OTC Monograph Drug User Fee Transparency Act

# OTC Monograph Drug User Fee Transparency Act Summary **What the Bill Would Do** This bill would require greater transparency and accountability for user fees charged on over-the-counter (OTC) monograph drugs. OTC monograph drugs are medications like pain relievers, cough syrups, and antacids that are pre-approved for safety and can be sold without a prescription. Currently, the FDA collects user fees from manufacturers of these drugs, but the bill would mandate more detailed public reporting on how these fees are collected, spent, and what they fund. **Who It Affects and Key Provisions** The bill primarily affects OTC drug manufacturers and consumers. By increasing transparency, it would allow the public and Congress to better understand the financial relationship between the FDA and OTC drug makers.

The specific provisions aren't detailed in the available information, but transparency bills of this type typically require detailed reports on fee amounts, allocation of funds, and how the money supports FDA operations related to drug oversight. **Current Status** As of now, the bill (S 2513) remains in committee and has not been voted on by the full Senate. It was introduced by Senator Tim Kaine (D-VA) in the 119th Congress. No further action has been taken on the legislation.