FDA drug and device user fee programs expire, threatening the agency's ability to review new medications

All four of the FDA's major medical product user fee programs expire on September 30, 2027: the Prescription Drug User Fee Act (PDUFA), Medical Device User Fee Act (MDUFA), Generic Drug User Fee Act (GDUFA), and Biosimilar User Fee Act (BsUFA). Together, these fees fund roughly 51% of the FDA's total budget — about half of all new drug reviewers are paid by industry user fees. If Congress fails to reauthorize by the deadline, the FDA cannot collect new user fees, severely curtailing its ability to review new drugs and devices. Every five-year reauthorization is also used as a vehicle to update FDA policy — from accelerated approval pathways to AI regulation and clinical trial requirements. HHS Secretary must submit the negotiated industry agreements to Congress by January 15, 2027; congressional debate will run through fall 2027.