News

FDA Reduction-In-Force expected to impact drug & biologic review and regulation, other operations

02 April 2025

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.

We are closely monitoring this sea change and are working with clients to develop strategies to navigate a rapidly changing FDA. We urge clients to carefully evaluate their ongoing work with CBER and CDER to assess the possible impact of these reductions and to conduct scenario planning around those impacts.

Authored by Lynn Mehler, Meredith Manning, Philip Katz, Komal Nigam, and Jason Conaty.