[{"_1":2,"_111":-5,"_112":-5},"loaderData",{"_3":4,"_26":27},"root",{"_5":6,"_17":10,"_18":19,"_20":21,"_22":10,"_23":-5,"_24":-5,"_25":10},"user",{"_7":8,"_9":10,"_11":10,"_12":-5,"_13":-5,"_14":15,"_16":-5},"roles",[],"isAuthenticated",false,"isPremium","planName","subscriptionStatus","featureFlags",{},"insightsBudget","isDevelopmentHost","userPreferences",{},"recaptchaSiteKey","6LcvOJcUAAAAAHsB-gPGfGktcRlKpH7OTIU_dMTD","isImpersonating","impersonation","affiliateStatus","isFreedomPortal","routes/v2/article/layout",{"_28":29,"_30":31},"notFound",true,"relatedArticles",[32,75,87,99],{"_33":34,"_35":36,"_37":38,"_39":40,"_41":42,"_43":44,"_45":46,"_47":48,"_49":50,"_51":52,"_53":54,"_55":56,"_57":58,"_59":60,"_61":62,"_63":64,"_65":66,"_67":68,"_69":70,"_71":72,"_73":72,"_74":72},"mediaId",6084384,"mediaKeyId","2916485-89dee193bd52234e641d61d6bc2a1721","parentId",2916485,"title","Witnesses press FDA and Congress to speed U.S. approval of new sunscreen filters, recommend non‑animal testing alternatives","audioSeconds",799,"startMs",2531000,"endMs",3330000,"viewUrl","/Search/View?dp=1&key=2916485-89dee193bd52234e641d61d6bc2a1721&start=2531&end=3330","thumbnailUrl","https://assets.pipeline.soar.com/2916485-89dee193bd52234e641d61d6bc2a1721/thumbnail_2531000.jpg","articleUrl","/articles/6084384/Witnesses-press-FDA-and-Congress-to-speed-US-approval-of-new-sunscreen-filters-recommend-nonanimal-testing-alternatives","mediaUrl","https://secure.pipeline.soar.com/6084384-ac3f1bdd7a9eef70e33020bb06e79883/orig.mp4?Expires=1770529686&Signature=PkQckrOgehEOuTaf8IFALj-cordXkseJ8id5VVF~PdUaKZSe51MDrYdI10TjQaD7r6~YVS8On0x0S9FAKT3cmOMeddPBzEiHZXu0lc0he6~qiZc27DioDfzPcZKzVRDH2fo~eZ0Uczp47RF066-eUkU-~E1specjgc0kY4zldleSiSbdXdCM1B-9nSlwdmg3ylYyXNLoYE~HnsTy-1Ce8QJLRDsayuYebi4k9LoUJNQtJalwVZcUQCRSnczHJN1eaZQPap57vktuy8xaqyC1~CO3JWAa65Aq08qzN4-7dUPkJgmJuxpbw-fRq6CIYM2WISPY6Vbv7nby10aFba6bKQ__&Key-Pair-Id=KUT5TJCACFTXG","author","U.S. House Committee on Energy and Commerce","date","2025-04-01T00:00:00Z","article","Advocates, manufacturers and environmental groups told the Energy and Commerce subcommittee that the United States has fallen well behind other countries in approving new ultraviolet (UV) filters for over‑the‑counter sunscreens and urged Congress and FDA to use the MUFA reauthorization to address testing requirements and incentives.

Kim Wiesick, director of advocacy for the Melanoma Research Foundation and lead for the PAS Coalition, told lawmakers that ‘‘the last time the United States approved a new over the counter sunscreen active ingredient was the 1990s,’’ and that limited filter options reduce Americans’ choices for formulations suited to different skin types and textures. She and others cited the public‑health importance of broader sunscreen access to prevent skin cancers.

The issue, witnesses said, rests on two regulatory barriers. First, FDA continues to require a ‘‘maximum usage trial’’ (MUST) and certain animal testing methods that are banned or not required in many peer countries; second, the lack of data protection and limited exclusivity under the monograph framework reduces firms’ incentives to pay the large costs of safety studies. Carl de Ruiz of DSM Firmenich, which has pursued a new UV filter through the monograph pathway, recommended wider acceptance of ‘‘new approach methodologies’’ such as in vitro, in silico and other non‑animal toxicology tools and closer alignment with international data‑protection practices.

Environmental Working Group’s Scott Faber and others argued that Congress could consider fee‑system changes to finance studies or give FDA authority to require or order studies where appropriate. Witnesses also urged that OMUFA reauthorization not relax safety standards but instead modernize the types of accepted evidence so that human real‑world data and newer toxicology methods can substitute for animal studies where scientifically valid.

Several members pressed witnesses on international experience and epidemiological evidence; witnesses said they could compile comparative safety and usage data from regulators such as Australia’s Therapeutic Goods Administration and European partners to help inform U.S. decision‑making. Panelists emphasized that broader, quicker access to suitable sunscreen formulations could increase use and help prevent melanoma and other skin cancers.

Ending: The subcommittee acknowledged that including targeted provisions in the MUFA reauthorization — on alternative test methods, data protection and clearer agency‑industry engagement — could accelerate safe sunscreen innovation for a wide range of consumers.","mediaType","Video","parentTitle","Health Hearing: Examining the FDA’s Regulation of Over-the-Counter Monograph Drugs","oneSentenceSummary","Patient advocates and manufacturers told the Energy and Commerce subcommittee that U.S. regulation has blocked new, internationally available sunscreen UV filters and urged alternatives to animal testing and the MUST human trial.","taxTitle","Energy and Commerce: House Committee, Standing Committees - House & Senate, Congressional Hearings Compilation, Legislative, Federal","taxId",1824,"location","","headline","shortSummary",{"_33":76,"_35":36,"_37":38,"_39":77,"_41":78,"_43":79,"_45":80,"_47":81,"_49":82,"_51":83,"_53":84,"_55":56,"_57":58,"_59":85,"_61":62,"_63":64,"_65":86,"_67":68,"_69":70,"_71":72,"_73":72,"_74":72},6084390,"House Energy and Commerce hearing urges timely reauthorization of OTC monograph user fee program",11478,696000,12174000,"/Search/View?dp=1&key=2916485-89dee193bd52234e641d61d6bc2a1721&start=696&end=12174","https://assets.pipeline.soar.com/2916485-89dee193bd52234e641d61d6bc2a1721/thumbnail_696000.jpg","/articles/6084390/House-Energy-and-Commerce-hearing-urges-timely-reauthorization-of-OTC-monograph-user-fee-program","https://secure.pipeline.soar.com/6084390-31a6633102fd518bf50d4ab78bbe4ffe/orig.mp4?Expires=1770529686&Signature=dVpWdRinqfUGSj8uizNPZoC-t9A2SImpr~Pex62GBD7FKnqxRRCei4TT44XEkJeUqIbr6Oz-UwbJg52uPjqU~~5YzfUrBo4lGS~3Tq~5GlcBEtlQ3XmMexmoaHVfNHjJT1H6K8mO15QaN6YuIhFRAjPMVFxHmCS02P3x6R7b8uzFU1dT7erg~iRkPkiTyKa6fqKw7sQsxE4CbSAWYxHuu~hl2EiIZP3Hs9i5iJtMaFLQJ-nnWtBzTfSOLztjdLoxsPZpCx9sw06Y78b1v3tjBrAPpU2lz5YkmBRAhYVZ~xaCGc~ub3el6airbEQHjJv4beaAhOWzsTG2aESHr196mw__&Key-Pair-Id=KUT5TJCACFTXG","The House Energy and Commerce subcommittee heard broad support from industry, patient advocates and scientists on the need to reauthorize the over‑the‑counter monograph drug user fee program, commonly called OMUFA or MUFA, which the witnesses said strengthened the FDA’s ability to modernize regulation of OTC medicines.

Witnesses, including Kevin Menzel, president of Focus Consumer Healthcare and a board member of the Consumer Healthcare Products Association (CHPA), told the panel that reauthorization is critical to preserve predictability and sustain investments in manufacturing and safety oversight. Menzel said OMUFA ‘‘provided FDA with dedicated resources to implement critical reforms’’ and supported a second five‑year cycle with additional full‑time employees and continued emphasis on surveillance and good manufacturing practice compliance.

The nut graf: the current statutory authority for OMUFA expires in September 2025. Without reauthorization, industry witnesses warned, planned staffing, surveillance and review targets could slow, and the regulatory predictability that underpins investment in U.S. OTC manufacturing could be undermined.

Members and panelists discussed several specific reauthorization priorities. Industry requested that OMUFA 2 maintain the standard of ‘‘generally recognized as safe and effective’’ (GRAS/GRASE), fund an FDA staffing increase the industry’s goals letter proposed (roughly 11 additional FTEs to reach about 112), and give FDA tools to address a roughly 200‑facility arrears list of registered monograph facilities that have not paid fees and which witnesses said correlate with poorer quality records. Menzel told the committee that resolving arrears and targeting inspections at nonpaying or low‑quality facilities would boost program integrity and product safety.

Witnesses also urged maintaining predictable, lean fee structures and clearer FDA‑industry communications to reduce delays. Douglas Trautman of the American Cleaning Institute asked for more timely, informal agency feedback during long studies to prevent regulatory uncertainty. Several witnesses said that OMUFA’s early years were focused on building infrastructure and that the next reauthorization should focus on delivering more final determinations and fostering innovation.

Panelists described consumer and system benefits tied to the monograph system: Menzel and others repeated widely used estimates that increased OTC availability reduces health care utilization and can save health system costs by enabling self‑care for minor ailments. Members from both parties stressed rural access and supply‑chain resiliency as reasons to keep a predictable regulatory pathway.

Ending: Committee members said they planned oversight on the agency and the reauthorization timetable; multiple members asked the administration for assurances that the FDA workforce and funding streams will be preserved so OMUFA can meet its performance goals.

","Members and industry witnesses at an Energy and Commerce subcommittee hearing urged Congress to reauthorize the over‑the‑counter monograph drug user fee program (OMUFA/MUFA) before expiration in September 2025, citing predictable funding, improved FDA capacity and industry priorities such as staffing, arrears enforcement and non‑animal testing.",{"_33":88,"_35":36,"_37":38,"_39":89,"_41":90,"_43":91,"_45":92,"_47":93,"_49":94,"_51":95,"_53":96,"_55":56,"_57":58,"_59":97,"_61":62,"_63":64,"_65":98,"_67":68,"_69":70,"_71":72,"_73":72,"_74":72},6084376,"Cleaning‑product group warns Congress about 'free‑rider' problem for antiseptic studies and flags California bill",224,2235000,2459000,"/Search/View?dp=1&key=2916485-89dee193bd52234e641d61d6bc2a1721&start=2235&end=2459","https://assets.pipeline.soar.com/2916485-89dee193bd52234e641d61d6bc2a1721/thumbnail_2235000.jpg","/articles/6084376/Cleaningproduct-group-warns-Congress-about-freerider-problem-for-antiseptic-studies-and-flags-California-bill","https://secure.pipeline.soar.com/6084376-a3a60713ed632ea7a66fb1f23c4cba0b/orig.mp4?Expires=1770529686&Signature=lrBbXq0xp9DHKiz4Jpq53YHeZdqk0mXxR-p1eOzYt6C4g6h1b5aR7KLrAh~UvL5-CLKdBW9OALD6TMk8A9WSGeArLwYtB-MuyWxThv-EA~2y75ytSDlQLw-sQ1bM7BSQc8yQN~SZ0lkCgLbHwjijpu3PVf5FUSKQvoIHCHJcq7~dJ12rwyn5YIh-xkOiMSxySgZ2Zj0PU-sCPvEXAzh5LjFIkwIkUJQ2ZhI91TmlQLEpEEmRFJcQ~XhCJG83BAubs6e9KXmRdx-nPQpq~BfvdpB2~JSTZK8AUF9dylBw5yIGSZo9Lid-Mpxx4aJZpqoEvC1MwbbsGPBqJpk-9160DA__&Key-Pair-Id=KUT5TJCACFTXG","The American Cleaning Institute (ACI) told the Energy and Commerce subcommittee that its members are spending significant sums to generate safety and efficacy data for topical antiseptic actives that FDA deferred for further study, but that the benefits of that research extend to non‑participating manufacturers who can continue to market products without paying for the studies.

Douglas Trautman, interim co‑CEO of ACI, described the ‘‘free‑rider problem’’: member companies are funding multiyear, multimillion‑dollar studies to satisfy FDA’s requests while other firms will benefit without contributing. He asked Congress to consider modifying facility or sponsor user‑fee treatment for companies that actively participate in data generation or to extend exclusivity periods for sponsors that fund the requested studies.

Trautman also warned that state legislation — citing California Assembly Bill 916, which would restrict certain antiseptic ingredients — can move faster than federal rulemaking and that clearer, timelier FDA communication about the status of deferred ingredients could reduce calls for state bans. ACI said the Federal Food, Drug, and Cosmetic Act contains preemption language that supports national uniformity for nonprescription drugs and that agency updates could reassure consumers.

Ending: ACI told the committee it will continue to supply data and urged congressional consideration of user‑fee or exclusivity adjustments and more regular FDA engagement to resolve deferred antiseptic monograph determinations without state patchworks.","Representing antiseptic suppliers, the American Cleaning Institute told the subcommittee that ACI members are funding costly safety studies requested by FDA while nonparticipating manufacturers benefit from the data; ACI suggested fee or exclusivity changes and urged more timely FDA communication in light of state bills such as California AB 916.",{"_33":100,"_35":36,"_37":38,"_39":101,"_41":102,"_43":103,"_45":104,"_47":105,"_49":106,"_51":107,"_53":108,"_55":56,"_57":58,"_59":109,"_61":62,"_63":64,"_65":110,"_67":68,"_69":70,"_71":72,"_73":72,"_74":72},6084380,"Lawmakers, witnesses warn HHS layoffs announced this week risk slowing FDA reviews and inspections",274,959000,1233000,"/Search/View?dp=1&key=2916485-89dee193bd52234e641d61d6bc2a1721&start=959&end=1233","https://assets.pipeline.soar.com/2916485-89dee193bd52234e641d61d6bc2a1721/thumbnail_959000.jpg","/articles/6084380/Lawmakers-witnesses-warn-HHS-layoffs-announced-this-week-risk-slowing-FDA-reviews-and-inspections","https://secure.pipeline.soar.com/6084380-8f6a55c6b060ab086ad7ad42618d56e1/orig.mp4?Expires=1770529686&Signature=Otd8xBK4XBYyrZfBZok3ul0JuLZWtk6Kv-qs0I1WV~sQsozL-tKxJb5Ld60zN0rRg7dgu~V4ayHLq-67w-YofxPPltrCSptFYQ0sx-kEBrj87kIY1Sm3gI1DX-mszHmiuxe7NV-8T8G5GJVqhyswLY9gGuAvyMXVUXSGl64KNbaQ5Us2EGNQumWO1oMNBvGCc35irmSonOQNL7bI6LZmF3g74InbIBqc-CYHguUPclT-33EIzevIgQkO4mVjWw01Gt0kk1Rzv6KHkiRYTgNZQCKsxKlvm4KwjExCY7yY8HW439vnvHElzgYq1OR8GfOBaHfiuYmO9dYAgpFSbZ38Ow__&Key-Pair-Id=KUT5TJCACFTXG","Several members used the OMUFA hearing to press immediate concerns about an administration reorganization and large layoffs announced at the Department of Health and Human Services that, they said, would materially affect FDA operations.

Representative Diana DeGette and Representative Frank Pallone said the administration’s planned cuts — described in testimony and press reports as including thousands of agency positions — risked delaying reviews, inspections and post‑market surveillance. Pallone called for prompt oversight hearings to compel the administration to explain the operational logic for the reductions. Multiple witnesses said they had confirmed staff already were being dismissed when they attempted to enter HHS offices.

Environmental Working Group’s Scott Faber said the reductions would ‘‘make it harder for FDA to do that work’’ and risked slowing approval timelines for drugs, devices and OTC products. Representatives and witnesses also highlighted the resignation of Dr. Peter Marks, former director of the FDA’s Center for Biologics Evaluation and Research; Representative DeGette read a line from his resignation letter that said, in her recounting, that Marks wrote, ‘‘truth and transparency are not desired by the secretary, but rather he wishes subservient confirmation of his misinformation and lies.’’ The committee made that letter part of the record at the request of a Democrat member.

Members and witnesses described concrete programs that rely on non‑fee funded FDA staff — food‑safety labs, cosmetic GMP development, post‑market surveillance and other support roles — and said those positions are not necessarily protected by fee funding. Witnesses warned layoffs of those specialists would increase inspection backlogs and slow final determinations that depend on cross‑team expertise such as biostatistics, toxicology and labeling review.

Ending: Members on both sides of the aisle said they would continue oversight and seek answers from HHS on the scope and operational impact of the announced reductions; several members said they would request documentation from the administration and invited FDA leaders to appear before the committee.","Members from both parties and several witnesses told the subcommittee that HHS’s announced workforce reductions, including plans to cut thousands at FDA, will disrupt reviews, inspections and public‑health functions; witnesses cited the forced departure of Dr. Peter Marks and asked for congressional oversight.","actionData","errors"]

Article not found

Witnesses press FDA and Congress to speed U.S. approval of new sunscreen filters, recommend non‑animal testing alternatives

House Energy and Commerce hearing urges timely reauthorization of OTC monograph user fee program

Cleaning‑product group warns Congress about 'free‑rider' problem for antiseptic studies and flags California bill

Lawmakers, witnesses warn HHS layoffs announced this week risk slowing FDA reviews and inspections