▶ 0:05:52Heat. Heat.
▶ 0:11:36subcommittee will come to order. The chair recognizes themselves for five minutes for an opening statement. I want to welcome everyone to today's hearing on the over-the-counter monograph drug user fee program referred to as AMUFA.
▶ 0:11:50I'm especially pleased that we are talking about the reauthorization of this program as almost five years to the date, the initial bill sponsored by my good friend from Ohio, Representative LA, as well as one of Georgia's finest, Senator Johnny Isaxson, was signed into law by President Trump in March of 2020.
▶ 0:12:08The enactment of this program reformed and modernized the regulation of OTC monograph drugs and authorized the FDA to assess and collect user fees dedicated to OCTC monograph drug activities. Industry and public health stakeholders supported these reforms which have provided FDA with additional resources and tools to streamline the monograph process to increase access to quality commonly used drugs and self-care products for the American consumer.
▶ 0:12:36This program is designed to improve innovation while maintaining the FDA gold standard of safety. The current legislative authority for AMUFA expires September the 30th, 2025. Again, September the 30th, 2025, at which point new legislation will be required to reauthorize the over-the-counter monograph user fee program for another 5-year term. Over-the-counter medications are widely used to treat common ailments such as colds, headaches, and seasonal allergies.
▶ 0:13:07In fact, nearly nine out of every 10 Americans use OTC medications regularly and trust these affordable remedies to get well and stay healthy. Safe, reliable, and affordable OTC drugs allow consumers to treat common ailments at home, usually without visiting a health care provider, saving the health care system billions annually. A particular note is a company named Simrise. They own and operate a manufacturing plant in Georgia's first congressional district that I have the honor and privilege of representing.
▶ 0:13:38Simrise manufactures aroma molecules and fragrance ingredients which are used in various consumer products across a number of product C categories. They also manufacture two of the key UV filters that are commonly used in many OTC sunscreens on the market today. Sadly, Simrise Colonel's Island plant experienced a serious fire in 2022.
▶ 0:14:00Simrise made the strategic decision to reinvest in the site and restore its CA capacity in my community at a time when other companies were leaving. They successfully completed renovations and today the plant is again fully operational back at its pre-fire capacity. This is a real success story and we are grateful for their commitment to Georgia. We are also fortunate to have Mr. Kevin Mensel before our committee today. Mr.
▶ 0:14:28Mensel is president of Focus Consumer Healthcare which is a wholly owned subsidiary of Kobashi Healthcare. Kooashi was founded as a family company in 1886 in Japan. They established a presidency in the United States in 1998 and maintain manufacturing and operations in Dalton, Georgia, employing 270 people with products ranging from OTC medicines and supplements to recreational products like Hot Hands Hand Warmers.
▶ 0:14:57Georgia's pro business climate and infrastructure make it an ideal location for companies such as Kobayashi and as Kobayeshi. In fact, just recently, Kobayashi began expanding its US manufacturing footprint even further with a significant announced investment in Georgia, doubling capacity to support ongoing growth and expand employment.
▶ 0:15:21Success stories such as SIME and Kobayashi highlight why it's critical for this subcommittee to reauthorize the over-the-counter monograph drug user fee program in a timely manner. This program demonstrated the ability to bring more jobs back to America while increasing access to safe, reliable, and affordable OTC drugs.
▶ 0:15:42I look forward to hearing from our witnesses today and working with my colleagues on both sides of the aisle to reauthorize this program on time and through regular order. I now recognize the gentle lady from Colorado, Representative Dette, for five minutes for an opening statement. Thank you very much, Mr. Chairman. Uh, the over-the-counter monograph drug user fee is an example of Congress identifying something that isn't working well and then fixing it. Congress fixed it.
▶ 0:16:11Elon Musk didn't fix it. His young Doge guys didn't fix it. Congress fixed it. Now, we have some outstanding issues and we're going to hear from our witnesses though that the new system is working a lot better than the old system worked and we are still refining it for through the user fee negotiation process.
▶ 0:16:29But frankly, I can't believe we're all sitting here having routine hearings like nothing's going on when I woke up to a headline this morning that says Kennedy lays off thousands across the health bureaucracy. Um, what did he do? Well, he laid off thousands of people in the FDA, in the CDC, in the NIH. Entire divisions have been eliminated. Um, and you know what?
▶ 0:16:57Congress established these divisions by statute. Congress established all of these agencies by statute. There's only one entity that can legally fix and improve this and that's Congress. Mr. chairman.
▶ 0:17:14So while we're sitting here having this hearing uh it the our our premier research institutions which are the gem of the entire world are being dismantled before our very eyes and we are just sitting here talking about sunscreen. We know we need to you know my staff wrote here we need to hold hearings on the re HHS reorganization. That's not true.
▶ 0:17:40We need to tell President Trump and Elon Musk and Kennedy they can't do this without our approval. Why are we giving away our article one authority to do this? We need to hold hearings on the damage that are being done to our biomedical research institution and we need to figure out how we're going to make them stop decimating this right away.
▶ 0:18:03We need to have hearings on bird flu, measles, and diminishing ability to tackle public health issues until the next global pandemic. Now, are we so eager to seed our constitutional authority to a rogue administration and just passively observe while the president, Elon Musk, and RFK Junior's shred the accomplishments of a generation?
▶ 0:18:28So, I just want to say it was Congress that did the last NIH reauthorization in 2006 and it was Congress that passed Fred Upton and my 21st century cures act to modernize the NIH and FDA with universal bipartisan approval from every single member of the Energy and Commerce Committee. Here's what's happening now, though. The administration canceled a grant for Florida Agriculture and Mechanical University, which is in Dr.
▶ 0:18:57Dunn's district, that supported the initiative re innovative research in breast cancer and pain. That grant supported FAMU's recruitment of two investigators, one specializing in cancer biology and the other in artificial intelligence. And the University of Colorado had a grant canceled that focused on a platform technology to rapidly develop vaccines for dangerous emerging threats like viruses like Ebola.
▶ 0:19:24I'm shocked that we would just sit by and watch grants like this be canled. It's not only NIH funded work that's being attacked, though. Last Friday, longtime center for biologics evaluation and research director Peter Marx who worked through the last Trump administration and helped design operation warp speed was forced out. We all were walk closely with Dr.
▶ 0:19:47Marx and I think everyone in this room has been impressed with his fairness, his rigor and his drive to use his position to improve h public health and save lives. So I want to quote from Dr. Mark's resignation letter at length. He wrote, "Over the past 13 years, I have done my best to ensure that we efficiently and effectively applied the best available science to benefit public health. I was willing to work to address the secretary's concerns regarding vaccine safety and transparency.
▶ 0:20:18However, it's become clear that truth and transparency are not desired by the secretary, but rather he wishes subservient confirmation of his misinformation and lies. Let that sink in. Mr. Chairman, I ask unanimous consent to put Dr. Marx's letter into the record.
▶ 0:20:48We'll be right back with you. Thank you. You know, subservient confirmation of the misinformation and lies. That's not how we make America healthy. That's how we end up with more dead kids. And so, I just want to say that we should be ashamed that the Republicans on this committee are allowing Trump and Elon Musk to plunder cancer research, drug safety, and pandemic preparedness. Rome is burning and we're talking about sunscreen. I yield back.
▶ 0:21:19General lady yields. Chair now recognizes the chairman of the full committee, Chairman Guthrie, for five minutes for an opening statement. Thank you, Chairman Carter, and thank you for our witnesses for being before us today. Today's hearing is about the FDA's over over-the-counter monogri drug user fee program known as AMUFA.
▶ 0:21:37Well, some may be uh more familiar with the prescription drug user fee act padufa or the medical devisor user fee act madufa or even the animal drug user fee act adufa we will uh which we reauthorized last congress this is the first reauthorization of amufa the over-the-counter drug user fee program was established under the corona virus aid relief and economic security act or cares act in 2020 this bill reformed the regulation of the overthe-counter monograph drugs and authorize
▶ 0:22:07the FDA to assess and collect user fees dedicated to the regulatory activities related to the OTC products. That may uh seem like a lot of jargon, but the decision to reform how OTC drugs are regulated was a critical one for patients walking into a pharmacy, gas station, or convenience store where they may access such treatments. Over-the-counter drugs include allergy medicines, cold and cough remedies, and common pain relievers.
▶ 0:22:35All routinely used medicines for our constituents around the country. In addition, products such as sunscreen and topical antiseptics are also regulated under the OTC monograph review process. Ensuring the safety and effectiveness of these drugs is critical. Unfortunately, prior to the CARES Act, the OTC monograph rulemaking process was burdensome, inefficient, timeconuming, and stagnant for innovation with FDA itself acknowledging it had limited speed and flexibility in responding to urgent safety issues.
▶ 0:23:05During testimony before this committee on September 17, 2017, the then director of the Center for Drug Evaluation and Research testified that prior to the CARES Act, there are approximately 88 simultaneous rulemakings in 26 broad therapeutic categories covering approximately 800 active ingredients for over,400 different therapeutic uses.
▶ 0:23:26And according to a July 2020 GAO report, seven of the original 26 original monograph categories had no final moni monograph in effect in effect. And of the 17, they did have a monograph. 12 had proposed changes associated with them. This means that over-the-counter drugs on the market had not received final determination regarding their safety and effectiveness.
▶ 0:23:48It was it was therefore critically important that we took the steps we did to reform the monograph process from a three-phase rulemaking process to administrative order process. This was done to reduce unnecessary bureaucracy, increase transparency, enhance the ability for public and stakeholder input, promote the opportunity for innovation to flourish and to and maintain the necessary checks to ensure the safety and effectiveness of these drugs.
▶ 0:24:15The current authority for this program is set to expire at the end of this fiscal year, September 30th. So, it is absolutely important that we continue this process and move forward on a reauthorization. The discussion we will have today is critical as we consider the first reauthorization of this new program that impacts so many Americans in their daily lives. These are the issues that affect our constituents on a daily basis and they expect this committee to be attuned to their needs.
▶ 0:24:45In closing, this program is important to ensuring FDA is effectively and efficiently reviewing OTC drugs and products. Whether it is helping to ease a headache or treatment of a cold, AMUFA plays a critical role in the health and well-being of Americans. I thank the witnesses for being here to participate today. I look forward to discussion of this reauthorization and this program and I yield back. Gentleman yields. I now recognize the ranking member of the full committee, Mr. Palone, for five minutes for an opening statement.
▶ 0:25:15Thank you, Mr. Chairman. An examination of user fees for over-the-counter drugs is a discussion that we should have were it not for the Trump administration's dismantling our public health infrastructure before our eyes. There's no logic in holding a routine discussion on user fees before understanding the Trump administration's plan masterminded by the reckless uninformed antics of Elon Musk's Doge to slash the Food and Drug Administration's workforce by an additional 3,500 public servants.
▶ 0:25:45And it's hard to see how a drastic cut of nearly 20% of the total FDA staff will not impact the crit critical functions of the agency. The administration is hemorrhaging our public health agencies and expertise without them while committee Republicans silently sit by and watch. Let's be clear what's happening here. The Trump administration's goal is to hollow out the agencies to find savings for their giant tax breaks for their billionaire friends, including Elon Musk himself.
▶ 0:26:14But it's also crystal clear that the administration is looking to get rid of those who refuse to bend to their anti-science agenda and medical quackery. Just last Friday evening, the Trump administration pushed out Dr. Peter Marx, the director of the Center for Biologics, Evaluation, and Research. Dr. Mark's hands was forced by the Trump administration's unprecedented assault on settled science regarding vaccine safety and efficiency. As Dr.
▶ 0:26:40Markx correctly noted in his resignation letter, I know Miss Neette mentioned it, but this this quote I have to repeat. He said truth and tr this a quote truth and transparency are not desired by the secretary but rather he wishes sub subservient confirmation of his misinformation and lies. Dr. Mars couldn't have said it better.
▶ 0:27:01Democrats too have experienced the administration's disdain for truth and transparency as we've tried to obtain basic information from the administration on the layoffs at HHS. HHS has refused repeatedly to provide an update on the status of its terminations, both those made in the first round and the additional 3,500 layoffs moving forward. The lack of transparency and stonewalling is unacceptable.
▶ 0:27:24And let's be clear, it shows that HHS knows that these terminations and the wholesale elimination of entire HHS operating divisions are indefensible and unlawful. Dr. Markx is not the first expert to be purged from the agency, and I'm sure he's not going to be the last. The attacks continue, yet our Republican colleagues refuse to demand answers or hold this administration accountable. Today, committee Democrats are once again demanding answers from the administration about last week's layoffs and reorganization announcement.
▶ 0:27:52And we would hope that Republicans would finally recognize that it's time for them to start asking questions as well. After all, these actions could significantly impact the FDA's job when it comes to over-the-counter drugs. FDA regulates the drugs, medical devices, and cosmetics Americans use, the food they eat, and much more. FDA's mission is to ensure the safety and security of these products before they reach consumers.
▶ 0:28:14And I fear that the administration's forced layoffs at FDA will result in dangerous products slipping through the cracks while promising new products will face delays in getting to Americans. And I'm not the only one sounding the alarm. Industry experts have raised concerns that these terminations will delay timely patient access to products regulated by FDA by months, if not years, and impact surveillance efforts, including delayed inspections.
▶ 0:28:38Reports already show that since the first round of terminations, FDA has been struggling to meet congressionally mandated deadlines as staff are being assigned double the number of new product applications for review. With a workforce stretched this thin, it seems inevitable that unsafe products will make their way into Americans grocery stores and medicine cabinets. And even though HHS claimed user fees reviews would not be affected, we are hearing from industry that 50% of the positions eliminated will be user fee related.
▶ 0:29:07And so while I hope we can look forward to a smooth reauthorization of this critical user review program, I am disappointed that our Republican colleagues do not see the urgency in conducting oversight of the illegal terminations that will impact the very program they plan to discuss today among many others. And with that, Mr. Chairman, I yield back the balance of my time. The gentleman yields. This concludes member opening statements. The chair would like to remind members that pursuant to committee rules, all members opening statements will be made part of the record.
▶ 0:29:38We want to thank all of our witnesses for being here today and taking the time to testify before the subcommittee. Our witnesses today are Mr. Kevin Mensel, a member of the board of directors of the Consumer Healthc Care Products Association and president of Focus Consumer Healthcare. Mr. Douglas Troutman, the interim co-chief executive officer of the American Institute. Miss Kim Whisk, director of advocacy for the Melanoma Research Foundation.
▶ 0:30:08I hope I pronounced that right. I'm from South Georgia, so our pronunciation down in South Georgia a little different from from a lot of other places, but I got it. Good. Thank you, Mr. Mr. Scott Faber, the senior vice president of government affairs for the environmental working group and Mr. Carl Diz, the senior science advocacy and business development manager for beauty and care in North America for DMS DSM, excuse me.
▶ 0:30:38Firm in. Is that okay? You got it. You got it. Amazing. Per committee custom, each witness will have the opportunity for a five-minute opening statement followed by a round of questions from members. The light on the timer in front of you will turn from green to yellow when you have one minute left. Again, we thank all of you for being here. We look forward to this hearing today's extremely important subject. We're going to stay focused on why we're here.
▶ 0:31:05That's to discuss the extension of this very vital program. At this time, I want to recognize Mr. Kevin Mensel for five minutes to give an opening statement. Thank you, Chairman Carter, Ranking Member Dette, and members of the subcommittee. My name is Kevin Mensel, and I'm the president of Focus Consumer Healthcare, as well as a member of the board of directors of the Consumer Healthcare Products Association, or CHIPA.
▶ 0:31:28Focus Consumer Healthcare manufactures and markets a broad portfolio of over-the-counter or OTC medicines and other health and wellness products that help Americans manage everyday health care needs. I started focus consumer healthcare in 2014 to revitalize a number of OTC brands marketed under OTC monographs. Our firm was subsequently acquired by Kobayashi Healthcare headquartered in Dalton, Georgia where they have an OTC monograph user fee paying manufacturing facility.
▶ 0:31:56CHIPA is the National Trade Association representing the leading manufacturers and marketers of OTC medicines in the United States. CHIPA's member companies produce the vast majority of OTC products available to consumers today, which are safe, effective, affordable therapies that empower millions of Americans to prevent and self-t treat many common everyday health conditions. Thank you for the opportunity to appear before you to discuss the OTC Monograph user fee program or OMUFA.
▶ 0:32:23Reauthorizing OMUFA this year will continue the bipartisan effort this committee helped lead more than five years ago to modernize the regulatory framework that governs most of the OTC medicines in the United States. The availability of OTC medicines is not only a matter of convenience. It is a vital part of our nation's public health infrastructure.
▶ 0:32:43These products save consumers money, reduce the strain of our health care system, and support informed health decisions by enab enabling individuals to manage common everyday conditions on their own. The strengths and benefits of OTC medicines fit seamlessly with the renewed national attention on healthy living, more affordable health care, transparency, and freedom of choice.
▶ 0:33:05In fact, every dollar spent on OTC medicines saves the health care system over $7 from fewer doctor visits and lowerc cost OTC medicines compared to prescription medicines. Most of the OTC medicines in our homes today are regulated under the OTC monograph system. The system currently covers more than 300 active pharmaceutical pharmaceutical ingredients used in more than 100,000 OTC products.
▶ 0:33:32The OTC monograph system is how the FDA regulates wellestablished OGC drug ingredients and determines whether they meet legal and scientific standard of general recognition of safety and effectiveness or grace. Rather than requiring individual applications for each finished OTC product, monographs establish rules and conditions for specific active ingredients within various therapeutic categories.
▶ 0:33:57This allows manufacturers to market OTC products without going through the SP product specific new drug application or NDA process that is required for newer OTC ingredients or prescription drugs. The OTC monograph system functioned effectively for many decades, but over time it became backlogged due to slow notice and comment rulemaking and understaffing.
▶ 0:34:20It was slow to add new safety labeling as new scientific data emerged and created barriers to innovation, making it more difficult to quickly meet the everinccreasing self-care needs of consumers. In 2020, as part of the CARES Act, Congress updated the law governing the OTC monograph system and created a new user fee program, OMUFA. This bipartisan law signed by President Trump had broad stakeholder support modernized the OTC monograph system and provided FDA with dedicated resources to implement critical reforms.
▶ 0:34:51The current statutory authority for AMUFA is said to expire on September 30th, 2025, and we strongly support its timely reauthorization for a second 5-year cycle referred to as AMUFA 2. Over the past five years, FDA has taken a series of steps to implement OTC monograph reform as they committed to in the original user fee goals letter.
▶ 0:35:13As we noted when we met with FDA in our goals letter for AMUFA 2 and as we speak with you today as you begin to work to reauthorize AMUFA, CHIPA has four key priorities to ensure continued success and modernization of the OTC monograph system. First, AMUFA did not change the long-standing standard of general recognition of safety and effectiveness, also known as grace. This foundational principle ensures that OTC drug ingredients are supported by a robust body of scientific evidence.
▶ 0:35:43The grace standard relies primarily on published studies and where appropriate is supplemented by unpublished research, real world data, and significant market experience. It is essential that FDA maintains this standard as grace determinations are not dependent on NDA submissions and reviews. Second, AMUFA needs to remain a lean, efficient program. For AMUFA 2, FDA's goal letter targets adding 11 full-time equivalents or FTEEs, which would total 112 FTEES.
▶ 0:36:12We see this as nearing steady state in terms of staffing and fees paid. Third, interaction between industry sponsors and FDA is critical to a successful program. AMUFA meetings often require lengthy scientific dialogue due to the long history of the monographs and data supporting them. FDA's AMUFA 2 goals letter tries to address this. Fourth, roughly 200 registry registered monograph facilities have not paid their user fees are and our inner rears. FDA's research shows that this is a predictor of poor product quality.
▶ 0:36:42We support efforts to address these user fee aars list. Taken together, these four priorities reflect a shared goal to move beyond successfully establishing infrastructure as was done in the first AMUA cycle to ensuring that AMUA 2 advances in fostering innovation, finalizing grass determination, and supporting FDA's ability to protect and promote public health. In closing, I want to thank again the subcommittee for the opportunity to provide testimony today.
▶ 0:37:06CHIPA and the broader OTC industry are committed to being constructive partners as we work together on the reauthorization of AMUFA. I look forward to your questions. The gentleman yields. The chair now recognizes Mr. Douglas Troutman for five minutes to give an opening statement. Chairman Carter, ranking member Dette. Members of the subcommittee, my name is Douglas Troutman and I am with the American Cleaning Institute. I appreciate the opportunity to appear today to discuss the over-the-counter monograph drug user fee program or AMUA.
▶ 0:37:37ACI is the home of the $60 billion US cleaning products industry. Our members include suppliers and formulators of soaps, detergents, and general cleaning products and topical antiseptic drug products sold in the US. These products promote public health and are used by consumers at home for the care of family members and other daily needs like food preparation or cleaning. These products reduce bacteria on hands and keep Americans healthy in numerous public spaces like airports, hospitals, and schools.
▶ 0:38:07ACI represents the manufacturers and suppliers of four topical and lawfully marketing our antiseptic ingredients. Ethanol, benzylconium chloride, benzathonium chloride, and chloro xylenol. FDA deferred these activives from final rulemaking because it seeks more data to evaluate the safety and effectiveness of them before making a final determination of grassy. ACI members are diligently working on the studies to help FDA make this determination.
▶ 0:38:37First, I'd like to address what we call the free rider problem. ACI is leading a multi-year, multi-million dollar effort to fulfill agency requests for additional safety and efficacy studies. To date, ACI has submitted multiple reports showing ongoing progress to FDA's requests. Those data gaps though are very costly and highly resource intensive over time.
▶ 0:39:00However, the ACI member companies funding the requested studies are a fraction of the antiseptic market that will ultimately benefit from the data. In short, ACI members are shouldering all the costs which we will do. The benefits derived from the data will support the continued marketing by all antiseptic manufacturers, including non-participating companies. A simple image may help. Think of a railroad.
▶ 0:39:28ACI members were told to follow the FDA policymade railroad tracks. But only ACI member companies built and paid for the locomotive and the passenger car which represent the data in the studies. Anyone can ride if they did not contribute to building the locomotive and the vehicles. No one also must help to pay for the vehicle's investment.
▶ 0:39:48The valuable benefit conferred on non-member contributors contributors discourages participation in data collection at a time when that very participation is critical to finalizing an FDA determination. We have two options for you to consider solutions.
▶ 0:40:06one, modify or the facility or user fees for sponsors that actively participate in the J data generation process or two extending or at very least maintaining the exclusivity period. These are discussed more fully in my written submission. The second item to be addressed that we'd like to talk with you about is timely and productive communication from FDA to the public. ACI appreciates engagement guidance from FDA to date.
▶ 0:40:34However, the agency should prioritize resources to facilitate informal agency feedback to promote collaboration to finish the studies and make a determination. And this is not an abstract matter. There is a California Assembly Bill 916 would actually ban the hand soaps and body washes containing three legally marketed activives, benzylconium chloride, benzathonium chloride, and chlorosyenol.
▶ 0:41:00The calls to ban the legal use of these ingredients are typically accompanied by unsubstantiated claims questioning their safety and effectiveness. But ACI believes that more consistent communication by FDA can help reassure the public that progress is being made toward grassy on deferred ingredients so as to void ban proposals. Moreover, the FFDCA contains an express preeemption provision for national regulatory uniformity for non-prescription drugs.
▶ 0:41:26In short, federal law has primacy in the space and the California bill would be federally preemptive. We believe ACI believes more timely communication by FDA is needed to update and reassure listeners that diligent work is ongoing. FDA should clarify that these products are lawfully marketed, play an important role in public health, and the federal agency work and lost primacy. We appreciate the opportunity to provide remarks today.
▶ 0:41:51We remain committed to working with the committee and the agency to achieve mutually shared objectives and I thank you for your time and look forward to your questions. Thank you Mr. Troutman. The gentleman yields when chair now recognizes Miss Kim Whisk for five minutes to give an opening statement. Thank you Chairman Guthrie, Ranking Member Palone, Subcommittee Chairman Carter, and Subcommittee Ranking Member Dette.
▶ 0:42:18Thank you for inviting me to offer my perspective on the first reauthorization of the over-the-counter monograph user fee act or AMUFA. My name is Kim Weisik and I'm the director of advocacy for the Melanoma Research Foundation, the largest independent organization devoted to melanoma, the deadliest form of skin cancer.
▶ 0:42:37I am here this morning to testify on behalf of the public access to sunscreens or PASS coalition which is a multistakeholder coalition dedicated to helping prevent skin cancer and improving public health by ensuring Americans have access to safe and effective sunscreens and evidence-based education on sunsafe practices. I hope to bring the patient perspective to this committee's deliberations on the importance of reauthorizing MUFFA and using this bill to turn the tide on the scourge of skin cancer.
▶ 0:43:07I have the privilege and the challenge of supporting individuals whose lives have been upended by a skin cancer diagnosis either for themselves or their loved ones. This is a disease that disfigures, kills, and financially exhausts real people. It is also largely preventable. Many of the patients I serve share with me how they missed the opportunity to protect their skin in their youth before many of us were even aware of the deadly effects of ultraviolet exposure over a lifetime.
▶ 0:43:36They are steadfast in their interests to prevent other Americans from getting a melanoma diagnosis and they are deeply concerned about the lack of action by the federal government to ensure Americans have access to over-the-counter products available around the rest of the world to prevent skin cancer. The last time the United States approved a new over-the-counter sunscreen active ingredient was the 1990s, meaning that we are generations behind the rest of the world, and that is unacceptable.
▶ 0:44:03Skin cancer is the most common cancer in the United States. And unlike many cancers whose origin is unknown or complex, we know that sun exposure is the primary cause of skin cancer. That means that skin cancer is preventable with access to the appropriate skin cancer prevention products like sunscreen and techniques like sunsafe behaviors. However, according to the World Cancer Research Fund, the United States represents approximately onethird of all global skin cancer diagnoses.
▶ 0:44:34Over 5 million Americans are treated for skin cancer each year at a cost of over 8 billion according to the surgeon general. And according to the Skin Cancer Foundation, the estimated new number of new melanoma cases diagnosed in 2025 are projected to increase by 5.9%. A future where US skin cancer rates continue to outpace the rest of the world does not have to be the future our families live in.
▶ 0:45:00With some common sense reforms that we recommend for inclusion in the AMUFA reauthorization, the PASS coalition hopes we can bring new safe and effective in skin cancer prevention products to market in a timely way. In 2012, the PASS coalition came together in a bipartisan effort to protect Americans from skin cancer. In 2014, this committee passed the Sunscreen Innovation Act by a vote of 46 to0. The Senate passed the bill by unanimous consent and the president signed the bill into law.
▶ 0:45:31We hoped that legislation would usher in a new era of skin cancer prevention, streamlining the sunscreen filter approval process and increasing the number of filters available in the US for a variety of skin textures, tones, and conditions. Unfortunately, over a decade later, no new filters have been approved in the US, limiting Americans choice to under 10 UV filters, while there are over 30 UV filters approved globally.
▶ 0:45:59We find ourselves today at risk not just of stymi progress, but in a situation where the FDA has called into question the existing sunscreen filters currently on the market. The current challenges stem from two primary issues. The first is the S FDA's use of a relatively obscure testing method for sunscreens not used in any other country. It's called the maximum usage trial or must test.
▶ 0:46:23And the second issue is the insistence on animal testing for sunscreens which is banned in most other developed nations. The past coalition would like to work with this committee to ensure that the AMUFA reauthorization addresses these challenges, not by reducing the safety and effectiveness of sunscreen, but by ensuring that the FDA considers testing alternatives to the must trial and animal testing.
▶ 0:46:47The American people rely on Congress and the administration to keep us safe, but a failure to approve new sunscreen filters leaves us vulnerable to unnecessary skin cancer diagnoses and deaths. Other countries around the world have achieved this balance. We urge Congress to address these concerns in the AMUFA reauthorization and appreciate the opportunity to serve as a resource for this committee. I look forward to your questions. Thank you, Miss Whisik. Chair now recognizes Mr.
▶ 0:47:14Scott Faber for five minutes to give an opening statement. Great. Thank you, Mr. Chairman, and ranking member to get uh again, my name is Scott Faber. I'm the senior vice president for government affairs for EWG. him. I'm also an adjunct law professor at Georgetown's law school. And before I worked for EWG, I was the head of government affairs for the Grocery Manufacturers Association or what's now known as the Consumer Brands Association. I worked with many of you to help enact FSMA now 15 years ago.
▶ 0:47:43And I mentioned that because of the announcements that were made this morning uh to fire so many FDA staff. Um, and let me just be blunt. Uh, having worked on FISMA with many of you, um, I know that many people will be second or worse by foodborne illness because of the decision to fire 3,500 FDA staff this morning.
▶ 0:48:07Uh, I don't know about you, but my phone's blowing up with people who've worked at the agency for 15 years or more, who spent their whole careers trying to make sure that our food is safe and only found out they were fired when they went to badge in to their jobs this morning. Um, we'll all be less safe because of the decisions that were made to lay those people off. Um, our life-saving drugs will take longer to get approved.
▶ 0:48:34uh many of the everyday products that we bring into our homes, our cosmetics, our sunscreens will be less safe because the people who review the chemicals in those products were fired this morning. Um and of course that includes sunscreens and and other subjects that are uh other products that are the subject of today's hearing. Let me just make a few points about sunscreens.
▶ 0:48:58First, everyone should use sunscreen, but uh many of our sunscreens uh fail to adequately protect consumers from both UVA and UVB rays. In addition, many consumers are confused about the SPF system, which is leading some consumers to mistakenly believe that their sunscreen is providing them with broadspectctrum protection. Um and some of the ingredients in sunscreens are linked to health harms.
▶ 0:49:26Um, the good news, as you've heard just now, is that safer ingredients are available, but the current system has failed to make them available to our consumers. And with the exception of DSM, companies have so far been unwilling to finance the studies needed to ensure the safety and effectiveness of these promising new ingredients.
▶ 0:49:48So to fund the studies necessary to prove safety, Congress should consider changes to the fee system in order to finance these needed studies and to give the FDA the power to order studies as you've done for other chemicals. Of course, we should quickly phase out harmful ingredients as Congress required in the car's act.
▶ 0:50:09Unfortunately, uh, the FDA has failed to meet your legislative deadline to determine whether some of the ingredients that are now being used in sunscreens are still safe to be on our bodies. Uh, cutting 3,500 staff, firing 3,500 staff this morning will only result in more delay in that decision-making process. uh and allowing sunscreens to continue to have ingredients that are linked to health harms will certainly not make America healthy again.
▶ 0:50:39Um consumers are right to expect that our sunscreens, our cosmetics, our food, all of the everyday products we bring into our homes are safe. Unfortunately, uh many of our sunscreens do not adequately protect consumers and pose needless health risks even though better alternatives a are available.
▶ 0:50:59Allowing legacy ingredients that are less effective and less safe to remain on the market while more effective and safer ingredients are available makes little sense. Cutting 3,500 FDA staff who review the safety of these products makes even less sense. Thank you for the opportunity to Thank you, Mr. Faber. The chair now recognizes Mr.
▶ 0:51:26Carl Derusi for five minutes to give an opening statement. Thank you, uh, Chairman Carter, Ranking Member Deette, Chairman Guthrie, Ranking Member Palone, and distinguished members of the subcommittee. It's really an honor to be able to testify before you today to discuss how FDA regulates OTC drugs with a focus on the regulation of sunscreen ingredients. I appreciate the committee's work to ensure the timely reauthorization of AMUFA.
▶ 0:51:56My name is Carl D. Ruiz. I am the senior manager of beauty and care business in North America for DSM Fermanich and former chair of the personal care products council sunscreen consortium. For more than 25 years, I've dedicated my career to advancing sunscreen standards in the United States, including leading efforts to seek FDA approval of bezenol, an advanced sunscreen ultraviolet filter that I first submitted to FDA in 2005, and that has been globally available since 2001, but is still
▶ 0:52:26waiting uh United States approval. At DSM Firmness, we're proud to be a global leader in health, nutrition, and bioscience, employing more than 55,000 Americans across 21 states with many facilities located in the districts of the members of this subcommittee. As the world's leading manufacturer of UV filters with 40 years of experience, we're also the first and only company to pursue the approval of a new sunscreen filter through FDA's recently established Omar tier one process.
▶ 0:52:55The urgency of this issue cannot be understated. Skin cancer is now the fastest growing cancer in America. Each year, 6.1 million adults are treated at an annual cost of nearly $9 billion. Fortunately, unlike most cancers, skin cancers are largely preventable so long as pro proper precautions are taken with sunscreens being one of the most effective forms of protection against a harmful skin cancer causer causing UV radiation.
▶ 0:53:24Unfortunately, due to regulatory barriers, Americans are at a significant disadvantage relative to other countries globally with access to the most innovative, safety, and effective, efficient sunscreens. The FDA has not approved new filters since 1999, more than 25 years ago. United States manufacturer have access only to 16 UV filters compared to nearly 30 in Europe and other countries. Of those 16, only seven are commonly used by the industry.
▶ 0:53:53This severely limits our ability to develop modern sunscreens that meet the preferences and needs of diverse skin types and tones. Despite bipartisan efforts like the sunscreen innovation act of 2014, the provision of the CARES Act of 2020 aimed at streamlining sunscreen approvals, no new UV filters have been approved under these frameworks.
▶ 0:54:16The reauthorization of AMUFA presents an excellent opportunity for to apply the lessons that we've learned with sunscreen approval process to ensure the regulatory hurdles are not barriers to innovation. As part of the re reauthorization, we st strongly encourage the committee to consider these three points of reform.
▶ 0:54:35First, we must move away from the ineffective and costless animal testing methods and leverage modern toxicological approaches and innovative methodologies specifically in reviewing OTC drug activives like sunscreens. This includes adopting non-animal mechanism based methods including incilico models, new approach methodologies and other cutting edge and nonclinical risk and safety assessment tools.
▶ 0:55:01Second, encourage innovation by streamlining the regulatoratory framework by aligning the United States confidentiality and data protection standards with global practices. Currently, pract current currently companies invest significant amounts of money up to $20 million for DSM firmness to pioneer new UV filters. But without data protection or proper data protection, competitors, particularly Asian or Chinese companies, can benefit from this investment and obtain the data without contributing to development costs.
▶ 0:55:30Third, we must address the declining consumer confidence in sunscreens. Frustrated by limited options, Americans increasingly purchase internationally approved sunscreens online, bypassing FDA oversight entirely. The FDA's continued reliance on animal testing for ingredients used safely for nearly 50 years further erodess consumer trust.
▶ 0:55:53As a committee looks to advance a timely OMUFA reauthorization, I encourage common sense reforms to nurture sunscreen innovation, including prioritizing the development of non-animal testing methodologies, ensuring continued FDA interaction with regulatory regulated industries, and aligning confidentiality standards with global practices. Thank you for the opportunity to participate in this area.
▶ 0:56:18I look forward to working with you to advance these important initiatives that will help Americans from skin cancer and the harmful effects of the fund. Thank you. Thank you, Mr. Dise. And the yields. I want to thank all of you for your testimony. We'll now begin questioning and I recogni recognize myself for five minutes. Ladies and gentlemen, over-the-counter medications are widely used to treat common ailments such as colds, headaches, and seasonal allergies.
▶ 0:56:45In fact, more than 240 million Americans use OTC products every year and trust these affordable remedies to get well and to stay well. Before Congress authorized over-the-counter monograph drug user fee program in 2020, the OTC monograph system was slow and it was outdated, leading to new products being stuck in the pipeline for years with no light at the end of the tunnel. Professionally, as a pharmacist, I know how important it is for patients to have access to safe and reliable and affordable OTC drugs.
▶ 0:57:15I have recommended them in my professional career many times and continue to recommend them to people. That's why I was proud to support the enactment of this program which reformed the regulation of OTC monograph drugs and authorized the FDA to access to assess and collect user fees dedicated to OTC monograph drug activities.
▶ 0:57:37To date, we are now seeing additional investment domestically in research and development, leading to new OTC medicines that will continue to save Americans and our health care system money. As a result, consumers now have access to over 100,000 of these products. Mr. Mensel, I want to ask you, how has uh AMUFA enabled the FDA to respond faster to emerging safety Thank you, Mr. Carter.
▶ 0:58:07So the the key uh aspect of AMUFA is predictability and whenever you have a predictable monograph system uh it allows for innovation and it allows for a focus on safety uh from the FDA. Um imagine if you had a new drug application system that required all of the reviews for products that are generally recognized as safe and effective. It would be a waste of resources.
▶ 0:58:32Uh so this monograph system and the OMUFA reforms allow for a focus on safety and efficiency as well as innovation. Great. Thank you for that answer. Mr. Duriz D Ruez, excuse me. Are there any new modern um alternative testing methods that could replace the use of animal testing? Yes, sir. Um these methods are widely used throughout the world to approve uh different types of chemicals including sunscreens.
▶ 0:59:02These are called new alternative methods. They include advanced in silicone testing uh methodologies and in vitro methods which uh were actually developed uh by the cosmetics industry since um in most of the world sunscreens are cosmetics and there are animal bans in place prohibiting the testing of sunscreens due to that legislation. So these uh science is is funny. Science doesn't stand still.
▶ 0:59:30It evolves over over the last five ten years. We see light speeded um changes in terms of the toxicological methods that are used to verify the safety of different types of products and ingredients worldwide. These are accepted by the environmental protection agency. These are used by the center for food drugs uh in in in FDA.
▶ 0:59:53Um however in cedar these are not yet accepted but the science is there right now with the advent of artificial intelligence it will get only better and I think this is the way that we can facilitate the approval and innovation process for new ingredients which are much needed to protect American consumers without sacrificing safety. Good.
▶ 1:00:15and and you do feel like obviously that it would um it would really accelerate the approval process by using AI by using new alternative methods. Yes sir. As as as a result of using these in different types of methods for evaluating safety we see that our our global counterparts are able to approve sunscreens in about three years period.
▶ 1:00:39In the United States, if we follow FDA's guidelines under the 2016 guidelines for determining generally recognizes safety and effectiveness and the also the the the pharmarmaccoon must guidelines, it would take about 10 years to conduct all those studies not including the review cycle associated with FDA review.
▶ 1:00:57So if we put our money where we get the biggest bang for the buck, it would be with regards to establishing modern methods that replace the outdated archaic methods which are based on animals. All right. U Mr. Thank you for that. Mr. Mensel, real quick, um what changes can we expect to see in the reauthorization of AMUFA? Yeah, thank you.
▶ 1:01:20with with the reauthorization, there's um improvements in the quality of surveillance and compliance uh with GMP or good manufacturing practices. As I'd mentioned, there's the addition of 11 uh full-time employees, which we see also as important in terms of being self-funded.
▶ 1:01:38Um and we believe addressing the ARA's list uh is important uh to make sure all the companies are paying their fair share and then um expanding as as was just mentioned uh by my panel member the non-animal testing uh methods uh to accelerate the uh the sunscreen approvals. Good. Thank you very much for that response. At this I yield back and at this time I'll recognize the ranking member Representative Dette for five minutes of questioning on the ODUFA.
▶ 1:02:07Thank you so much, chairman, and I'm so happy to talk about ODUFA and the reauthorization, particularly in the context of what um Secretary Kennedy did this morning by gutting FDA. Um as we've been discussing, um uh he has he's reducing the headcount at FDA by firing 3,500 people or about 20% of the agency.
▶ 1:02:32Now FDA has an enormous statutory responsibility that involves regulating about 20% of our economy. And Mr. Faber, I really want to thank you for recognizing sort of the elephant in the room today as we talk about reauthorizing this agency, but yet the agency itself is being gutted. And as you said, people are going to die.
▶ 1:02:54people are going to be sickened by uh food born illness because these layoffs and also if you lay off 3,500 people I believe you said that there'll be more delay in approving drugs, devices, etc. Is that is that generally accurate? That's right. And and um so so HHS this morning said, "Well, don't worry.
▶ 1:03:17The firings will not impact drug device and food reviewers or inspectors." So I guess I want to act ask you because you're intimately familiar with this agency. Is every FDA employee who supports a product review staff? No. What are some of the other functions that they perform there? There are many other people who serve on review teams biostisticians as other kinds of scientists providing administrative support writing guidances interacting with industry.
▶ 1:03:47There there are a lot of roles on a review that are not done by reviewers. So, if you if you fire these other people who don't have that title, reviewer, inspector, um are product reviews likely to be adversely impacted by those firings? There's there's no question that the reviewers would have to take on more responsibilities and that they would have less time to conduct their reviews and ultimately that means reviews would be take much longer to complete. They would they would take a lot longer and that's right.
▶ 1:04:17What one of the issues that we've had and and not just with sunscreens and and all that, but but with drugs and devices in general, we've had issues that Congress in its statutory authority of oversight of the agency has undertaken to try to figure out how we can expedite those reviews of new drugs, new sunscreens. Is that right? That's right.
▶ 1:04:40So if so if you lay off 20% of this agency uh by the way without congressional approval what do you think it's going to do overall to reviews not just for sunscreen but for other products? Well it means new new drugs will be delayed new OTC drugs will be delayed. It means that the new methods that some of the witnesses talked about non-animal methods will not be validated will not be available to expedite the review of new sunscreen ingredients.
▶ 1:05:08It means many of the things Congress has asked FDA to do like test uh for the presence of of asbestous and tal containing cosmetics will be delayed. Many things will be delayed. Well, let let me give you another example. Congress directed FDA to issue a rule relating to cosmetic fragrance allergens. Is that correct? That's correct. And what by what date do you know? Was by June 2024. 2024. And so has FDA published such a rule? FDA has not published that rule now.
▶ 1:05:37Do you think these firings are going to help expedite the publishing of that rule? All of the folks who support the review and regulation of cosmetics are not funded by fees. So, they will be among the first that were likely fired today. Okay. So, when Mr. Menso's talking about 11 employees, this seems kind of like like a minimal thing, but they're funded by fees. But these other people, they're they're going to be laid off. They almost certainly What are some of the other functions that'll be laid off?
▶ 1:06:04Unfortunately, uh, virtually none of our food safety functions are funded by fees. So, the thousands of people who make sure that we don't get sick or worse when we have our lunch and dinner today, many of those people were fired this morning. Um, they are people who work in labs, they're people who are microbiologists, they're people who support inspectors. They're they're they're folks they're the folks who make sure that we don't get sick when we eat.
▶ 1:06:28So, so see this is why I think it's important for Congress to exercise its oversight because what's going to happen here, um, Secretary Kennedy can't probably won't fire the people who are funded by fees, but he'll fire the other people. There's no there's no real scientific basis for restructuring your agency just based on who's who pays people's salaries. Is that right? That's right.
▶ 1:06:52Um now Congress directed the um food and drug omnibus reform act in 2022 to do good manufacturing for cosmetic facilities and these are all due in the next year. Now that would be done by FDA employees other than inspectors and reviewers. Is that right? That's correct. So what do you think the cuts uh to FDA will will impact their ability to produce this work?
▶ 1:07:17the GMPS for cosmetics that make sure that our cosmetics are produced in ways that don't become contaminated has already been delayed and will almost certainly not be finished. Thank you. I yield back. Gentle lady, the gentle lady yields. The chair now recognizes chairman of the full committee. Thank you. I I appreciate that. And obviously if the review wasn't completed in July 24, then we're obviously you're out.
▶ 1:07:43So the the previous administration didn't accomplish the mission given to them and the people that they had and and it is our job and and I'm agreeing with my friend from Colorado that we have to have the proper oversight to make sure the things that Congress directs administration is in place. I know President Trump talked campaign. He talked I mean everybody knew that that coming into this they were going to try to make government work to make government more efficient.
▶ 1:08:07But it is also our responsibility as they do that to make sure that our mission's accomplished and have the proper oversight to do that. And so we will we're going to make sure these things are done and done correctly. And so but the other part of it is will you yield? I just want to say thank you. Okay. Thank you. We're we we need to make sure that we accomplish the mission and that's I'm former military and so thank thanks for that.
▶ 1:08:33So two things one we have to have oversight that is being done and but we also have to get what needs to be done correct and so that's I want to focus on now and then we we will we will make sure that we're all up to date on on what's going on. But so to get correct, I just want to kind of go down the list and and I've got almost three and a half minutes. So you So I want each of you to say what's the one thing that says, "Boy, you guys got it right in the reauthorization." I mean, in the original authorization. And the second thing is this is something that really needs to be improved.
▶ 1:09:01And I will see the point we have to make sure we have I don't know how many people in place, but people in place to get it done. So Mr. Mensel, if you'll start. Not I'm excuse me. Um Yeah, Mr. Mensel. Yeah. Well, I think in terms of what what was right, um this reauthorization and the previous OMOA bill allowed for innovation and allowed for predictability. Those two things are critically critically important um for the over-the-counter drug industry.
▶ 1:09:32Um and without that innovation and predictability, um it's going to delay healthc care uh uh innovation. Um, in terms of what can we expect, I I think the the questions concerning um the uh the the headcount cuts are are are completely valid and it's a concern. Um the uh the full-time employees that are being funded by this program, we would expect to allow for efficiency.
▶ 1:09:57Um but I think it is a question that What would you like in the legisl I get that, but what would you like in the And I understand that. That's a fair point. What in the legislation do you think we should put in? I I think the legislation as written is is accurate. I mean, I think a reauthorization uh to move forward as written uh is effective and Okay, Mr. Tro, I only have about two and a half minutes. Mr. Tropman. Yeah, thank you for the question. Um I'd echo a lot of the remarks by Mr. Mensel.
▶ 1:10:22um the the confidence, the clarity, the certainty, the rules of the road that are there right now. We would continue to really rally behind those because we know what the expectation is for data uh sa uh safety or efficacy or the things that we need to supply on these types of ingredients. And then we do look for more collaboration and feedback from the agency and that uh in to to know that we are staying on the right path that way so we can get to the final determination.
▶ 1:10:51Okay, Miss Wizick, thank you. I would just echo what the others have said as far as what's going right um with the original bill. From our perspective, I you know, we feel very strongly that there are other ways to achieve safety data on sunscreens um such as moving away from animal testing and the must trial um and at least considering other uh methodologies as supplemental. Okay. Thank you.
▶ 1:11:19Yeah, I think my senator Ran Paul kind of led that fight in the last Congress. So, thank you for that. Mr. Faber, I'll just say two quick things. One is we still haven't sent a signal to industry to produce the studies that FDA needs to effect to really evaluate whether these chemicals, especially the ones that penetrate our skin and get into our bloodstream, are indeed safe.
▶ 1:11:40And we still haven't yet sent the right signal to FDA to just decide whether the 10 active ingredients that we've been using for decades should continue to be allowed in our sunscreens. Okay. So, Mr. Rus, Dr. D. Ruse, I'm sorry. Yes. Dr. Ree on our on our committee. So, is that Yeah. So, um I think we need to realize that skin cancer doesn't discriminate on the basis of age, gender, race, or skin color.
▶ 1:12:04And we need to encourage common sense re reforms to miniaturature sunscreen innovation to provide access to modern, safe, efficient, sustainable UV filters. This includes the prioritization, transparency, accountability, and funding of new approach methods in the development and validation of new ingredients, the continued interaction between FDA and regulated industries with regards to the use of alternative methods to support those ingredients for which they have asked for further data and aligning the confidentiality and data privacy
▶ 1:12:34privacy standards with global practices. Okay, thank you. Perfect. I yield back. Gentleman yields. The chair now recognizes the chairman of the full committee, Representative Palom, for five minutes of questioning. Thank you, Mr. Chairman. You know, I wanted to say with regard to Chairman Guthrie, I know you talked about the agency becoming more efficient. But the problem that I see is that these cuts are just indiscriminate, right?
▶ 1:13:00We don't have any information to suggest that these 20% cuts in the workforce, would you? I I we need to fight. We need to have That's why we should have a hearing. We need to have a hearing where you guys you drag Kennedy in, you drag the FDA in, and you say, "Look, what do why are you doing this?" If if you're saying it's going to make it more efficient, I'd like to know. I mean, that's the problem. We're not getting that, and it's, you know, we feel it's your obligation to have a hearing and get these answers.
▶ 1:13:27I'm just, you know, we'll get to the right for, but your your point's well taken. All right. Well, thank you. Let me ask uh um Dr. Faber. Um some of my questions were were uh asked by um by Mr.
▶ 1:13:41get um but one of the things that I worry about is when I talk to industry people you know the industry always talks to me whether whatever it is you know the in medical products whatever about good versus bad actors and they're always afraid that if the FDA doesn't have the ability to enforce things to go after unadulterated products or unproven products that um you know the bad actors are going to sell stuff that they shouldn't and the good actors are going to get a bad reputation.
▶ 1:14:10So, let me ask you about FDA's ability to uh to to take enforcement actions to go after the bad actors. How how is this going to be impacted by these cuts, if you will? Well, thank thank you for the question.
▶ 1:14:23One of the reasons that we worked uh together on the Food Safety Modernization Act and with John Dingle on on FSMA was to make sure that industry had a partner at the FDA because our supply chains were so long and so complicated that we couldn't police them without a partner at FDA. We needed someone to help us make sure that the bad actors weren't selling us contaminated ingredients as PCA was and which ultimately led to the to FSMA being enacted.
▶ 1:14:53So without enforcement, the likelihood that companies will sell us contaminated ingredients like we recently saw with cinnamon and applesauce pouches will significantly increase. And I mean that is so important because again, you know, we keep talking about the gold standard, but I just find increasingly now people people don't feel that they can rely on FDA's advice if they're not, you know, actually looking at this stuff, enforcing the law. I This is the problem.
▶ 1:15:19What about um the impact on FDA's ability to catch uh I I mean, what about um let me put it this way. Are you concerned that the way the administrators is is treating the federal employees is going to harm FDA and HHS's ability to recruit and retain top talent? Because I was told, I think I don't know if Mr.
▶ 1:15:40Deette mentioned this, but I was told that right now there are civil servants at HHS who are showing up to do their work, but are being told that their position has been terminated as they show up for work. And I mean, that's a terrible way to treat employees. I think it's rather shameful. So, how does all doesn't this impact the ability to recruit and and to retain top talent? We're we're losing people with decades of expertise who are going to be extraordinarily hard to replace.
▶ 1:16:08And the people who have that expertise are not going to want to work at a place where they'll be summarily fired without the courtesy of a phone call or an email. That's right. Yeah. I mean, I I I was at the other hearing. Thank you. All right.
▶ 1:16:21At the other um hearing that we're having this morning on um I guess cyber cyber attacks and medical devices and I kind of raised the same issue again because you know I just don't see it's so easy for I for example I had a doctor that I talked to who said you know I don't know that I can rely on um CDC or FDA for advice anymore about how to treat patients. Right.
▶ 1:16:49In the past, people relied on the FDA, CDC, all these things for what we called the gold standard. Meaning, I would, you know, I could I figured that if it had a stamp of approval, whether it was a a ter a type of treatment or a medical device or a dietary supplement, that I could rely on that. But this is all being undermined now and and that's my fear. I don't know if you want to comment of 30 seconds. Well, I'll just say I'll say two things to your point, your first point.
▶ 1:17:17industry relies on FDA not just to police bad actors, but to provide approvals, to provide guidance, to clarify what they can and can't say on their products. And consumers rely on FDA to make sure that the labels are clear, that they're not confusing, that they have uh nutrition information, they know when their food's contaminated, when they should throw it away because it might make them sick.
▶ 1:17:42Um, and in the absence of trusted leaders and and credible institutions like FDA, consumers are going to turn to third parties that don't have the same uh evidence-based uh science-based judgments and and expertise. That's right. Thank you. Thank you, Mr. Chairman. Gentleman yields. The chair now recognizes the vice chair of the subcommittee, the gentleman from Florida, Dr. Dunn, for five minutes of questioning. Thank you very much, Mr.
▶ 1:18:09chair and thank you again to our witnesses for being with us today. As a medical doctor, I I know that over-the-counter treatments are vital to the health of our patients. They serve as a frontline option for patients who need readily available option care for common medical problems. And as a representative from the sunshine state, I'm particularly interested in sunscreens. I'm so glad that everybody else is today as well. Every year, millions of tourists visit Florida. Many, of course, visit our beautiful beaches.
▶ 1:18:37However, the rates at which Americans are diagnosed with skin cancers such as melanoma and others has really become quite concerning. We're all aware of the dangers of extended unprotected sun exposure. Uh we also know that the appropriate sunscreens are helpful in preventing these skin cancers and I'm concerned that the current regulatory framework does not support new innovative sunscreens to market. The last time the FDA approved a new active ingredient for sunscreen in the United States was 1990s.
▶ 1:19:07Uh we know that there's a bunch of new products that are currently available in other countries, but uh regulatory challenges have prevented those sunscreens from coming to the United States. Miss Wesnik, I want to commend you, by the way, on the body of work that you've done uh to ensure safe and effective sunscreens are available in the US. Can you speak to the difference in sunscreen products that are available here in the United States? compare with other, you know, countries that have so many more Yes, thank you for that question.
▶ 1:19:37Um, in the United States, we have mineral sunscreens, we have chemical sunscreens. Um, those are available globally as well. The main difference to me is the number and the types of UV filters that are available in the United States versus other countries. In some cases, we are 20, 30 years behind in terms of what's available here versus countries like Australia or the European Union or Asia. In your opinion, these are qualitatively better sunscreens.
▶ 1:20:08Yes, they they have advanced technology um that we just don't have available here and they're safe in your opinion. Yes. That's good. So uh also to Miss Wesnik in your uh another opinion have the products that have been available overseas lead led to increased usage of sun protection in those countries compared to what they were doing before.
▶ 1:20:32Well um that I'm not sure but since the United States is responsible for about a third of all global skin cancer cases I would say that you know clearly um there's something they're doing right over there in Australia that we're not doing right. Oh yeah, in Australia you hear slip, slap, slop. If Do you think if we we introduced a bunch of these new sunscreens in the US that there would be good uptake on them? Yes, I do think um introducing better products that fit more skin textures, tones, and conditions.
▶ 1:21:02The best sunscreen is the one you will use, and we need to make products available for more people. Imagine that a better mousetrap. How about that? Um uh so also Miss Resnik, what can this committee and what can a FDA what can this committee do and what can the FDA do to help foster these country? What can we do to get these things to market get them approved in the United States? I think the AMUFA vehicle is really what we need this committee to do.
▶ 1:21:29We need to re-examine and encourage the FDA to move away from the must trial, to move away from animal testing, um consider other uh types of studies as either supplemental or um a replacement for the way they currently assess safety. I am not a scientist. I am not trying to tell the FDA which tests to use.
▶ 1:21:51Um but I think other countries have figured out how to get safety data without going down these the must trial and the animal testing roads. So clearly we can figure out a way to get safe sunscreens without using those two methodologies. Are you aware of epidemiological research coming out of these other countries that have apparently robust use of these uh sunscreens for years that we could just look up? I'm sure there is real world human data that we could get our hands on.
▶ 1:22:19Um, I'm happy to dig into that to you and actually this I would be grateful. I think this entire committee would be grateful. I suspect the FDA would be too. So I thank you for that and I'm I'm certainly hopeful that these new protections will be available soon in the United States. I think uh we all do. I look forward to working with my colleagues on the committee and and over at FDA to get that done. With that, Mr. Chairman, I yield back. Gentleman yields. The chair now recognizes the gentleman from California, Dr.
▶ 1:22:48Ruiz for 5 minutes of questioning. Thank you, Mr. Chairman. The Food and Drug Administration plays an essential role in ensuring the safety and effectiveness of medications, medical devices, and food. We rely on the FDA to ensure consumers have access to safe and reliable prescription medications, over-the-counter drugs, and more.
▶ 1:23:09The reauthorization of the over-the-counter monograph safety innovation and reform act ora is timely and necessary so that FDA can ensure it has the resources needed to carry out its essential functions and provide critical regulatory oversight of over-the-counter medications.
▶ 1:23:27Do you want to know what else is essential to making sure FDA has the resources it needs to keep Americans a skilled workforce experts scientists with unique qualifications to evaluate food and medications for consumer safety.
▶ 1:23:46But sadly, House Republicans continue to support or remain silent and turn a blind eye in the face of this administration's alarming efforts to disrupt and dismantle the FDA by blindly slashing its workforce. Along with that of other agencies that play a key role in public health and advancing medical science, the so-called Department of Government Efficiency fired about 700 FDA employees as part of its initial governmentwide purge of the federal workforce.
▶ 1:24:15And now, Secretary Kennedy has announced plans to cut an additional 3,500 employees from the FDA. So, how can anyone with a share a shred of common sense believe that cutting about 20% of employees won't have dire implications for the AY's ability to carry out its core functions?
▶ 1:24:36These staffing cuts are going to have a direct impact on FDA's ability to review, inspect, and evaluate the safety of the medications and food Americans rely on you and use every day. This is a fact whether my Republican colleagues will admit it or not. Mr. Faber, how would significantly reducing staffing levels at FDA potentially impact the reviews process for medications and other products?
▶ 1:25:04Well, everyone on this panel would like to see FDA go faster and review promising new ingredients and and to weed out the ingredients that may be less effective and less safe. Um, today's announcement to fire 3,500 staff will make it harder for FDA to do that work. So, it would mean that it would take much longer much longer for that to happen. Uh also due to reductions in staffing, would you expect any impact on supply chain?
▶ 1:25:32And will this affectarmacies and stores ability to keep important medications that many Americans rely upon stocked on shelves, especially in rural areas? Well, there's no question that life-saving drugs, over-the-counter drugs, everyday products will take longer to be reviewed and ultimately made available to consumers. That's right. And how would the proposed staffing cuts affect innovation in the drug and medical device space?
▶ 1:25:58Well, without uh scientists who are to join the reviewers on review teams to decide whether promising new drugs, promising new sunscreen ingredients, other over-the-counter drugs are indeed safe and effective. Those products will simply remain unavailable and uh formulators will go elsewhere.
▶ 1:26:17They'll go to other countries where they can get their drugs and over-the-counter drugs approved faster and make those products available to their consumers, not to our You know, there's a theme that we experience um almost like a broken record. It keeps happening. You see a lot of cuts and decreases in budgets and fundings to operate uh these agencies and programs in a timely fashion.
▶ 1:26:45then they don't aren't able to perform their duties in a timely fashion or mistakes are made because of the overburdened uh environment that they exist on in you know my colleagues start bitching and hollering about why aren't they doing their job. You hear it.
▶ 1:27:06And they want to bash government employees for not doing their job after they just cut and stress them out by giving them an unmanageable workload uh for such critical points, but then they want to yell at them and say they're not doing their job and their solution is more cuts and the cycle continues. And so this is what we're going to experience. We're going to experience delays, backlogs.
▶ 1:27:34Uh we're going to experience uh mistakes. Uh and you're going to see that they're going to come in and they're going to be yelled at and their uh their punishment is going to be more cuts that will lead to more uh delays. With that, I yield back. Gentleman yields. The chair now recognizes. Gentleman from Virginia, Mr. Griffith, for five minutes of questioning. Miss Wisac, is that did I say it correctly? Weezek. Weezek and I apologize. I was at another hearing.
▶ 1:28:03I had to leave shortly after this one started and go to another hearing and I apologize in advance that when I finish my questions here and we'll be going back to that hearing for for a bit before I go to the floor. If I understood what I heard though when I came in when you were answering uh Dr. Dunn's questions, we're 20 to 30 years behind the Australians on Yes, that's correct.
▶ 1:28:28So clearly there are problems that have existed for some time in developing new sunscreens. Is that correct? Yes. Now it may take congressional action. So I don't want to be, you know, accused of beating up on the FDA workers, but don't you think we could import some of the studies and tests they've done in reliable nations like Australia or the UK? I understand there are other nations that may not do the testing that we do, but some of these nations do testing.
▶ 1:28:55And if the Australians have products on the market for 20 to 30 years, we probably have a pretty good feel that they're safe. Wouldn't you agree with that? Yes. So, the issue is that we rely on the we the FDA has insisted on the must trial um maximum usage trial as well as animal testing to ensure safety data.
▶ 1:29:15um other countries don't have those two um regulatory frameworks and so they're able to approve other filters whereas we are kind of stuck in neutral here and when it comes to something like sunscreen which is not taken internally but is spread on the skin can't we pretty much I mean I'm just trying to figure out why we can't import data from some place like Australia that's been using these products for 20 to 30
▶ 1:29:45Yes. So if we, you know, change, if we reauthorize AMUFA, um, with that with what we're asking for, which is to allow supplemental data, um, such as real world human data, to your point, the hope is that we would see new filters come to market um, certainly much faster than things have been going. Yeah, I'm happy to help in any way I can on that.
▶ 1:30:10It would seem to me also that if if we could somehow import the data that other nations that we rely on like our friends in Australia, like our friends in the UK and France and some other places that we could actually make it more efficient and maybe even do it with fewer workers. I'm not going to ask you to comment on that, but this is of concern to me because u like so many of us, I have a 17-year-old who knows more than mom and dad.
▶ 1:30:38So last week he went on a mission trip to a sunny area of the country to help clean up trash and work in some construction uh settings out and and because he had read reports and he does read a lot that our current sunscreens can cause cancer, he decided not to use sunscreens. You can imagine the result. I got back a lobster boy.
▶ 1:31:04Uh but but it was all I mean he made all the decisions himself and he's 17 and he's told us any number of times he knows what he's doing. But it sure would have been nice if he'd had a product out there that was safe that he hadn't read those reports on because he's correct. There are reports out there that the sunscreens currently approved by FDA are now showing signs that they may actually be causing the problem more than solving it or at least equal. Is that fair?
▶ 1:31:30our position with both the past coalition and the MRF um the best sunscreen is the one you will use and so whether that's a mineral sunscreen which physically blocks the sun or a chemical sunscreen um that's personal preference that's you know what your son is most comfortable with we encourage him to wear a sunscreen I would agree but he determined based on reports he read that none of the products available to him in the United States were uh safe in his mind Again, I'm
▶ 1:32:01not agreeing with him. I'm just saying what he thought. Uh, Mr. Diz, do you have any comments you want to make on the comments I've made and the comments that Miss Wheezik has made? Yeah, absolutely. Um, I I'm in good agreement. I think from a global perspective, we have to understand that the data globally is protected on the compensation uh reimbursement requirements. So if a company wants to use somebody else's data, they would have to compensate them in most of the European companies countries.
▶ 1:32:30Um the fact that these methods are scientifically being employed in many parts of the world is intriguing in that FDA continues to rely on their uh animal testing which is not seen toxicology as a gold standard anymore due to false positives in interspecies differences.
▶ 1:32:48But for the most part, I think we can build upon the knowledge of data that already exists and in fact has existed for 30 years with this ingredient that we're bringing forward has been available for 24 years and has been used safely as evidenced by pharmarmacco vigilance data which is collected by the ta the therapeutic goods authority of Australia which regulates sunscreens which is collected by health Canada which is also collected by FDA on existing ingredients.
▶ 1:33:18So we have a body of evidence on human adverse events which show that there aren't any remarkable adverse events associated with these ingredients and we should build upon this common network of knowledge to fortify our knowledge in terms of bringing these ingredients quickly to the United States because people only use what they want to use and right now they're voting with their feet and buying out the internet. I yield back. Thank you. The gentleman yields.
▶ 1:33:46The chair now recognizes the gentle lady from Michigan, Representative Dingle, for five minutes of questioning. Thank you, Mr. Chairman, and thank you for holding this important hearing uh on this program that's expiring this year. I'm proud to have been a co-lead to the bipartisan over-the-counter monograph drug user fee program, AMUFA, uh with Chair Guthrie, Deette, and Lada.
▶ 1:34:09and through discussions across the aisle involving members, patients, doctors, pharmacists, and advocates, I'm committed to a thorough and fair reauthorization review process. I'm troubled since we cannot ensure we are safely and effectively monitoring both over-the-counter and prescription drugs without a strong FDA workforce. Yet, the Trump administration is creating tremendous uncertainty by firing and then rehiring the FDA workforce.
▶ 1:34:40On February 24th, George fired 700 employees and then had to rehire many of them back after realizing that many of them were safety experts. And then last week, Secretary Kennedy announced a plan to cut 3,500 employees from the FDA. Firing key drug safety officials of the in the name of efficiency is shortsighted.
▶ 1:35:03It's not the way our health care system should be run and quite frankly it risks American So having said that to ensure that the overount over-the-counter drugs are safe, we expect them to follow a general recognition of safety and effectiveness, also known as grace. Mr.
▶ 1:35:22Mensel, we know that the Trump administration is enacting staffing cuts, but on the other hand is touting the importance of grays and is saying to quote essential that it is essential that the FDA maintains this stat standard. Are staffing cuts at the FDA hampering the program? Well, I do agree with you. I believe the FDA has been the gold standard.
▶ 1:35:49Uh I don't envy uh the position that that you all are in to navigate uh all of these variables. Uh I I can't speak to the administration's decision um in a situation like this from an industry perspective. What I would say is the OMUFA reauthorization, especially considering all the staffing cuts and the impacts it could potentially have, is so so critical. So that there's a clear path.
▶ 1:36:16Uh there's going to be a lot of variables that aren't clear paths right now with the FDA, but this particular situation with AMUFA reauthorization and the safety effectiveness of overthe-c counter drugs um is one of those. Thank you. This part seems obvious, but it needs to be stated. An essential aspect of a successful government program is communicating.
▶ 1:36:42I've heard serious concerns from stakeholders that they are not being included in the conversations regarding the upcoming reauthorization. Now, Mr. Mensel, you mentioned that the FDA needs to be transparent and open to ensure a successful OMFA reauthorization if the administration decides to act independently. And without frequent meetings, what's the risk?
▶ 1:37:07Historically, FDA has been a a very good partner to to myself uh and to industry. Again, I can't speak to the impact of the of the job cuts or the potential rehiring or whatever happens uh as the FDA moves forward. But again, I just restate they have been the gold standard. They've been good partners uh in industry, at least for us. and reauthorization of AMUFA is is critical uh for my company and our industry to allow that to keep happening.
▶ 1:37:37Thank you. Okay. Well, I'm co-chair of the skin cancer caucus. So, I want to end with sunscreen regulation. Sunscreen is critical in the prevention of skin cancer as we've been discussing. Yet, there are concerns that the current FDA regulations regarding sunscreen active ingredients are not sufficient. there. As we have said, there's not been an approved new active ingredient in sunscreen since 1999. Dr.
▶ 1:38:03Wasik, I first want to get your opinion on the current situation of this sunscreen testing requirements. Does Congress need to alter the requirements on testing to increase the available active ingredient list? And then, because we're running out of time, what's the biggest issue facing the melanoma community with regards to this monograph reform? Yes, we need Congress to help guide the FDA on where those gaps are.
▶ 1:38:32Um, again, just to reiterate, it is animal testing and the must trial. Those are the two biggest issues with why we're not getting new filters. Um, as far as what the melanoma community, you know, needs and the impact here, this is a preventable cancer. I have the privilege of working with advocates from hopefully preventing melanoma in the first place all the way through navigating um treatment and care for metastatic disease. It is it is brutal.
▶ 1:39:02It is parting your hair on the other side of your face to hide a big scar. It is missing work uh because your only option is a clinical trial at that point. Um and so we really appreciate Congress's support to help us in that prevention space. um because we don't want people to get to that point where it's stage four doesn't have to happen. Okay, I yield back, but I would point out it boy it's been since 1999 that we've done anything. Yield back, Mr. Chair.
▶ 1:39:31Gentle lady yields. The chair now recognizes the gentleman from Florida whose team is in the final four this weekend. Representative Bill Rakus for five minutes of question. I I I appreciate that plug very much, Mr. Chairman, and thank you for holding uh this hearing. uh on the uh the FDA's regulation of overthe-counter drugs.
▶ 1:39:54Access to safe and affordable over-the-counter drugs is an important issue for all Americans, and I look forward to learning more about how the FDA can improve the process of the user fee program and help incentivize American innovation in the drug market. One issue that I'm particularly interested in uh is the role of foreign manufacturers and the over-the-counter drug market.
▶ 1:40:24In my new role as a member of the House Select Committee on on China and uh Dr. Dunn is also a member. It's my duty to help facilitate ideas between my work there and the jurisdiction of this great health subcommittee led by my good friend.
▶ 1:40:43Uh I'm concerned with increasing stories of safety issues and violations at uh foreign manufacturing facilities for the over-the-counter drugs and the impact to American consumers. In 2024, dozens of drug recalls exposed a link to tainted factories in China and India that manufacture children's over-the-counter drugs.
▶ 1:41:10In 2023, bacterial contamination of eye drops at an overseas manufacturer blinded 14 people and killed four. Mr. Uh Ruiz uh in your testimony you mentioned the role that Chinese companies play in the overthe-counter market particularly as it impacts innovation.
▶ 1:41:34What steps can the FDA currently take to both promote innovation in the market and protect against safety issues? If you could answer that question, appreciate it, sir. Yes, sir. Um, so this is this is all related to the confidentiality provisions which do not currently exist under the OTC monograph process because it's a public rulemaking.
▶ 1:41:58So any study data that is generated on behalf of a sponsored company supporting an ingredient will be publicly made available on the FDA docket visible to anybody who wants it. These tests which or studies that have been conducted usually cost hundreds of thousands to millions of dollars.
▶ 1:42:17Now those companies which are competing with the sponsor are at an advantage of obtaining that data free of charge and then supporting the um the marketing or the development of the same ingredient without paying of scent and getting lunch for free. It's further exasperated in that these all USPRA ingredients on the monograph. Right?
▶ 1:42:42So in order to be sold it has to meet the quality impurity standards of the United States Pharmacopia. If there is only 18 months uh for a sponsor to who generates all these studies to uh get the ingredient approved by FDA on the monograph. After that 18 months it becomes a generic drug subject to USP and anybody can manufacture it.
▶ 1:43:05Having that data for free is unfair and presents a big problem in terms of innovation and return of investment and is not supporting other companies from wanting to do this. So if we do not fix that, you'll have a system, but nobody's going to want to be in the system because there's no return on investment given the way it's currently set up. Thank you very much for that answer. Uh Mr.
▶ 1:43:31Uh, Mensel, your testimony discusses the need for the FDA to improve the AR's process, the list of facilities that have not paid their user fees. Can you elaborate further on the AR's list and how addressing this would help provide additional transparency for consumers? Yeah, abs. Absolutely. So, uh, what the AR's list is, as mentioned, it's around 200 facilities that have not paid uh their user fee.
▶ 1:44:00Historically, those companies are also because they haven't paid, they're also very poor quality uh companies. So, if FDA focuses their attention on those particular companies, uh not only would those fees likely be paid, but a lot of the quality issues that have been mentioned are coming out of uh companies like that. So, it's a target list, if you will, to correct uh the non-payment, but also to uh to highlight companies uh that have poor quality histories.
▶ 1:44:29A simple publication of that, a rears list, uh would likely cause some of those companies to uh to either pay and improve their quality or um or or disclose what's what's going on with them. All right. Thank you very much. Thank you, Mr. Chairman. I yield back. The gentleman yields. The chair now recognizes the gentle lady from Illinois, Representative Kelly, for five minutes of questioning. Thank you, Chair Carter and Ranking Member Deette for holding this hearing on the FDA user fee authorizations.
▶ 1:44:58It is imperative that we ensure our regulatory system, particularly in the realm of over-the-counter medications, work to protect all Americans, regardless of their background or economic status. I firmly believe in the power of science and trust the expertise of the dedicated scientists and professionals at the FDA who work tirelessly to safeguard public health.
▶ 1:45:22Unfortunately, we are at a time where the narrative of combating waste, fraud, and abuse is taken away from science and efficiency. As we've talked about last Thursday, the Department of Health and Human Services directed by Elon Musk Department of Government Efficiency announced it would slash this workforce by one quarter and consolidate several agency functions, leaving few offices or programs untouched. HHS Secretary Robert F. Kennedy Jr.
▶ 1:45:49declared the department would lay off 10,000 workers on top of another 10,000 who already had been forced to navigate early retirement buyouts or restructuring. These specific layoffs will impact on about 4,200 employees at the Food and Drug Administration, which is almost 20% of the total agency workforce. Mr. Favor, what potential risk and transparency do these workforce reductions create?
▶ 1:46:17and how would the potential workforce gaps impact vulnerable populations who rely on clear, accessible information to make informed decisions about their health? Yeah, thank you for the questions. And while you've heard the administration say they won't cut reviewers or inspectors, they notably left out all of the folks who are in charge of making sure our labels are clear, that consumers know what's in the products that they're eating or putting on
▶ 1:46:47their bodies, that consumers are alerted when products uh have been contaminated in some way so they can clear their pantries. and the people who do postmarket surveillance so we know when th things do go wrong so that we can respond and take action. So, uh all of those people were presumably fired today and they will not be no longer be helping consumers and industry share these basic facts with us.
▶ 1:47:17So, it leaves all Americans in a very unhealthy way. It could be. I'm glad to see FDA's commitment to real world evidence reflected in the user fee agreements. Innovation has also come with time, which is why my colleague Rep. Walderson and I created a caucus on dig digital health to encourage modernization.
▶ 1:47:37Unfortunately, massive reduction in force notices that notices put forward by the Trump administration would not help innovation come faster to patients across the nation. Mr. D. Ruiz, you mentioned in your testimony that regulatory barriers can often limit consumer access to innovative products such as in the development of new UV filters, which could be helpful to minimize gaps in skin protection for communities of color.
▶ 1:48:05In your opinion, how can the FDA modernize its regulatory framework to encourage innovation while also ensuring consumer safety? Right. So, um, thank you for that question. Uh it's important to realize that industry has been working for the last five years since uh the 2019 uh tenifi of monographs which became the 2021 uh admin proposed administrative order in terms of providing them with a framework by which they would be able to
▶ 1:48:36review the safety of the existing filters on the market using we have a evidence approaches which include a human uh real world evidence which include additional silicico methods which include a variety of other modern toxicological techniques.
▶ 1:48:54And we have presented that to the agency um as an a proposal in terms of modernizing the way that they look at things with an eye that this can be used to build upon the science to generate the internal knowledge base that is required to facilitate the innovation process with existing ingredients that are used elsewhere in the world that currently have extensive amount of data associated with it.
▶ 1:49:22So, it's important to realize that we have the ability to do this. It's being done. We just need to do it right and use what's available in order to protect the American consumer from skin cancer and the harmful effects of the sun. Thank you so much and thanks to all the witnesses. Appreciate your time. Thank you. I yield back. Uh the gentle lady yields back and I now recognize a gentleman from Texas, Mr. Krenshaw, for five minutes. Thank you, Mr. Chairman. Thank you all for being here.
▶ 1:49:52I'll start with you, Mr. Mensel. Um, on the question of efficiency and maybe just talking about the monograph process more generally, uh, as it compares to the traditional new drug application process, does it does it do as intended, cut red tape, speed up the pathway? Yes. Uh, the short answer, um, a new drug application for every monograph uh, type product right now would be a burden to the system. Products wouldn't, uh, get approved.
▶ 1:50:20Um, importantly right now with the monograph system and with AMUFA um you have um products that are generally recognized as safe and effective in terms of the active ingredients. Currently in our industry and it does allow for innovation in terms of form in terms of other inactive ingredients that are really important to the consumer. So innovation is ongoing.
▶ 1:50:41It doesn't always have to be an active ingredient innovation, but let me let me just say that that's very very important to consumer to the consumer texture, taste, all of those things um that that drive a product to perform well. So yes, have you seen an improvement in the in the system since the user fee program was put in place? Uh I I think the the framework is there for the user fee program. I think the first five years a lot of the infrastructure was built with the FDA.
▶ 1:51:09Our anticipation is that the next five years will allow for uh more innovation and more processes uh now that the infrastructure is in place uh for more innovation to to actually come to market. Yeah. I I guess did did the user fee program in your in your in your calculation your observation create a faster approval process or not? Uh yes. Um are we seeing and what are the roadblocks then? Um if if we were to reform this or improve it.
▶ 1:51:40Uh I mean I think the the current uh roadblocks the you know some of the items that we we've mentioned um in terms of the um the full-time employees um that that funding needs to remain in place so that those uh those uh employees can be approving uh the the products that come through. Um, and then you know, communication and transparent, continued transparency with the FDA. Okay. Uh, that gets to my next question. I was going to ask you and Mr.
▶ 1:52:07Troutman if you'd like to uh weigh in on this about communication. I I think it's a it's a big deal um between industry and regulators and we need to get it right. Transparency uh provides that clarity that we need to innovate, bring products to market efficiently. You have you have to know what's wrong with your with your testing or with your with your process and FDA doesn't always do a great job telling you that. Um, does does the user free program create that? Does it has it improved communication or is that still an issue? Uh, thank you for the question, Mr.
▶ 1:52:37Crunchaw. It it has been a bit of an issue uh over the course of the program just in we've submitted a number of uh progress reports uh which are part of my written testimony from ACI uh with regard to when and how things are going uh with the safety or data uh submissions that are part of that uh work that uh FDA has asked us to do.
▶ 1:53:03uh but the actual response from the agency on the progress or whether that's on track or where that may be uh has been few and far between. So we'd like a little bit more res uh flexibility there um and resource dedication to making sure that that communication is ongoing. Yeah, fully agree. Anyone want to add anything to Um I I think that's something this committee needs to address. I'm not sure exactly how. Um Mr. Mr.
▶ 1:53:32Benzel, another question on on modernizing our our system here. You know, there's Australia, parts of the EU that use what's called a behind-the-counter pathway, sort of a middle ground between prescription and over-the-c counter drugs. Uh allows you to consult directly with a pharmacist at the counter to get access to certain medications like insulin without a full doctor's visit. Um, a lot of this does seem like common sense. Uh last year the FDA finalized the additional condition for non-prescription use rule creating new pathways to move some prescription drugs into non-prescription category.
▶ 1:54:02So would a behind the counter system work in the US? Uh what are the trade-offs? I mean I think it's something that has to be looked at with the FDA. I think there's pros and cons. Uh certainly the pros in increased access um and price transparency I think are are two really big important items. there's some learnings uh from other countries. Um uh I wouldn't want to move every situation uh over to behind the counter because then you limit access.
▶ 1:54:32Um but I think certainly uh for us I mean I think if it improves access to the consumer, it ensures safety and it's an established uh product then um it's a pathway that we should evaluate in coordination with the FDA. Uh thank you. I yield back. The gentleman from Texas yields and I now recognize the gentle lady from California, Miss Baragan, for five minutes for questioning. Uh, thank you. Um, Mr.
▶ 1:55:02Chairman, as we have this hearing today on the FDA, um, it's can't help but notice that just last week, the Trump administration announced that they will fire 10,000 employees across the Department of Health and Human Services. This includes plans to cut thousands of jobs at the FDA, about oneif of the workforce.
▶ 1:55:23These federal workers protect our country's public health by ensuring the drugs Americans take are safe, including over-the-counter drugs. How can we have this hearing to look at how the FDA regulates over-the-counter drugs while Republicans severely cut the FDA staff?
▶ 1:55:42These cuts will slow down the approval of drugs, which means that Americans will have to wait longer to access new life-saving medications for diseases that affect us, and that is unacceptable. Mr. Faber, the FDA employs about 19,700 employees to ensure the safety of food, drugs, and medical devices.
▶ 1:56:04Of those over 7,000 employees are under the FDA's Drug Review Division, the Center for Drug Evaluation and Research, which reviews um non-prescription drugs, including over-the-counter drugs such as sunscreen. How has FDA's current staffing levels been able to keep up with timely review of drug applications and other safety reviews?
▶ 1:56:32Well, the FDA has done an excellent job of reviewing drugs and over-the-counter drugs, and I think everyone on this panel would agree that we we all trust FDA to tell us what science is necessary, what studies are necessary in order to ensure that the drugs, especially our over-the-counter drugs, are are safe, but also are effective, and that they block both the UVA and UVB rays that uh can lead to to uh to skin cancer.
▶ 1:56:59Uh unfortunately um uh the current policies that we have in place are not providing a strong enough signal to industry to pay for and provide the studies that FDA not industry that FDA is insisting is necessary to know whether our sunscreens are ultimately safe and effective. And uh do you see uh any of the reduction in the workforce having an impact on these reviews?
▶ 1:57:26A absolutely e even if we as as the secretary has said protect reviewers and inspectors there are many thousands of people who help who are part of review teams who play other roles as biostisticians or economists or other experts who contribute to these reviews.
▶ 1:57:46If we want to update the science that FDA applies to these questions of safety and effectiveness, we need to have toxicologists, epidemiologists, biostisticians, economists, others who are not reviewers and who would know who and many of whom were fired today.
▶ 1:58:05So if we do want to advance the science and have better science applied to this question of which whether or not these ingredients that are used in other countries are safe, we need to have qualified people at the FDA to make those determinations.
▶ 1:58:20I know you'd want to take my word for it or the other witness's word for it, but ultimately, don't we all want a qualified person at the FDA deciding whether the things we rub on our bodies and our famil family's bodies every day are actually safe and whether they're actually blocking the sun's harmful rays. U Thank you. Um Mr. Faber, last Friday, FDA's top vaccine official, Dr. Peter Marx was pushed out of the administration after serving in the ay's leadership since 2016.
▶ 1:58:50Dr. Markx has express had expressed his willingness to work with HH Secretary Robert F. Kennedy Jr. to address any concerns about vaccine safety, but the secretary just wanted unquestioned confirmation of his misinformation and lies over vaccine safety. This is just another example of the Trump administration's anti-science approach in their decision-making. What would be the ramifications to our country's public health if we push out our scientific experts on drugs, food, and medical devices?
▶ 1:59:20Well, if we don't have qualified experts reviewing the safety of these products, obviously many of these products as well as our food will be less safe and people will get sick or or worse. Uh they won't be able to have access to life-saving treatments. Our antibiotics won't continue to be effective. um many of the other things we bring into our homes may pose risks that we're not aware of.
▶ 1:59:43But more importantly, and and ranking member Palone alluded to this earlier, people will lose faith in the FDA as a source of expertise. And ultimately we want a regulator that we can all trust to give us good advice about the safety of products and and uh in the absence of that we'll turn to faith healers and fraudsters not the people who really are looking at the science. Right. I want to move quickly to the um FDA.
▶ 2:00:10Um the Congress has authorized the FDA to collect user fees from manufacturers that market process and develop over-the-counter drugs in order to support the FDA's workforce in product evaluations. If Congress fails to reauthorize the user-free program on time, how would underserved populations be disproportionately affected? Well, uh, many people lack access to information about the products they bring into their homes.
▶ 2:00:34They don't have the the luxury of time to, uh, do go online and research products as many of us do. Um, and so they will be at greater risk of of products that pose health harms. No question. Great. Thank you. I yield back. The gentle lady yields back. Uh, the chair now recognizes gentleman from Pennsylvania, Mr. Joyce. Thank you, chairman, for holding this hearing today and for our panel for testifying.
▶ 2:00:59As a John's Hopkins trained dermatologist, I have personal experience treating skin cancer and I'm aware of how devastating this can be for a diagnosis for patients and for their families. On a personal level, I never met my grandfather. He died of skin cancer before I was even born. We know that sun exposure is the primary cause of skin cancer.
▶ 2:01:22As a doctor and as a member of Congress, I continually advocate for the importance of regular sunscreen and the use of it for skin cancer prevention and also regular skin evaluations and examinations for early detection. And despite attempts by Congress to ensure that the newest and most effective sunscreens can reach the US market, we are still far behind the rest of the world in approving innovative UV filters in sunscreens.
▶ 2:01:52And this has led to real public health alarms. I ask unanimous consent to submit the white paper from the public access to sunscreen coalition on the history of this issue for the record. Uh, Miss Weezik, can you speak to the current rates of skin cancer diagnosis in the United States and how that compares to rates in other countries? Yes, thank you.
▶ 2:02:20Um, so in 2014, which was when the Sunscreen Innovation Act passed, um, through 2022, there were over 700,000 new cases of skin and cancer in the United States and 75,000 deaths in that same 8-year time span. Um, again, as I uh stated in my remarks earlier, the United States is responsible for about a third of all skin cancer cases globally.
▶ 2:02:46So clearly we have an outsiz um I think problem with how we prevent skin cancer, how we message skin cancer prevention. Um it's a huge opportunity for us in the public health space. And during that time period since 1999, not one single new skin protection in a sunscreen, none approved. Correct. Correct. And yet we have seen other approvals.
▶ 2:03:13We've seen the development of of Opiva of Kruda for the treatment of metastatic melanoma, but we're not starting at the beginning. We're not working where we should be working to the numbers that you just stated, the incredibly alarming numbers of increased skin cancers. These are troubling numbers. They're troubling numbers worldwide, but they're specifically troubling numbers here in the United States.
▶ 2:03:36Would you agree that this public health risk, Miss Weezek, warrants the inclusion of legislative provisions in a mufas to resolve this issue? Yes, Thank you. I agree with that completely. The United States is home to the world leading medical innovation. In fact, I often talk about innovation being the cornerstone of American medicine, being the cornerstone of how I practice medicine.
▶ 2:04:04Unfortunately, the FDA's inaction has prevented this innovation, allowing the rest of the world to access new active sunscreen ingredients that are unavailable to Americans. Mr. Druz, can you expand upon some of the barriers that are hindering the great innovation by not utilizing the clinical allies that our friends not utilizing the clinical information our friends and allies have access to?
▶ 2:04:34Well, I mean, people don't die from using sunscreen. They die from not using sunscreen. Number one, and I think there is there's a large body of evidence worldwide indicating that the news of young sunscreen filters, which have been developed over the last 10 years, are much more efficient. You use less, less exposure. They're much more effective in reducing the harmful effects of both UVA and B. and three they're more sustainable in terms of environmental impact.
▶ 2:05:04So from that perspective that body of data has propelled the industry globally outside of the US to develop new UV filters at a rapid pace. The technologies go beyond what used to be just synthetic filters and now new technologies which are nowhere near being reviewed in the United States in terms of natural UV filters, filters that are biotechnology based.
▶ 2:05:29Nobody's investing in any of this because of the cost involved in the United States, the lack of data protection and the fact there's no exclusivity. So you have a system and we are very proud to be the only ingredient manufacturer to be in the system and I can tell you that we've been in touch with FDA and it's working. Do you feel access to these natural filters can prevent skin cancers, can prevent deadly melanomas from occurring?
▶ 2:05:57I think that science is evolving at the most rapid pace we've seen in generations and that the technology that's now being generated from biotechnological biotech tech um innovations simply are astounding and should be considered in a new framework in terms of reviewing how these filters can be approved to augment what we have and even accelerate beyond what the rest of the world is doing in terms of technology. again innovation here in America.
▶ 2:06:26It is my goal that we can work as a committee to streamline and unleash the process of developing these natural abilities to filter the harmful ultraviolet rays in order to unleash that innovation in the skin care protection ability of your industries. It is our duty to protect the American people from skin cancer. Mr. Chairman, thank you. My time is expired. I yield back. The gentleman yields back. The chair now recognizes the gentle lady from Washington, Miss Shrier.
▶ 2:06:58Thank you, Mr. Chairman, and thank thank you, Madam Ranking member, and thank you to all of our witnesses for being here today. I'm really grateful for your commitment to making sure that our drugs, devices, and foods are safe. Uh, as a doctor, it is important for me to trust that an over-the-counter product that I recommend to a patient isn't going to harm them and will work as intended to.
▶ 2:07:23And whether that's the efficacy and safety of my daily sunscreen or the really important standardization of infant and children's Tylenol concentration many years ago that's prevented accidental overdoses. We all rely on a well-funded and staffed FDA to carefully review those products. Uh the over-the-counter monograph safety innovation reform act was designed to accelerate and streamline OTC drug approval.
▶ 2:07:53Uh and uh we're discussing uh reauthorization this morning. It's really hard to have a good faith discussion about reauthorizing this program. uh when the Trump administration just this morning fired 3,500 FDA staff, uh in fact, they just couldn't get in the building. That's how they found out. And this action is only going to make approval of over-the-counter products and prescriptions slower and less safe.
▶ 2:08:22There is just no way that cutting 20% of FDA's employees will have zero impact on drug and medical device review that the FDA was already struggling to keep up with. Mr. favor. Uh I I need to know again that the the OTC products I recommend are safe and effective. This includes sun block.
▶ 2:08:43As we've heard, the FDA has not approved a new sunblock since 1999 and the rest of the world has twice the options uh that we have. Do you believe that the FDA uh had adequate staffing to effectively review the safety of sunscreen ingredients before today? No. And then can you comment on how today's firing of 20% of FDA staff will change their capability?
▶ 2:09:11Today's decision to fire 3,500 staff will be devastating to the efforts to bring safer, more effective sunscreens to American consumers, a goal all of us share because the people who will advance the science that allows us to know which of these ingredients are indeed safer or effective were fired this morning. It's outrageous. I want to turn my attention just with the remainder of my time to vaccinations. Uh Dr.
▶ 2:09:39Peter Marks decided to resign this weekend from uh the FDA Center for Biologics Evaluation and Research. He was the head of the department responsible for ensuring the safety and effectiveness of vaccines. Uh basically he was told by HHS Secretary uh RFK Jr. that he better either get on board with the misinformation and doubt about vaccines or get fired or resign.
▶ 2:10:06And he chose noly to resign. But that is a loss for the country and for the world. And frankly, you know, I I've spent now many years uh trying to combat the misinformation that RFK Jr. and others like him have been spreading willfully for the past decades. Um I am outraged about this resignation are being muzzled right now.
▶ 2:10:35Um and I just worry as a pediatrician who has only seen one case of measles uh from in a child under one who had been traveling that these diseases that I haven't even seen are going to come back and cause menitis and death and pneumonia and measles as we are seeing right now. totally unnecessarily.
▶ 2:10:58And I also want to be clear um that I will lay every single one of these outbreaks at the feet of our health and human services secretary RFK Jr. Um would any of you like to comment about the risk to vaccination in this country?
▶ 2:11:18Well, I I'll just volunteer uh that I'm not the only one who's probably sitting here today because I'm taking a medication that was approved by the FDA. We all depend on the FDA to keep us safe, to provide us life-saving drugs, to make sure our antibiotics work.
▶ 2:11:39And the notion that we are undermining this this incredible resource, this incredible national resource in this way is putting all of us at risk. It's making it harder for the industries here and industries generally to produce the life-saving drugs that we all depend on. That's right, drugs. We didn't even talk about baby formula today. Thank you very much. I yield back. The general lady yields back.
▶ 2:12:07The chair now recognizes the general lead from Tennessee, Miss Harshburgger. Thank you, Mr. Chair. Thank you to the witnesses for being here today. Um, I'll start with Mr. Mensel. Um, how does AMUFA increase supply chain resilience because we've had some shortages shortages in OTC's like your ibuprofen, your acetaminophens, those type things. Uh, yeah. So, the the key to supply chain is predictability.
▶ 2:12:34And you know if you the the AMUFA reauthorization is critical in terms of predictability um so that the supply chain can be sourced from various other places. Um I will say too that um you know there's there's been a great effort uh within our industry uh even with us uh personally um where we have uh increased um supply chain resilience um by as you heard in the notes uh increasing manufacturing in the United States.
▶ 2:13:04Um but you can't do that if you don't have predictability of what those active ingredients are going to be and that's what reauthorization allows for. Yeah. Exactly. Because when you you know that over 90% of your ibuprofen comes from China, that's a problem. Then there's FDA registered facilities, but they might not necessarily be FDA inspected facilities. And we know there's small and large manufacturers that participate in this AMUFA user fee program.
▶ 2:13:32And maybe we need to look at that um publication of the Aars list. And maybe the FDA could also put out an import alerts uh for uh foreign non-paying facilities if over 200 haven't paid. I agree. So um and this is to Mr. Mensel and uh Mr. D. Ruiz. Uh Mr. Mensel, you said the OTC monograph drug user fee program improved the FDA's ability to review and update OTC monographs.
▶ 2:14:01And can you provide uh an update on the number of OTC monograph order requests submitted and approved by Do you have that number? I think I do. If you don't, don't worry about it. You can get it back to me. I'm just I'm curious about that. Oh, somebody's got it.
▶ 2:14:31It it should have been an obvious number. There's one that's been public. Um, it it goes back to the uh the discussion that I had that the first five years created the infrastructure. We would certainly expect with reauthorization that that that number would uh dramatically increase over five years. I'd be curious um Mr. D.
▶ 2:14:51Ruiz uh has AMUFA affected small and midsize OTC drug manufacturers since there's two types uh of facility fees you know you've got your MDF and your CMO fees I guess my question would be has it discouraged or limited participation by smaller companies has what the you've got your small and midsized OTC drug manufacturers has uh these user fees discouraged ed
▶ 2:15:21or limited participation by smaller companies. Well, I I think um under the uh GMP requirements for OTC drugs, you have a standardized method for ensuring that the safety of these ingredients and the quality and purity is in place per FDA standard. You do and that's and these apply to both large and small organizations.
▶ 2:15:44Um so for the most part I think those uh requirements must be adhered to but agree the problem is that if people are buying sunscreens that are on the internet that are not regulated FDA what's the problem there circum you can make it in some cases so we got a bigger problem exactly um so um I I think it's important to realize that the industry does not do anything that is uh safe and
▶ 2:16:15effective for its consumers and that we will continue to do so. Um regardless of what environment we're in and we have uphold those standards as responsible citizens. Yeah. And I mean I'm a compounding pharmacist for God's sakes. I have to have cgmp if I'm doing sterile or non-sterile. So and I'm held to very high standards. So Mr.
▶ 2:16:36Menel, do you think uh AMUFA how does it compare to other um FDA user fee programs in terms of efficiency and industry burden? Yeah, I mean I think the principle of the of the program is that it distributed distributes the burden and you know so AC our organization pays one fee but because the uh burden is distributed it's not an overt taxing burden and uh and I think in that regard it's effective.
▶ 2:17:05I think that's probably having that base and smaller entities a level playing field. Absolutely. Do you think it's increased the uh had an impact on the cost of OTC? I do not. Medications. Okay, that's very good. I think my time's up. I've got many more questions, but I yield back, sir. General lady yields back. Uh the chair now recognizes the gentle lady from Texas, Miss Fletcher. Thank you, Mr. Chairman. Um and thank you to the witnesses for your testimony today.
▶ 2:17:34I understand uh from your testimony and from our work that this is an important program that needs to be reauthorized by September of this year if it's going to continue. Is it going to continue? Uh if we reauthorize it, will it continue? If we even fund 11 positions, will they still be there?
▶ 2:17:53While we have been sitting here today, we have gotten reports from multiple people that HHS employees are lined up around the block at the building just down the street swiping their badges to see if they are employed. If you scan your badge and it's green, you can go in. If you scan your badge and it's red, you are fired. Is this really happening in the United States of America?
▶ 2:18:21to the people who work to keep us safe, to the people that we're talking about this morning in this hearing, where is the evidence that these staffing cuts are necessary, let alone a good idea in the context of the agency's mission? Where is the evidence that cutting 20% of the employees on top of the thousands already fired is a good idea?
▶ 2:18:44We keep hearing even in this room, even on this committee, from members of this committee that Musk and Doge and Kennedy are focused on fraud, waste, and abuse. They are, but they aren't eliminating it. They are engaging in it. Firing thousands of scientists and civil servants who work to keep us safe from disease, who protect us from harmful products, who carry out critical research to advance new cures and treatments.
▶ 2:19:13a total waste. Telling them that they're fired from jobs they've worked at for years, even decades, to protect and serve the American people by a green or red light when they arrive at the building where they work and try to swipe in, that is an abuse.
▶ 2:19:31and telling all of us that those dedicated scientists and public servants cannot be trusted and replacing them with quacks who deny the efficacy of modern medicine and vaccines. Telling people in my home state of Texas during a measles outbreak to use vitamin A and cod liver oil instead of the MMR vaccine. A total fraud.
▶ 2:19:57While we have been sitting here, former FDA Commissioner Robert Caiff said, "The FDA as we know it is finished with most of the leaders and institutional knowledge and a deep understanding of product development and safety no longer employed." So I ask again, Mr. Chairman, does it really matter whether we have this hearing today? Does it really matter whether we reauthorize this law? What will happen then?
▶ 2:20:25The answer to that question is actually in your control. Congress can and must assert its authority here. We must conduct oversight. We must ensure that the legislation that we pass after hearings like this is implemented as directed, that the funding that we appropriate for health and research safety is spent as directed. Mr. favor.
▶ 2:20:53I'm sorry that I'm running out of time here to ask you all of the questions about our efforts to prohibit the use of certain hazardous chemicals like formaldahhide and mercury from personal and professional care products that are used at homes and in salons and sold in the United States. I prepared a bunch of those questions for you, but what we are seeing and hearing this morning is outrageous.
▶ 2:21:14So, I'm going to submit those questions to you for the record um because I think that that is critically important work that we can and should continue to do on this committee and I hope we will. But, Miss Whisk, I want to uh close by thanking you for your work.
▶ 2:21:30As someone who lost my most beloved uncle to met metastatastic metastatic melanoma many years ago, whose life was extended by more than 15 years after his stage 4 diagnosis in 1997 when it was almost unheard of to survive. He lived for another 15 years because he enrolled in a cutting edge clinical trial at MD Anderson Cancer Center in Houston.
▶ 2:21:58And I am so proud now to get to represent so many of the scientists and researchers and professionals who work there and throughout the Texas Medical Center in the city of Houston. As someone who represents those people, I urge this committee and this Congress to fight back against the cuts to research funding, against the cuts to personnel at NIH, at FDA, and to the overall destruction of HHS that we are witnessing
▶ 2:22:28in real time at this moment. With that, I yield back. The gentle lady yields back. The chair now recognizes the gentle lady from Iowa, Miss Miller Uh thank you very much, Mr. Chairman, and I thank uh the witnesses for testifying before the subcommittee uh today.
▶ 2:22:47I just recently heard about legislation being carried out as it was enacted, and that brings to mind something very important to me as a physician, and that was the No Surprises Act, which it seems that the last secretary of HHS in fact did not go with the intent of Congress or how that law was supposed to be delivered. uh and uh has left uh both patients uh and providers in the lurch once again.
▶ 2:23:10Um we're here to discuss the first reauthorization of the over-the-counter monograph drug user fee program, otherwise known as AMUFA. And yes, it's important that we actually discuss that and do the oversight uh for this important program because it facilitates over-the-counter drugs being made available to people across the nation.
▶ 2:23:28OMUFA which was established by the CARES Act during the CO 19 pandemic allows FDA to enter into agreements with the regulated industry to ensure the agency can meet review goals and guidelines established between the FDA and industry. As it was noted, these agreements are vital to the FDA's ability to provide a timely and comprehensive review of drug applications to ensure patients can access safe and effective options in this case without direct physician oversight.
▶ 2:23:56Increasing access to OTC medications is critically important to Americans living in rural areas who already face access challenges due to their geographic location. Whether it's Zerek or over-the-counter birth control, it's key that we as lawmakers empower patients to make their own informed healthc care decisions by giving them access to approved treatments and remedies. And in fact, as a uh state senator in 2019 in Iowa, I introduced uh oral contraception over the counter at that time. Mr.
▶ 2:24:27Menzel, thank you for being here today. Can you um please describe what you believe to be the biggest challenges facing the OTC industry today? And do you believe current FDA data requirements for prescription to prescription switch are clinically Um in terms of the challenges um you know I think just like any industry we have to navigate consumer demand um transparency in the supply chain um the challenges with import etc.
▶ 2:24:56Those are all very important. Uh, I actually was involved in in a few RX to OTC switches. And for any I saw a few sneezes in the room and so for anybody that uh is using an allergy medication, really nearly all of the allergy medications that are available to the consumers, our product of the RX Toast Z switch.
▶ 2:25:19We, the company that I was at, navigated that in 2010 effectively with the FDA and they were good partners and that has been a good a good process to uh to allow for good products to come to available to the consumers. Perigo, the manufacturer that produces Opel, the first OTC approved birth control, is a member of the Consumer Health Products Association.
▶ 2:25:42Do you believe that Congress through meaningful FDA reforms should continue to facilitate increasing access to the number of uh approved OTC oral contraceptive products for women? And secondly, do you believe these products are a benefit to those in rural areas? Yeah, I mean I think the OTC process allows for consumer access to drugs that that they normally wouldn't have access to.
▶ 2:26:06um health deserts are real things and I think the OTC industry helps mitigate that uh to some extent. Um certainly something that still needs to be addressed but I absolutely believe that um the access to OTC drugs the utilization of pharmacists and pharmacies uh for self-medication for advice uh at that level uh improves health care health care outcomes in the US.
▶ 2:26:31Well, in addition to, as you mentioned, uh the allergy medications which I'm suffering through at this point in time both in DC and back in Iowa, um you know, one of the products that has come on board, and as a woman, I thought was extraordinarily beneficial was monostat or uh antifungal medications for uh vaginitis, which most women if they've had one yeast infection, they know exactly what it is and they know how to treat it.
▶ 2:26:55And so this advance of prescription to OTC switch has been very helpful in that regard and helpful in rural areas especially as we're trying to undergo PBM reform which is causing small rural and independent and communityarmacies to close around the nation. So uh with that my time is ending. Thank you so much for your testimony and I yield back. Mr. the gentle lady yields back. The the chair now recognizes the gentle lady from New York, Miss Okasio Cortez. Thank you, Mr.
▶ 2:27:25Chair. Um, and I I appreciate um the majority calling in particularly some of the focus on sunscreen uh here in this hearing as well. Uh in addition to many of the over overthe-c counter treatments that we're examining here today, um the Food and Drug Administration, as has been noted, the FDA has not approved any new sunscreen filters since 1999.
▶ 2:27:50In fact, uh this has allowed many other countries to far outpace the United States in the technology of what's available to us. And this has an impact on working people, construction workers, farm workers who are exposed to very high degrees uh of of sun exposure, sun exposure and radiation really suffer as well as everyday people from not having access to these filters. I'm using a Korean sunscreen this morning.
▶ 2:28:20because the filters, as a someone who's more melanated, um, US filters oftentimes don't really cut it. Um, and advocates, consumers, myself, even my Republican colleagues all agree that we need new sunscreen filters in the United States and we should at some point discuss ways in which we can improve the sunscreen that is available in the United States.
▶ 2:28:45However, it is difficult for us to be having this conversation when in the conduct of this hearing, as these hearings are proceeding, not too far away, there are blocks and blocks of lines of HHS and FDA employees who are waiting outside of a building and tapping their badge to see if they can get inside that building right now.
▶ 2:29:13And if that badge turns green, they are they are they're they are still employed. And if that badge turns red, that's how they find out that they've been fired. FDA employees are not are are not just this kind of vague idea of a bureaucrat. These are scientists. These are individual individuals responsible for assessing what can come to market and what can also be brought over the counter.
▶ 2:29:40And in fact, just last week, we received notification the Trump administration will be cutting 3500 employees from the FDA. Uh, a skeleton crew. So, Mr. Faber, what do the employees at the FDA do when it comes to reviewing OTC drugs and medical devices? Well, they do everything from making sure that these ingredients are are safe.
▶ 2:30:06that is that they don't pose any risk of of harm, cancer, reproductive harm, neurological harm, harm to our hormone systems, as well as making sure they're effective, that they actually block both UVA and UVB rays so that we're not at greater risk of skin cancer. And would cuts to the FDA's workforce limit the FDA's ability to review and approve new over-the-counter drugs like sunscreen, but of course many others? Absolutely.
▶ 2:30:30If we if we cut if we cut the funding for people who aren't reviewers, um that doesn't mean FDA won't be able to complete these reviews. All the other experts, the biostisticians, the economists, the label experts, all of those people are part of a review team that make these sunscreens available to us. And what are some examples of drugs that the FDA has been able to make available over the counter without a prescription in recent years? Well, we've heard some great examples.
▶ 2:30:59um Claritin, allergy medications, Opill, oral contraceptions, Narcan or Nlloxxone has been a a great innovation that's now available over the counter. Anything that delays access to over-the-counter products is a step backwards. Absolutely.
▶ 2:31:15And for so many people, you know, as uh as was noted, not just in rural areas, but also in urban areas like mine, the added obstacle of having to see a doctor um can prevent someone from getting really critical and important treatment for them. And to bring something over the counter can be just as seismic as bringing it to the market in the first place for a lot of people who have trouble accessing these drugs.
▶ 2:31:42And not only are these significant medical breakthroughs, but they make them more affordable and accessible. Um, Mr. Faber, what could happen to products, for example, like baby formula? You know, baby formula is also regulated by the FDA. Many people may not know that some things that are considered an over the over-the-counter OTC or within the purview of the FDA are in the purview of FDA. And we saw a couple of years ago um that there were shortages around baby formula.
▶ 2:32:12What could happen to products like baby formula if there if there are not enough FDA staff to review? One of the reasons that infant formula was contaminated and that babies died was because yesterday we didn't have enough people to inspect food manufacturing facilities, including infant formula facilities, and they weren't being properly trained to do so. Today, by firing 3,500 people, we've made that problem even worse.
▶ 2:32:42And you know going back to that baby formula issue, there was also a market issue where a lot of there's been this shift in saying companies can review themselves. They can be they can investigate theirelves themselves. They can investigate their own supply chains.
▶ 2:33:00And I cannot think of something worse for people than not having an independent investigator whose job is to be responsive to the public um in order to verify that the safety of our food and drug supply is all right. Um do you have anything else to add, Dr. I'll just I'll just say this committee passed the Food Safety Modernization Act 15 years ago for two reasons. One was to make sure that we inspected facilities more often.
▶ 2:33:31And the second was to make sure that inspectors were properly trained to know what to look for. And we did that in part because the food industry wanted a partner at the FDA that could help them police these long complicated supply chains. Today, we made the job of industry to keep our food safe. you. Uh the gentle lady yields back and I now recognize a gentleman from Oregon, Mr. Bence for five minutes.
▶ 2:34:02Uh thank you, Mr. Chair, and thank thank all of you for being here. I'm looking at the staff report. It says uh historically monographs were established and amended through a three-phase public rulemaking process. Uh FDA and stakeholders reported challenges with this process. And then it lists three things. Uh well, one of them is a lack of flexibility for industry to propose innovative modifications. Mr. Manzel, innovative modifications. The the there must have been some to try to speed things up.
▶ 2:34:32Uh can you share with us what those might be and have there been some or are there some in mind? uh in terms of in terms of uh uh innovative modifications that would mostly be around inactive ingredients and um and so what's what's critical to the uh OMUFA and the monograph system is whenever you have the monograph in place you have a a cookbook if you will as it relates to the active ingredients and and that's stable the innovation that can then be around inactive
▶ 2:35:03ingredients forms etc as long as the claims and the uh and the active ingredients are The entire concept as I understand it of of the CARES Act and and later uh AMUFA uh the fees that were paid by the industry was to kind of speed things up to try to coordinate uh do something to make this all happen faster.
▶ 2:35:26I notice I noticed over time uh that the number of people working for the FDA has increased substantially close to 20,000 people now working for the FDA. Uh we've heard a lot about the 3,500 that are uh being cut, but they're still we start with 20,000 folks.
▶ 2:35:43Now somehow that number was not adequate to speed things up and that thus uh AMUFA it says here again in the staff report FDA in turn commits to adhere to certain performance goals negotiated uh by the FDA and regulated industry representatives. You indicated that the framework was being put in place to to make this work. Is it going to work? Is we got 20,000 people and now we have fewer, but it wasn't working at the time.
▶ 2:36:12Thus, the legislation is this legislation going to help speed things up? Yeah, I I think so. I I I still I still believe that the infrastructure in place was a big issue. I think the first five years was uh was built um for that. Um I think the FDA uh did meet performance goals. there were some uh guidance documents and hiring efforts that um that were delayed.
▶ 2:36:34Um but again, the FDA has been a fair and constructive partner uh in all this and um you know the uh the guidance that's been uh been implemented by the FDA has been somewhat delayed and I think that's uh that's another thing that um in terms of transparent talks with the FDA that that this group has already addressed. Thank you. I'm going to you Mr.
▶ 2:36:58Dur Ruiz, um I note in your report you mention uh the fact that uh no new filters have been approved in the US limiting Americans choice to 10 over time and and I'm guess I'm I'm I'm sorry I'm I'm speaking to the wrong I'm looking at the wrong report. Let me flip to you, Miss Wes Wesk.
▶ 2:37:22Um, and what you mentioned is that there are 10 UV filters, but there are over 30 approved globally. And and again, and you kind of kind of state that this is because of an insistence on animal testing on sunscreens. Is is there something happening in that space that the agency just refuses to acknowledge that it could be doing these things differently as is the case around the world? What what's what's going on with why why are we going so slowly is the is the question. Yeah.
▶ 2:37:51And it's it's a very valid one. I think um in the United States we regulate sunscreen as a drug and not a cosmetic. There are places in the world that have the inverse in effect. So they have different safety standards that they have to meet. Um safety and efficacy. Um so that's issue one. Issue two is that even within the countries that do regulate sunscreen as a drug like we do, they have different testing criteria.
▶ 2:38:17Um, so for us, we insist on the maximum usage trial, the must test, as well as animal testing to get that safety and efficacy data. Let me hop back because it doesn't seem like throwing more people at the problem's going to solve it. It seems like it's more of a policy issue.
▶ 2:38:34Do you think that Congress should be stepping in here and saying, "Hey, stop this type of testing, or do you have some other approach that we should use?" We have asked Congress um both with you know various hill days with my organization as well as when the past coalition came to the hill to address that regulatory framework to you know move away from must trials and animal testing um or to at least consider as uh Mr.
▶ 2:38:57Ruiz said to consider other data as supplemental or alternatives to those two issues. Thank you so much. Yield back. The gentleman yields and I now recognize Mr. Oenclaus from Massachusetts for five minutes for questioning. Thank you, Chairman.
▶ 2:39:15Over the last week, as I've been preparing for this hearing, I've been reading about AMUFA and uh have learned a lot about what strikes me as a very effective program that is a hallmark of how Congress should operate, which is to see a problem, to work in a bipartisan format, to get stakeholder input, to implement round one, which as you described, Mr. Menzel is laying the infrastructure, getting feedback on that heading into round two to uh make improvements to the program. And I was struck by something you said in your testimony, Mr.
▶ 2:39:44Menzel, about the FDA is a fair and productive partner in this, which I think is descriptive of an organization that is not just about a bureaucracy, but it's really a culture and a standard. And once that culture and standard is impaired, it engenders uncertainty throughout the business environment, it undermines our standing globally.
▶ 2:40:10And it can take us decades to recover what was once the gold standard of biomedical regulation. And so while I appreciate the discussion we're having today about this important topic, it's the wrong hearing to be having. the hearings that we have to be having is for my colleagues on the other side of the aisle to bring in first of all this gentleman Mr.
▶ 2:40:34Brad Smith who is the Doge healthc care lead uh under Elon Musk and I'm going to read from reporting this morning I believe in Politico. Brad Smith co-founded a teleahalth startup called Carebridge in 2019 before in 2021 founding Russell Street Ventures and later Main Street Health a rural focused provider network. He has since sold CareBridge but he remains tied to Main Street Health which is subject to regulation by CMS.
▶ 2:40:59So he his companies are subject to regulation by CMS and he is the one who is running the reductions in force across health and human services. He worked closely with senior CMS officials in crafting the reduction in force plan ultimately incorporating suggestions that reduced the overall impact on the agency. A contrast from other HHS agencies where he played a smaller role according to one of the people familiar with the matter. Smith and his top aid Rachel Riley quote keep everything close to their chest. the playbook isn't clear whereas everything else is.
▶ 2:41:30They are isolationists. I would love to bring in Mr. Brad Smith and in a bipartisan format talk about whether there's perhaps a conflict of interest in having the person whose companies whose whose uh business career that he's taken a sobatical from is subject to CMS. There's a conflict with that when he works with the CMS regulators to spare their jobs in the cuts that he's in charge of.
▶ 2:41:58Does that inspire confidence amongst any of you that you are working with regulators who are not subject to fear or favor but are following the evidence? Do any of you think that that is a good way for the federal government to inspire confidence in the business community when someone who could be a competitor of yours for all we know, who knows what his venture capital firm is going to do next, is going to get preferential treatment by CMS for billing codes and reimbursements. Is that the kind of climate that we want to create in a free and open market here in the United States? I don't think so.
▶ 2:42:28I'd also love to ask him about his views on efficiency because one of the great stupidities of Doge's actions in healthcare has been conflating the concept of efficiency with return on investment. When you cancel the lease for the Office of Pharmaceutical Quality in St. Lewis that employs some of the most highly trained scientists in the federal government to detect toxins in the pharmaceutical supply chain. Are you saving a few million dollars in rent payments for the federal government? Sure. Yeah. Okay.
▶ 2:42:57You you you save some money. Does that have a return on investment when you now have toxins in the pharmaceutical supply chain that go undetected for years that lead to multi-billion dollar recalls that lead to toxicity and illness in the broader population? Over and over again, Mr. Brad Smith seems to think that taking a chainsaw to the gold standard uh culture and and organization of the FDA somehow is saving money.
▶ 2:43:26And what it is actually doing is it is a bad investment for the American people. This is the hearing that we need to be having right now. not talking uh about a great piece of bipartisan legislation that even if we get it right, he is going to take a chainsaw to anyway and my colleagues on the other side of the aisle won't stand up to him to do anything about it. So why are we even wasting our breath on legislation that won't be enforced? I yield back.
▶ 2:43:56The gentleman yields and I now recognize the gentleman from Michigan, Mr. James, for five minutes for his question. Thank you, Mr. Chairman. Michigan's 10th Congressional District is home to growing pharmaceutical manufacturers and packaging firms that play a critical role in getting safe and effective over-the-counter medicines to consumers. I've heard from small business owners like those at BMI Injection Molding just outside my district in Chesterfield, Michigan, who are struggling to keep up with the cost and complexity of FDA monograph updates.
▶ 2:44:26These firms don't have the compliance departments or uh the resources of big pharmaceutical companies, yet they're being hit with the same fees and the same paperwork. If we want American manufacturing to remain strong, if we want pharmaceutical independence, we need to ensure that these businesses can stay competitive. Mr. D.
▶ 2:44:46Ruiz, what specific challenges do smaller OTC drug manufacturers face in keeping up with FDA monograph updates and how can we ensure that they remain competitive without excessive regulatory hurdles? Well, thank you for that question. Um, obviously the smaller companies because of their size and and and their income don't have the internal resources to uh have staff on board to to comply.
▶ 2:45:14But um at the same time you know there are organizations such as the personal care products council the u independent beauty association which provide that level of detail. Also small companies do not really have the capacity to own their manufacturing and generally go out to manufacturing contract manufacturing organizations.
▶ 2:45:36The contract manufacturing organizations are the ones that have registered that are responsible for complying with the GMP requirements under OTC drug regulations and those are the responsible parties in terms of ensuring that those drugs are manufactured according to the quality standards. The owner will be liable as their name appears on the product for any health related in incidences.
▶ 2:46:02So from that perspective, they need to make sure that the safety of the product that they sell are fully vetted out and most of the time they refer to outside consultants for that type of um kind of a virtual team to put together the package of information for that particular product and and that's how it generally works. So Mr. how can we here in this body how can we uh help with uh some of these excessive regulatory hurdles? What would your advice be?
▶ 2:46:30Well, I think you know outreach and communication are important, right? Um, one of the biggest issues with tons is people don't read the label, right? And that's and you reapply every two hours, right? Uh, and they don't know it's a drug. I mean, simple stuff like that in terms of outreach, communication, knowledge sharing, um, on both the industry side and on the congressional side. I think, you know, this is AMU, right? Um, is all about bringing new ingredients, right?
▶ 2:46:58We've provided the first one in the bucket. We paid the fee. We're under review. It's everything is working properly in terms of FDA engaging. I think if you make a few tweaks on the um the incentives, this could be a great program.
▶ 2:47:14Those would be the confidentiality again the the incentives in terms of exclusivity and then I think you would see a lot more innovation coming forward which would include the smaller companies which by definition are all about innovation. Right. Perfect. Thank you so much for that answer. I'm going to move on to Mr. Menzel. Mr. Menzel, um I just like everybody to know every parent in Michigan knows how essential OTC medications are from pain relievers to cold medications for their children.
▶ 2:47:43But if regulatory fees are driving up production costs, those expenses eventually get passed down to families at the pharmacy counter. At a time when families in Michigan are already dealing with rising costs, we need to ensure that regulatory policies aren't making it harder for them to access basic health care essentials. Again, Mr. Menzel, do you believe the current user fee structure is contributing to increased costs for consumers? and what steps can we take to ensure Americans continue to have affordable access to essential OTC drugs?
▶ 2:48:14Yeah, thanks for the question. Um, in terms of small companies, it whenever I started focused consumer healthcare, it didn't get smaller than zero dollars in stale in sales. So, I started at zero and then built it up. and with cough and cold medicines and and everything you just described. For us, it it works exactly the way uh the other witness testified is that um uh all those fees are paid by third party manufacturers.
▶ 2:48:39In terms of overall cost, if you think about a product, I mean, it's a $25,000 fee for the third party manufacturer. So, it's a distributed cost for us. Whenever OMUFA went into place, it did not um create a cost of goods increase. So the third party manufacturers did not increase their cost to us. So we did not increase our cost uh to the consumer.
▶ 2:49:02So I can speak my experience uh over the last 5 years there was no um cost of goods increase that was uh tagged to us that required us to increase price to the consumer. Um and so in my personal experience with with the company that I started and and with other members of the board of directors um with Consumer Healthcare Products Association, those were not issues that um drove up cost.
▶ 2:49:29Certainly COVID and everything else uh increased our cost of goods and decreased our margins. Um but but that was not one of them. Thank you everyone for your participation. Thank you, Mr. Chairman, for your patience. I yield. Thank you. The gentleman yields back. I now recognize the gentleman from Ohio, Mr. Lance, for five minutes. First Thank you, Mr. Chair, uh, and ranking member.
▶ 2:49:55As I've sat here over the last hour or two, it occurs to me that we are living in two different worlds. And this to this has to be um top of mind for for all of you.
▶ 2:50:10I mean, in one world, everything is normal and we can have a legitimate conversation about over-the-counter drugs and sunscreen and what we can do to help American companies and innovation and provide safe products to Americans.
▶ 2:50:32But then we live in this world, this other world where the world's richest and the largest donor arguably having given hundreds of millions of dollars to Trump and and and and my colleagues on the other side of the aisle, he's burning the government to ground.
▶ 2:50:58So, as we we we're sitting here having we're trying to have a normal conversation about sunscreen and 10,000 public employees at the Department of Health and Human Services, public employees who are dedicated to our health and safety have been fired. Thousands from the FDA.
▶ 2:51:23The FDA is ostensibly a different broken now organization just in a matter of hours. And we've heard about the lines outside of the building just down the street where they don't know workers don't know whether or not they've lost their jobs. They're going to find out when they swipe their cards.
▶ 2:51:49And I I just at some point we have to pretending that we're living in any other world than the world in which it seems as if a foreign adversary has taken over the federal government, crashed the economy, is burning the federal government to the ground, upending our relationships with uh you know countries all over the country
▶ 2:52:21And focus entirely on that. Mr. Faber in the wake of 10,000 people losing their jobs, 3,500 at the FDA, will food safety get better or worse?
▶ 2:52:45Because virtually none of our food safety funding is generated by user fees, those people will be the people who are most likely who will most likely lose their jobs. The the people who make sure our food's safe by inspecting it, by running labs, by looking for pathogens, by alerting industry when pathogens are present, by alerting us when pathogens are present. All of those people were likely fired today.
▶ 2:53:17So with that in mind, is food safety going to get better or worse? Much Baby formula you talked about, safer, less safe? Less safe. The approval of of over-the-c counter drugs, is that going to be slower or faster? Much slower. devices, uh, the approval of those devices slower or faster? much slower.
▶ 2:53:45The safety of those medical devices less Consumer choice, is that going to go up or down? Consumers will have fewer choices and we'll be taking more risks. Vaccines, are we going to is that going to be undermined our ability to provide meaningful vaccines across the board? Firing thousands of people will do nothing to address the safety of our of our vaccines.
▶ 2:54:11Innovation in the United States, especially in the context of food, drugs, medical devices, innovation, is it going up or down because of these firings? All of the companies that are sitting here before you with innovative new products will have to wait longer to offer them to our consumers. If there are fewer products and fewer people checking to see the safety of those project, determine the safety of those project.
▶ 2:54:40prices, less safety. Is that fair? Fewer products, riskier products and those prices will most likely go up for many reasons. Yes. And those products will be less safe. that many of the products that we count on that we bring in our homes every day, our food, our cosmetics are already pose unnecessary risks because we're not providing we weren't providing enough yesterday.
▶ 2:55:10They will be more dangerous because of the decisions that were announced today. That's the world we're living in. And I yield back. Gentleman yields. The chair now recognizes the gentleman from New York, Representative Langworthy, for five minutes of questioning. Thank you very much, Mr. Chairman. Dr. Ruiz, as you know, we're here today to examine how the FDA regulates over-the-counter drugs like sunscreen and identify areas for improvement.
▶ 2:55:36Uh, with skin cancer rates on the rise, consumers need broad access to these protective products. In my district in western New York and the southern tier counties, melanoma uh incidence rates are among the highest in New York state, soaring almost 64% above New York's average and 25% higher than the national average.
▶ 2:55:57Uh given these alarming trends ensuring the access to affordable and over-the-counter sunscreens, the most effective products that we can put forward uh and skin care is a public health priority. uh as far as I'm concerned. However, time and again FDA regulations have stood in the way of innovation and evolving science. Dr.
▶ 2:56:20Ruse, uh given these challenges, what steps can the FDA take to modernize its regulatory framework to ensure Americans have access to the most effective and up-to-date sun protection Um, well, I think the situation we're in right now is unacceptable. There are only two ingredients that are generally recognized as safe and effective, right?
▶ 2:56:47And these ingredients put at a disadvantage people of color in that people of color do not want to have a white cast on their skin and therefore won't use it. So, they're more susceptible to getting skin cancer.
▶ 2:57:02Imperatively we need to change the system to bring more innovation and to protect all people of different skin types melanin rich or not and providing FDA with the information in terms of what's going on in the rest of the world in terms of how they regulate sharing that bringing in the new science which is already being used by other government agencies in the United States such as EPA today such as
▶ 2:57:32a center for food drug. Uh that is the most important thing we can do in terms of protecting our people and in New York City. I'm in New York. I grew up in New York City. So I I appreciate that. Um we need to do something about it because skin cancer is the largest cancer in the United States with the most prevalence and the most morbidity and mortality if it's not treated.
▶ 2:58:00And the the beauty of it is that it's preventable, right? So if we can prevent instead of treat the disease, we're in a much better state altogether. So I think that's kind of my my view. Very good. Uh on quality asurances, Dr. Mensel, uh like the supply chain for prescription drugs, the over-the-counter supply chain is complex. It requires raw materials, active pharmaceutical ingredients, inactive ingredients from sources all over the world.
▶ 2:58:27Uh consequently, quality assurance in this area can be complicated and over the past few years uh we've seen a number of quality related import alerts for over-the-counter monograph drug products. Uh Dr. or Mr. Mr. Mensel, what do you see as the most significant quality control challenges faced by the over-the-counter manufacturers? And what opportunities do you see for AMUFA 2 to focus on strong quality controls that can address these issues?
▶ 2:58:58Yeah. Um, I would say first of all, I think the industry as a whole regulates themselves very effectively. Uh, as I mentioned, I started out as a very small company, but we're proud that we, uh, have no quality issues and, you know, self-regulate very effectively. Um, we monitor batch releases for all the products that are released to make sure that, um, everything is safe and effective before it gets released.
▶ 2:59:22And, and that's the the situation, I think, with the high high percent of uh, of companies uh, that are being represented here by CHPA. Um I do think that one of the issues are these these uh manufacturers that are in a rears. That's an easy an easy target list. Um that should be targeted. Uh typically the the companies that haven't paid their fees are also the companies that are having these quality issues. And so that would be an easy target list.
▶ 2:59:51As mentioned, this could be public uh published. It could be a uh an initial target list that the FDA could go after to monitor facilities and uh and determine if if they're actually, you know, meeting quality requirements. But I would say overall the quality system within the FDA is is is first in class. It's a gold standard and companies that adhere to those um have maintained safe and effective products for the US consumers. Well, thank you very much.
▶ 3:00:17Modernizing regulations and strengthening quality control are essential to asssuring the safety and accessibility of over-the-counter drugs. And I look forward to working with my colleagues here on the committee to reauthorize AMUFA. And I thank the witnesses for being here today. And I yield back, Mr. Chairman. Gentleman yields. The chair now recognizes the gentle lady from Massachusetts, Representative Trhan, for five minutes of questioning. Uh thank you, chair. Thank you, ranking member. Uh and also to our witnesses here today.
▶ 3:00:44Um, the over-the-c counter monograph uh user fee program is not a partisan issue. Uh, it's a common sense industry supported initiative that keeps Americans safe, helps manufacturers bring new products to market faster, and ensures that the FDA can do its job efficiently. Now, I believe we've all been pretty clear on one thing, however.
▶ 3:01:07Elon Musk gutting the FDA um puts the very foundation of user fees risk. Now, we know what that means. It means fewer resources for inspections, slower responses to emerging safety concerns, and a regulatory system that just won't keep up with innovation. What happens when you the FDA? Well, more dangerous drugs are put on shelves.
▶ 3:01:34More consumers are exposed to untested, contaminated, or fraudulent med medications. More delays in approving new affordable over-the-counter treatments. So, so much for the MAHA movement. We've seen what happens when public health protections are weakened, whether it's the baby formula crisis, the rise in tainted medications, or the failure to catch deadly contaminants in common OTC drugs like sunscreen. Mr.
▶ 3:02:00Faber, can you just provide examples of past public health emergencies such as contaminated OTC drugs or recalls that were successfully managed due to proper FDA funding and what the consequences might have been without those resources? Well, there are so many examples of where postmarket surveillance has allowed us to quickly identify the source in particular of contaminated food.
▶ 3:02:26We're all we can all think of recent examples with cucumbers and onions and carrots and and it was having that postmarket infrastructure in place that was able to identify the source of contamination quickly address it quickly tell consumers take that out of your fridge that saves lives.
▶ 3:02:45So, while inspectors are really important and having properly trained inspectors is really important, having those people who are on the lookout for pathogens and then working with companies and ultimately consumers to get that stuff out of our pantries and refrigerators saves lives. A lot of the people who do that work were fired today. Yeah. And as a mom, I am uh totally reliant on those alerts uh when they when they do arise.
▶ 3:03:11And if Republicans argue that cutting red tape means reducing government oversight to promote efficiency and innovation, how do they justify weakening the FDA's ability to regulate OTC drugs given that that could lead to more consumer lawsuits, product recalls, and public health crisis? I mean, wouldn't the increased legal battles, the medical costs, the emergency interventions ultimately create more bureaucracy and inefficiencies rather than streamlining the system?
▶ 3:03:42The FDA plays a critical role in maintaining the safety and credibility of American OTC drugs, ensuring they meet high standards for consumers both at home and abroad. With the FDA playing a critical role in ensuring the safety and credibility of American OTC drugs, what would weakening its oversight mean for consumer trust and international market acceptance?
▶ 3:04:06Well, consumers until today depended on the FDA to make sure that their sunscreens were safe and effective. They're counting on the FDA to review the applications from companies like DSM to so that we can all be confident that these new ingredients are not only safe to put on our bodies, but they're effective at blocking the sun's harmful Today, the administration greatly undermined consumer faith in the judgment of the FDA by firing 3,500 staff without
▶ 3:04:36a plan. We don't know who's going to do those reviews. We don't know how they'll be done. We don't know which science they'll rely upon. That's what consumers need answers for. I appreciate those. And I never expect to have enough time, but I did want to ask one more qu question. Would a because we're going to be marking up and working on a bunch of uh bills tomorrow.
▶ 3:04:59I'm curious, would a gutted FDA be able to effectively regulate new categories of OTC drugs such as nlloxxone for opioid overdoses? Are we risking unnecessary delays in access to life-saving medications? Absolutely. Thank you, Dr. Faber. Thank you. I yield back. The gentle lady yields back. The chair now recognizes gentle lady from from Florida, Representative Kamik for five minutes of questioning. Well, thank you, Mr.
▶ 3:05:28Chairman, and thank you to our witnesses for being here today. In 2020, Congress took an important step uh by finally replacing a decades old outdated rulemaking process, as you know, with a more modern framework under the car's act. Now, this provided FDA a new administration administrative order system and resources to update monographs faster, supporting safe innovation in over-the-counter drugs. Now, this was a step in the right direction as we can all agree, but clearly we have a lot of work to do.
▶ 3:05:58So, even with this in place, we're hearing that innovation is still being stalled. Responsible companies are navigating a maze of delays, unclear guidance, and inconsistent enforcement. Meanwhile, bad actors continue to exploit loopholes, avoid user fees, and benefit from data that they didn't generate. So whether it's sunscreen, and there has been a lot of talk about sunscreen today, vitamins or everyday cold and flu products, Americans deserve access to safe, effective, and up-to-date options.
▶ 3:06:26And manufacturers need a regulatory system that is efficient, fair, and importantly predictable. So, as we look to reauthorize, I'm interested to hear in how we can continue to improve the system, cut red tape, protect consumers, and reward responsible innovation. So, I'm going to jump in with you, Mr. Menzel. Given what you've said about the number of facilities not paying for the fees uh and the link to poor quality products, it raises real concerns about enforcement.
▶ 3:06:55In your view, how can Congress ensure that the FDA is fully using it its existing authority to crack down on non-compliant manufacturers? That's the first part. Second part is what steps can be taken to reinforce program integrity without adding new burdens to the companies because that always seems to be the answer. Just throw more at them, right? Um that are already doing things the right way. Yeah. Thank you.
▶ 3:07:22I I think that the first and obvious is what we're all I think in alignment on today which is reauthorize AMUFA. Um I think that you know that first step I think is is essential. Um whenever you think about the the Arers list I mean I think there's u we've already mentioned three or four obvious items in terms of publishing the list uh giving FDA guidance on what to do with those companies inspections priority inspections for those companies.
▶ 3:07:48I think that would um move that along very quickly and I think this committee can give guidance to the FDA as as it's related to to the AR's list. Um and uh your second question was uh so the second part was you have companies that are already doing the things the right way. We don't want to punish them by putting additional burdens on them to try to capture those companies that are not uh in compliance. How can we handle that? Yeah.
▶ 3:08:16And and I think that's it's it's an incredible incredibly important point that we need we don't need more uh regulation uh as it relates to this. Um and so there needs to be predict predictability. The AMUFA program allows predictability. The Monograph program allows predictability, allows for innovation, allows for speed. Um I think there's some some gaps that we've all discussed um that can be fixed and I don't need to revisit those.
▶ 3:08:45Um but those those key items, predictability, speed, and allowing for innovation go along with uh not increasing uh regulations. Okay. Uh Mr. D, am I saying this right? Dere, did I say that right? Sorry. Um now I know that sunscreen has gotten a lot of air time today as I mentioned. And listen, I'm a Flidian. I'm basically clear. I get it. I look at the sun, I burn. I I I hear everyone loud and clear.
▶ 3:09:15It's an important issue certainly for folks back home. Um but I want to get to the core issue when we're talking about this. No new UV filters have been improved since 1992. I was born in 1988. So since I was four years old, despite repeated input from industry and experts. So what is actually preventing FDA from adopting that input and moving forward? And what tools do we need the incentive?
▶ 3:09:46What do we need in order to fix it? Yeah, it's been a long time especially for me. I've been working on way to make me feel seven. Um so so yeah it's been a long time and you know there've been various iterations in the law with the you know time extent application the sunscreen aviation act culminating now with the cares act and a mufa right so now finally after all these years we know what's required we know what they need and we also know that what they need doesn't quite jive
▶ 3:10:16with what's going on with the rest of the world and if you do do the animal testing then you are shutting yourself out from being able to compete in the rest of the world which had animal testing bands. There are alternative ways of assessing risk which the industry has provided FDA with a framework. We have done a lot of the leg work.
▶ 3:10:38Now it's a matter of looking at what's that framework is how it can be applied and we've conducted this using international experts experts that are experts in carcinogenicity developmental reproductive toxicity and these will submitted to the monograph in terms of the docket but FDA is still relying on the existing framework which was requires the animal testing if we were be able to work through that I think we will be able to make a lot of headway in terms
▶ 3:11:09of moving forward and this will be something that we collaborate with working tandem in terms of our people know sunscreens. We do all the testing. We know how to formulate. We create the molecules. We can provide a lot of the data that they require in order to make decisions more efficiently and effectively. But we need the incentive to do that. And I think Thank you. Thank you. Thank you. I yield, Mr. Chairman. Gentle lady yields. The chair now recognizes a gentleman from New Jersey, Representative King, for five minutes of questioning.
▶ 3:11:40Thank you, Mr. Chairman, and thank you to our witnesses for being here today. I'm very interested in hearing how we can ensure and strengthen predictability of the approval process for the over-the-counter drugs. Mr. Manzel, first I want to highlight the strong presence that the over-the-counter product manufacturers have in the great state of New Jersey.
▶ 3:12:03These are several companies headquartered in the state and even more who have manufacturing and development presence there. These companies not only spur innovate in innovation nationwide, but they provide jobs and live livelihoods in New Jersey. I often highlight the great work done by prescription drug companies in New Jersey. I do want to acknowledge the innovation that your member companies produce. We see these products on store shelves every day. We use them to help our kids feel better in their childhood years.
▶ 3:12:32So, I want to thank this New Jersey industry for its wonderful work. My questions first, can you explain how the OTC user fee program established by Congress in 2020 has helped drive innovation and growth in your industry, especially in New Jersey? And second, what pitfalls should Congress avoid as it moves to reauthorize the program for the first time?
▶ 3:12:56the uh the guidance that was given by OMUFA which many members of this committee were were were critical to to getting approved initially provides for predictability and allows for that predictab predictability allows for innovation.
▶ 3:13:13Uh I was actually a part uh in a previous life a number of years ago of one of those fine New Jersey uh companies uh before starting my own company and uh and I can say that uh having a structure and a framework that a MUFA provides that the monograph system provides allows for that innovation. Um I think some of the some of the issues that you that you ask on how to improve some of that is timing.
▶ 3:13:36uh reauthorization of A M A M A M A M A M A M A M A M A M A MUFA 2 would allow for um some of the infrastructure that's been put in place to uh to be capitalized on um but then additional transparency uh from the FDA uh in terms of timing and and publication of notices etc as we've mentioned is also critical for success over the next five years. Thank you. Um, on a separate topic, I also serve on the House Foreign Affairs Committee.
▶ 3:14:03So, I'm aware that many industries have global supply chains even as they are currently trying to move more of these supply chains to the United States. Could you give me an update on the exposure that OTC product supply chain has abroad and what Congress can do to strengthen that supply chain? Yeah, it's an important issue. It's it's an important issue in terms of safety.
▶ 3:14:28Um it's an important issue for us to make sure that we don't run out of stock if there are issues in terms of the the supply chain. I will say for us personally um we um we have uh initiated a pretty large investment in Georgia um to increase onshore uh manufacturing for some of our products. We also have two products that we uh we just initiated a technology transfer from Canada uh into the US um to to increase US uh manufacturing.
▶ 3:14:58Um and so you know both of those items are are not unique to us and within the consumer healthcare products association uh and a poll of members uh the majority of products are actually already manufactured in the United States. Um, a key aspect of consumer products is transparency and pricing. You know, I I have products that sell for $4 or $5 a bottle.
▶ 3:15:25Um, I can't just all of a sudden decide to charge the consumer $100, you know, for that same that same bottle. And so, we have to be efficient in terms of our supply chain. And some of that efficiency is why we're looking at sourcing in the United States. Thank you, Mr. D. weeks. Uh, and before I I get to my question, I want to acknowledge the presence that DSM Formanish has in the great state of New Jersey and the great work that your company does there.
▶ 3:15:54My understanding is your company's New Jersey work relates more to multi, excuse me, to nutritional products and not to OTC products. I still want to highlight what you do in New Jersey. I know that many of my colleagues have already asked about how the FDA's approach to the approval of sunscreen filters and ingredients has hindered innovation.
▶ 3:16:13However, I want to focus on um on New Jersey and ask how these actions by the FDA have affected DSM firm initi's business and to be able to reinvest in other product lines like those in New Jersey. Yeah. So, being from New Jersey, I think we're leading the way. Okay. We are the only brave company to stand out amongst everyone else that has decided to take the bull by the horns and do what FDA has required.
▶ 3:16:43We paid the user fee. We're the first company to do the Omar. We are setting the standard and the pace of what's required for public health and we're pretty proud of that. And I think in all everything we do, it's all about the desirable, the obtainable, and the sustainable. And I think that's our company DNA.
▶ 3:17:01And as long as we can continue to provide this as we do for all consumers throughout the United States being based out of New Jersey, as you said, I think we're doing a service to everyone in the United States. Thank you. I yield back. The gentleman yields. The chair now recognizes the gentleman from Ohio, Representative LA, for five minutes of question. Well, first, uh, Mr. Chairman, thank you very much for allowing me to wave on to the subcommittee today. Greatly appreciate it. And to our witnesses, thanks for being with us today.
▶ 3:17:31The over-the-counter monograph drug user fee program at the Food and Drug Administration has produced more than 100,000 safe and effective drugs, giving consumers access to manage their own care in a safe and affordable manner. The AMUFA program has also reduces the number of visits consumers need to make to a doctor to obtain a prescription for a simple treatment, reducing the burden on our health care systems. Mr.
▶ 3:18:00Mensel, if I can uh start with you, the AMUFA program has increased access and choice for consumers. Could you provide examples of how this is beneficial to the public within the United States? Yeah, absolutely. But before I do, let me let me recognize yourself and and Miss Deed and and uh and Krenshaw and Dingle um for uh leading the initial OMUFA charge. I think that's incredibly important.
▶ 3:18:29And and just to reinforce that, you know, so that everybody uh is reminded that this was a 10-year process uh to get approval, a bipartisan process with a lot of negotiation to move forward to the point at which we are now.
▶ 3:18:44Um so I think you know in terms of the uh the benefit to the US consumer um one of the items that I think continually needs to be reinforced is for every dollar uh spent in in this space on over-the-counter medicines it saves the um the United States um system $7 um in terms of doctor visit cost savings, pharmaceutical alternatives to pharmaceutical cost savings.
▶ 3:19:11Um, and the other thing that self-care does is it allows for a shrinking of um of these uh these health care deserts um where access um would be limited not just rural areas but also urban areas that um that are limited by access to health care. Um so this has been a this has been a fundamental bipartisan approach that's u that that I should think should be highlighted especially uh in the days that we're now in.
▶ 3:19:38and um and so thanks thanks to you and the other members that were a part of this. Well, and again, just to follow up, why is it so important for Congress to get this reauthorized and get it reauthorized now so that it can keep moving forward? I mean, I think we've we've laid the the the groundwork uh with the first five years, I think we're going to reap the benefits over the next five years is the way I see it.
▶ 3:20:02Well, you know, uh, as I mentioned a little bit earlier, when you look at the, uh, there's over 300 active pharmaceutical ingredients in more than a 100,000 OTC products. You know, when you think about that, just those numbers alone and what you'd mentioned about $1, putting $1 to save seven is is a tremendous benefit to the public, right? And and again, just, you know, we kind of know this, what would be the effect to the consumer if this doesn't get reauthorized?
▶ 3:20:28Because again, when you look at the number of of the ingredients out there and the number of products, what would happen to all those products out there if the consumer on that on that shelf in the in the drugstore You know, I if the if if this process wasn't reauthorized, I think you limit future innovation. I mean, I think that's the that's the the the fundamental aspect of it as as it relates to the current products on the shelf.
▶ 3:20:55I mean, how devastating to the public could that be if, you know, those 100,000 products weren't potentially available? Um, but future innovation, you know, companies like mine and as well as other companies being represented, um, are constantly innovating. You know, we're looking to put out new products every year, uh, every quarter, uh, for the consumer. That's why that's how effective companies continue to grow and, um, and this predictable process is what allows for that.
▶ 3:21:23Well, and see that's a fear of mine because again we want to make sure things are done in this country. We found out from CO how bad our supply chain uh really is and when you think about what you just said about the innovation that's that's the great thing about the energy and commerce committee. We we touch so many different areas but innovation is one of the things we talk about in this committee at all the time where where the innovation occur if it wasn't occurring in this country if we didn't give that ability for these companies to go out and innovate.
▶ 3:21:51I I mean I don't think it would occur. I think we this industry along with other industries I think the US is is the the lead horse in terms of driving innovation and so I don't believe that um that without us uh driving that without this predictable process that the innovation would would occur at the same pace. Well, thank you very much and again to our witnesses, thanks very much for being here. Mr. Chairman, I yield back the balance of my time. The gentleman yields.
▶ 3:22:18At this time, I ask unanimous consent to insert into the record the documents included on the staff hearing documents list. Mr. Chairman, does that include the letter I had requested? Yes, it does. Thank you. Without objection, that'll be the order. I'd like to thank our witnesses again for being here today. We appreciate you and appreciate you taking time out to be with us. Members may have additional written questions for all of you and I ask that you respond to those in writing.
▶ 3:22:47I'll remind members that they have 10 business days to submit questions for the record and I ask the witnesses to respond to the questions promptly. Members should submit their questions by the close of business on April 15th. Without objection, the subcommittee is adjourned.