OTC Monograph Drug User Fee Transparency Act

This bill makes the Food and Drug Administration (FDA) share more clear, timely information about over-the-counter (OTC) drugs. Starting in fiscal year 2026, the FDA’s yearly report must show how many OTC rule-change requests it proposed and finalized, how long reviews took on average, and what it is doing to track safety after products are on shelves. It also must list newly registered OTC drug facilities and whether each paid the required fees, while still protecting confidential business information .

The FDA must also post detailed minutes from its industry negotiation meetings within 30 days, including key proposals and points of disagreement. This helps the public see how decisions are shaped. In addition, a federal watchdog (GAO) must, within two years, report on the strength of the OTC drug supply chain and what more may be needed to prevent shortages and disruptions .

• Who is affected: Consumers who use OTC medicines; OTC drug makers and their contractors; the FDA.
• What changes: More public reporting on review speed, safety tracking, facility registration and fee payment; public minutes from FDA–industry talks; an independent review of the OTC supply chain .
• When: New report details begin with fiscal year 2026; negotiation minutes must be posted within 30 days of each meeting; the GAO report is due within two years of enactment .