OTC Monograph Drug User Fee Transparency Act

More FDA transparency for OTC drugs

If enacted, the FDA would expand its yearly OTC monograph report starting with fiscal year 2026. The report would list counts of proposed and final orders for Tier 1, Tier 2, specified safety, and generally recognized-as-safe-and-effective finalization requests for the prior fiscal year. It would show average processing times overall and by submission type. The report would describe postmarket safety work, adverse event collection, and the analytical and IT systems used, including activities under section 760. It would name facilities first registered under section 510(c) or 510(i) in the year and say whether each facility assessed a fee under section 744M(a) paid that fee. The bill would require the FDA to post written minutes of negotiation meetings on its website within 30 days, showing substantive proposals, major disagreements, and their resolution. If enacted, the Government Accountability Office would deliver a report within two years assessing the OTC monograph drug supply chain, the FDA’s data and use of it, coordination with other agencies, and any additional authorities or information needed to ensure supply stability.