OTC Monograph Drug User Fee Transparency Act

The OTC Monograph Drug User Fee Transparency Act would make several changes to how the FDA handles over-the-counter (OTC) monograph drugs. It would require the FDA to add a broad set of transparency and performance information to its annual report starting in fiscal year 2026, including metrics on how many monograph order requests are proposed and finalized across different tiers, processing timelines, and postmarket safety activities. It would also require disclosure about facilities that manufacture or contract-manufacture OTC monograph drugs and whether they pay associated facility fees. In addition, the bill would require the FDA to publish robust minutes of all negotiation meetings with industry within 30 days of each meeting. Finally, the Government Accountability Office (GAO) would study the OTC monograph supply chain within two years of enactment, detailing how information is collected, used, and what might be needed to ensure stability. The bill maintains confidentiality protections for sensitive information. In short, the bill markedly increases public reporting and accountability around OTC monograph processes and the supply chain, while opening negotiation discussions to public view and ensuring oversight by the GAO.