▶ 0:18:02Chair Cassidy: The senate committee will please come to order. Over-the-counter drugs a part of the fabric of americans maintaining their health, treating common ailments including pain relief, allergies, and cold symptoms. I could use a little right now. At an affordable cost. They are available at every pharmacy in virtually every grocery store nationwide. Being readily available to americans, otc's save americans a lot of money.
▶ 0:18:31Chair Cassidy: The drugs generate an estimated 1.46 billion dollars in annual savings from fewer doctors visits and prescription drug purchases. For decades otcs were required to go through a cumbersome review before going onto the market. This process known as a drug monograph typically took years to finalize. Many new otc drugs were never fully approved.
▶ 0:18:59Chair Cassidy: The review also made it more difficult for the fda to update safety information on these drugs, sometimes delaying safety recommendations for several years. As a result of these challenges, congress created the bipartisan, over-the-counter, monograph drug user fee program in 2020 to streamline fda review of otc drugs making these drugs more quickly available to americans while ensuring safety.
▶ 0:19:28Chair Cassidy: It is set to expire at the end of this fiscal year. As congress looks to reauthorize we must see how we can further improve the program to better serve americans. That is why the hearing is so important. I highlight that today is the first time that congress will hear directly from the fda about reforms of the otc drug review and plans to make more low-cost drugs directly available to americans. I appreciate Dr.
▶ 0:19:54Chair Cassidy: Corrigan-curay coming before the committee on behalf of the fda. Fda has failed to ease regulatory hurdles that allow prescription drugs to be sold otc. These delays make it harder for consumers to directly access low-cost treatments.
▶ 0:20:21Chair Cassidy: The agency continues to struggle with reviewing new sunscreens despite the well-documented public-health value of using sunscreen. The fda has not approved a new sunscreen filter since 1999. In contrast, countries in europe and asia have many more, high-quality sunscreen products available to consumers. The fda needs to do a better job with sunscreen.
▶ 0:20:45Chair Cassidy: I look forward to discussing how congress can improve omufa and the otc review process. I recognize senator kaine with his opening statement.
▶ 0:20:55Sen. Kaine: Welcome Dr. corrigan-curay, this is an important program because it is important for americans to have access to safe and effective over-the-counter drugs, recognizing the importance of regulating drugs that can be used without a prescription and the challenges facing the fda peered congress passed the over-the-counter monograph user fee program in 2020 to support the work of the fda and expand access to medications that are safe and easy to access and use.
▶ 0:21:27Sen. Kaine: The magnitude of this is pretty big. U.S. consumers spend over $40 billion on over-the-counter drugs in 2020 four. Eight in 10 U.S. adults use over-the-counter products as the first response to a minor injury. Over-the-counter drugs and save americans money and the health care system money.
▶ 0:21:46Sen. Kaine: Researchers found that $51.6 billion in drug cost savings occurred when lower-priced over-the-counter products are used instead of higher priced prescription drugs. That is really important both for the public treasury and for consumers. While over-the-counter drugs can generate savings, they can also be misused, leading to 178,000 hospitalizations each year due to adverse drug events. It's important that we get the balance right.
▶ 0:22:16Sen. Kaine: Older adults represent one third of over-the-counter drug users and over 65% of these adverse drug events. Proper oversight is important. That is why we are here today. I was happy to support the initial passage of the user fee program and I'm glad the committee is backing to marketing I partisan legislation and I hope we will do more of it.
▶ 0:22:38Sen. Kaine: I want to conclude putting on the table that we will be grappling soon with the reconciliation bill that deals what he significantly with the fda. In the last hour the cbo released a report indicating that the house reconciliation bill would deprive 60 million americans of health insurance. That is the house-passed bill. That tells us what the stakes are as we grapple with the reconciliation bill.
▶ 0:23:06Sen. Kaine: Obviously, I know that my colleagues and I will be fighting hard to avoid that. Let's focus on the fda. Since the administration took office, 20,000 employees at the department of health and human services have been dismissed, including over 3500 fda staff currently on administrative leave. Many other staff have been forced out or are leaving because of the chaos at the agency, including the center for drug evaluation and research, which we are to talk about today.
▶ 0:23:36Sen. Kaine: I asked senator kennedy about the effect of some of these cuts in particular detailed questions about how many of these folks laid off were veterans and I wait an answer and have not received it yet. The mission of the fda is to assure the safety and effectiveness of millions of drugs and medical products, including this program that we are focused on today, is so important. The way to overhaul the agency isn't to indiscriminately fire thousands of experts.
▶ 0:24:01Sen. Kaine: I hope that we get some answers about how the decisions were made on these layoffs and what impact they could have on the ability of the fda to successfully implement the program we are here to discuss today. Mr. chair, I yield back.
▶ 0:24:12Chair Cassidy: We are joined by Dr. corrigan-curay come the acting director of at the U.S. food and drug administration. In her role as the acting director Dr. corrigan-curay is responsible for ensuring the safe, effective, high-quality drugs available to the public. She brings a long career of medical research, including numerous positions at the fda and nih. Dr.
▶ 0:24:41Chair Cassidy: Corrigan-curay holds degrees from harvard law school, the university of maryland school of medicine, and harvard university. I look over to hearing from her today and thank you for joining us. Is your microphone on?
▶ 0:24:54Dr. Corrigan-Curay: Thank you. Can you hear me now? Good morning, chair cassidy, ranking member kaine, members of the committee, for the opportunity to speak with you today. I want to talk about something that benefits nearly every american household, over-the-counter medications are an antiseptic when your child has a scrape and antihistamines when the pollen counts rise. An antacid after a heavy meal.
▶ 0:25:23Dr. Corrigan-Curay: They are trusted essentials and they must be safe, effective, and up-to-date. That is where the otc monograph user program comes in. Prior to 2020 our ability to regulate otc drugs had not been modernized in decades, it was slow, outdated, inflexible, and reform was overdue. When congress passed the reform as part of the cares act it was a bipartisan success that brought real change.
▶ 0:25:48Dr. Corrigan-Curay: Critically, the user fees that congress authorized modernized reform and set the program for success. With congressional support and timely reauthorization, we have the opportunity to realize the full potential of the otc monograph reform, insuring a nimble regulatory process, fostering innovation to better serve patients and consumers,
▶ 0:26:20Dr. Corrigan-Curay: And enhancing transparency and accountability from the fdand industry. What have we accomplished? In five years at his help the fda modernize the drug review process, transforming it from a paper-heavy rulemaking system to a responsible electronic one. Five guidance document providing clarity to manufacturers and enhancing public-health protections. We posted 33 final orders and five opposed administrative orders providing transparency for manufacturers on what is expected to market a particular otc drug. I want to highlight our most recent proposed order because we believe that it foster some exciting innovation for children and families.
▶ 0:26:50Dr. Corrigan-Curay: If finalized this order would let companies create easier to take forms of over-the-counter medications like chewable tablets and thin films for certain medications that only come as tablets or capsules and could help people who have trouble swallowing them. Omufa has helped hire 85 dedicated staff members and regulatory experts who help ensure that the products on our shelves are safe and effective.
▶ 0:27:17Dr. Corrigan-Curay: Importantly it opened the door to more innovative products like a new sunscreen ingredient. If congress does not authorize omufa, momentum would come to a grinding halt. The impact would be immediate and damaging. Engagement on activities to oversee the safety and quality of otc monograph products would slow or stop as dozens of staff with clinical quality expertise would lose their positions.
▶ 0:27:44Dr. Corrigan-Curay: Critical progress on proposed and final orders from the monograph forecast would be shelved including essential updates on labeling drug facts and ingredients, including for products intended for pregnant women and children. No new agreements from the recent letter could be implemented including important steps like improving meeting management with sponsors and quickly assessing the quality of facilities as companies bring new products to the U.S.
▶ 0:28:07Dr. Corrigan-Curay: Perhaps most concerning, we risk sliding backwards, losing the transparency, protect ability, and innovation that omufa was designed to create. Without reauthorization, the system that was fixed begins to break again.
▶ 0:28:24Dr. Corrigan-Curay: The recently negotiated agreement for the next five years of omufa include smart, achievable goals, increasing opportunities for industry and fda to attract and foster innovation, improving the transparency of the user fee program, investing in product quality and safety, and continuing to publish the annual guidance forecast that give industry and public health stakeholders a clear roadmap for the future. These are not just words, they are a commitment to the public to keep this progress going.
▶ 0:28:53Dr. Corrigan-Curay: Every delay in regulation or review affects real people. Without omufa innovations are stalled, safety improvements delayed, and consumers may unknowingly continue to use products that have not been adequately reviewed under modern science. It's not red tape, it is about the medications americans buy off-the-shelf each day. Congress made a smart investment when it created omufa and that is paying off but we cannot stop now.
▶ 0:29:20Dr. Corrigan-Curay: Reauthorizing omufa means continuing modernization, and keeping american families safe. I look forward to your questions.
▶ 0:29:29Chair Cassidy: Thank you, doctor. I have a question, but it goes against the flavor of your testimony. Your testimony was very positive about the positive things that omufa has done. It seems the rx to otc switch from prescription to nonprescription that the fda has struggled to make that happen.
▶ 0:29:57Chair Cassidy: Is that a misperception on my part or is there -- has this been more successful than I understood?
▶ 0:30:10Dr. Corrigan-Curay: In the past few years we have brought a certain prescription drugs to over-the-counter including naloxone that became over-the-counter and was critical in helping us address the opioid crisis. We have brought contraceptives over-the-counter as well, and we have brought some of the nasal allergy sprays over-the-counter, and we have a rule that should be finalized to bring additional medications
▶ 0:30:41Dr. Corrigan-Curay: Over-the-counter with a condition of use. To have a new way of bringing medications over-the-counter, and we hope that that would greatly expand --
▶ 0:30:49Chair Cassidy: Explain condition of use.
▶ 0:30:52Dr. Corrigan-Curay: Under this rule, if we determine that you could not bring a drug over-the-counter with just the drug facts label because with that label alone a person cannot appropriately self-select for that drug and use it, a company could propose an additional condition. Maybe a mobile app with questions.
▶ 0:31:16Dr. Corrigan-Curay: If we can show with the use of that additional condition or questions before they access the product that they can access it safely, that would open the door to products that we currently don't have over-the-counter.
▶ 0:31:30Chair Cassidy: Can you give an example?
▶ 0:31:31Dr. Corrigan-Curay: They are still in development. We can think potentially about drugs for more chronic conditions where we could select a population for which that drug was safe to take over-the-counter.
▶ 0:31:47Chair Cassidy: Let me go back to -- you listed some that have become over-the-counter, but you listed five or six.there are a heck of a lot of drugs that could be over-the-counter. You're just giving me a sample? A sample, for example, of five or six drugs? Or that is the universe of those that have been approved? Let me ask you that.
▶ 0:32:10Dr. Corrigan-Curay: Thank you. In the recent timeframe those were the words -- those were the ones I highlighted. We work hard to look for opportunities to bring drugs over the counter that patients can self select and use.
▶ 0:32:24Chair Cassidy: Let me understand the process. I have limited time. Does the drug company have to apply or can -- for example, I think benadryl used to be a prescription drug.claritin used to be a prescription drug.
▶ 0:32:39Dr. Corrigan-Curay: Right.
▶ 0:32:41Chair Cassidy: Really, you could have looked at those and said this could be over-the-counter. Does the drug company have to apply or can the agency say, this drug can safely be given otc?
▶ 0:32:55Dr. Corrigan-Curay: Thank you for that question. The application does need to come in. In the case of naloxone, if I recall, we put out an fr notice to say that we were working to bring the locks on over-the-counter. We have opportunities to signal where we think there might be opportunity. We also do speak to companies and can suggest that we might be open to a development program.
▶ 0:33:27Dr. Corrigan-Curay: It does require development program to show --
▶ 0:33:28Chair Cassidy: What do you mean by development program?
▶ 0:33:32Dr. Corrigan-Curay: A company would need to show that consumers can self select appropriately and use it with the information on the drug facts label.
▶ 0:33:41Chair Cassidy: Let's go back to something that at one point was a prescription drug, or prilosec which was a prescription drug, you could have looked at that initial -- rhetorical you -- could have looked at that and said this is a pretty safe drug that people can take for heartburn.
▶ 0:34:04Chair Cassidy: I guess that I'm asking, that would save a lot of money for patients, a lot of money for patients if they could buy those drugs otc as opposed to having to see a physician. Is there something that congress can do to expedite that? Or do you have all of the tools that you need to generate a more aggressive approach to the rx to otc method?
▶ 0:34:25Dr. Corrigan-Curay: Thank you. In the case of that drug we would certainly say, yes, doesn't look like it has a safety profile that we have enough experience? Then we do have to have the information saying that the consumers can self select. We are happy if you have ideas to work with you on those.
▶ 0:34:43Chair Cassidy: Senator kaine.
▶ 0:34:46Sen. Kaine: You are such an omufa nerd I will stay for the whole hearing. I will yield and take my questions later.
▶ 0:34:55Sen. Kim: I wanted to ask you about some of the reduction in force. Are you able to tell us if any of the staff in the office of nonprescription drugs were terminated under the reduction in force efforts?
▶ 0:35:11Dr. Corrigan-Curay: Thank you. Unfortunately consistently with our policy when something is the subject of litigation we do not comment on the specifics. As you know, there is a preliminary injunction around the reduction in force, so I cannot go into details at this point.
▶ 0:35:28Sen. Kim: When you are able to provide answers I would like to know how many staff have been let go or resigned from the office of nonprescription drugs at how many were funded by user fees. I want to talk about the commitments the fda made with the otc industry as part of the omufa commitment letter, specifically the agreement that fda would hire 11 new full-time employees over the length of the reauthorization. I understand that there is a hiring freeze at the fda.
▶ 0:35:59Sen. Kim: Is that the case? And if so will the fda be able to stand by the commitment of hiring 11 additional full-time staff?
▶ 0:36:06Dr. Corrigan-Curay: Yes, there is a hiring freeze. I notice that Dr. mcgarry has indicated that he is working to allow us to hire the reviewers that we need for all aspects. I am confident that he will be working with us to give us the resources we need to be successful under omufa 2.
▶ 0:36:27Sen. Kim: I want to hone in on a particular example to get a sense of how omufa is moving forward and is performing. For instance, sunscreen. This is something where we understand that the united states has continued to lag behind other countries in terms of uv filters that are approved for use in sunscreens. The fda has not approved a new filter since 1999, correct?
▶ 0:36:55Dr. Corrigan-Curay: That is correct, although we do have a new otc monograph order under review for a new sunscreen ingredient.
▶ 0:37:03Sen. Kim: I would like to hear more from you. Despite congress creating this new pathway, and several years overhauling the entire otc monograph order process, we still have no new sunscreen ingredients formally approved. You said there is something in the works ? I wanted to ask you, how do we try to address this? How do we make sure we are moving forward and addressing these main challenges of approving new ingredients?
▶ 0:37:32Dr. Corrigan-Curay: I would like to explain a little about the sunscreen market. Sunscreens for us are considered drugs because they are used to protect against the damages of the sun and skin cancer. Any drug that we approve that is topical, but has systemic absorption, we need to make sure that the sub -- that the systemic absorption has no on towards effects like disrupting the inter-can system or the
▶ 0:38:03Dr. Corrigan-Curay: Abnormal growth of cells and tumors. Certain ingredients in the literature have been highlighted as potential intercurrent disruption. In order to do that we would ask a company to do those tests like any other drug that we approve. We've laid out the data that we think would be necessary for us to do an assessment. We are waiting for more companies to come to us with that data. And then we would be happy to review it and work on that.
▶ 0:38:31Dr. Corrigan-Curay: I would like to note that I know that there are additional sunscreens in different countries. Not all of them are under -- are treated as a drug. I would like to say that there is no data that those are more effective or that we don't have effective sunscreens in the united states.
▶ 0:38:49Sen. Kim: I would like to switch gears to another angle. I am the father of a seven-year-old and a nine-year-old. A lot of parents in the bleary early mornings of a sick child tried to wander off and figure out what we can do for our kids. I understand the fda has stated its intentions to develop pediatric weight-based dosing of acetaminophen. I want to know for myself if I'm getting my kids the right dosage.
▶ 0:39:18Sen. Kim: Can you explain to the committee what staff resources are needed to make that change happen? How do we make sure we are able to move that forward promptly?
▶ 0:39:25Dr. Corrigan-Curay: We will be asking for omufa 2 to put out orders and guidances, but this is a priority for us. We know that there have been improvements in the way that the acetaminophen is concentrated on the shelf but we need to address this weight-based and it is on our agenda.
▶ 0:39:52Sen. Kim: I raise this as another example of the importance that we have staff, that we have experts that are able to process this. When we see much the slashing of employees and staff, I worry that these direct benefits to people will be cast aside. I yield back.
▶ 0:40:02Chair Cassidy: Senator marshall.
▶ 0:40:05Sen. Marshall: Thank you, and welcome to our guest today. Let's talk about measuring success. How do you measure success? I assume that from a safety standpoint every month you are reviewing things that went wrong and how come, but beyond that how do you measure success from the ones coming into the system? Is there a set amount of time that you would like to have them out by?
▶ 0:40:35Sen. Marshall: What percentage made it through the process in that amount of time? How do you measure success?
▶ 0:40:38Dr. Corrigan-Curay: In omufa 1 we measured success and provided identities creating an electronic efficient way for companies to communicate with us. And then we have the first new proposed order and that we are reviewing. We are making commitments on meetings, so we are meeting with companies, so our success will be to continue to move those development programs --
▶ 0:41:07Sen. Marshall: You are trying to improve success, but I don't see measuring success from the standpoint of you run a hospital or a bank, every month you look to key metrics to say are we heading these measures?
▶ 0:41:21Dr. Corrigan-Curay: What will be putting out our planned three-year agenda and that will tell you the successes of getting these orders out. For example, the new order that we just put out that will allow for changes in the dosage forms, and we think that that is very innovative.
▶ 0:41:36Sen. Marshall: You don't have a monthly dashboard of metrics that you are looking at to see if we are meeting them?
▶ 0:41:41Dr. Corrigan-Curay: We are tracking all of the things we are doing in terms of proposed orders that we are meeting timelines on reviews.
▶ 0:41:47Sen. Marshall: Can you share your dashboard with us?
▶ 0:41:51Dr. Corrigan-Curay: I don't know if it is an electronic dashboard. We are tracking what we are doing and our commitments.
▶ 0:41:59Sen. Marshall: I would love to see how you are measuring success. I would encourage you to get one. Let's talk about inactive ingredients. The otc monographs active ingredients. A lot of our concerned about inactive ingredients like artificial flavors and sweeteners, etc. What is going on in the world of over-the-counters as far as identifying inactive ingredients and is there an effort to get the ones that aren't safe out of these over-the-counters?
▶ 0:42:27Dr. Corrigan-Curay: Thank you for that question. Any time that we identify that there is an issue with an inactive ingredient, we would review it and we would like to make changes in an inactive ingredient. We have guidances. We did one on color additives to allow firms a pathway if they want to change their inactive ingredients or color additives. We can get back to you with more information.
▶ 0:42:54Sen. Marshall: Isn't it pretty simple for monographs to include the inactive ingredients?
▶ 0:43:00Dr. Corrigan-Curay: I think that I might have to get back to you on that question about could we just do that, if you don't mind.
▶ 0:43:09Sen. Marshall: Let's talk about studies. More and more it would seem that ai can replace animal studies. Probably even more accurately. So often you read that what happened in monkeys and dogs has nothing to do with the biology of human beings. Is there any effort in your department to convert to ai and do less animal studies?
▶ 0:43:31Dr. Corrigan-Curay: We are engaged on the new initiative to reduce animal studies in the monoclonal antibodies. Previously we had been looking for alternatives to animal studies. We no longer use animal studies for eye or skin rotation, and we are looking at both ai, as we are looking at these nonanimal approaches.
▶ 0:43:56Dr. Corrigan-Curay: There are still challenges in coming out with validated studies when you're looking at -- looking for an effect that would affect multi-organ systems. That doesn't mean that we won't get there and we will continue to work on that.
▶ 0:44:09Sen. Marshall: If there is a way that you can measure that and show us -- we were doing so many animal studies five years ago. We did this many last year, this many this year. Prove to me that you making progress in that. That would be very helpful.
▶ 0:44:25Dr. Corrigan-Curay: We will get back to you.
▶ 0:44:27Sen. Marshall: Thank you, I yield back.
▶ 0:44:30Chair Cassidy: Senator kaine.
▶ 0:44:32Sen. Kaine: Senat hickenlooper.
▶ 0:44:37Sen. Hickenlooper: . Thank you for being with us and for your service and hard work. I know that there are hard times. Several of us are working on a bill called skinny labels big savings. Senators collins, kotten, welsh, and I are trying to address the endless procession of lawsuits against generic drug manufacturers who have skinny
▶ 0:45:12Sen. Hickenlooper: Lable fda approvals. If we can encourage more generic drugs to come to market we will lower costs widely for the american consumers. Dr. corrigan-curay, are you willing to commit to work with us to advance this legislation so we can lower drug costs? And as the acting director for the center of drug evaluation and research, what else are you working on to try to create our competition, generic competition?
▶ 0:45:36Dr. Corrigan-Curay: Absolutely we support additional generic competition. We know that generics make up 90% of the prescriptions in the united states. We think the skinny labeling, we are happy to work with you on that legislation. Other things that we are doing is we are continuing to put out guidances, product specific guidances that are a roadmap for developers.
▶ 0:46:01Dr. Corrigan-Curay: In addition, it is very important as we see more opportunities in complex generics that we work with industry and academia to develop the science to allow those to tongue forward. We have a very -- allow those to come forward. We put guidance.
▶ 0:46:21Dr. Corrigan-Curay: We seek to meet all of our goals and I believe in 2024 we approved about 59 first generics, generic drugs for which there was no generic competition before we approved them.
▶ 0:46:36Sen. Hickenlooper: I appreciate that. I will come back to ai because you touched on ai as well. This week you launched elsa, a new ai tool. Mr. mcgarry stated that it wasn't designed to expedite review processes at the agency with the goal of making them shorter and yet more successful, better. He stated, all information stays within the agency and the ai models are not being trained on data submitted by the industry.
▶ 0:47:06Sen. Hickenlooper: So, can you share with us a little about, Dr. corrigan-curay , some of the additional details about how exactly the fda is going to ensure that the data within elsa remains secure? I view elsa as a tool, but we have to handle it safely.
▶ 0:47:26Dr. Corrigan-Curay: We are very excited about the initiative that Dr. mcgarry is leading on ai because we see that there is utility to the tool. We are not training it on the data. What we are doing is ai could be helpful when we have a number of documents that we want to summarize for one of our reviews. We still have to check it and make sure that it is right.
▶ 0:47:56Dr. Corrigan-Curay: The confidentiality and privacy of data within the fda is one of our top priorities. We are trusted to keep that and will continue to work on that even as we incorporate new tools into our review processes.
▶ 0:48:09Sen. Hickenlooper: I support that 100%. Let's talk about transparency at the fda. Secretary kennedy and commissioner mcgarry -- commissioner makary sat in your seat saying transparency would be a priority for the agency and yet the fda appears to have attempted to get the team that responds to the freedom of information requests.
▶ 0:48:37Sen. Hickenlooper: Everyone was let go or encouraged to retire. The fda bypassed the advisory committee on immunization practices and at the recent covid vaccine guidance taking one of the few forms that we have a clear and open debate on vaccines and they skip over it. Does any of this promote transparency?
▶ 0:49:00Sen. Hickenlooper: How do we reconcile the public commitments to transparency with some of these opaque actions, or at least as they appear to me and to many of us? How can we course correct and make sure that americans feel confident that they are getting transparency? They are seeing what is coming and they can believe in these actions?
▶ 0:49:23Dr. Corrigan-Curay: We are very committed to being transparent. We held an advisory committee a month ago on our opioid pmr's and we continue to communicate and will continue to keep that transparency with the public.
▶ 0:49:43Dr. Corrigan-Curay: We have several initiatives that we will be doing in terms of webinars with the firms that didn't and did pay to provide transparency around that and around exclusivity. We will continue to do that.
▶ 0:49:56Sen. Hickenlooper: I yield back.
▶ 0:49:58Chair Cassidy: Senator tuberville.
▶ 0:50:01Sen. Tuberville: Thank you for being here. We know secretary kennedy is all in modernization. While we are waiting for user fees to be reauthorized, what are we doing in the meantime of getting ready for dealing with the atmosphere we are in today? What are we doing?
▶ 0:50:20Dr. Corrigan-Curay: Are you asking me how we are preparing for these negotiations? Thank you. As we do every cycle for the user fees, obviously for omufa we are here to talk about the reauthorization. For the other user fees we have internal processes that we undertake to think about the next agreements and what we would like to propose.
▶ 0:50:49Dr. Corrigan-Curay: Of course, those would be discussed with Dr. makary. I believe notices of our public meetings for july are out and we will have those public meetings and engage the public on those user fees.
▶ 0:51:03Sen. Tuberville: We have already talked a little bit about the sweeteners that go into a lot of our over-the-counter drugs. You go into these places, drugstores, and they look like candy stores. They are enticed to be marketed in certain ways because of the color.
▶ 0:51:26Sen. Tuberville: Do we have -- what kind of priorities do we have on labeling of -- number one, what goes into some of the over the counter drugs, where they are made. I have looked at a lot of bottles and things inside our stores and you cannot find out where they are made, in korea, in china, or in the united states. Shouldn't that be a priority?
▶ 0:51:56Dr. Corrigan-Curay: Thank you for that question. One thing when we think about where he drug is made, we are committed to making sure that wherever the drug is made, and if it is being marketed as safe, we apply the same standards if it is made domestically or internationally. We are certainly very supportive.
▶ 0:52:17Dr. Corrigan-Curay: I know the administration is looking to onshore pharmaceutical manufacturing, and that would be for prescriptions or otc, and we are supportive of that and will work with them in terms of our regulatory frameworks to make that happen. Now, we don't have a labeling on the drug for we are dismayed. We are happy to work with you if that is a priority.
▶ 0:52:37Sen. Tuberville: I think in the future with the problems we are having worldwide it would probably be a good suggestion that people when they find out where it is made. We found out during covid we don't make much anymore. Most of it comes from china. We really don't know what's in it. We are finding out a lot of metals are in the drugs and foods we have. Another question I had about sunscreen. Most of us use sunscreen.
▶ 0:53:06Sen. Tuberville: I don't know how it's evaluated, but over the years, the last 50 years, melanoma and skin cancers have almost quadrupled. I don't know whether if people don't use it or if it is not working or we get some kind of skin cancer from ingredients that are in sunscreen. All of us use it at some point.
▶ 0:53:31Sen. Tuberville: It doesn't really feel safe every time I put it on, but I put it on because sometimes you look at the worst-case scenario. What are your thoughts on that?
▶ 0:53:41Dr. Corrigan-Curay: Thank you for that. First of all, we are very aware that the skin cancer risk is very serious, a very serious problem. The sunscreens testing say they are effective when used properly. When we are testing for systemic absorption it is how you use them. We have two mineral sub we have two mineral s sunscreens that are not absorbed.
▶ 0:54:07Dr. Corrigan-Curay: For those absorbed we asked for additional tests to ensure their safety that the systemic absorption has no on towards effects.
▶ 0:54:13Sen. Tuberville: Are we looking into the ingredients that are so-called cancer cause or is? -- cancer causers?
▶ 0:54:22Dr. Corrigan-Curay: Yes. 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.
▶ 0:54:32Sen. Tuberville: Yield back.
▶ 0:54:33Chair Cassidy: Senator kaine.
▶ 0:54:35Sen. Kaine: Senator markey.
▶ 0:54:38Sen. Markey: . The trump administration has fired 4500 federal employees at the food and drug administration out of 20,000. 800 out of the 7500 people at the center for drug evaluation and research.
▶ 0:54:58Sen. Markey: Despite assurances from commissioner makary that slow downs would not happen, I have heard from researchers and companies that the drug review process has slowed to a crawl and many have been stuck in limbo for months waiting on reviews and approvals to be completed.
▶ 0:55:18Sen. Markey: In massachusetts in a survey released by mass bio in may, 67% of firms surveyed were concerned workforce reductions would delay drug approvals. At least 50% were already feeling the impacts from the fda layoffs.
▶ 0:55:41Sen. Markey: So, this is not a good situation for all of these biotechs in my state and across the country. The trump administration's actions have guaranteed that every stage of developing life saving drugs is slowed down or stopped.
▶ 0:56:01Sen. Markey: We are witnessing a real-time giveaway of our global leadership in drug research in development, in biomedical innovation. In firing fda officials responsible for drug approvals and evaluation is part of the problem. My question is, obviously there have been many essential employees who have left as part of this reduction in workforce.
▶ 0:56:34Sen. Markey: The goal has to be to increase the timeliness of the review processes. What is your plan to replace the institutional knowledge that was lost from long-time fda employees being fired or resigning?
▶ 0:56:48Dr. Corrigan-Curay: Thank you for that question. I know that we cannot really discuss details around the litigation, but our reviewers are --
▶ 0:56:59Sen. Markey: Can you move the microphone a little bit?
▶ 0:57:01Dr. Corrigan-Curay: Our reviewers are in place and we are meeting our timelines.
▶ 0:57:06Sen. Markey: Timelines to do what?
▶ 0:57:09Dr. Corrigan-Curay: Timelines for the approval of our drugs. We do occasionally miss timelines.
▶ 0:57:15Sen. Markey: 50% of my companies are already saying they are fueling the impacts of the fda layoffs?
▶ 0:57:21Dr. Corrigan-Curay: We will certainly look into that. I would note that we are proving drugs and making our timelines -- there are certain times. All of our agreements we have 90% not 100%, because sometimes issues come up that are complex in scientific issues that we would rather take a little more time if we need to to make sure we get them right. But we are also going to work with Dr. makary. We have turnover in our review staff every year.
▶ 0:57:52Sen. Markey: You are down 800, which is a lot in the real-time that these companies have to get answers. What was your role in the firing of the 800 employees at the drug evaluation and research?
▶ 0:58:10Dr. Corrigan-Curay: Because of the ongoing litigation I cannot comment.
▶ 0:58:16Sen. Markey: Was doge involved in the firings at the fda?
▶ 0:58:22Dr. Corrigan-Curay: Because of the ongoing litigation I'm not able to comment on that.
▶ 0:58:24Sen. Markey: In a lawsuit that was filed by federal workers yesterday, a federal worker stated that march 21, 2025 on the ago, group of doge employees visited the fda offices. Someone dressed in business attire yelled, "this is doge and this is your last supper" at an fda employee.
▶ 0:58:54Sen. Markey: Doctor, can you walk me through what happens when someone at the center of drug evaluation and research is fired in terms of who signs off on the termination paperwork and how the notification is sent to employees?
▶ 0:59:06Dr. Corrigan-Curay: Again, because the risk is involved in -- riff is involved in litigation, I can't comment am not aware of that incident.
▶ 0:59:17Sen. Markey: Obviously you are in a difficult position, which I appreciate. I appreciate that, but whether it is makary or kennedy or doge who are calling the shots, it is obviously going to rebel dow -- ripple down into negative consequences for the bio farm industry and people across our country and nation who are waiting for these drugs to be available to help their families.
▶ 0:59:48Sen. Markey: So, it is a crisis. Combined with all of the cuts at nih research funding, we might as will giftwrap 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 is just completely unnecessary. I thank you so much.
▶ 1:00:12Chair Cassidy: Senator moody. Senator cruz said -- senator husted.
▶ 1:00:21Sen. Husted: Thank you. I appreciate you joining us. The 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. That time is money. The faster we can do things we can lower costs, improve access to consumers.
▶ 1:00:51Sen. Husted: Whether it is moving from prescription to over-the-counter, approval of generics, whether it is decreasing the time development and approval process parallel approval tracks, give me your thoughts on how we can go faster, maintain quality, but also in everything that the fda touches to reduce the cost of delivery ultimately within the economy to our consumers, our
▶ 1:01:23Sen. Husted: Patients.
▶ 1:01:28Dr. Corrigan-Curay: I think there are number of different things we do. For example, on the innovative drug side when we approve a new molecular entity, a new drug, a novel drug that has an unmet need, it often undergoes priority review. We speed up that review. In 2024, we approved 50 new drugs. 52% were for rare diseases. Of those, 56% we did priority review, shaving off time. We realize that our role in this is to increase competition.
▶ 1:01:58Dr. Corrigan-Curay: As I spoke, our generic program is very robust and we seek to get generic drugs on the market by working to provide clarity on the pathway, by working on regulatory science that can make a difference, and the other younger program is bio-similar but we are seeing that accelerate with the number of approvals we have.
▶ 1:02:20Dr. Corrigan-Curay: We are working on inking about this, bio-similar to interchangeable that in most cases you don't need additional study. We've also convened a meeting with the public and international regulators to think more on how we can rely on analytic than clinical studies, because we know that those take the longest and are the most expensive. Those are some areas we are working on.
▶ 1:02:43Sen. Husted: I know the issue of ai has been discussed in terms of process and refinement, but it also is that quantum computing and tools are being used in the health care sector to speed development. Do you have any comments or thoughts on that and how that can enhance the time involved?
▶ 1:03:07Dr. Corrigan-Curay: Yes, thank you. We have a program in which we do modeling and we use machine learning to look at how we can accelerate a review program, maybe looking at different doses through modeling. Our bio-statisticians do modeling if they are doing complex statistical modeling to see how we can work on a development program. So, we are very committed to using ai.
▶ 1:03:37Dr. Corrigan-Curay: Some of our research in the generic industry is in generic science focusing on some ai approaches. We can get more in-depth information if you would like.
▶ 1:03:45Sen. Husted: I didn't really hear you touch on generic approval, generics approval and generics timeframe. Are their thoughts on that? -- there thoughts on that?
▶ 1:03:59Dr. Corrigan-Curay: We have two different tiers in the generics. If there's not a lot of competition, we speed up those timelines to meet the need. We have been meeting the timelines that we have agreed with in the industry and we will be working for efficiencies. Ai in terms of summarizing and some of the paper and administrative tasks involved, we will try to work on that.
▶ 1:04:22Sen. Husted: I will give you an opportunity to give us some advice. What laws exist that are inhibiting you from going faster and what should we change?
▶ 1:04:33Dr. Corrigan-Curay: In the generic industry, one thing would be to make the ingredients transparent so they would not have to ask us the ingredient and amount. That is what we call q1 and q2. We often have to go back and forth on that topic. What was spoken about with skinny labeling is important to give certainty in that area.
▶ 1:05:00Dr. Corrigan-Curay: In the bio-similar area, we've talked about not having this bio-similar interchangeable classification and have everything that is bio-similar be interchangeable. That would also be quite helpful.
▶ 1:05:12Sen. Husted: Thank you.
▶ 1:05:14Chair Cassidy: We had a drug bill last september before you came in that addressed the q1, q2. We hope to get that backup. Senator kaine. Senator hassan.
▶ 1:05:26Sen. Hassan: Thank you senator kaine, chairman cassidy. We have the q1, q2 bill that the witness was talking about and we would love it if you would take a look at it, too. Dr. corrigan-curay, thank you for being here and thank you for your work at the fda, from one administration to the next. It is really important work.
▶ 1:05:54Sen. Hassan: Before 2015, the fda used a labeling system that made it hard for pregnant women to understand the health risks of different medications. For example, the old system labeled two different types of medications under a single category. Medications wear animal studies suggested risks for pregnant women and medications where the risk for pregnant women had not been studied at all.
▶ 1:06:16Sen. Hassan: The fda replaced the system in 2015, but as of earlier this year there were still several drugs on the market using the old system, including common indications like antibiotics. Senator budd and I wrote to the fda in january urging the agency to address this issue. Has the center for drug evaluation and research brought all drug manufacturers into compliance with pregnancy labeling?
▶ 1:06:43Dr. Corrigan-Curay: We had several put into pllr labeling.
▶ 1:06:49Sen. Hassan: I appreciate it very much. I understand that over-the-counter drugs sometimes have pregnancy warnings on the label, but the fda doesn't have a specific standard for pregnancy safety labeling for over-the-counter drugs. Is the fda working to improve the labeling for over-the-counter drugs as well?
▶ 1:07:09Dr. Corrigan-Curay: In our proposed order we will be looking at some labeling for pregnancy. I believe it is around the -- but we can take that under advisement.
▶ 1:07:18Sen. Hassan: That would be important to look at and I look forward to working with you on that. That commissioner makary's confirmation hearing we discussed lowering drug prices by increasing generic drug competition, something we were just talking about. Pharmaceutical companies currently use loopholes in the patent system to build so-called patent walls around their products. The patent walls can block low-cost generic versions of medications for decades.
▶ 1:07:45Sen. Hassan: What steps is the fda taking, and you talked about this a little with senator husted, what is the fda doing to improve court nation with patent labelers in the united states to low-cost generics?
▶ 1:07:59Dr. Corrigan-Curay: We've started meeting with the patent and trade office and sharing our expertise with them, as well as we are cooperating. The ftc has sent some letters about certain products in the orange book. We are not the experts in this, but we will certainly work with the other agencies on these issues.
▶ 1:08:18Sen. Hassan: I appreciate that. I have a bipartisan bill that would improve access to generic drugs by closing a loophole through which drugmakers currently exploit a lack of coordination between the fda and patent office. The bill would allow patients to access lower-cost medication sooner and would save taxpayers $100 million over a decade. I'm hopeful that the chair and my colleagues on this committee will work with me to advance the legislation.
▶ 1:08:48Sen. Hassan: Families 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. Unfortunately, in recent years we have seen vulnerabilities in our supply of common medications like children's cold and flu medications. In the winter of 2023, many families, including my own, could not find children's tylenol or motrin on the shelf due to the extreme increased demand and strain on the supply chain.
▶ 1:09:17Sen. Hassan: How can congress help the fda identify and address vulnerabilities in our over-the-counter drug supply chains so that we can ultimately stop these shortages from happening?
▶ 1:09:32Dr. Corrigan-Curay: Thank you. That was a very unfortunate time when we had a very rapid increase in demand for those medications, and our shortage of staff has worked very hard to resolve it, like they do with other shortages. I think one thing that we do, we have reporting, and you gave us this authority, when there is an interruption in supply through manufacturing or lack of api, but we don't have the same required reporting for increased demand.
▶ 1:09:57Dr. Corrigan-Curay: In that case, if we can get an earlier signal that increased demand could lead to a shortage, that is when we can take action. Last year in 2024 there were 11 new shortages. We would like that to be zero. We prevented over 250 shortages. The early action allows us to start doing things quickly in terms of getting new suppliers, getting new apis. Demand would be great.
▶ 1:10:23Sen. Hassan: That would be something I would be really interested in working on. There is nothing like watching a child's temperature go up and up and not have the medication you need to not only get that child comfortable but prevent further risks and complications.
▶ 1:10:41Chair Cassidy: Senator moody.
▶ 1:10:44Sen. Moody: Thank you for being here and thank you for your service. We are grateful to you. I'm from the sunshine state. I am ashley moody, the newest senator in the sunshine state. Sunscreens are really important to our almost 24 million citizens. This is a topic that I want to get into.
▶ 1:11:05Sen. Moody: I know speed and delay has been addressed. That is across federal agencies, but what I'm loving about this new administration is they are focusing on efficiency and getting back to the mission of these agencies. I'm hopeful we will see that on some of these issues. I know in your testimony you talked about sunscreen and how we can move forward. I think we are basing trying to get new products on the market that may be more effective.
▶ 1:11:36Sen. Moody: It is adding some ingredients. Do you expect that to be addressed quickly? I cannot tell you how important it is to all of the golfers, beachgoers, florida folks, and tourists. We broke another record in tourism in florida this year. We want people to be safe, obviously. Is not going to be expeditiously approved?
▶ 1:12:00Dr. Corrigan-Curay: We are excited to be reviewing the first new sunscreen. We will get the public comment and we will meet our goals on that hopefully.
▶ 1:12:08Sen. Moody: What is that timeline? What is your goal?
▶ 1:12:12Dr. Corrigan-Curay: I would have to look at exactly when it was submitted. Our timeline for a new ingredient is 17 months, which seems a long but is different from our others. We have a 45 day comment period. Often the public is wanting to provide us a lot of comment.
▶ 1:12:37Dr. Corrigan-Curay: We have to make sure that we take that comment into spec when we move forward with the final order. What is different in the omufa and why the timelines look longer is, when we are in, it is one company, one drug. In the otc monograph, it is one monograph that could be thousands of drugs. We have to make sure that we really get that right when we issue that final order. Again, we are committed to working with companies.
▶ 1:13:07Dr. Corrigan-Curay: They give us data, so we make sure any of those ingredients that were absorbed are safe. We are looking at alternative test methods to make sure they are validated and we can use them.
▶ 1:13:22Sen. Moody: I think that is one of the key things and issues you've been addressing today, speed. We want to make sure we are protecting the health, safety, and welfare of americans, obviously, but we need to make sure that bureaucracy is not weighing down what is meant to be a protection mechanism. It 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.
▶ 1:13:48Sen. Moody: I think if that can be achieved that is what promotes a thriving, successful, populist country. Only when it is necessary to protect rights or safety of our citizens, and even then as the bare minimum. As attorney general in florida I had to fight the biden administration because they wanted to put masks on 2-year-old's when they were outside.
▶ 1:14:16Sen. Moody: They wanted to be involved in every facet of american life, and I believe that the first thing that should cross a bureaucrat's mind when they are going to act is, do we need to be involving ourselves in this issue or in americans' lives? The majority of the time it should be no, but when they do it should be minimized and we should deliver and act as efficiently as possible. One of the things I'm happy about is how quickly we were able to get naloxone to the market. I know that you've been happy about that.
▶ 1:14:46Sen. Moody: You used both the monograph drug user fee program and other things to make sure that that was done. I believe that is significantly contributing to the decrease in deaths as it relates to the opioidnationally, we saw over a2 month period in 27% decline nationwide. In florida, we exceeded that number, a 30% decline.
▶ 1:15:13Sen. Moody: It is not just about interdiction efforts or getting people to seek treatment but being able to get that over-the-counter. So thank you for that. Was there anything you can learn working with the drug sponsor, getting information quickly, getting that through the process that we can apply moving forward to making sure we are streamlining this program? Because the deadline to reauthorize is coming up quickly, I know.
▶ 1:15:38Sen. Moody: If we are going to have a program that is supposed to push things forward quicker, if government is going to involve itself in the lives of americans to protect them, how do we do that quicker? Is there something you learn from that, the fda approval of the drug to over-the-counter that we can apply to this program?
▶ 1:15:57Dr. Corrigan-Curay: Yes, thank you. Just to clarify, and was not under the program, but yes, one of the things we were introducing is we need to make sure when we are working with a company and they are meeting with us that we are maximizing that time and getting them on the right path. So one of the things we will do, we will expand the meaning of it is complex. We will make sure we give them advice on the critical synopsis if they need it -- clinical synopsis if they need it.
▶ 1:16:29Dr. Corrigan-Curay: If we give them advice and they are still not your what to do, they have the opportunity to ask for advice. When we interact, we make sure it is clear to the company whatever expectations are. I 100% agree with you we want to streamline and take a risk-benefit approach to try to get products to the market that are -- to be a -- to meet an incoming need.
▶ 1:16:59Chair Cassidy: Senator alsobrooks.
▶ 1:17:03Sen. Alsobrooks: Good morning, Dr. corrigan-curay, and thank you for being here today. I want to thank you for your service. It is unfortunate because I know you have been thrust in a position today to answer for many of the very reckless decisions of political leadership at the federal drug ministration, but the reality is that administration -- administration, but the reality is this administration has not been able to answer questions about their reduction in force.
▶ 1:17:34Sen. Alsobrooks: This week, a meeting was canceled with the maryland delegation. We were simply acting about the impact of the administration's. Cuts to my state -- administration's cut to mice -- impact of administration's cuts to my state, and I have been waiting for seven weeks now. They were terminated on the probation status or currently on administered of leave pending termination.
▶ 1:18:02Sen. Alsobrooks: I don't like the term workforce reduction because it softens the reality of what is happening, the heartless and cruel firing of thousands of very critical civil servants without cause and without announcer thought -- an ounce of thought on the consequences to health and public safety.
▶ 1:18:23Sen. Alsobrooks: We are here to talk about reauthorizing the over-the-counter monograph drug user fee program to keep americans safe, and we also know the administration has terminated 3500 staffers from the fda, including at the center for drug evaluation research, which undermines its ability to really operate, so I want to just make very clear to the public because the staffing cuts have been framed as duplicate of
▶ 1:18:53Sen. Alsobrooks: -- duplicative administrative staff but the truth is they contribute to the core functions of the fda to keep humans safe. Each of them make sure pharmaceutical advertising is accurate, that the public is aware of potential risks, drug shortages are medicated, and approval is conducted in a timely manner.
▶ 1:19:17Sen. Alsobrooks: So I understand you are not able to answer specific questions about the so-called reduction in force but I hope you can demonstrate today the importance of the work civil servants do every day and to talk generally about the implications. So quickly, can you briefly share with the center for drug evaluation and research for example does every day?
▶ 1:19:39Dr. Corrigan-Curay: Yes, thank you. In the center for drug evaluation and research, we oversee several different programs including the otc, so our office of nonprescription drugs, I can tell you we have had very little loss in that office as an office primarily. We review new drugs coming through.
▶ 1:20:02Dr. Corrigan-Curay: We work with sponsors, have meetings on development programs, review safety data in the marketing and make sure the labels are up-to-date, we review direct to consumer advertising, and make sure promotion. We work on generic drugs. We were to get generic drugs in competition, in the bio similar space, we are reviewing bio similars to develop a science to bring those drugs to the forefront sooner.
▶ 1:20:32Dr. Corrigan-Curay: And then we always communicate what we are doing. We are putting out. We have advisory committees when needed to bring further transparency and expertise to inform our decisions.
▶ 1:20:44Sen. Alsobrooks: So these are critical staff. Can you talk to us about what the staff members -- I know you have been saying there are very few cuts, but cuts in any of these areas I think really impact public health. So can you tell us what the center does?
▶ 1:21:02Dr. Corrigan-Curay: Yes, and I am sorry, I should have mentioned that because they are core to our programs. They are responsible for looking at the manufacturing and the quality of the drug manufacturing. For example, we will put more resources so that when a facility comes and starts to market an .
▶ 1:21:20Dr. Corrigan-Curay: Monograph -- an otc monograph that we get those requests out there, that we update our risk model to make sure we are taking appropriate and selecting the facilities that we need to do an inspection on. And they carry that out for our bio similars and generics in our new drugs as well. And they are also working to sort of be very forward working.
▶ 1:21:51Dr. Corrigan-Curay: So when there is a priority by the end ministration to try to bring our manufacturing back -- by the administration to bring back our manufacturing, we think about that. Several years ago, we started a special program to work with manufacturers so when they want to use these new technologies, they can come talk to us early and we give them advice and get them on the right path.
▶ 1:22:14Sen. Alsobrooks: Thank you so much. So the work you do is critical, all of the staff are critical. Just making the point that they are not wasteful. Thank you so much. I yield.
▶ 1:22:25Chair Cassidy: Senator banks.
▶ 1:22:26Sen. Banks: What improvements will the public see in the products on their drugstore shelves if congress re-authorizes it in five years?
▶ 1:22:37Dr. Corrigan-Curay: Thank you for that question. I think the first thing I would mention, the order that we just did that would allow certain drugs to be changed from just a tablet or a capsule into an oral dissolving or chewable capsule, I think that will be a lot of innovation that will make these drugs more accessible to children and for those who have trouble swallowing.
▶ 1:23:00Dr. Corrigan-Curay: As I said, the more that we innovate with the industry by providing them further guidance, by meeting with them, and making sure they have clarity on our expectations, we will do some webinars on the grass standard and talk to them about confidentiality guidance when they are doing a new ingredient. All of those things we think will speed up innovation. We hope to see additional otc orders come out on new products.
▶ 1:23:27Sen. Banks: On that point, the monographs and user fees are supposed to streamline the fda's process to approve over-the-counter drugs. So better products come to market faster. But that only happens when the fda uses that authority. How are you going to make better use of the authority over the next five years to encourage that type of innovation?
▶ 1:23:50Dr. Corrigan-Curay: Again, the commitment we have agreed to are to make the meetings with our companies, make them as productive as possible, extend them if we need to, give them advice on the critical synopsis so they get their products. We are also asked to create a new tier so they can update their test methods. That may be more efficient.
▶ 1:24:18Dr. Corrigan-Curay: We will continue to give them education on the standards, on how to submit their orders, and what should be in there, and their eligibility for that. And we will make sure to be transparent in all of this, including all of the historical documents. It will be up on the web so everyone can learn from those. They can learn from all the issues that we identify, and we will do some work on good manufacturing practices so the expectations are clear.
▶ 1:24:46Dr. Corrigan-Curay: When the expectations are clear, I think that allows for innovation.
▶ 1:24:48Sen. Banks: On another point, I am curious, why doesn't the fda inspect more overseas facilities that export over-the-counter drugs to the U.S.?
▶ 1:24:58Dr. Corrigan-Curay: So right now, we do use a risk-based model to determine our inspections, and we do inspections overseas and domestically. We can get you those exact numbers. I don't have them off the top of my head. One of the things we will do is we are going to update our risk-based model, make sure it is taking into account any factors that may be specific to otc monograph facilities, and that will determine instructions.
▶ 1:25:24Dr. Corrigan-Curay: We will also more rapidly do those requests to assess the facilities that might need an inspection.
▶ 1:25:31Sen. Banks: Are there loopholes there that allow for some overseas facilities not to be as inspected as much?
▶ 1:25:38Dr. Corrigan-Curay: In terms of if we can do the inspection, what is different in the otc monograph space is in the others there is a time point in which we can do the inspection before the product comes to the market, whereas there is that one time point they can come to and register with us and start to distribute and then we start the assessment of that facility.
▶ 1:26:02Sen. Banks: Mr. chairman, contaminated nonsterile eyedrops coming from china and other countries has been a problem for years. I would like to enter three different letters, fda warning letters to these companies into the record. Doctor, how do you determine whether these over-the-counter drugs actually follow the monographs and are safe or whether they are fraudulent and dangerous?
▶ 1:26:29Dr. Corrigan-Curay: Again, we look for reports. With the eyedrops, we had adverse events and followed up on them and issued the warning letters. We do inspections to see. So we monitor the safety of the products on the market. That is how we do a risk-based approach to that.
▶ 1:26:48Sen. Banks: I would like to dig into that more further at another time. Thank you, Mr. chairman. I yield back.
▶ 1:26:55Sen. Kaine: Thank you. I will focus my five minutes on transparency, which has been mentioned by many of my colleagues and you mentioned in your testimony. 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 has been here before us. I am in trouble that while conservancy -- there is this one area we just can't get answers.
▶ 1:27:23Sen. Kaine: I asked secretary kennedy about the number of people who have been riffed or took the fork in the road initiative, and he could not answer at the time. He did not have the number at his fingertips. But when I did a follow-up, I still had not gotten a response. That was kind of an interesting contrast to how customer focused secretary kennedy was in my questioning of him when he was recently before us.
▶ 1:27:51Sen. Kaine: I raised the issue of his response to some of my constituents who were writing in about concerns, and they were getting response from hhs. It was actually a cms response saying because of the change in administration, we can no longer entertain these kinds of questions. When I showed that, secretary kennedy went back and he found that was an improper response. He told me and was, and he said he was going to correct it and this was not authorized. He responded to my concern about that.
▶ 1:28:23Sen. Kaine: I think senator murray a particular constituent concern she raised and he was very solicitous, we want to respond to that. So it seems like there is this sort of gag order on talking about the number of people that are employed or the number of people that are riffed.
▶ 1:28:40Sen. Kaine: For an oversight committee trying to exercise oversight over these programs or even trying to decide how to reauthorize a program survey can be more effective, if we cannot get an answer about this basic issue, it hobbles us and our ability to do our job. And I know that policy decisions of this kind are probably not yours, but let me just ask if you could answer this question. Within the center for drug evaluation and research, how many people were subject to the issue by secretary kennedy?
▶ 1:29:10Dr. Corrigan-Curay: Again, because it is under litigation, I am not allowed or I can't discuss specifics, but we would be very happy when that litigation is resolved to come back and provide you those.
▶ 1:29:23Sen. Kaine: I am assuming you would enter the same way if I ask a question about how many of these folks were veterans. You would answer the same way?
▶ 1:29:31Dr. Corrigan-Curay: I would answer the same way.
▶ 1:29:34Sen. Kaine: So you and I both went to law school, and I had to give a lot of advice to witnesses about pending litigation. So I did not ask you who was involved in the discussion, who was involved in the decision, what was the rationale for the decision, where there different rationales -- were there different rationales? I have not asked you any of that.
▶ 1:30:00Sen. Kaine: What I ask you is what should be public information because the public is paying for this about the numbers of people. The fact that I cannot get that answer from you, from senator kennedy, we asked similar questions to folks from the department of labor. Nobody wants to enter the question, how many people have been laid off, and what percentage are veterans? The veteran issue matters to me because in virginia we are such a heavy betterment state.
▶ 1:30:25Sen. Kaine: I have been able to cobble together that this administration has fired more veterans than any administration in the history of the united states. That is based on what I have been able to cobble together. I would like to be proven wrong. Maybe if I got the answers to my questions, I am making an assertion that is incorrect, but I think I am entitled to the information. I have been instructed to not answer it. It is not that you can't or you want but you have been instructed not to.
▶ 1:30:54Sen. Kaine: I will say pending litigation is not really an excuse for not answering a basic factual question that the knowledge of which is within the ambit of the administration. On transparency, I do have some proposals about the reauthorization. You did a good job in your testimony of kind of laying out if this program is reauthorized, here are some bad things that can happen. But also, the chairman is very much into this idea if you are going to reauthorize, we don't just reauthorized as is -- reauthorize as is.
▶ 1:31:25Sen. Kaine: We should reauthorize and improve. There have been longer standing, more established user fee programs where there are lessons learned about how we can improve. I have been getting feedback from groups about how this particular program can be improved. With the updates I am proposing that are in the transparency space, we would have answers to questions like, how many otc monographs were filed and approved during a fiscal year?
▶ 1:31:57Sen. Kaine: Which drug facility and contract manufacturing organizations have actually paid their user fees instead of only having visibility into those who haven't paid their user fees? How is the fda addressing post-market safety for otc products? I think a lot of the questions today wrapped around that important topic, including how the agency response to individual reports -- responds to individual reports of adverse events.
▶ 1:32:27Sen. Kaine: I think it can be bipartisan and we can reauthorize and improved by taking some of the lessons from other similar programs and pro transparency initiatives. I think we will get nice support from both sides of the dais. With that, I yield back.
▶ 1:32:40Chair Cassidy: I have a couple of follow-ups. How many otc drugs in the last one year, two years, three years have made the transition from being a prescription to being an otc?
▶ 1:32:57Dr. Corrigan-Curay: Thank you for that question. I know naloxone would have been in 2023, and another was also around that time. I would have to go back further and get you the details on the rest of the drugs.
▶ 1:33:11Chair Cassidy: So I will ask about a dashboard but that seems to be where the rubber hits the road. We only had three drugs in the last two and a half years that have gone from rx to otc.
▶ 1:33:26Dr. Corrigan-Curay: I believe that is correct. For some reason, I believe I am forgetting one but I will get back to you.
▶ 1:33:33Chair Cassidy: That seems like a very unproductive record.
▶ 1:33:36Dr. Corrigan-Curay: The issue is we need to find drugs. Drugs that are safe for a population for anyone to walk in and look at that drug facts label and appropriately self select and use that drug. So we need to look at the drugs that we have and think of that as appropriate and look at the development programs. I think that is why the new rule that we are coming out is trying to open up the space more.
▶ 1:34:06Dr. Corrigan-Curay: Because for any drug, it may be relatively safe in this population, and it may be, but sometimes the drug facts label is not sufficient for just those folks to understand that as a drug for them and not for others.
▶ 1:34:22Chair Cassidy: Anything nonsteroidals, you should not take if you have a history.
▶ 1:34:27Dr. Corrigan-Curay: Right.
▶ 1:34:29Chair Cassidy: And yet we have approved them all over the place. So we are willing to accept there is a risk. And so for the greater good, it turns out we have worked out. Not that many people are taking them and exacerbating the disease.
▶ 1:34:45Dr. Corrigan-Curay: Right, that is true.
▶ 1:34:48Chair Cassidy: I want to lean into this because that cost consumers a heck of a lot of money to go to a prescription for something you are saying can safely be taken otc.
▶ 1:35:00Dr. Corrigan-Curay: Yes, we are going to look for opportunities. As I said, it is adding something to the self-selection to the drug facts label that has a real potential to open up for other conditions. It can be for chronic conditions and open up consumer choice. We are going to work to finalize that rule and work on development programs that can come under that rule.
▶ 1:35:26Chair Cassidy: I asked you this earlier but did not follow the answer so I will ask you this. Do you feel as if this final rule, that you have the tools particularly with this final rule to expedite the transition from rx to otc, or does congress need to do something to light a fire?
▶ 1:35:46Dr. Corrigan-Curay: I think with this rule we have a new tool that will be very powerful and effective for us.
▶ 1:35:52Chair Cassidy: When do you expect the new rule to be implanted?
▶ 1:35:59Dr. Corrigan-Curay: The new rule was delayed. I think it should be the end of may but I have to check. We had a delay after transition. >> I have a follow-up based on the chairman's questions. To what degree was the fact that there have only been three or four rx to otc in the time period he was discussing the
▶ 1:36:30Dr. Corrigan-Curay: Shared personnel or resources versus the regulatory structure that shapes what can be approved?
▶ 1:36:40Dr. Corrigan-Curay: I would say in the last five years, and is more about the regulatory structure and what could be appropriately put over-the-counter and selected. And so hopefully
▶ 1:36:51Sen. Kaine: -- Sen. kaine: and so hopefully this new rule will help you accelerate.
▶ 1:36:58Dr. Corrigan-Curay: Yes.
▶ 1:36:59Chair Cassidy: For any senator wishing to ask additional questions, questions for the record will be due in 10 business days on june 18 at 5:00 p.m. I think you Dr. corrigan-curay.
▶ 1:37:10Dr. Corrigan-Curay: Thank you.
▶ 1:37:12Chair Cassidy: The committee stands adjourned. [captioning performed by the national captioning institute, which is responsible for its caption content and accuracy. Visit ncicap.org]