Bill > S2491

This bill aims to improve the process for evaluating the safety and effectiveness of nonprescription drugs applied topically, with a particular focus on sunscreen. The legislation would require the Secretary of Health and Human Services to use more flexible evidence standards when reviewing active ingredients in topical drugs, including the ability to incorporate real-world evidence alongside traditional clinical trials. The bill also emphasizes reducing animal testing by requiring the FDA to consider and develop guidance for alternative testing methods within one year. For sunscreen specifically, the bill directs that any final administrative order on sunscreen ingredients must take into account historical safety data, the role of broad-spectrum sunscreens in preventing skin cancer, and the new evidence and testing standards. Additionally, the bill mandates that the Secretary submit annual reports for five years to congressional committees detailing the implementation of these new standards, including the number of sunscreen ingredient reviews and progress on alternative testing methods. The reports must also be published on the FDA's website within seven days of submission. By introducing these provisions, the bill seeks to make the drug review process more adaptive, scientifically comprehensive, and less reliant on animal testing.

Health and Social Services

https://www.congress.gov/bill/119th-congress/senate-bill/2491/all-info