S. 2513 — OTC Monograph Drug User Fee Transparency Act

This section amends annual performance reports on over-the-counter (OTC) monograph drug order requests and facilities under Section 744N of the Federal Food, Drug, and Cosmetic Act (FD&C Act) by (1) requiring, beginning in FY2026, additional details on FDA progress toward processing goals—including numbers of proposed and final orders issued for Tier 1, Tier 2, specified safety, and generally recognized as safe and effective (GRAS/E) finalization requests; average processing timelines by type; postmarket safety activities (e.g., adverse event review and surveillance under Section 760); and facility registrations and fees under Sections 510(c), 510(i), and 744M(a)—and minor conforming changes to existing report language; (2) specifying that such reporting does not authorize disclosure of confidential information prohibited under FD&C Act Section 301(j), 18 U.S.C. 1905 (trade secrets), or 5 U.S.C. 552(b)(4) (FOIA commercial information exemption); and (3) requiring FDA to post on its website, within 30 days, detailed minutes of all negotiation meetings with industry under subsection (d), including substantive proposals, controversies, and resolutions. Separately, this section directs the Government Accountability Office (GAO) to report to the Senate Committee on Health, Education, Labor, and Pensions and House Committee on Energy and Commerce, not later than two years after enactment, on the OTC monograph drug supply chain—including reported stability, FDA data collection and use, interagency coordination on disruptions, marketplace characteristics, and any additional authorities needed.