The Senate Health Committee held a hearing on Wednesday on the Reauthorization of the Over-the-Counter Monograph Drug User Fee Program.
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00:00:00Over-the-counter drugs are part of the fabric of Americans maintaining their health, treating
00:00:06common ailments, including pain relief, allergies, and cold symptoms, I could use a little bit
00:00:11right now, at an affordable cost.
00:00:15They're available at every pharmacy and virtually every grocery store nationwide.
00:00:20Being readily available to Americans, OTCs, save Americans a lot of money.
00:00:26The drugs generate an estimated $1.46 billion in annual savings from fewer doctor's visits
00:00:35and prescription drug purchases.
00:00:37For decades, OTCs were required to go through a cumbersome review before going onto the market.
00:00:44This process, known as a drug monograph, typically took years to finalize.
00:00:50Many new OTC drugs were never fully approved.
00:00:53The review also made it more difficult for the FDA to update safety information on these
00:00:59drugs, sometimes delaying safety recommendations for several years.
00:01:04As a result of these challenges, Congress created the bipartisan, over-the-counter, monograph
00:01:09drug user fee program, AMUFA, in 2020 to streamline FDA review of OTC drugs, making these drugs more
00:01:18quickly available to Americans while still ensuring safety.
00:01:22AMUFA is set to expire at the end of this fiscal year.
00:01:27As Congress looks to reauthorize, we must see how we can further improve the program to
00:01:31better serve Americans.
00:01:33This is why today's hearing is so important.
00:01:36I highlight today is the first time Congress will be hearing directly from the FDA about
00:01:42how they've implemented reforms to the OTC drug review and their plans to make more low-cost
00:01:47drugs directly available to Americans.
00:01:50I appreciate Dr. Corrigan-Gurray coming before the committee on behalf of the FDA.
00:01:56While the FDA has made progress in improving the OTC review pathways since 2020, there is
00:02:02more to do.
00:02:03FDA has failed to ease regulatory hurdles that allow prescription drugs to be sold OTC.
00:02:11These delays make it harder for consumers to directly access low-cost treatments.
00:02:17The agency continues to struggle with reviewing new sunscreens.
00:02:20Despite the well-documented public health value of using sunscreen, FDA has not approved a
00:02:26new sunscreen filter since 1999.
00:02:29In contrast, peer countries in Europe and Asia have many more high-quality sunscreen products
00:02:36available to consumers.
00:02:38The FDA needs to do a better job with sunscreen.
00:02:41I look forward to discussing how Congress can improve OMUFA and the OTC review process.
00:02:46And with that, I recognize Senator Kaine for his opening statement.
00:02:50Senator Kaine, President of the United States of the United States of the United States of
00:02:51the United States of the United States of the United States of the United States of the United States of the United States of the United States of the United States of the United States of the United States.
00:02:52Thank you, Chairman Cassidy and thanks to my colleagues.
00:02:54Welcome, Dr. Corrigan-Gurray.
00:02:56This is an important program because it's critically important for Americans to have access to safe
00:03:00and effective over-the-counter drugs, recognizing the importance of regulating drugs that can
00:03:06be used without a prescription and the challenges facing the FDA.
00:03:11Congress passed the over-the-counter monograph user fee program in 2020 to support the work
00:03:16of the FDA and expand access to medications that are safe and that are also easy to access
00:03:21and use.
00:03:23The magnitude of this is pretty big.
00:03:26U.S. consumers spent over $40 billion on over-the-counter drugs in 2024.
00:03:31Eight in ten U.S. adults use over-the-counter products as a first response to a minor injury.
00:03:37Over-the-counter drugs can save Americans money, can save the healthcare system money.
00:03:41Research has found that $51.6 billion in drug cost savings occurred when lower-priced over-the-counter
00:03:49products are used instead of higher-priced prescription drugs.
00:03:53So that's really important both for the public treasury and for consumers.
00:03:58While over-the-counter drugs can generate savings, they can also be misused, leading to 178,000
00:04:06hospitalizations each year due to adverse drug events.
00:04:08So it's important that we get the balance right.
00:04:11Older adults represent one-third of over-the-counter drug users and over 65 percent of these adverse
00:04:18drug events.
00:04:19So proper oversight is important.
00:04:21That's why we're here today.
00:04:22I was happy to support the initial passage of this user fee program.
00:04:26I'm glad the committee is back to marking up bipartisan legislation.
00:04:30Hope we'll do more of it.
00:04:31I do want to just conclude by just, you know, putting on the table, we're obviously going
00:04:35to be grappling very soon with the reconciliation bill that deals pretty significantly with healthcare
00:04:41and with the FDA.
00:04:44Just in the last hour, the CBO released a report indicating that the House reconciliation
00:04:50bill would deprive 16 million Americans of health insurance.
00:04:55That's the House passed bill.
00:04:56That tells us what the stakes are as we grapple with the reconciliation bill.
00:05:02And obviously, I know my colleagues and I are going to be fighting very hard to avoid
00:05:05that.
00:05:06But let's just focus on the FDA.
00:05:08Since the administration took office, 20,000 employees at the Department of Health and Human
00:05:13Services have been dismissed.
00:05:15And this includes over 3,500 FDA staff currently on administrative leave.
00:05:20Many other staff have been forced out or leaving because of the chaos at the agency, including
00:05:25the Center for Drug Evaluant Research, which we are here to talk about today.
00:05:29I asked Senator Kennedy, who was before us, about the effect of some of these cuts, in particular
00:05:34some detailed questions about how many of these folks laid off were veterans.
00:05:38I await an answer and haven't received it yet.
00:05:41The mission of the FDA to ensure the safety and effectiveness of thousands of drugs and
00:05:45medical products, including in this program that we're focused on today, is so important.
00:05:51And the way to overhaul the agency is not to indiscriminately fire thousands of experts.
00:05:56So I hope we get some answers about how the decisions were made on these layoffs and what
00:06:00impact they could have on the ability of the FDA to successfully implement the program that
00:06:05we are here to discuss today.
00:06:06With that, Mr. Chair, I yield back.
00:06:09We're joined today by Dr. Jacqueline Corrigan-Carré, the Acting Director of the Center for Drug
00:06:15Evaluation and Research, or CDER, at the U.S. Food and Drug Administration.
00:06:20In her role as Acting CDER Director, Dr. Corrigan-Carré is responsible for ensuring that safe, effective,
00:06:26and high-quality drugs are available to the public.
00:06:29She brings a long career in medical research, including numerous positions at FDA as well
00:06:34as the NIH.
00:06:35Dr. Corrigan-Carré holds degrees from Harvard Law School, the University of Maryland School
00:06:40of Medicine, and Harvard University.
00:06:42I look forward to hearing from her today, and thank you for joining us.
00:06:49Is your microphone on?
00:06:51Can you hear me now?
00:06:54Good morning, Chair Cassidy, Ranking Member Cain, and members of the committee, and thank
00:06:57you for the opportunity to speak with you today.
00:07:00I want to talk about something that benefits nearly every American household, over-the-counter
00:07:04medications.
00:07:06These are the products that millions rely on every day.
00:07:08An antiseptic when your child has a scrape, antihistamines when the pollen counts rise,
00:07:12Will you pull the microphone closer to you, please?
00:07:15Yes.
00:07:16And an antacid after a heavy meal.
00:07:18They are trusted, essential, and they must be safe, effective, and up-to-date.
00:07:22And that's where the OTC Monograph User Program, or AMUFA, comes in.
00:07:27Prior to 2020, our ability to regulate OTC drugs hadn't been modernized in decades.
00:07:32It was slow, outdated, and inflexible.
00:07:35Reform was overdue.
00:07:36When Congress passed the OTC Monograph Reform as part of the CARES Act, it was a bipartisan
00:07:41success that brought real change.
00:07:43Critically, the user fees that Congress authorized, AMUFA, are what facilitated and supported OTC
00:07:48Monograph Reform, and has set the program for success.
00:07:52Now, with congressional support and timely reauthorization, we have the opportunity to
00:07:56realize the full potential of the OTC Monograph Reform, ensuring a nimble regulatory process,
00:08:03fostering innovation to better serve patients and consumers, and enhancing transparency and
00:08:08accountability from the FDA and industry.
00:08:10So what have we accomplished so far?
00:08:12In just five years, AMUFA has helped FDA modernize the OTC drug review process, transforming
00:08:18it from a paper-heavy rulemaking system to a responsive electronic one.
00:08:22We've delivered five guidance documents, providing clarity to manufacturers and enhancing public
00:08:27health protections.
00:08:28We've posted 33 final orders and five proposed administrative orders, providing transparency
00:08:33for manufacturers on what is expected to market a particular OTC drug.
00:08:38And I want to highlight our most recent proposed order, because we believe it will foster some
00:08:42exciting innovation for children and families.
00:08:45If finalized, this order would let companies create new, easier-to-take forms of OTC medications,
00:08:51like chewable tablets, tablets that melt in your mouth, and thin films.
00:08:55And these would be for certain medications that currently only come as tablets or capsules,
00:08:59and could help people who have trouble swallowing them.
00:09:02AMUFA has also helped hire 85 dedicated staff members, scientists, safety reviewers, and regulatory
00:09:08experts, who help ensure the products on our shelves are safe and effective.
00:09:12And importantly, it has opened the door to more innovative products, like a new sunscreen
00:09:15ingredient, through the administrative order process.
00:09:19If Congress does not authorize AMUFA this year, the momentum would come to a grinding halt.
00:09:23The impact would be immediate and damaging.
00:09:26Engagement on development programs and activities to oversee the safety and quality of OTC monograph
00:09:31products would slow or stop, as dozens of FDA staff with clinical quality and safety expertise
00:09:37would lose their positions.
00:09:39Critical progress on proposed and final orders from the FDA's monograph forecast would be
00:09:43shelved, and these include essential updates on labeling, drug facts, and ingredients, including
00:09:48for products intended for pregnant women and children.
00:09:51And no new agreements from the recent commitment letter could be implemented, including important
00:09:55steps like improving meeting management with sponsors, and more quickly assessing the quality
00:10:00of facilities as companies bring new products to the U.S.
00:10:05And perhaps most concerning, we risk sliding backwards, losing the transparency, predictability,
00:10:11and innovation that AMUFA was designed to create.
00:10:14Without reauthorization, the system that was finally fixed begins to break again.
00:10:19The recently negotiated agreement for the next five years of AMUFA includes smart, achievable
00:10:24goals, increasing opportunities for industry and FDA to interact to foster innovation, improving
00:10:30the transparency of the user fee program, investing in product quality and safety, and continuing
00:10:36to publish the annual guidance forecasts that give industry and public health stakeholders
00:10:41a clear roadmap for the future.
00:10:43These aren't just words, they're a commitment to the public, a commitment to keep this progress
00:10:47going.
00:10:48Every delay in regulation or review affects real people.
00:10:52Without AMUFA, innovations are stalled, safety improvements are delayed, and consumers may
00:10:56unknowingly continue to use products that haven't been adequately reviewed under modern science.
00:11:01This isn't about red tape.
00:11:02The tape is about real lives, real trust, and the medications that Americans buy off the
00:11:06shelf every day.
00:11:08In closing, Congress made a smart investment in 2020 when it created AMUFA.
00:11:12That investment is paying off, but we can't stop now.
00:11:15Reauthorizing AMUFA means continued modernization, supporting innovation, and most importantly, keeping
00:11:21American families safe.
00:11:23Thank you, and I look forward to your questions.
00:11:25Thank you, Doctor.
00:11:29So I have a question here, but it kind of goes against the flavor of your testimony,
00:11:35and your testimony was very positive about the positive things that AMUFA has done.
00:11:41But my question is, it seems like the RX to OTC switch, which is from prescription to non-prescription,
00:11:50that FDA has struggled to make that happen.
00:11:53So is that a misperception on my part, or has this been more successful than I have understood?
00:12:05Thank you for that question.
00:12:07In the past few years, we have brought certain prescription drugs to over-the-counter, and
00:12:12that would include the naloxone that became over-the-counter.
00:12:14It was very critical, I believe, in helping us address the opioid crisis.
00:12:19We have brought the contraceptive over-the-counter as well, and we have brought some of the nasal
00:12:26allergy sprays over-the-counter, and as you also may be aware, we have a rule that should
00:12:32be finalized, and that would be to bring additional medications over-the-counter with a condition
00:12:38of use.
00:12:39So, to have a new way of bringing medications over-the-counter, and we hope that that would
00:12:44greatly expand.
00:12:45I'd explain the condition of use.
00:12:47Yes.
00:12:48So, under this rule, if we determined that you could not bring a drug over-the-counter
00:12:55with just the drug facts label, because with that label alone, a person could not appropriately
00:13:02self-select for that drug and use it, then a company could propose an additional condition.
00:13:08It might be a mobile app or something with some questions.
00:13:11And then, if we can show that with use of that additional condition or those questions before
00:13:18they access the product, they can access it safely, that would open the door to products
00:13:23that we currently do not have over-the-counter.
00:13:25Now, can you give an example of that?
00:13:27Or is it a...
00:13:28They're still in development.
00:13:30There are things in development.
00:13:32But we could think potentially about drugs might be for more for chronic conditions,
00:13:37where we could select a population for which that drug was safe to take over-the-counter.
00:13:41Now, let me go back to...
00:13:44You listed some that have become over-the-counter, but you listed like five or six.
00:13:49And there's a heck of a lot of drugs out there that could be over-the-counter.
00:13:53And so, is it that you're just giving me a sample, that there's...
00:13:56You're giving me a sample, for example, five or six drugs I want to mention?
00:14:00Or is it, no, that's the universe of those that have been approved?
00:14:04Because...
00:14:05Let me ask you that.
00:14:07You know, in the recent timeframe, those were the ones I highlighted.
00:14:11You know, we certainly work hard to look for opportunities to bring drugs over-the-counter
00:14:16that patients can safely self-select and use.
00:14:19And then, as I said, I think our...
00:14:21Now, let me understand the process.
00:14:23Don't mean to interrupt, but I have limited time.
00:14:24No, please.
00:14:25Sorry.
00:14:26Does the drug company have to apply, or can you...
00:14:28For example, Benadryl, I think, used to be like a prescription drug.
00:14:33And so...
00:14:34And Claritin used to be a prescription drug.
00:14:36Right.
00:14:37So...
00:14:38But really, you could have looked at those and said, this doesn't have to be a prescription
00:14:41drug.
00:14:42I mean, this could be over-the-counter.
00:14:43So does the drug company have to apply, or can the agency say,
00:14:49this drug can safely be given OTC?
00:14:53Thank you for that question.
00:14:55It does...
00:14:56The application does need to come in.
00:14:58However, in the case of naloxone, if I recall, we put out an FR notice saying that we were
00:15:03open to working to bring naloxone over-the-counter.
00:15:07So I think we have opportunities to signal where we think there might be opportunity.
00:15:13We also...
00:15:14You know, we do speak to companies, and we can, you know, suggest that we might be open
00:15:20to a development program.
00:15:22It does require a development program to show that...
00:15:25And what do you mean by development program?
00:15:27Yes.
00:15:28So a company would need to show that consumers can self-select appropriately and use it with
00:15:34the information that's on the drug facts label.
00:15:37Now, let's go back to something like Tagamet, which, again, at one point was a prescription
00:15:42drug.
00:15:43Or Prilosec, which at one point was a prescription drug.
00:15:48You could have looked at that initial information, I'm saying you, rhetorical you, could have looked
00:15:52at that and said, you know, this is a pretty safe drug.
00:15:56And people could take it for heartburn.
00:15:59And so I guess I'm asking, since that would save lots of money for patients, lots of money
00:16:05for patients, if they could buy those drugs OTC as opposed to having to see a physician,
00:16:10is there something Congress can do to expedite that?
00:16:14Or do you have all the tools that you need to actually generate a kind of more aggressive
00:16:19approach to the Rx to OTC method?
00:16:24So in the case of that drug, we certainly would say first, yes.
00:16:26Does it look like it has a safety profile that we have enough time, you know, we have
00:16:30enough experience?
00:16:32But then we do have to have the information saying that the consumers can self-select.
00:16:36We're always happy, if you have ideas, to work with you on those.
00:16:39Senator Kim.
00:16:40I'm such an AMUFA nerd that I'm going to stay for the whole hearing.
00:16:45So I'm going to yield to Senator Kim and take my questions later.
00:16:47Senator Kim.
00:16:48Okay.
00:16:50Thank you for coming on out.
00:16:52I wanted to ask, it was raised in the opening remarks about some of the reduction in force.
00:16:56So I guess I just wanted to ask you, are you able to tell us if any of the staff in the
00:17:00Office of Non-Prescription Drugs were terminated under the reduction in force efforts?
00:17:05Senator Kim.
00:17:06Yes.
00:17:07Thank you for that question.
00:17:08You know, unfortunately and consistent with our policy, when there's something that's
00:17:12a subject of litigation, we don't comment on the specifics.
00:17:16And as you know, there is a preliminary injunction around the reduction in force, so I can't
00:17:21go into any details at this point.
00:17:24When you're able to provide answers, I'd like to know how many staff have been let go or
00:17:30resigned from the Office of Non-Prescription Drugs and how many of those were funded by
00:17:34user fees.
00:17:36Also want to talk about the commitments that the FDA made with the OTC industry as part of
00:17:41the OMUFA commitment letter, specifically the agreement that FDA would hire 11 new full-time
00:17:47employees over the length of the reauthorization.
00:17:50I understand that there is currently a hiring freeze at the FDA.
00:17:54First, is that the case?
00:17:55And second, if so, will the FDA be able to stand by this commitment of hiring 11 additional
00:18:01full-time staff?
00:18:02Yeah.
00:18:03Thank you for that question.
00:18:04Yes, there is a hiring freeze, but I know, as Dr. McCary has indicated, he is working to
00:18:11allow us to hire the reviewers that we need for all aspects.
00:18:17And so I am confident that he will be working with us to give us the resources we need to
00:18:21be successful under OMUFA II.
00:18:23Okay.
00:18:24I want to just kind of hone in on a particular example to try to get a sense of how OMUFA
00:18:30is moving forward and how it's performing.
00:18:33So for instance, sunscreen, you know, this is something where we understand that the United
00:18:38States has continued to lag behind other countries in terms of UV filters that are approved for
00:18:44use in sunscreens and the FDA has not approved a new filter, a UV filter since 1999.
00:18:51Is that correct?
00:18:52That is correct, though we do have a new OTC monograph order under review for a new sunscreen
00:18:59ingredient.
00:19:00Well, I guess I'd just like to hear a little bit more from you because, you know, despite
00:19:04Congress creating this new pathway and then several years overhauling the entire OTC monograph
00:19:10order process, so, you know, we still have no new sunscreen ingredients formally approved.
00:19:17You said there's something in the works?
00:19:18Yes.
00:19:19I guess I just want to kind of ask you, like, how do we try to address this?
00:19:24How do we try to make sure that we're moving forward and addressing these main challenges
00:19:27of approving new ingredients?
00:19:29Yeah.
00:19:30So, I'd like to explain a little bit about the sunscreen market.
00:19:34You know, sunscreens for us are, they're considered drugs because they're used to protect against
00:19:39the damages of sun and skin cancer.
00:19:41And any drug that we approve that's topical but that has systemic absorption, we need to
00:19:49make sure that the systemic absorption has no untoward effects.
00:19:54And those could include things like disrupting the endocrine system or even abnormal growth
00:19:58of cells or tumors.
00:20:00And we do know that certain ingredients in the literature, it's, have been highlighted
00:20:04as potential endocrine disruption.
00:20:06So, to do that, you know, we would ask a company to do those tests just like for any other drug
00:20:12that we approve.
00:20:13And we've laid out the data that we think would be necessary for us to do an assessment.
00:20:18And we're waiting for, you know, more companies to come to us with that data.
00:20:24And then we'd be happy to review it and work on that.
00:20:27I'd also like to note that I know that there are additional sunscreens in different countries.
00:20:32Not all of them are, are under, treated as a drug.
00:20:35But I'd also like to say that, you know, there's no data that those are more effective or that
00:20:39we don't have effective sunscreens on the market here in the United States.
00:20:43Yeah.
00:20:44I want to just switch gears a little bit, just sort of another angle.
00:20:46You know, I'm a father of a seven-year-old and a nine-year-old.
00:20:49A lot of parents in the bleary, you know, early mornings of a sick child, you know, try
00:20:56to wander off, try to figure out what we can do for our kids.
00:20:59I understand that the FDA has stated its intention to develop pediatric weight-based dosing for
00:21:04acetaminophen during the next user fee authorization.
00:21:09I guess I want to know, you know, for myself, if I'm giving my kids the right dosage here.
00:21:13So could you explain to the committee what staff resources are needed to make that change
00:21:18happen?
00:21:19How do we ensure that we're able to move that forward promptly?
00:21:21Yes.
00:21:23We will be asking for new staff in AMUFA II to continue to put out our orders and guidances.
00:21:29But this is a priority for us.
00:21:30We do know that there have been improvements in the way the acetaminophen concentration's
00:21:35on the shelf.
00:21:36And you need to address this weight-based.
00:21:39And we will put that as a priority.
00:21:41It's on our agenda.
00:21:42Well, I just raise this as another example of just the importance that we have staff,
00:21:46that we have the experts there able to be able to process this.
00:21:49And when we see so much slashing of employees and staff, I worry that these types of direct
00:21:55benefits to people will be casted aside.
00:21:57And with that, I'll yield back.
00:21:58Senator Marshall.
00:22:00Senator Marshall.
00:22:01All right.
00:22:02Thank you, Chairman, and welcome to our guest today.
00:22:06Let's talk about measuring success.
00:22:09My question is, how do you measure success?
00:22:11I assume that from a safety standpoint, every month you're reviewing things that will, did
00:22:17we get anything wrong and how come?
00:22:19But beyond that, how do you measure success from the standpoint of the ones that are coming
00:22:24into the system?
00:22:25Is there a set amount of time you'd like to have them out by?
00:22:28What percentage of those made it through the process in that amount of time?
00:22:32How do you measure success?
00:22:34I think, you know, in AMUFA I, we've measured success in that we've stood up the program.
00:22:38We've provided those foundational guidances.
00:22:41We've created electronic efficient way for companies to communicate with us.
00:22:47And then we have the first new proposed order in that we're reviewing.
00:22:52We're also making all of our commitments on meetings.
00:22:56So we are meeting with companies.
00:22:58And so our success will be to continue to move those development programs.
00:23:02So all those are, you're trying to improve success, but I don't hear you measuring success.
00:23:08In the standpoint of, you know, you run a hospital, you run a bank every month, you look to these
00:23:12key metrics to say, are we hitting these measures?
00:23:15Yes.
00:23:16For us, we'll be putting out our agenda, and that's the plan three-year agenda.
00:23:21And that will tell you the successes of getting these orders out.
00:23:24So, for example, the new order that we just put out, which will allow for changes in the
00:23:29dosage forms.
00:23:30And we think that's very innovative and will help.
00:23:32So you don't have a monthly dashboard of metrics that you're looking at to see if we're
00:23:36meeting them?
00:23:37We are tracking all of the things that we're doing in terms of proposed orders that we're
00:23:41meeting our timelines on reviews, and when there is-
00:23:45Can you share your dashboard with us?
00:23:48I don't know if it's an electronic dashboard, but, you know, we are tracking what we're doing
00:23:52in our commitments.
00:23:53Okay.
00:23:54I would love to see how you're measuring success.
00:23:56Sure.
00:23:57If it's not a dashboard, I would encourage you to get one.
00:24:00Let's talk about inactive ingredients.
00:24:02As you know, the OTC monographs only list active ingredients.
00:24:05A lot of mahal moms out there concerned about inactive ingredients, artificial flavors, sweeteners,
00:24:11etc.
00:24:14What is going on in the world of over-the-counters as far as identifying those inactive ingredients,
00:24:19and is there an effort to get the ones that are not safe out of these over-the-counters?
00:24:24Thank you for that question.
00:24:25We certainly, any time we identify that there's an issue with an inactive ingredient, we would
00:24:31review it and we would look to make changes in that inactive ingredient.
00:24:36We do have ways and guidances.
00:24:39We just did one on color additives to allow firms to a pathway if they want to change their
00:24:45inactive ingredients or their color additives.
00:24:48And we can get back to you with more information on that.
00:24:51By the way, isn't it going to be pretty simple for your monographs to include the inactive
00:24:55ingredients?
00:24:58I think I might have to get back to you on that question about, could we just do that?
00:25:02Okay.
00:25:03If you don't mind.
00:25:05When you talk about, you know, studies, more and more it would seem that AI can replace
00:25:11animal studies, and probably even more accurate.
00:25:15So often you read, well, what happened in monkeys and dogs has nothing at all to do with the
00:25:20biology of human beings.
00:25:22Is there any effort in your department to convert over to AI and doing less animal studies?
00:25:28We're engaged on the new initiative to reduce animal studies in the monoclonal antibodies.
00:25:34And we had previously, we have been working on looking for alternatives to animal studies.
00:25:39We already do, we no longer use animal studies for eye irritation or skin irritation, and we
00:25:45certainly will, you know, are looking at both AI as we're looking at these non-animal approaches.
00:25:52There are still challenges in coming out with validated studies when you're looking at, you're
00:25:57looking for an effect that would affect multi-organ systems.
00:26:01That doesn't mean that we won't get there, and we'll continue to work on that.
00:26:04Okay.
00:26:05Again, if there's a way that you could measure that and show us, we were doing so many animal
00:26:11studies five years ago, this is something we did last year, this is something we're doing
00:26:15this year.
00:26:16You know, prove to me that you're making progress in that.
00:26:20That would be very helpful.
00:26:21We can get back to you.
00:26:23Thank you so much, Chairman.
00:26:24I yield back.
00:26:25Senator Kaine.
00:26:26Senator Hicke, I move her.
00:26:29Thank you, Mr. Chairs.
00:26:33Thank you, Doctor, for being with us and for your service and hard work over there, and
00:26:37I know there are hard times.
00:26:39Several of us are working on a bill we call Skinny Labels Big Savings.
00:26:44Skinny Labels Big Savings Act.
00:26:46Senators Collins and Cotton and Welch and I trying to address the endless procession
00:26:55of lawsuits against generic drug manufacturers who, you know, obtain the Skinny Label FDA approvals.
00:27:03I think if we can encourage more generic drugs to come to market through this legislation,
00:27:10we're going to lower costs widely for the American consumers.
00:27:15So, Dr. Kerrigan-Curray, are you willing to commit to work with us to advance this legislation
00:27:21so that we can lower drug costs, and as the acting director of the Center for Drug Evaluation
00:27:26and Research, what else are you working on to try and create more competition, more generic
00:27:31competition?
00:27:32Thank you for that question.
00:27:34Absolutely, we support additional generic competition.
00:27:37We know that generics make up 90 percent of the prescriptions in the United States.
00:27:43We think the Skinny Labeling, we're happy to work with you on that legislation.
00:27:48Other things that we are doing, we are continuing to put out our guidances, our product-specific
00:27:52guidances, which are a roadmap for developers.
00:27:56In addition, it's very important, as we see more opportunities in complex generics, that
00:28:01we work with industry and academia to develop the science to allow those to come forward.
00:28:07So, we have a very robust regulatory science program, and in fact, our science meeting on
00:28:11generics is ongoing today.
00:28:14And then we put guidance.
00:28:15We also seek to meet all of our goals.
00:28:18And I would just note, I believe in 2024, we approved about 59 first generics.
00:28:25So those are generics drugs for which there was no generic competition before we approved them.
00:28:31That's great.
00:28:32I appreciate that.
00:28:33I'll come back also to AI, because you're touching on AI there as well.
00:28:38This week, you launched ELSA, this new AI tool, and Commissioner McCary stated that ELSA
00:28:45was designed to expedite, to review processes at the agency with the goal of making them shorter,
00:28:52and yet more successful, better.
00:28:54He stated, and I quote, all information stays within the agency, and the AI models are not
00:28:59being trained on data submitted by the industry.
00:29:03And so, can you share with us a little bit, Dr. Corrigan-Carré, some of the additional details
00:29:10about how exactly the FDA is going to ensure that the data within ELSA remains secure?
00:29:16I mean, I view ELSA as a tool, but like any tool, we've got to make sure we handle it safely.
00:29:21Yes, thank you.
00:29:23We are very excited about the initiative that Dr. McCary is leading on AI, because we do
00:29:27see there's utility to this tool in our work, and we are not training it on the data.
00:29:34What we are doing is AI, this type of AI, could be very helpful when we've got a number of documents
00:29:42and we want to summarize them, and we have to summarize them for one of our reviews.
00:29:47We still have to check it, and we have to make sure it's right.
00:29:49But, you know, the confidentiality and privacy of data within the FDA is one of our top priorities.
00:29:56I mean, people, we are trusted to keep that, and we will continue to work on that, even
00:30:01as we incorporate new tools into our review processes.
00:30:03All right.
00:30:04Well, I appreciate that, and I support that 100%.
00:30:08Let's talk a little bit about transparency at the FDA.
00:30:12Secretary Kennedy, Commissioner McCary both sat in your seat and committed during their confirmation
00:30:18that transparency would be a priority for them and for the entire agency.
00:30:22And yet, FDA appears to have attempted to gut the team that responds to the Freedom of Information requests.
00:30:29In other words, those requests for the transparency, everyone disappear, everyone's let go or encouraged to retire.
00:30:36Also, the FDA bypassed the Advisory Committee on Immunization Practices, ACIP, in the recent COVID vaccine guidance,
00:30:44taking one of the few forums we have for clear and open debate on vaccines, and they kind of skipped right over it.
00:30:51So, does any of this promote transparency?
00:30:55You know, how do we reconcile the public commitments to transparency with some of these opaque actions?
00:31:04At least they appear to me and to many of us.
00:31:07And how can we course-correct and make sure that Americans feel confident that they are getting transparency,
00:31:15they're seeing what is coming, and that they can believe in these actions?
00:31:19Thank you for that.
00:31:20At CEDAR, we're very committed to being transparent.
00:31:23We held an advisory committee, I believe, about a month ago on our opioid PMRs.
00:31:29We continue to communicate, and we will continue to keep that transparency and communication open with the public.
00:31:36And in AMUFA, we have several initiatives that we'll be doing in terms of webinars,
00:31:41posting not only the firms that didn't pay, but the firms that did pay to provide transparency around that,
00:31:48transparency around exclusivity.
00:31:50So, we will continue to do that.
00:31:52Appreciate that.
00:31:54Chairs, I yield back.
00:31:55Senator Tuberville.
00:31:58Thank you, Doctor, for being here.
00:32:00We know Secretary Kennedy is all in the modernization while we're waiting for these user fees to be reauthorized.
00:32:07What are we doing in the meantime of getting ready for, you know, dealing with the atmosphere that we're in today?
00:32:14What are we doing?
00:32:17Are you asking me how we're preparing for the user fee negotiations?
00:32:21Yes.
00:32:22Right.
00:32:23Yes.
00:32:25So, as we do every cycle for the user fees, obviously for AMUFA, we're here to talk about the reauthorization.
00:32:34For the other user fees, we do have internal processes that we undertake to think about the next agreements and what we would like to propose.
00:32:45And, of course, those would be discussed with Dr. McCary.
00:32:49I believe the notices of our public meetings for July are already out.
00:32:54And so, we'll have those public meetings and engage the public on those user fees.
00:32:59We've already talked a little bit about dyes, some things, sweeteners that go into a lot of our over-the-counter drugs.
00:33:09You go into these places and drug stores that look like a candy store, and they're enticed to be marketed in certain ways because of the color.
00:33:20Thank you, Senator.
00:33:21Do we have, what kind of priorities do we have on labeling of, number one, what goes into the, you know, some of the over-the-counter drugs?
00:33:34Where they're made?
00:33:37I've looked at a lot of bottles and things inside our stores, and you can't find out whether they're made in Korea, whether they're made in China, or whether they're made in the United States.
00:33:49Shouldn't that be a priority?
00:33:52Thank you for that question.
00:33:54One thing, when we think about where a drug is made, we are committed to making sure that wherever the drug is made, if it's being marketed as safe,
00:34:03so we apply the same standards, whether it's made domestically or it's made internationally.
00:34:08We certainly are very supportive.
00:34:10I know the administration is looking to onshore pharmaceutical manufacturing, and that would be for prescriptions or for OFTC,
00:34:18and we're very supportive of that, and we'll work with them in terms of our regulatory frameworks to help make that happen.
00:34:25But right now, we don't have a labeling on the drug for where it's made.
00:34:30If it's me, we're happy to work with you, if that's a priority.
00:34:33Well, I think in the future, with the problems we're having worldwide, I think it'd probably be a good suggestion that people, when they go in, they find out where it's made.
00:34:43We found out during COVID we don't make much anymore.
00:34:45Most of it comes from China, and we really don't know what's in it.
00:34:50You know, we're finding out now a lot of metals and things are in a lot of the drugs and even the foods that we have.
00:34:55Another question I had about sunscreen.
00:34:59Most of us use sunscreen.
00:35:01I don't know how it's evaluated, but over the years, last 50 years, melanoma and skin cancers have almost quadrupled.
00:35:12And I don't know whether people don't use it, or it's not working, or we get some kind of skin cancer from ingredients that are in sunscreen.
00:35:22It's because all of us use it at some point.
00:35:25It doesn't really feel safe every time I put it on, but I put it on because sometimes, you know, you look at the worst-case scenario.
00:35:35So what's your thoughts on that?
00:35:37Yeah, thank you for that.
00:35:38First of all, we're very aware that, you know, skin cancer risk is a very serious problem.
00:35:44And the sunscreens we have, the testing does say they are effective if used properly.
00:35:49And some of our tests, when we're testing for systemic absorption, is how you use them.
00:35:54We do have two sunscreens that are mineral sunscreens that are grass.
00:35:58They're not absorbed.
00:35:59For those that are absorbed, you know, we've asked for additional tests just to assure their safety, that that systemic absorption has no untoward effects.
00:36:08Are we looking into the ingredients that are so-called cancer causers?
00:36:12I would hope we would be.
00:36:14Yes.
00:36:15We hear it and read it all the time.
00:36:17Sorry to interrupt.
00:36:18Yes, part of the testing that we want to do whenever a drug is absorbed and it reaches systemic levels is a test for tumor formation.
00:36:27I yield back.
00:36:28Senator Kaine.
00:36:30Marky.
00:36:31Thank you, Mr. Chairman.
00:36:33The Trump administration has fired 3,500 federal employees at the Food and Drug Administration out of 20,000.
00:36:44And 800 out of the 7,500 people at your center for drug evaluation and research.
00:36:52And despite assurances from Commissioner McCary that slowdowns would not happen, I have heard from researchers and companies that the drug review process has slowed down to a crawl and many have been stuck in limbo for months waiting on reviews and approvals to be completed.
00:37:13Up in Massachusetts in a survey released by MassBio.
00:37:18In May, 67% of biopharma firms surveyed were highly concerned that workforce reductions will delay drug approvals,
00:37:28and at least 50% were already feeling the impacts from the FDA layoffs.
00:37:37So this is not a good situation for all these biotechs up in my state and across the country.
00:37:44The Trump administration's actions have guaranteed that every stage of developing life-saving drugs from research to clinical trials to approvals is slowed down or stopped.
00:37:57We are witnessing in real time a giveaway of our global leadership in drug research, in development, in biomedical innovation.
00:38:07And firing FDA officials responsible for drug approvals and evaluation is part of the problem.
00:38:13So my question is, obviously there have been many essential employees who have left as part of this reduction in workforce,
00:38:27and the goal has to be to increase, obviously, the timeliness of the review processes.
00:38:34So what is your plan, doctor, to replace the institutional knowledge that was lost from long-time FDA employees being fired or resigning?
00:38:45Thank you for that question.
00:38:48I know we can't really discuss details around the RIF about the litigation, but our reviewers are in place.
00:38:54Can you move over the microphone a little bit?
00:38:56Sorry, our reviewers are in place.
00:38:57And I would say that we are meeting our timelines.
00:39:01I know that occasionally...
00:39:02Timelines to do what?
00:39:04The timelines for approval and for our approval of our drugs.
00:39:08We do occasionally miss timelines.
00:39:10If you look at our...
00:39:11I have 50% of my companies who are already saying they're feeling the impacts of the FDA layoffs.
00:39:17So they're already feeling it.
00:39:18We certainly will look into that.
00:39:20I would note that, you know, we are approving drugs and making our timelines.
00:39:24There are certain times, you know, all of our agreements, we have 90%, not 100%, because sometimes there are issues that come up that are complex and scientific issues that we'd rather take a little bit more time, if we need to, to make sure we get them right.
00:39:38But we are also going to work with Dr. McCary.
00:39:41We have turnover in our review staff on a routine basis every year.
00:39:47I appreciate that, but you're down 800, which is a lot, you know, in the real time that these companies have to get some answers.
00:39:58So what was your role in the firing of the 800 employees at the Center for Drug Evaluation and Research?
00:40:04Again, I apologize, but because of the ongoing litigation, I can't comment a lot about the RIF and the employees and the reduction form.
00:40:12Was Doge involved in the firings at the FDA?
00:40:15Again, because of the ongoing litigation, I'm not able to comment on that.
00:40:20In a lawsuit that was filed by federal workers yesterday, a federal worker stated that on March 31st, 2025, just two months ago, a group of Doge employees visited the FDA's office.
00:40:36And that day, someone dressed in a business attire yelled, this is Doge, and this is your last supper at an FDA employee.
00:40:48So, doctor, can you walk me through what happens when someone at the Center for Drug Evaluation and Research is fired in terms of who signs off on the termination paperwork and how the notification is sent to employees?
00:41:02Again, you know, because the RIF is involved in litigation, I can't comment further on the process, and I'm not aware of that incident.
00:41:12Yeah, well, obviously, you're in a difficult position, which I appreciate.
00:41:19I appreciate that.
00:41:20But whether it's McCary or Kennedy or Doge who are calling the shots, it's obviously going to ripple down into very negative consequences for the biofarmer industry, but for people across our country and nation who are waiting for these drugs to be available to help their families.
00:41:44So, it's really, it's a crisis, and combined with all of the cuts in NIH research funding, we might as well gift wrap the biotech sector as a gift to the Chinese government, because this is just an absolute tragedy in real time that is unfolding in our nation, and it's just completely unnecessary.
00:42:05So, I thank you so much.
00:42:07Senator Moody.
00:42:11Who's dead?
00:42:12I'm sorry.
00:42:12Senator Who's dead?
00:42:19I appreciate you joining us today.
00:42:23The realm of my question is really around the idea that health care costs are the most inflationary costs in the 21st century in the American economy, and that time is money.
00:42:38The faster we can do things, the faster we can lower costs and improve access to consumers, and whether it's moving from prescription to over-the-counter, whether it's approval of generics, whether it is decreasing the time development and approval process, parallel approval tracks, all of those things.
00:43:01Give me your thoughts on how we can go faster, maintain quality, but also in everything that FDA touches to reduce the cost of delivery ultimately within the economy to our consumers, our patients.
00:43:20Thank you for that.
00:43:21Thank you for that.
00:43:22I think there's a number of different things we do.
00:43:34Anti-ness As I mentioned today, I mentioned before it came up.
00:43:35I know I have some other approach and we weren't informed, but I was able to improve a new molecular entity, a new drug, a novel drug.
00:43:35It has an unmet need.
00:43:36It often undergoes priority review, so we speed up that review.
00:43:37And in 2024, we approved 50 new drugs.
00:43:4052% were to for rare diseases.
00:43:4656% we did priority review, so shaving off the time.
00:43:50We also realized that our role in this is really to increase competition.
00:43:54So as I spoke, our generic program is very robust, and we seek to get generic drugs on
00:44:00the market by working to provide clarity on the pathway, by working on regulatory science
00:44:06that can make a difference.
00:44:07And then the other younger program is the biosimilar, but we're seeing that accelerate
00:44:12with the number of approvals we have.
00:44:14And again, we've been working on, you know, thinking about this, the biosimilar to interchangeable,
00:44:21you know, that in most cases you don't need any additional study.
00:44:24We also have convened a meeting with the public and our international regulators to think more
00:44:29on how we can rely on analytic than clinical studies, because we know those take the longest
00:44:34and are the most expensive.
00:44:35So those are some of the areas that we're working on.
00:44:38And I know that the issue of AI has been discussed in terms of process refinement, but it also
00:44:48that quantum computing and other tools are being used in healthcare sector to speed development.
00:44:56Do you have any comments or thoughts on that and how that can enhance the time involved?
00:45:02Yes, we have, yes, thank you.
00:45:06We do have a program called model informed development in which we do modeling and we use machine learning
00:45:12to look at how we can accelerate a review program, maybe looking at different doses through modeling.
00:45:20Our biostatisticians also do a lot of modeling.
00:45:22If they're doing, you know, complex statistical modeling to see how we can work on the development program.
00:45:29So we're very committed to using AI.
00:45:31Some of our research, I believe, in the generic industry is also in generic science program also focuses on some AI approaches.
00:45:38We can give you more information if you'd like.
00:45:40Yeah, that'd be great.
00:45:41And again, I didn't hear you really touch on generic approval,
00:45:46of generics, approval of generics and timeframe around that.
00:45:49Is there any thoughts on that?
00:45:51Again, you know, we do have two different tiers in the generic.
00:45:55So if it's a first generic or there's not a lot of competition, again, we do speed up those timelines to really try and meet the need.
00:46:04We've been meeting the timelines that we've agreed with with industry and we will be looking for efficiencies.
00:46:09I think the AI in terms of, you know, summarizing in some of the paper and administrative tasks that are involved, we'll try and work on that.
00:46:16So I'm going to give you an opportunity to give us some advice.
00:46:21What laws exist that are inhibiting you from going faster and what should we change?
00:46:26Well, in the generic industry, I think one thing would be to make the ingredients transparent so that they wouldn't have to ask us the ingredient in the amount.
00:46:38That's what we call the Q1, Q2.
00:46:41I think we've put forth legislation because we often have to go back and forth on that topic.
00:46:46So that would be very helpful.
00:46:47I think, you know, what was spoken about with the skinny labeling is very helpful to give certainty in that area and bring generics.
00:46:54And I think in the biosimilar area, you know, we have talked about not having this biosimilar interchangeable classification and have everything that's a biosimilar be interchangeable.
00:47:05I think that would also be quite helpful.
00:47:07Great.
00:47:09We did have a drug bill last December before you came in, John, that addressed the Q1, Q2.
00:47:16And so we do hope to get that back up.
00:47:18Great.
00:47:19Thank you, Mr. Chairman.
00:47:20Senator Kaine.
00:47:21Senator Hassan.
00:47:22Thank you, Senator Kaine and Chairman Cassidy.
00:47:25And Senator Husted, Senator Paul and I have the Q1, Q2 bill that the witness was just talking about.
00:47:32And we'd, you know, love it if you'd take a look at it, too.
00:47:36Dr. Kargan-Kure, thank you for being here today.
00:47:39And thank you for your work at the FDA from one administration to the next.
00:47:45It's really important work.
00:47:47Before 2015, FDA used a labeling system that made it hard for pregnant women to understand the health risks of different medications.
00:47:56For example, the old system labeled two very different kinds of medications under a single category.
00:48:02Medications where animal studies suggested risks for pregnant women and medications where the risks for pregnant women hadn't been studied at all.
00:48:10The FDA replaced this system back in 2015.
00:48:13But as of earlier this year, there were still several drugs on the market using the old system, including common medications like antibiotics.
00:48:22Senator Bud and I wrote to the FDA in January urging the agency to address this issue.
00:48:27Doctor, has the Center for Drug Evaluation and Research brought all prescription drug manufacturers into compliance with pregnancy labeling standards?
00:48:35Yes, thank you.
00:48:36We now have submissions from all of the drugs that were outstanding to put into the PLLR labeling.
00:48:43That is really good progress.
00:48:45And I appreciate it very much.
00:48:47Now, I understand that over-the-counter drugs sometimes have pregnancy warnings on the label, but the FDA does not have a specific standard for pregnancy safety labeling for over-the-counter drugs.
00:48:58Is the FDA working to improve the labeling process for over-the-counter drugs as well?
00:49:03I know we do have, in our proposed order, we're going to be looking at some labeling for pregnancy.
00:49:10I believe it's around the NSAIDs, but we can take that under advisement.
00:49:13I think that would be a really important thing to look at, and I'd look forward to working with you on that.
00:49:18At Commissioner McCary's confirmation hearing, he and I discussed lowering drug prices by increasing generic drug competition, something we were just talking about.
00:49:27Pharmaceutical companies currently use loopholes in the patent system to build so-called patent walls around their products.
00:49:35The patent walls can block low-cost generic versions of medications for decades.
00:49:40So what steps is the FDA taking?
00:49:42You talked about this a little bit with Senator Husted.
00:49:45What steps is the FDA taking to improve its coordination with patent regulators in the United States to facilitate more access to low-cost generics?
00:49:55We have started meeting with the Patent and Trade Office and sharing our expertise with them, as well as we are cooperating.
00:50:03As you know, the FTC has sent some letters about certain products in the Orange Book.
00:50:08We're not the experts in this, but we certainly will work with the other agencies on these issues.
00:50:14Well, thank you. I appreciate that.
00:50:16I have a bipartisan bill that would improve access to generic drugs by closing a loophole through which drug makers currently exploit a lack of coordination between the FDA and the Patent Office.
00:50:27The bill would allow patients to access lower-cost medication sooner and would save taxpayers $100 million over a decade.
00:50:35So I am hopeful that the chair and my colleagues on this committee will work with me to advance the legislation.
00:50:41Families across the country rely on over-the-counter medications to stay healthy, especially during bad cold and flu seasons like the one we just had.
00:50:51Unfortunately, in recent years, we've seen vulnerabilities in our supply of common medications such as children's cold and flu medications.
00:50:59In the winter of 2023, many families, including my own, could not find children's Tylenol or Motrin on the shelf due to extreme increased demand and strain on the supply chain.
00:51:11How can Congress help the FDA identify and address vulnerabilities in our over-the-counter drug supply chain so we can ultimately stop these shortages from happening?
00:51:21Yes, thank you. And that was a very unfortunate time where we had a very rapid increase in demand for those medications.
00:51:28And our shortage staff have really worked and worked very hard to resolve it like they do with other shortages.
00:51:36I think one thing that we do have a lot of we do have reporting and you gave us this authority when there's an interruption supply, for example, for manufacturing or a lack of API.
00:51:47But we don't have the same required reporting for increased demand.
00:51:51So in that case, you know, whether we could get if we can get an earlier signal that increased demand could lead to a shortage.
00:51:58That's when we can take action. You know, each year, last year in 24, there were 11 new shortages. That's unfortunate.
00:52:04Yeah.
00:52:05I'd like that to be zero. But we prevented over 250 shortages.
00:52:08And it's that early action that allows us to start doing things quickly in terms of, you know, getting new suppliers, getting new API.
00:52:16So demand would be great.
00:52:19Yeah, no, that that would be something I'd be really interested in working on.
00:52:23There's nothing like watching a child's temperature go up and up and up and not have the medication you need to not only get that child comfortable, but prevent further risks and complications.
00:52:34So thank you so much. Thank you, Mr. Chair.
00:52:37Senator Moody.
00:52:38Thank you, Mr. Chair. Thank you for being here.
00:52:41And thank you for your service. We are grateful to you.
00:52:45I am from the Sunshine State. I'm Ashley Moody. I'm the newest senator in the Sunshine State.
00:52:52Sunscreens are really important to our almost 24 million citizens.
00:52:58And this is a topic that I want to get into.
00:53:01And I know that speed and delay has been addressed with you.
00:53:04That is an issue across federal agencies.
00:53:07What I'm really loving about this new administration are they are focusing on efficiency and getting back to you.
00:53:14Getting back to the mission of these agencies and I'm hopeful that we're going to see that on some of these issues.
00:53:19I know in your testimony, you talked about sunscreen and how we can move forward.
00:53:24You know, I think we're we're basing trying to get new products on the market that may be more effective and it's adding some ingredients.
00:53:33And do you expect that to be addressed quickly? Because I cannot tell you how important it is to all the golfers and all the beach goers and all the Florida folks and all the tourists.
00:53:43By the way, we broke another record in tourism in Florida this year to have that looked at.
00:53:49We want people to be safe, obviously. But is that going to be expeditiously approved?
00:53:53Yes, so we are. We're very excited to be reviewing the first new sunscreen and we will review that on time.
00:53:59We'll get the order out and get the public comment and we'll meet our goals on that. Hopefully it will be successful.
00:54:04And what is that? What is that timeline? What is your goal?
00:54:06So when something I'd have to look at exactly when it was submitted, our timeline for a new ingredient is 17 months, which seems long, but it's quite different than our other UFA.
00:54:17So it would have because it has a public comment period because the public is so involved in this process.
00:54:22And so we have a 45 day comment period and then we get those comments.
00:54:27And, you know, often the public is is wants to provide us a lot of comment.
00:54:32We have to make sure that we take that comment into effect when we then move forward with the final order.
00:54:37And I think what's in what's different in the AMUFA and why the timelines look a little bit longer is when we're in the PDUFA or GDUFA, it's one company, one drug.
00:54:47When we're in the OTC monograph, it's, you know, one one monograph, but it could be many and thousands of drugs.
00:54:54So we have to make sure that we really get that right when we issue that final order.
00:54:59And again, we, you know, we are committed to working with companies.
00:55:03They get us that data, as you said, so we make sure any of those ingredients that were absorbed are safe.
00:55:09We're also looking at alternative test methods to see if they're validated and we can use them.
00:55:14I think that's one of the key things.
00:55:16And one of the key issues you've been addressing today, I think, is speed.
00:55:20We want to make sure we're protecting the health, safety and welfare of Americans, obviously, but we need to also make sure bureaucracy is not weighing down what is meant to be a protection mechanism.
00:55:34It would be my preference as not just a United States senator, but as an American, that government stay out of our business as much as possible.
00:55:42In fact, I think that if that can be achieved, that is what promotes a thriving, successful populous country.
00:55:53Only when it's necessary to protect rights or safety of our citizens.
00:55:59And even there at the bare minimum, as attorney general in Florida, I once had to fight the Biden administration because they wanted to put masks on two year olds while they were outside.
00:56:07I mean, it made absolutely no sense.
00:56:09They wanted to involve themselves in every facet of American life.
00:56:12And I, for one, believe that the first thing that should cross a bureaucrat's mind when they are going to act is, do we really need to be involving ourselves in this issue or in Americans' lives?
00:56:24The majority of the time, it should be no.
00:56:26But when they do, it should be minimized and we should deliver and act as efficiently as possible.
00:56:32And one of the things that I'm happy about is how quickly we were able to get naloxone to the market.
00:56:38I know that you have been happy about that.
00:56:40Yes.
00:56:41You used both the monograph drug user fee program and other things to make sure that that was done.
00:56:49I believe that that is significantly contributing to the decrease in deaths as it relates to the opioid crisis.
00:56:55In fact, I think nationally we saw over a 12 month period of 27% decline nationwide in Florida.
00:57:02We exceeded that number, a 30% decline.
00:57:05But it was not just about interdiction efforts or getting people to seek treatment.
00:57:09It was also about access to naloxone and people being able to get that over the counter.
00:57:14So, thank you for that.
00:57:16Was there anything that you can learn from working with the drug sponsor, getting information quickly,
00:57:21getting that through the process, that we can apply to how we're moving forward to making sure we're streamlining this program?
00:57:30Because the deadline to reauthorize it is coming up quickly, I know.
00:57:33If we are going to have a program that is supposed to push things forward quicker,
00:57:38if government's going to involve itself in the lives of Americans to protect them,
00:57:44how do we do that quicker?
00:57:45Is there something you learned from that in the FDA approval of the naloxone drug to over-the-counter
00:57:50that we can apply to this program?
00:57:53Yes, thank you.
00:57:54And just to clarify, the OTC, naloxone was not under the monograph program because they're not monographs, but yes.
00:58:00You know, one of the things that we were introducing in AMUFA II is we need to make sure
00:58:05when we're working with a company and they're meeting with us that we're maximizing that time
00:58:10and getting them on the right path.
00:58:11So, one of the things that we will do, we'll expand those meetings if it's complex.
00:58:15We'll make sure that we give them advice on their protocol synopsis if they need it.
00:58:21And if we give them advice and they're still not sure what to do,
00:58:24they have the opportunity to ask us to clarify that advice.
00:58:26So, I think, you know, making sure that when we interact, it's very clear to the company what our expectations are.
00:58:33And I 100% agree with you.
00:58:35We want to streamline.
00:58:37We want to take a risk-benefit approach to every action that we do
00:58:41and to try and get products to the market that are, you know, to meet and I'm in need as quickly as possible.
00:58:51Senator Kaine.
00:58:53Senator Alsterbrooks.
00:58:54Thank you so much.
00:58:56Good morning, Dr. Currigan-Carray.
00:58:59And thank you so much for being here today.
00:59:03And I also want to just thank you for your service.
00:59:06It's really, it is unfortunate because I know you've been thrust in the position today
00:59:11to answer for many of the very reckless decisions of political leadership at the Federal Drug Administration.
00:59:18But the reality is that this administration really has been unable to answer basic questions about their so-called reduction in force.
00:59:26Just this week, Commissioner Macri canceled a meeting with the Maryland delegation.
00:59:30We were just simply asking about the impact of the administration's cuts to my state.
00:59:36I've been waiting, for example, for seven weeks now for specific answers from the department.
00:59:41And we just need to know how many staff at FDA have received a RIF notice.
00:59:45We'd like to know how many participated in the deferred resignation program, were terminated on the basis of their probationary status,
00:59:53or are concurrently on administrative leave pending termination.
00:59:57I don't like the term reduction in force because it softens, I believe, the reality of what has happened.
01:00:02It is the very heartless and cruel firing of thousands of very critical civil servants without cause and without an ounce of thought
01:00:11about the potential consequences to public health and safety.
01:00:15So public health and safety is what brings us here today.
01:00:18I know that we're here to talk about reauthorizing the over-the-counter monograph drug user fee program to keep Americans safe.
01:00:26And we also know that the administration has terminated 3,500 staffers from the FDA,
01:00:32including at the Center for Drug Evaluation Research, which undermines its ability to really operate.
01:00:40So I want to just make very clear to the public, because these staffing cuts have really been framed as duplicative or administrative staff that have no bearing on public health.
01:00:51But the truth of the matter is that these staff members really contribute to the core functions of the FDA to keep humans safe.
01:00:59Each of them makes sure that, for example, pharmaceutical advertising is accurate, that the public is aware of potential risks,
01:01:06that drug shortages are mitigated, and that approvals are conducted in a timely manner.
01:01:11And so I understand that you're not able to answer specific questions about the so-called reduction in force.
01:01:19But instead, I hope that you can demonstrate today the importance of the work that the civil servants do every day
01:01:26and to talk generally about the implications of it.
01:01:29So just quickly, can you briefly share what the Center, for example, for Drug Evaluation and Research does every day?
01:01:35Yes, thank you.
01:01:36So in the Center for Drug Evaluation and Research, we oversee several different programs,
01:01:41including, obviously, the AMUFA program and the OTC.
01:01:44So our Office of Non-Prescription Drugs, I can tell you, we've had very little loss in that office.
01:01:50That's the office that's primarily.
01:01:53We review new drugs that are coming through.
01:01:56We work with the sponsors.
01:01:57We have meetings on development programs.
01:01:59We review safety data in the post-marketing and make sure that the labels were up-to-date.
01:02:05We do review direct-to-consumer advertising and make sure promotion.
01:02:10As I said, we work on generic drugs.
01:02:12That's a big priority to get additional generic drugs in competition.
01:02:16In the biosimilar space, we're reviewing biosimilars, and we have a regulatory science program under that
01:02:22to develop the science to bring those drugs to the forefront sooner.
01:02:27And then we need to, we always communicate what we're doing.
01:02:30We are putting out.
01:02:31We have advisory committees when needed to bring further transparency
01:02:35and get additional expertise to inform our decisions.
01:02:39So these are critical staff, the Center's Office of Pharmaceutical Quality.
01:02:44Can you just talk to us about what those staff members, I know you said there have been very few cuts,
01:02:48but cuts in any of these areas I think really do impact public health.
01:02:52So can you just tell us what the Center's Office of Pharmaceutical Quality does?
01:02:57Yes, and I'm sorry, I should have mentioned that because they're really core to all our programs.
01:03:01They are responsible for looking at the manufacturing of the, and the quality of the drug manufacturing.
01:03:08And so under, for example, under a MUFA II, we're going to put more resources so that when a facility comes
01:03:15and starts to market an OTC monograph, that we quickly evaluate that facility,
01:03:21that we get those records requests out there, that we're going to update our risk model to make sure we're taking appropriate,
01:03:28and selecting the facilities that we need to do an inspection on.
01:03:33And they do carry that out for our biosimilars, and our generics, and our new drugs as well.
01:03:40And they're also working to sort of be very forward-working.
01:03:44So when we, there is a priority by the administration to try and bring our manufacturing back,
01:03:50and for supply chain reasons, and we've been thinking about that,
01:03:53and understand that companies would probably want to use advanced manufacturing to be more competitive.
01:03:58So several years ago, we started a special program to work with manufacturers.
01:04:03So when they want to use these new technologies, they can come talk to us early,
01:04:07and we can give them advice and get them on the right path.
01:04:10Thank you so much. So the work you do is critical.
01:04:12All of these staff are critical as well, just making the point that they're not wasteful.
01:04:15These are critical to our public health and safety. Thank you so much. I yield.
01:04:21Senator Banks.
01:04:23Thank you, Mr. Chairman.
01:04:24Doctor, what improvements will the public see in the products on their drugstore shelves
01:04:29if Congress reauthorizes a MUFA for another five years?
01:04:32Yeah, thank you for that question.
01:04:33I think the first thing I would mention, the order that we just did,
01:04:38which would allow certain drugs to be changed from just a tablet or a capsule
01:04:44into an oral dissolving or a chewable capsule or a film.
01:04:47And I think that will be a lot of innovation that will make these drugs more accessible to children
01:04:53and for those who have trouble swallowing.
01:04:56As I said, the more that we innovate with the industry by providing them further guidance,
01:05:02by meeting with them and making sure they have clarity on our expectations.
01:05:07We're going to do some webinars on the GRAS standard and talk to them about confidentiality guidance
01:05:14when they're doing a new ingredient.
01:05:16All those things, we think, are going to speed up innovation,
01:05:18and we hope to see additional OTC orders come out on new products.
01:05:23On that point, the monographs and user fees are supposed to streamline the FDA's process
01:05:29to approve over-the-counter drugs, so better products come to market faster.
01:05:35But that only happens when the FDA uses that authority.
01:05:39How are you going to make better use of the OMUFA authority over the next five years
01:05:44to encourage that type of innovation?
01:05:46Again, the commitments that we've agreed to is really to work, you know,
01:05:51make the meetings with our companies, make them as productive as possible,
01:05:56extend them if we need to, give them advice on their protocol synopsis so they get their products.
01:06:03We're also going to ask to create a new tier, too, so they can update their test methods,
01:06:09and that may be more efficient.
01:06:11We're going to continue to give them education on the GRAS standards,
01:06:16on how to submit their orders and what should be in there and their eligibility for that.
01:06:20And we're going to also make sure that we're being very transparent in all of this,
01:06:25including all the historical documents that will be up on the web so everyone can learn from those.
01:06:30They can learn from all the issues that we identify in the inequality,
01:06:35and we'll do some work on good manufacturing practices so that the expectations are clear.
01:06:41And when the expectations are clear, I think that allows for innovation.
01:06:45On another point, I'm curious, why doesn't the FDA inspect more overseas facilities
01:06:52that export over-the-counter drugs to the U.S.?
01:06:54So, right now, we do use a risk-based model to determine where our inspections,
01:07:00and we do inspections overseas and domestically, and we can get you those exact numbers.
01:07:05I don't have them off the top of my head.
01:07:07One of the things we will do is we're going to update our risk-based model,
01:07:11make sure it's taking into account any factors that may be specific to OTC monograph facilities,
01:07:17and that would determine inspections.
01:07:20We're also going to more rapidly do those record requests to assess the facilities that might need an inspection that are coming.
01:07:27Do you think are there loopholes there that allow for some overseas facilities not to be as inspected as much?
01:07:34In terms of we can do the inspection, what's different in the OTC monograph space is in the other UFAs,
01:07:41there's a time point in which we can do the inspection before the product comes to the market,
01:07:47whereas in the AMUFA, there isn't that one time point.
01:07:51They can come into and register with us and start to distribute,
01:07:55and then we start the assessment of that facility.
01:07:59Mr. Chairman, contaminated non-sterile eye drops coming from China and other countries have been a problem for years.
01:08:07I'd like to enter three different letters, FDA warning letters, to these companies, end of the record.
01:08:16Doctor, how do you determine whether these over-the-counter drugs actually follow the monographs and are safe,
01:08:24or whether they are fraudulent and dangerous?
01:08:26Again, we look for reports with the eye drops we did do.
01:08:32We had adverse events and we followed up on them.
01:08:35We issued the warning letters.
01:08:36We do inspections to see.
01:08:38So we do monitor the safety of the products on the market, and that's how we do a risk-based approach to that.
01:08:45Okay. I'd like to dig into that more further at another time.
01:08:48Thank you, Mr. Chairman. I yield back.
01:08:50Thank you. Senator Kame.
01:08:51Thank you, Dr. Curry. I'm going to focus my five minutes on transparency, which has been mentioned by many of my colleagues,
01:08:59and you've mentioned it in your testimony.
01:09:01And I think it needs to be a hallmark of this particular program, and it also matches up with the values that Secretary Kennedy talked about when he's been here before us.
01:09:11And I've been troubled that while transparency is a goal, there's this one area where we just can't get answers.
01:09:17I asked Secretary Kennedy about the number of people who've been riffed or took the fork in the road initiative, and he could not answer at the time.
01:09:27He didn't have the number, you know, at his fingertips.
01:09:29But when I did a follow-up letter, I still have not gotten a response.
01:09:34And that was kind of an interesting contrast to how customer focused Secretary Kennedy was.
01:09:43In my questioning of him when he was recently before us, I raised the issue of his response to some of my constituents who were writing in about concerns,
01:09:52and they were getting response from HHS, it was actually a CMS response, saying because of the change in administration,
01:09:59we can no longer entertain these kinds of questions.
01:10:03And when I showed that, Secretary Kennedy went back and he found that that was an improper response,
01:10:09and he told me that it was, and he said he was going to correct it, and this wasn't authorized.
01:10:13So he actually responded to my concern about that.
01:10:17And I think Senator Murray had a particular constituent concern that she raised,
01:10:21and he was very solicitous, we want to respond to that.
01:10:24So it seems like there's this sort of gag order on talking about the number of people that are employed
01:10:32or the number of people that are riffed.
01:10:33And for an oversight committee that's trying to exercise oversight over these programs,
01:10:37or even trying to decide what's the right way to reauthorize a program so that it can be effective, more effective,
01:10:43if we can't get an answer about kind of this basic issue, it hobbles us in our ability to do our job.
01:10:50And I know that policy decisions of this kind are probably not yours, but let me just ask,
01:10:57if you could answer this question, within the Center for Drug Evaluation and Research,
01:11:02how many people were subject to the riff issued by Secretary Kennedy?
01:11:07Again, because it's under litigation, I'm not allowed to, or I can't discuss specifics,
01:11:14but we would be very happy when that litigation is resolved to come back and provide you those numbers.
01:11:19And I'm assuming you would answer the same way if I asked you the question about how many of these folks who were riffed were veterans.
01:11:26You would answer the same way.
01:11:27I would answer the same way.
01:11:29So you and I both went to law school.
01:11:31And I've had to give a lot of advice to witnesses about not talking about pending litigation.
01:11:37And so I didn't ask you who was involved in the discussion, who was involved in the decision,
01:11:43what was the rationale for the decision, you know, were there different rationales.
01:11:48I haven't asked you any of that.
01:11:50All I've asked you is the factual question, which is public, it should be public information,
01:11:56because the public is paying for all of this, about the numbers of people.
01:12:00And the fact that I can't get that answer from you, from Secretary Kennedy,
01:12:04we ask similar questions of folks who've been here from the Department of Labor.
01:12:07Nobody wants to answer the question, how many people have been laid off and what percentage are veterans?
01:12:12Now, the veterans issue matters to me as a Virginian because we're such a veteran-heavy state.
01:12:17I have asserted, based on what I've been able to cobble together,
01:12:21that this administration has fired more veterans than any administration in the history of the United States.
01:12:26That's based on what I have been able to cobble together.
01:12:29I'd like to be proven wrong.
01:12:31Maybe if I got the answers to my questions, I'm making an assertion that's incorrect.
01:12:37But I think I'm entitled to the information.
01:12:39I know you've been instructed not to answer it.
01:12:41It's not that you can't, and it's not that you won't.
01:12:44It's that you've been instructed not to.
01:12:46But I will say, pending litigation is not really an excuse for not answering a basic factual question,
01:12:53that the knowledge of which is within the ambit of the administration.
01:12:58On transparency, I do have some proposals about the reauthorization.
01:13:02You did a good job in your testimony of kind of laying out,
01:13:06if this program is not reauthorized, here are some bad things that can happen.
01:13:10But also, you know, I know the chairman is very much into this idea.
01:13:14If you're going to reauthorize, we don't just reauthorize as is.
01:13:17We should reauthorize and improve.
01:13:19There have been, obviously, longer-standing, more established user-free programs,
01:13:28where there's lessons learned about how we can improve.
01:13:31And I have been getting feedback from groups about how this particular OMUFA program can be improved.
01:13:38With the updates that I'm proposing that are in the transparency space,
01:13:42we would be able to have question answers to questions like,
01:13:46how many OTC monographs were filed and approved during a fiscal year?
01:13:51Which drug facility and contract manufacturing organizations have actually paid their user fees,
01:13:57instead of only having visibility into those who haven't paid their user fees?
01:14:01How is the FDA addressing post-market safety for OTC products?
01:14:07I think a lot of the questions today have kind of wrapped around that important topic,
01:14:11including how the agency responds to individual reports of adverse events.
01:14:17My hope is that we will do this bill.
01:14:19I think it is going to be bipartisan.
01:14:21I think we can not only reauthorize but improve by taking some of the lessons from the other similar programs
01:14:28and pro-transparency initiatives are things that I think are going to get pretty nice support on both sides of the dais here.
01:14:34With that, I yield back.
01:14:36And I have a couple follow-ups.
01:14:38How many RX to OTC drugs in the last one year, two years, three years,
01:14:46how many have actually made that transition from being a prescription only to being OTC?
01:14:51Thank you for that question.
01:14:53I know that the naloxone would have been in 23, and I think the O-pill was also around that time.
01:15:02I'd have to go back further and get you the details on the rest of the drugs.
01:15:07So, Marshall asked about a dashboard, but that seems to be rubber hits the road.
01:15:15We've only had three drugs in the last two and a half years that have gone from RX to OTC.
01:15:22I believe that's correct.
01:15:23For some reason, I think I'm forgetting one, but I will get back to you.
01:15:27That just seems like a not very productive record.
01:15:31Again, I think the issue is we do need to find drugs.
01:15:35Drugs are safe, that are safe for a population, for anyone to walk in and look at that drug facts label
01:15:43and appropriately self-select and use that drug.
01:15:47And so we need to look at the drugs that we have and think if that is appropriate and look at the development programs.
01:15:54And I think that's why the new rule that we're coming out is really meant to try and open up that space more.
01:16:01Because for any drug, it may be relatively safe in this population and it may be, but we're, you know,
01:16:10sometimes a drug fact label is not sufficient for just those folks to understand that that's a drug for them and it's not for others.
01:16:16That's true of everything.
01:16:18Nonsteroidals, you shouldn't take if you have a history of active peptic ulcer disease.
01:16:22Right.
01:16:23And yet we've approved nonsteroidals all over the place.
01:16:27And so we're willing to accept that somewhat of a risk.
01:16:32And so for the greater good, it turns out we've worked out not that many people are taking nonsteroidals
01:16:38and exacerbating their peptic ulcer disease.
01:16:41Right, that is true.
01:16:43And so I just want to lean into this.
01:16:45Because, I mean, this costs consumers a heck of a lot of money to go to a doctor to get a prescription for something
01:16:51which they could safely take OTC.
01:16:54Yes, I agree.
01:16:55And, you know, we are going to look for opportunities.
01:16:58And as I said, I think the new rule in which we can sort of just, it's adding something in the self-selection
01:17:05to the drug facts label has a real potential to open up for other conditions that could be for chronic conditions
01:17:11and open up consumer choice.
01:17:14And so we're going to work with, to finalize that rule and work on development programs that could come under that rule.
01:17:21And I asked this earlier, but I didn't quite follow the answer, so I'll finish with this.
01:17:25Okay.
01:17:26Do you feel as if this final rule, that you have the tools, particularly with this final rule,
01:17:33to expedite the transition from Rx to OTC, or does Congress need to do something to kind of light a fire?
01:17:40I think with this rule that we have a new tool that's going to be very powerful and effective for us to move things from Rx to OTC.
01:17:47And would you expect the new rule to be implemented?
01:17:50The rule was, the implementation was delayed.
01:17:54I think it should be the end of May, but I need to check.
01:17:57There was a delay after we had the transition.
01:17:59Okay.
01:18:00Okay.
01:18:01Yes.
01:18:02I have a follow-up just based upon the chairman's questions.
01:18:05To what degree was the fact that there have only been three or four Rx to OTC in the relevant time period he was discussing?
01:18:20To what degree is that a function of just, you know, just sheer personnel or resources within CDER versus, you know, the regulatory structure that shapes what can be approved?
01:18:37I would say in the last five years, it's more about the regulatory structure and what can be appropriately put over the counter and selected.
01:18:46And so hopefully this new rule, when it becomes effective, will help you accelerate.
01:18:52Yes.
01:18:54Okay.
01:18:55For any senator wishing to ask additional questions, questions for the record will be due on 10 business days on June 18th at 5 p.m.
01:19:04Thank you very much, Dr. Corrigan Curry.
01:19:07The committee stands adjourned.