FDA Chief Calls for Lower User Fees as PDUFA VIII Negotiations Begin
Formal negotiations on the eighth round of the Prescription Drug User Fee Act (PDUFA VIII) are beginning in 2025, with a public meeting held on July 14, 2025, to discuss proposed recommendations for fiscal years 2028–203235.
The FDA is discussing possible changes to the structure and level of user fees it charges the pharmaceutical industry for drug review, signaling openness to reducing the current fee burden4.
FDA leadership, including the Commissioner and Deputy Commissioner, has indicated that reducing user fees may help address long-standing concerns about conflicts of interest that arise when industry pays large fees for product review14.
Recent FDA initiatives, including a launch of a pilot program aiming to speed up drug application reviews, are seen as reflective of the agency’s emerging negotiating position and its potential approach to PDUFA VIII1.
Significant staff cuts at FDA, including among user fee program negotiators, may affect the agency’s leverage and effectiveness during these critical negotiations with industry stakeholders2.
Sources:
1. https://www.skadden.com/insights/publications/2025/06/fda-commissioner-launches-pilot-program
2. https://www.fiercepharma.com/pharma/kennedys-fda-staff-cuts-claimed-key-user-fee-negotiators-threatening-reauthorization-talks
3. https://www.fda.gov/industry/public-meeting-reauthorization-prescription-drug-user-fee-act-pdufa-07142025
4. https://www.raps.org/news-and-articles/news-articles/2025/5/fda-deputy-commissioner-hints-at-potential-changes
5. https://friendsofcancerresearch.org/blog/pdufa-at-a-glance-enabling-innovation-and-timely-access-to-new-treatments/