Bill > S2513

This bill amends the Federal Food, Drug, and Cosmetic Act to enhance transparency and reporting for over-the-counter (OTC) drug monographs, which are standardized guidelines for drug classification and regulation. Beginning in fiscal year 2026, the Food and Drug Administration (FDA) will be required to provide more detailed annual reports that include specific information about OTC monograph order requests, such as the number of Tier 1, Tier 2, and safety-related requests processed, the average timeline for processing these requests, and postmarket safety activities. The bill also mandates that the FDA publicly share detailed minutes of negotiation meetings with the regulated industry within 30 days of each meeting, ensuring greater transparency about discussions and proposals. Additionally, the bill requires the Government Accountability Office (GAO) to submit a report within two years examining the OTC monograph drug supply chain, including an assessment of supply chain stability, information collection methods, regulatory decision-making, inter-agency coordination, and potential recommendations for improving the marketplace. The goal is to provide more comprehensive oversight and information about OTC drug regulation and market dynamics.

Health and Social Services

https://www.congress.gov/bill/119th-congress/senate-bill/2513/all-info