RFK Jr.’s FDA staff cuts claimed key user fee negotiators, threatening renewal talks with pharma: Reuters
Title
RFK Jr.'s FDA Staff Cuts Eliminate Key User Fee Negotiators, Jeopardizing Pharma Renewal Talks
Keywords
- RFK Jr.
- FDA staff cuts
- user fee negotiators
- pharmaceutical industry
- user fee reauthorization
- HHS restructuring
- Prescription Drug User Fee Act (PDUFA)
- drug review budget
- agency layoffs
- regulatory negotiations
Key Facts
- The FDA recently laid off approximately 3,500 staff members as part of broader Department of Health and Human Services (HHS) reductions initiated by Secretary Robert F. Kennedy Jr., with the goal of streamlining operations and reducing federal workforce size3.
- Among those laid off, at least 15 staffers directly involved in user fee negotiations with the pharmaceutical industry were dismissed, including both the head and deputy head negotiators for a key FDA user fee program2.
- These negotiators played a central role in talks to renew user fee agreements under the Prescription Drug User Fee Act (PDUFA), which allows the FDA to collect fees from drug manufacturers to support faster and more efficient product reviews2.
- User fees currently make up about 70% of the FDA’s drug review budget and nearly half of the agency’s overall budget, meaning disruptions pose major risks to FDA operations and the drug approval process2.
- The staff cuts have raised concerns about the FDA’s ability to effectively negotiate and renew critical user fee agreements with the pharmaceutical industry, potentially delaying drug approvals and undermining industry confidence25.
- RFK Jr. has acknowledged some necessary roles were mistakenly cut and stated there are plans for reinstatement, but uncertainty remains regarding timelines and the potential impact on upcoming negotiations and FDA credibility5.
- The mass layoffs are part of a larger HHS restructuring effort to reduce redundancy, consolidate divisions, and refocus agency missions, but have led to confusion, increased workloads, and concern among remaining staff34.
Sources:
2. https://www.fiercepharma.com/pharma/kennedys-fda-staff-cuts-claimed-key-user-fee-negotiators-threatening-reauthorization-talks
3. https://www.biopharmadive.com/news/hhs-layoffs-restructuring-kennedy-fda-cms-trump/743694/
4. https://www.politico.com/news/2025/04/04/confusion-and-despair-as-health-agency-workers-tally-their-losses-00272639
5. https://www.fiercepharma.com/pharma/fda-staff-cuts-could-hinder-drug-reviews-putting-agencys-critical-user-fee-programs-risk