OTC Monograph Drug User Fee Transparency Act

This bill requires the FDA to publish detailed annual reports starting in 2026 about its processing of requests for standardized over-the-counter (OTC) monograph drugs. These reports must include specific metrics like processing timelines, the number of finalized orders by drug category, and safety monitoring activities. It also mandates that the FDA make public, within 30 days, detailed written records of all industry negotiations about these drugs. Additionally, the bill directs the Government Accountability Office to assess the stability of the OTC monograph drug supply chain within two years. The law primarily affects the FDA and the pharmaceutical industry by increasing transparency in regulatory processes for common OTC medications.