OTC Monograph Drug User Fee Transparency Act

This bill amends the Federal Food, Drug, and Cosmetic Act to increase transparency and reporting requirements for over-the-counter (OTC) monograph drug user fees and activities.

Sec. 2, OTC monograph drug performance reports: This section expands the annual performance report from the Food and Drug Administration (FDA) to include, starting in fiscal year 2026, detailed progress on achieving goals, such as the number of Tier 1, Tier 2, specified safety, and generally recognized as safe and effective OTC monograph order requests for which proposed or final orders were issued in the previous fiscal year, as well as average processing timelines and postmarket safety activities. The report must also include information on registration of OTC monograph drug facilities and contract manufacturing organizations, and whether facilities assessed a fee paid it. The section also requires the FDA to make publicly available, within 30 days, robust written minutes of all negotiation meetings with the regulated industry, detailing substantive proposals and significant controversies. Additionally, it requires the Comptroller General to submit a report to Congress within two years assessing the supply chain of OTC monograph drugs, including stability, information collected by the FDA, how the FDA uses that information, coordination with other federal agencies, and unique marketplace characteristics.