Last week, Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. announced an impending reduction in force (RIF) of approximately 10,000 positions, including about 3,500 Food and Drug Administration (FDA) employees. On Tuesday morning, countless FDA workers were notified that they had been let go from the agency, with no reason given.
Although HHS says it did not target FDA product reviewers or inspectors, FDA employees who assist with reviews in various capacities were let go, including project managers and staff in administration, policy, communications, and logistics positions. This workforce reduction will likely affect a wide range of FDA regulatory activities, such as:
- Evaluating NDAs/BLAs and supplements, including for drug labeling
- Developing and issuing regulations and guidance
- Formulating and communicating policies, including responses to petitions and public inquiries
- Issuing external communications, including drug safety communications and recall notices
- Tracking user fee performance and preparing for user fee negotiations
Notable recent departures include CBER Director Peter Marks, CDER Office of New Drugs Director Peter Stein, the agency’s Chief Medical Officer and Chief Information Officer, and Deputy Directors in the Oncology Center for Excellence. FDA’s leadership page also indicates a vacancy for the FDA Chief Counsel, indicating that Hilary Perkins, who resigned days after being named to the position, has not been replaced. Key CDER components significantly affected by the layoffs include the Office of Executive Programs, which manages informal dispute resolutions between industry and FDA, as well as internal CDER scientific and review issues, the Office of Prescription Drug Promotion, and the Office of Compliance.
Late on Tuesday, Scott Steele, Ph.D., a CBER senior advisor, was named acting director of CBER.
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