelines [1:06:12] of when that review will be completed. The commitment would be that that study has to be done in the [1:06:18] most durable, scientific way possible, and the results communicated transparently. We'll note it is not [1:06:24] just the Louisiana court case that is waiting for that update to the court. There's another case from [1:06:30] Hawaii that has asked the FDA to remove the REMS altogether, and they are also looking for an update [1:06:36] from the safety study. So if I'm confirmed as commissioner, my job would be to use all of [1:06:41] the clinical and the research training that I have to make sure that that study is well-designed, [1:06:46] it is the analysis is appropriate, it's adjusted appropriately, and the results can be transparently [1:06:52] shared so that all Americans have an opportunity to know what exactly is in those findings. [1:06:58] As you know, the FDA commissioner has investigatory authority. Is it in the public interest to [1:07:05] investigate companies that dispense abortion drugs and mislead women about their risk? [1:07:11] Thank you, Senator. I think every drug that has been approved by the FDA has robust post-market review [1:07:18] and enforcement. If there are issues identified, and especially when there is a REMS on a medication, [1:07:24] the manufacturers have to abide by the law. The committee, this committee published a report recently [1:07:29] that highlighted some potential concerns from those manufacturers in regards to meeting the [1:07:33] current REMS, not related to the ongoing safety study. So if I'm confirmed as commissioner, I would [1:07:39] be committed to making sure that every company is following the law regarding the requirements, [1:07:44] especially when a drug necessitates a REMS on the medication. I want to work with you on reforming the [1:07:50] GRAS standard as well. The mandatory ingredient notification rule that Secretary Kennedy announced [1:07:57] last month was a big step forward. Does the FDA have enough resources to do all the ingredient safety [1:08:04] evaluations? And how can Congress help you provide better and more resources? [1:08:08] Thank you, Senator. To my understanding, the agency would need more resources in its Human Foods [1:08:15] program to properly be able to do all of those mandatory notifications. I know there are proposals in [1:08:21] Congress. There are some that I believe the FDA has given technical feedback to work on this problem [1:08:26] together. And I think it is it is critically important that we get it right. The FDA has the [1:08:30] appropriate priorities and resources. So you'll get back with us on what else? [1:08:32] Last question. Several states have passed their own food ingredient bans and labeling requirements. [1:08:38] Do you think many states have adequate personnel and expertise to review food ingredients and determine [1:08:45] safety, which has traditionally been the FDA's job? Thank you, Senator. I think there has been a lot of [1:08:51] progress in the states. I think it is important that we have Mr. Chair, if I may answer. I think it [1:08:57] is I think it is very important that when certain thresholds are met across states, there are times [1:09:02] that it is appropriate to consider a national standard, a strong national standard to have uniformity [1:09:07] historically across the FDA and EPA. There have been cases when there is kind of a threshold met that a [1:09:13] number of states have done something on an issue. But it is appropriate then for the federal regulatory body to look at [1:09:19] having a strong national standard. Thank you. Thank you. Senator Hassen. Well, thank you, Chair Cassidy. And I thank you and the [1:09:27] ranking member for this hearing. Congratulations, Dr. Overton, to you and your family. And thank you for your [1:09:34] willingness to serve your country. I just want to start by level setting a little bit here. Mifepristone safety [1:09:41] studies show that it is in 99.8 percent of medication abortions using Mifepristone. [1:09:47] There are no serious adverse events. And you know what? Recent studies on telehealth [1:09:53] use of Mifepristone has the exact same statistic. About 6,000 women studied in the United States and 20 [1:10:01] states and Washington, D.C. It has been approved for telehealth in the United Kingdom, in Canada, [1:10:07] in Scotland. So I just want to level set with that. Before turning to other issues, I want to ask you a [1:10:13] simple question, Doctor. If directed by the President to take action that would break the law, [1:10:18] would you follow the law or follow the President's directive? Senator Hassen, thank you. I appreciate [1:10:23] the opportunity to meet and share especially the patient stories and the perspective. I appreciate [1:10:27] that. Our time is limited. Yes or no? Senator, I will follow the law if I'm confirmed as FDA Commissioner. [1:10:32] Thank you. Do you think it's possible for the President to ever be wrong about something? [1:10:38] Senator, as I've shared here before, I've had the privilege of working for the President for over a year and a [1:10:44] half and have had robust discussions with him along with all of his advisors. Is it possible for him [1:10:49] to be wrong? Is it possible for him to be wrong? Senator, it is the President who sets the policy [1:10:56] directions, but he works with all of his advisors to get the best information. My experience has been [1:11:01] he wants to make the best decision and the best decision. I appreciate this. I have limited time, [1:11:05] so I'm going to stop you there. I was asking you about whether the President of the United States could [1:11:09] be wrong because I want to talk about a specific comment the President recently made. You were [1:11:14] standing right behind President Trump at an August 10th press conference when he talked about the [1:11:19] combined measles, mumps, and rubella vaccine that is given to children to protect from these diseases. [1:11:25] The President said of the combined vaccines that, quote, together there could be a possibility [1:11:31] they're quite lethal, close quote. Do you believe that the combined measles, mumps, and rubella vaccine is [1:11:37] possibly quite lethal? Senator, the MMR vaccine is safe and effective. It is our best current tool [1:11:44] to combat the measles outbreak that is happening. Right, so the President said that the combined [1:11:49] measles and mumps vaccine could kill children who receive it. So was the President wrong when he [1:11:54] suggested that the combined measles, mumps, and rubella vaccine may be lethal? Senator, the President [1:12:02] asks questions and wants the best outcomes for the American people right now. As he said recently in the [1:12:07] Oval Office, the MMR vaccine, every American should get it. It is the best tool that we have. [1:12:13] Let me let me get to why I'm going down this line. This is an important issue because the American [1:12:17] people need a leader at the FDA who is able to say that the President is wrong when he is, [1:12:24] especially when it comes to medicine for kids. So I'll ask you again, was the President wrong when [1:12:28] he suggested, I don't care what he has said recently, but when he suggested that the combined [1:12:34] measles and mumps vaccine may be lethal to children, was he wrong? Senator, the MMR vaccine [1:12:41] is safe and effective. It is the best tool that we have in the current measles outbreak, and every [1:12:45] American that's unvaccinated should get it. I wish it wasn't so difficult for members of the [1:12:50] administration to just plainly say that the President's wrong, and it's really concerning to [1:12:56] me that you are equivocating on it here. He was wrong about that. In September of last year, [1:13:01] during your time advising President Trump, he gave a press conference claiming that Tylenol [1:13:06] causes autism in children. He stated the following about women's use of Tylenol during pregnancy, [1:13:11] quote, I want to say it like it is, don't take Tylenol, don't take it. If you just can't, I mean, [1:13:16] it's fight like hell not to take it. So do you believe that Tylenol causes autism and that women [1:13:22] should fight like hell not to take Tylenol during pregnancy? Senator, I have not seen any causal evidence [1:13:28] that Tylenol causes autism. The Tylenol label, as I understand it, recommends that pregnant women [1:13:34] talk to their doctor, which as a physician and as someone that has taken care of... Right, but was [1:13:38] the President wrong, the President said Tylenol is linked to autism and that women should not take it [1:13:42] during pregnancy. Was he wrong when he said that? Yes or no? Senator, there is no current evidence of [1:13:48] a causal link between Tylenol and autism. Was he wrong when he told women not to take Tylenol during [1:13:53] pregnancy? Of course, because a high fever during pregnancy, which Tylenol could ameliorate, is [1:13:59] also highly dangerous for women. So was he wrong? Yes or no? Senator, if I'm confirmed as FDA [1:14:04] Commissioner, I will communicate what is known about the medications. Right now, the label says [1:14:09] pregnant women should talk to their doctor about medicines. But that's not what the President said. [1:14:15] Look, my time is limited and I'm going down this path because I am really concerned that if an FDA [1:14:23] commissioner will not tell the American public that the President is wrong about something, [1:14:26] that poses a real threat to our health. Last comment, if I may, Mr. Chair, Dr. Overton wrote [1:14:34] an article in 2023 saying mifepristone was dangerous. I believe you should recuse yourself from any [1:14:40] studies and make sure that career scientists conduct them at the FDA concerning mifepristone safety, [1:14:46] especially with regard to telehealth. Thank you. We have time and we got to vote. So, Senator Murkowski. [1:14:54] Thank you, Mr. Chairman. I will stick to my time. Dr. Overton, thank you for being here. Thank you for [1:14:58] the conversation. I want to continue with the discussion about mifepristone. As you and I [1:15:05] shared in my office, this is a drug that is FDA approved, has been in use for well over two decades [1:15:13] now. I believe Senator Hassan has provided some statistics for the committee in terms of the efficacy. [1:15:19] I do understand what is happening within the process right now as it is being reviewed. But my concern [1:15:27] is, as I have shared, that there was political pressure, that there is political pressure to [1:15:33] to revisit the approval status of certain products. And I think we're seeing this with mifepristone that [1:15:39] have already gone through the scientific review process, have been shown to be safe and effective. [1:15:45] As I mentioned, we are going to be in a very challenging position in a very rural state like [1:15:54] Alaska when, if in fact, the move to require in-person dispensing of the medication as opposed to [1:16:04] telehealth appointments is the direction. You have effectively taken about 80 percent of our state [1:16:12] and put them in a really challenging, excuse me, 80 percent of the communities in the state and put [1:16:19] them in a very challenging position in terms of of access to providers, access to to this this FDA [1:16:28] approved drug. So I can I can go down this same rabbit trail and probably get the exact same very specific [1:16:38] technical responses that you have provided the committee. But know that this is something that I'm I'm very [1:16:43] concerned about and I am concerned about the political pressure that does come to bear on on the scientific [1:16:52] review process when you have directives that are said this is this is an area that we want to revisit [1:17:00] and find a reason. Now I'm not going to ask you to respond to that. What I would like to do is to [1:17:06] to to move my questions over to food safety issues right now. We rely a lot on probably the the healthiest [1:17:18] of of proteins out there and that's salmon vital part of the diet in and our economy and in our communities [1:17:27] as the FDA is assessing levels of PFAS and seafood I would like your commitment to ensure that any public [1:17:34] communications are science based they're balanced they avoid creating unnecessary fear that could [1:17:40] miss inform consumers about health risks. Yes Senator thank you and thank you for the time discussing [1:17:48] Alaska and and especially our shared passion for the tribal communities. Yes if I'm confirmed I'd commit [1:17:54] to making sure that every food safety review is to the highest standard and communication about it is accurate. [1:18:00] We need that. I have had many conversations with previous FDA commissioners regarding the importance also [1:18:09] of labeling. I am not a fan of genetically engineered salmon. I think that mother nature has done a mighty fine [1:18:17] job and we need to label that as such but I would ask for your commitment to ensure again that consumers are [1:18:24] able to make informed decisions when they're purchasing a product like salmon whether it is wild caught [1:18:31] or whether it is genetically engineered and my goal is to make sure they're not choosing the genetically engineered [1:18:37] but I just need your commitment on the labeling. Yes Senator I will work with you to have accurate labeling [1:18:42] and I know the America first seafood strategy is is still in works by the administration and I believe [1:18:46] that that this is this is a top priority that's shared by the administration of getting that right and making sure labels like [1:18:52] center baldwin labels are accurate and informed informed the American people. Last question and this is on [1:18:58] food safety inspections as you know the state and the local governments conduct about 60 percent of food [1:19:05] processing facility inspections in Alaska like like others we perform our DEC performs food safety inspection [1:19:13] permitting and enforcement work under contract for FDA and has for many years. There's been efforts to cut [1:19:20] funding for these state and food local food safety programs and we're told and we believe this that FDA [1:19:29] says that they cannot as cost effectively replace the state's DEC food inspectors we got some challenging [1:19:39] geographic conditions in Alaska but in other places as well so I just need your commitment that FDA will [1:19:44] maintain funding for these contracts with state and local governments because we need to have [1:19:49] not only a good inspection system but one that is cost effective and uh uh obeys or follows the wheel of [1:19:58] Congress. Yes Senator I will I will work with you on that and ensure that that is we're following the law getting [1:20:03] the best resources to Alaska I know the FDA asked for foreign facility fees but also better state uh sharing [1:20:09] with state and local partners in food inspection so yes it's my commitment it'd be a high priority get that right. [1:20:14] Appreciate that thank you Mr. Chairman. Uh Senator Lisa Blunt Rochester. Thank you Chair Cassidy and [1:20:28] congratulations Dr. Overton on your nomination to be con uh the Commissioner of the Food and Drug Administration uh Dr. [1:20:36] Overton you were standing in the Oval Office uh when the President signed the Executive Order calling for the [1:20:43] reduction of the number of universally recommended childhood vaccines and splitting the MMR vaccine into three [1:20:50] separate shots. Um it's been reported that you provided a list of options to the President and so [1:20:57] obviously you think these were were good options correct? Senator thank you I enjoyed our meeting and [1:21:04] getting to talk to you about our shared passion for public health and your your public service um my [1:21:09] yes it's just a yes or no you think these are good options the splitting of the MMR vaccine as well as [1:21:15] recommending um your recommendation for reducing the number of childhood vaccines? My job and my [1:21:22] pride and my current role is to take a President's directive provide options to him but you provided [1:21:27] options you wouldn't have provided bad options right? With an interagency process that is would you have [1:21:32] provided him bad options? Senator these are in the current job is to take a request and to deliver something [1:21:39] that the President has requested. This is just a simple question I this I thought was the easy question you [1:21:44] you provided him what you thought in your expertise were good sound recommendations? Senator I have [1:21:50] worked to always bring my clinical background I'm going to assume that's a yes and I'm going to just ask [1:21:55] what scientific evidence did you personally review that shows um giving measles mumps and rubella as three [1:22:03] separate vaccines is safer or more effective than the combined MMR? Senator my current role is a policy [1:22:11] coordination process for agency input and and advice did you personally review any scientific evidence [1:22:18] is basically the question. Senator if I'm confirmed as FDA Commissioner which is what I'm here to talk to [1:22:24] you about I'm I'm asking a question of what you did to help inform the President before he made the decision I [1:22:33] I guess the other question I would have is currently are the separate single antigen measles mumps or rubella [1:22:41] vaccines commercially available in the United States? Senator there are no commercially available [1:22:49] monovalent vaccines for that okay so so they don't exist um the President gave you a directive as you [1:22:56] said to go fast um but vaccine manufacturers have indicated that developing trialing and obtaining FDA [1:23:03] approval for new single disease vaccines could take up to a decade in light of that what would be your [1:23:11] implementation timeline knowing that it could take a decade to even implement something like this. [1:23:17] Yes Senator if I'm confirmed as FDA Commissioner and companies would submit an application they would [1:23:23] be reviewed as appropriate to the safety and standard um safety and efficacy standards and if they meet [1:23:29] that an individual product would be approved but it is up to the companies to submit an application [1:23:33] to the FDA that would be the role so confirmed as Commissioner. In making the recommendation to the [1:23:37] President to do something like this we didn't take into account the science or the timeline it sounds [1:23:43] like the President has also proposed giving babies micro dosed vaccines at roughly 20 percent of the current [1:23:51] dose so wouldn't that mean that they'd have to have five times the amount of shots as well as the parents [1:23:58] would have to visit five times with their child as well as who pays for that is it insurers who pay for it is it [1:24:06] um the is it the parents who pay for it is the are is it the taxpayers who pay for it just kind of getting [1:24:13] into the how does this actually happen yeah Senator thank you for the question the President is aware and he [1:24:19] has talked about recently he knows that companies would need to submit an application to the FDA that this [1:24:25] would take time I believe that he is solving for a feedback he has gotten of parents wanting an additional [1:24:31] option on the market it is not taking anything away the current MMR vaccine is safe and effective is [1:24:36] our best tool and right now people should get that I think the challenge I'm having here is that the [1:24:42] administration is saying they want people to do less shots but then they're telling them to here's a do [1:24:48] more shots and it's not based on science and I'm really concerned about that and he also claimed I think [1:24:54] it was in that press conference that vaccination the size of a bottle of soda are poured into little [1:25:00] he's seen vaccines poured into a child's body the size of a soda bottle do we have that much vaccine [1:25:09] that goes into a child's body like a 20 ounce soda even a mini I don't think so would you say doctor [1:25:19] Senator I would say right now in the products licensed by the FDA are safe and effective they are given [1:25:25] and they're not the size of a soda bottle either I'm really concerned as I shared about the the [1:25:34] science piece the the implementation piece and ultimately the fact that we're in the middle of a [1:25:40] three decade measles outbreak the largest in three decades and so I you know we heard the the comments [1:25:49] before we hope that you will use science if you're confirmed and and we hope that you will [1:25:56] stand up if the information is incorrect or wrong because people's lives are on the line [1:26:01] thank you I yield back thank you very much thank you senator senator cassidy has left me with the [1:26:05] gavel which is frightening prospect isn't it senator kane um but I won't take more than 10 or 15 minutes [1:26:10] no I'm just kidding dr overton it's great it's great to see you uh I enjoyed our conversation the [1:26:15] other day congratulations on your nomination I just want to ask you about something I want to start with [1:26:19] something you said to senator baldwin a little bit earlier I just want to make sure I understand what [1:26:23] you're what you're saying this is on the topic of the abortion drug which is now causing abortion [1:26:28] numbers in this country as you know to be higher than when roe versus wade was still the law of the [1:26:32] land over a million abortions committed last year in my state of missouri where we have tight [1:26:36] restrictions on the abortion drug those restrictions are being completely overridden by pharmaceutical [1:26:42] companies that are mailing in the drug without missouri permission in fact in contravention of missouri law so [1:26:48] this is something in my state's gone to court to stop that so this is something that is very directly [1:26:53] personal to the state of missouri and to me you said in response to senator baldwin mifepristone has [1:26:58] been approved by the fda with the appropriate risk evaluation mitigation strategies it has met the safety [1:27:05] and efficacy determinations of the fda you went on and said according to fda standards the drug is safe [1:27:12] and effective as labeled today do i have that right i'm just reading a transcript just want to make sure i've got that [1:27:17] correct yes that was the discussion of the current labeling of of the drug okay i'm confused by this [1:27:25] though because that's not the fda's position in court the the right now there is an ongoing safety review [1:27:35] that is being done to assess if the risk evaluation mitigation strategy is appropriate but the the fda [1:27:41] this is very important the fda's position in court is that they will not defend they are not defending the [1:27:47] merits of the rims that the biden administration put into place that they have admitted in court [1:27:55] that those rims were not are not safe and effective that they were not done according to fda standards [1:28:01] that's the official position of the food and drug administration in court in louisiana and also in [1:28:07] the case that my state has brought so i want to get to the bottom of this is i want to be sure that the fda [1:28:13] is not changing its position i think it's gonna be news to the court so are you saying that the fda's [1:28:18] position is now that the drug is safe and effective and appropriately labeled let's say i'm talking [1:28:24] about the risk evaluation mitigation strategy specific rooms the rems it is there is an ongoing safety [1:28:31] review after a rems was changed it is appropriate to be doing the safety review because the fda has not [1:28:36] done an internal updated recent safety analysis but what to connect what i was saying before right now [1:28:43] there has not there has not been a change to the label that safety study is ongoing and very important [1:28:49] women's health and women's safety um is a critical piece of this so there is no change in position [1:28:55] the fda does need to do that safety study to look at the internal data that has not been looked at since [1:28:59] a rems change was made i i agree with all of that i mean i think that the safety study is absolutely [1:29:05] vital it's it's long overdue the fact that this drug sends one in ten women more than that more [1:29:09] than one in ten women who take it to the hospital with a life-threatening condition that's what the [1:29:14] data shows that's extraordinary the label on the drug that these pharma companies put on it doesn't [1:29:19] disclose any of that and no wonder because many of these pharma companies are overseas they're based in [1:29:23] the caymans they're making billions of dollars by lying to women about the dangers of this drug i think [1:29:28] all of that's indisputable i just want to be real clear though because it matters a lot the fda is not [1:29:33] defending the merits of the biden administration's rims in court the fda's position is they admit [1:29:40] in court that the rims were not appropriately put into place i'm talking about joe biden's rollback of [1:29:46] any safety procedures as you know there are no safety protocols left on this drug it used to be [1:29:51] that if you if you wanted to get the drug you had to get a screening for an ectopic pregnancy which [1:29:56] is important you had to see a physician that physician had to be able to admit uh the woman to a [1:30:01] hospital if needed for her health the biden administration got rid of all of that and the [1:30:06] fda in court has said we don't defend any of that we admit that that was that that's a huge problem i [1:30:12] just want to be sure that that's your position is that your position my my position is that if [1:30:17] confirmed the ongoing safety review is a critical piece for the fda because there has not been an [1:30:22] internal safety review since that change was made it significantly changed how the medication was [1:30:28] prescribed so that the fda's current position is accurate and align with mine okay let me let me [1:30:35] try this a different way both your predecessor dr mccary and the the secretary secretary kennedy have [1:30:42] said and i quote now that the biden rims suffered from a lack of adequate consideration and also of [1:30:48] safety risk testing do you agree with that sir i think it my view it is critical that the fda complete [1:30:57] that safety analysis but do you agree with that that's your predecessor that's dr mccary and the [1:31:01] secretary that the biden rims suffered from a lack of adequate consideration and safety risk testing [1:31:07] as i understand how part of how the bite administration's decision was made it relied [1:31:11] a lot on external evidence and since that time happened there has not been an updated internal [1:31:16] safety analysis from the fda that i think is critical so that americans know what happened so [1:31:21] it that is if confirmed the most urgent thing that i would go and get briefed on and updated on the [1:31:26] status of that safety review to reach the best decision for americans all right if i don't stop [1:31:31] now then um everybody else is gonna say josh you know you're abusing the gavel so i i'm gonna and i [1:31:37] don't want that so i'll i'm gonna have some more questions for you on this subject because this is so [1:31:41] important dr overton thank you for being here and is okay senator also brooks you are recognized thank you [1:31:47] so much uh and thank you dr overton good afternoon thank you for uh for being here uh you know in another [1:31:53] series of these crackpot conspiracy theories of this administration the environmental protection [1:31:59] agency just launched a drinking water study that will test for birth control mifepristone and emergency [1:32:07] contraception and so the first question is do you have any reason to believe that birth control [1:32:14] contaminates our drinking water in our country thank you senator if confirmed as fda commissioner my job [1:32:21] will be to work within the fda statutory requirements for individual review individual product review for [1:32:28] safety and efficacy determination what the epa i think to your question is outside of the jurisdiction [1:32:34] of the fda i think it is important for all agencies to answer questions that american people might have [1:32:39] yeah i mean well actually so you're you're a medical doctor so i'm sure you're well versed in these [1:32:44] issues do you have any reason to believe that that uh taking birth control is that women are [1:32:49] contaminating our drinking water in our country by taking birth control senator thank you for the [1:32:55] question if if confirmed as fda commissioner i will work within what the fda is required to do for [1:33:01] individual product reviews safety and efficacy of those applications post-market review and of those [1:33:07] individual products but this is also a part of what the fda is required to do and in fact the fda is [1:33:14] required uh it requires pharmaceutical companies to submit an environmental assessment and that [1:33:20] assessment is a part of an approval process and the fda center for drug evaluation and research um looks [1:33:26] at data and so this is a part of what you will be uh tasked with doing uh as leading the fda and so i'm [1:33:33] just asking you you know whether this is an issue that you believe the american people should should is [1:33:38] this something you are concerned about senator i think i think as i've understood from the american [1:33:44] people and polling and questions they they want transparency in the ingredients of every part [1:33:49] of drinking water food supply and that's a critical function of public health and the epa and the fda [1:33:54] have different roles epa is again the entire water supply fda is looking at individual product [1:34:00] determinations and environmental impact in that case but if i'm confirmed i will get brief fully on [1:34:05] the science by the career experts and ask them this question well it's already been studied i mean it's [1:34:11] it's the fact birth control has been approved for over 65 years now um and the fda has thoroughly [1:34:17] studied it the data exists um and so there you know this is just another effort i believe uh by this [1:34:23] administration to um to seek out uh answers to things that are not problems this is another conspiracy [1:34:29] theory which is the reason that i'm asking it um i also want to take you back to another area of [1:34:34] concern and it is that as a senior advisor to the president i know you answered some questions about this [1:34:39] um you helped to lead an interagency process and make recommendations on health policy and one of [1:34:45] the huge issues of course of interest would be big tobacco and i want to know whether or not you know [1:34:51] how much uh money big tobacco has contributed to the president's uh super PAC uh inauguration or to his [1:34:58] ballroom senator those are not questions that i'm familiar with well i know you've been a senior [1:35:05] advisor to his but the answer is 20 million dollars and whether you know as well do you know how much the [1:35:10] president owns in tobacco stocks i think these are questions the american people deserve to know [1:35:15] well the answer is 1.64 million dollars the president owns in philip morris and and holds altria [1:35:22] investments and then based on the numbers that i just gave would you say that the president [1:35:28] then has a vested personal financial interest um in the success of the tobacco industry is that a fair [1:35:34] statement senator i reject the framing of that the president's interest is in the best outcomes for the [1:35:39] american people he is he is here to serve in that capacity but you acknowledge that he's an investor [1:35:45] then in the in big tobacco i mean he's earned 1.64 million dollars in philip morris and in holes [1:35:53] investments and i would say that that would give you a financial interest in it but let me go further [1:35:57] um and clarify a timeline that is of interest um the president met with some folks uh at his golf course [1:36:05] on may 2nd and it's no coincidence i would say that just a few days later on may 5th um the fda [1:36:12] authorized the sale of flavored uh e-cigarettes on may 8th we saw that fda rolled back enforcement of [1:36:19] unauthorized vapes and then we know that uh the former fda commissioner who was very against all of [1:36:24] this was fired on the 12th so these things don't feel like coincidences to me um does it feel that way to [1:36:30] you senator if i'm confirmed as commissioner of food and drugs my job will be to uphold the law and [1:36:35] to abide by the statutory standards for the appropriate protection of the public health [1:36:39] that is required for all reviews regarding vapes and and in the case of flavored vapes i will note [1:36:45] it was the career officials who made a recommendations that those products that were that were authorized [1:36:51] by the fda met that standard but you can acknowledge and this is my last that the that [1:36:56] timeline i just gave you would raise eyebrows for some people you can understand why that would be [1:37:00] a troubling timeline uh you know if your boss met with these folks and then suddenly [1:37:05] the approvals came thank you further thank you thank you mr chair and thanks to dr overton um [1:37:16] a comment because that is not a question because it's already been put on the record but i just want [1:37:21] to point it out and that is in 2026 compared to 2025 there has been fda reports of foodborne outbreaks 16 [1:37:33] times the reported cases from 2025 so we've seen this 16x increase in fda reports about foodborne outbreak [1:37:42] related illnesses at the same time at the same time um the reports are that the number of food inspectors [1:37:52] employed by the federal government is at the lowest since 2005 the head of the human foods program and fda quit [1:37:59] early last year because of indiscriminate layoffs of technical experts and dr overton should you be [1:38:06] confirmed you would walk into an fda that has lost 4 500 staff members since the beginning of the [1:38:12] administration which is about 20 percent of its workforce you will have your hands full if you're [1:38:18] confirmed dramatic increases in foodborne illness and we're not talking about measles and all the other [1:38:24] things but dramatic increases in foodborne illness dramatic shrinking in staff including the resignation [1:38:31] of some of the key technical experts in this space that is an important thing for us to contemplate i'm [1:38:36] not going to ask you about it you didn't do the layoffs others did the layoffs i want to ask you about [1:38:41] this there was an article that was published last night in the wall street journal that i would like to [1:38:44] introduce in the record and it here's the title u.s regulators plan major move to speed authorization of vapes [1:38:51] tobacco pouches from the wall street journal september 23 2026 i'd like to introduce it into the record [1:38:59] just to read a couple of sections the trump administration is planning to smooth the way for [1:39:04] more tobacco products such as flavored vapes to legally enter the market by changing the rules to [1:39:09] split up the authorization process people familiar with the matter said the food and drug administration [1:39:17] is expected to announce in coming days that it will revisit a 2021 rule that outlined requirements for [1:39:25] new tobacco applications that 2021 rule was done by trump term one administration it was proposed by [1:39:34] president trump in his first term it was only finalized after president biden became president but the [1:39:41] rule that the administration is contemplating changing if this is accurate would be backtracking [1:39:47] on a trump term one priority during trump term one this committee for example passed the law raising [1:39:53] the age of federal tobacco products from 18 to 21 got it out of committee went to president trump's desk [1:39:58] he signed it i was the co-sponsor with senator mcconnell so what are you aware of about the trump [1:40:07] administration plan to smooth the way for more tobacco products senator thank you and thank you for the [1:40:13] great discussion we had and for your leadership on that on tobacco 21 like i've said before it is a [1:40:18] key priority that we all agree on that nicotine should be kept out of the hands of kids and that [1:40:23] we have to have the proper enforcement strategies to do that and so thank you again for your leadership [1:40:28] on that i i am not aware of that decision making since i've been nominated to the role i've not been [1:40:33] involved in that you're and what's your current position center currently a deputy assistant to the [1:40:38] president for domestic policy for domestic policy so you're telling me you have no awareness [1:40:44] in your current position as a domestic policy advisor at the white house of trump administration [1:40:51] discussions about planning to smooth the way for more tobacco products such as flavored vapes [1:40:58] senator since the time of my nomination i've not been involved in those discussions what i do know [1:41:02] that the overarching goals of and i'm not asking kids listen i'm not asking whether you've been [1:41:08] involved in them i didn't ask that are you aware i mean we're talking to you as an fda director this [1:41:14] report says within days the fda is is is putting out a rule to roll back advances made during trump [1:41:23] term one you're a domestic policy advisor i know you're not assuming the duties of the fda [1:41:29] administrator until you get confirmed but your testimony here today is you are completely unaware [1:41:35] of any of the discussions that are going on right now within the trump administration about rolling back [1:41:41] tobacco regulation senator i'm not involved in those discussions i didn't ask nomination what i can say [1:41:48] is that dr overton now come on don't play games with me i didn't ask whether you involved in them [1:41:53] i asked are you aware that this matter that bears directly on the position to which you've been nominated [1:42:00] and which is at least in sort of the subject matter bailiwick you currently operate are you aware of [1:42:05] discussions that is going on about whether the fda will roll back tobacco safety regulations and [1:42:12] that's an easy you're either aware of them or you're not thank you senator you know i'm not involved in [1:42:19] those conversations the the the administration wants to protect kids wants to have legal pathways [1:42:25] to authorized vapes let the record reflect that the witness refused to answer the question idly yield [1:42:32] senator markey thank you mr chairman um dr overton um thank you for meeting with me earlier this week [1:42:42] um what was your role in the executive order president trump signed last month regarding childhood [1:42:50] vaccine recommendations senator markey thank you i enjoyed our meeting and your length of public service [1:42:56] and thank you for for taking the time in my current role i serve as an advisor to the president if he [1:43:02] makes a request i run interagency processes get feedback from all the agency experts present options [1:43:08] to the president for his decision okay so last month the america first policy institute where you served [1:43:18] in a leadership role said that you were quote critical in the president's executive order to deliver gold [1:43:25] standard childhood vaccine recommendations and quote modernize the childhood vaccine schedule [1:43:32] so it doesn't sound like you were just part of the process um you stood beside the president uh when he [1:43:40] signed that executive order calling for splitting up the measles mumps rubella or mmr uh vaccine and called [1:43:49] it and called it quote a a historic day and and historic action and at the signing the president said quote we want [1:44:01] it in three separate vaccinations given at separate times together there could be a possibility they're [1:44:09] quite lethal and separately it looks like they are not at all lethal so dr overton we've heard you and [1:44:17] other members of the administration repeatedly champion gold standard science at that signing you told the [1:44:25] country quote take a look at this scientific assessment and for more than 50 years the fda the agency [1:44:33] you want to run has found the combined mmr vaccine safe and effective you have said today that it is safe [1:44:40] and effective minutes after the president suggested it could be quite lethal you had the microphone you [1:44:48] didn't correct him instead you said parents should have quote the option to separate them out so why [1:44:56] didn't you correct the president at that moment so that the correct science was understood by american [1:45:04] parents senator thank you and i think again for the committee and for what the president has said [1:45:10] recently the mmr vaccine is safe and effective it is our best tool for those that are unvaccinated to get [1:45:17] in the current measles outbreak and i i do believe that what the president is responding to is [1:45:22] providing additional options there is very clear to not take anything away to keep that vaccine available [1:45:28] it is the best tool that we have any anything new to the market would take time to develop but [1:45:34] that that option was for the president's decision and he he wanted to provide an option to americans [1:45:40] that right now are getting zero vaccinations after covid trust plummeted and they want to make sure [1:45:47] he he wants to provide an additional option while saying that it is safe and effective you thank the [1:45:51] president for correcting the wrong of americans not having a scientific assessment of this vaccine [1:45:59] which you have called safe and effective so when the fda science and the president's [1:46:06] erroneous scientific claims conflict as they did that day which which one will you defend yeah senator [1:46:14] i will use my clinical training my research experience and and the career expertise that [1:46:20] is at the agency to get their input on and and to take a review of all of the scientific determine [1:46:27] determinations for individual products that have been determined to be safe and effective that's [1:46:31] the role of the fda commission you had a chance you had a chance last month and you didn't take it to [1:46:36] correct the president and his dissemination of erroneous medical recommendations so why [1:46:42] should we expect you to stand up to the president as fda commissioner senator i believe the president [1:46:49] is responding to wanting to give options to people that are currently getting zero vaccinations [1:46:54] and as he has said the mmr is not lethal but what he said was what he said was false what he said was [1:47:00] false he said he said it was lethal and he said that with you standing right next to him you did not [1:47:04] correct him when he said that senator the mmr vaccine is safe and effective every american that is [1:47:11] unvaccinated should get it it is the most effective tool that we have the president has said that [1:47:16] now he said it recently in the oval office and that is important that is what if i'm confirmed that [1:47:20] is what i would do in the role is to make sure that americans know that is currently the best available [1:47:25] tool it is safe and effective right but it is not lethal see as fda commissioner we have to have faith [1:47:31] in you uh that you will stand up for the science and in my faith in you was undermined at that moment [1:47:37] because the consequence of that is fewer children are being vaccinated in our country right now the [1:47:42] president has cast a shadow over the efficacy safety of these vaccines and i'm i i don't have [1:47:51] confidence that you will stand up to the president where it's necessary thank you mr chairman thank you [1:47:56] uh i wish to enter letters of in support of dr overton's nomination into the record and it will be [1:48:01] done without objection i want to compliment the mom and the grandmom of of that little baby right there [1:48:06] who's been incredibly well behaved um i wish you could teach that to my grandchildren uh and um for [1:48:17] any senator wishing to ask additional questions questions for the record will be due 5 p.m friday [1:48:23] september 25th dr overton i thank you for coming here and i thank you for your willingness to serve our [1:48:30] country and for the service you've already done and i thank your family for being here to support you [1:48:35] believe us uh the committee stands adjourned [1:48:47] um [1:48:48] the committee stands adjourned [1:48:49] um