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Senators question FDA on decades‑long delay approving new sunscreen filters
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Summary
Committee members pressed the FDA on why no new sunscreen UV filters have been approved since 1999 and sought timelines for the agency's current review and safety testing approach; acting CDER director said a new OTC order is under review and described testing expectations for systemic absorption.
Senators at a Senate HELP hearing pressed the acting director of the FDA's Center for Drug Evaluation and Research about why the United States has not approved a new sunscreen UV filter since 1999 and what steps the agency is taking to accelerate safe approvals.
Lede: "Is it correct that the FDA has not approved a new filter since 1999?" Senator Roger Marshall asked. Dr. Jacqueline Corrigan confirmed the factual point and told the committee that the agency has a proposed OTC monograph order under review for a new sunscreen ingredient.
Nut graf: The exchange highlighted scientific and regulatory considerations that distinguish U.S. sunscreen review from processes in Europe and Asia. Senators emphasized the public health value of broad sunscreen availability and pressed the agency for timetables and alternative testing strategies to evaluate systemic absorption and long‑term safety.
Details and agency position: Corrigan explained that sunscreen active ingredients are regulated as drugs in the United States because they are intended to prevent sun‑related skin damage and that ingredients with systemic absorption require additional testing. "Any drug that we approve that's topical but that has systemic absorption, we need to make sure that the systemic absorption has no untoward effects," she said, citing concerns such as endocrine disruption and tumor formation tests as part of required data packages.
Corrigan told senators the agency is reviewing an administrative order for a new sunscreen ingredient and will follow its planned timeline: a public comment period (45 days) and, for new ingredient reviews, a statutory review trajectory Corrigan said runs about 17 months. She added the agency is exploring alternative test methods and non‑animal approaches when validated.
Senators pressed for speed and safety. Senator Ashley Moody (R‑Fla.) noted high Florida sun exposure and tourism and called for an "expeditious" review; Corrigan said the agency will "review that on time" and meet the statutory goals for the submission under review. Senator Mike Marshall and others asked for clarity on the tests the agency requires and whether international use of other filters implies U.S. safety; Corrigan said international differences in classification and the absence of comparative effectiveness data mean foreign approvals are not a substitute for the FDA's required systemic‑safety data.
What's next: Corrigan said the agency will continue to request data from sponsors, pursue validated alternative test methods where appropriate, and complete the current monograph order review on its timetable. Senators asked for follow up on timelines and whether the agency can promote alternate test methods to accelerate review while ensuring safety.
Ending: The committee recorded bipartisan interest in quicker sunscreen approvals paired with rigorous safety data; the agency committed to follow up with additional details on its review timeline and testing expectations.
