Bill > S2292

This bill updates the Over-the-Counter (OTC) Monograph Drug User Fee program, which governs how the Food and Drug Administration (FDA) regulates and assesses fees for over-the-counter medications. The bill extends the user fee program through fiscal year 2030, establishes new fee structures and timelines for facility fees, and introduces several key improvements to the OTC drug regulatory process. Specifically, the bill creates new standards for evaluating active ingredients in topical drugs, allowing for more flexible use of real-world evidence and alternative non-animal testing methods, and establishes a more predictable process for converting prescription drugs to nonprescription status. The legislation also requires the FDA to provide more transparent reporting on OTC drug review processes, including details about order request processing, safety activities, and facility registrations. Additionally, the bill mandates a Government Accountability Office (GAO) report assessing the OTC drug supply chain and requires the FDA to develop guidance for sponsors seeking to switch drugs from prescription to nonprescription status, with the aim of increasing clarity and predictability in the regulatory process. The user fee program will be funded through fees paid by drug manufacturers, with specific revenue amounts and adjustment mechanisms outlined for fiscal years 2026 through 2030.

Health and Social Services

https://www.congress.gov/bill/119th-congress/senate-bill/2292/all-info