FDA User Fee Talks Offer Clues on Upcoming Reforms
Healthcare & Life Sciences Team members Michael Werner, Parker Reynolds, Sara Klock and Jordan Brossi collaborated on a Law360 article examining the U.S. Food and Drug Administration's (FDA) user fee act reauthorization process and the policy issues likely to shape the next cycle for drugs, devices, generics and biosimilars. They explain how the user fee framework has evolved since the Prescription Drug User Fee Act's (PDUFA) enactment in 1992 to fund FDA review activities, support performance goals and serve as a recurring vehicle for broader regulatory reforms. The article also identifies where the four major programs – PDUFA, Medical Device User Fee Amendments (MDUFA), Generic Drug User Fee Amendments (GDUFA) and Biosimilar User Fee Amendments (BsUFA) – stand in the current negotiation cycle and highlights issues under discussion. The authors additionally analyze how the Trump Administration's "America First" priorities may influence the negotiations, particularly through efforts to onshore manufacturing and align FDA operations with broader policy goals. They further note Congress may use the reauthorization package to pursue wider FDA reforms on topics such as clinical trial modernization, artificial intelligence (AI) and inspection processes. The article concludes by advising sponsors and stakeholders to engage early through hearings and legislative advocacy.
The authors also published a Holland & Knight alert on this topic.