Over-the-Counter Monograph Drug User Fee Amendments

Key Points

• This bill extends the FDA's authority to collect user fees from manufacturers of over-the-counter monograph drugs for fiscal years 2026 through 2030. These fees fund the staff and technology needed to review common medicines like pain relievers and cold remedies, ensuring they are safe and effective.
• The bill creates a clearer, more predictable pathway for switching prescription drugs to over-the-counter status. It requires the FDA to issue guidance within 18 months on standards for approval, including how companies can show consumers can safely self-select and use the drug without a doctor's supervision.
• The bill updates how sunscreens and other topical treatments are reviewed by encouraging real-world evidence and non-animal testing methods. The FDA must issue draft guidance within one year on how sponsors can use nonclinical testing alternatives to animal testing for drugs intended for topical administration.
• To help prevent medicine shortages, the Government Accountability Office must submit a report by September 30, 2027 assessing the supply chain for over-the-counter monograph drugs, including what information the FDA collects and how it coordinates with other agencies to prevent disruptions.
• The bill adds new transparency requirements, including detailed annual performance reports on FDA progress reviewing OTC drug requests and public minutes of all negotiation meetings between the FDA and industry within 30 days of each meeting.