Drug user fees and SCORE Act

Over-the-Counter Monograph Drug User Fee Amendments

• Continues the FDA fee program: The bill would continue the Over-the-Counter Monograph Drug User Fee Program through fiscal year 2030. It changes how facility fee revenue is calculated, including allowing a one-time increase in fiscal year 2028, 2029, or 2030 if specified conditions are met
• Changes facility fee due dates: Facility fees would be due on different schedules for fiscal years 2026 and 2027, including two installments in fiscal year 2027. For fiscal year 2028 and later, fees would generally be due on or after October 1, subject to the timing of an appropriations act that allows fee collection and use
• Adds a type of testing request: A request to add or change a testing procedure for an over-the-counter monograph drug could qualify as a Tier 2 request if it reflects a recognized voluntary consensus standard for pharmaceutical quality. Tier 2 requests do not qualify for market exclusivity

1. Introduced
2. In committee
3. Reported▲ THIS MARKUP
4. Passed House
5. Passed Senate
6. Law

What’s next: a floor vote. None is scheduled.