BioCentury
ARTICLE | Regulation

The case for scrapping user fees

Back to School 2025: In a better world, Congress, not regulated industry, would fund medical product regulation

August 13, 2025 12:49 AM UTC

Medical product user fee programs are the public policy equivalent of a gas: They expand to fill any available space.

Originally intended as a temporary fix to help FDA clear a drug review backlog, PDUFA and its offshoots — MDUFA, GDUFA, BsUFA, OMUFA, ADUFA, AGDUFA, and more — have become permanent fixtures. While user fees offer predictable funding insulated from the vicissitudes of a fickle Congress, in a better world, medical product regulations would be fully taxpayer-funded...