In our Venable FDA Pulse series, we report on critical developments within the Food and Drug Administration (FDA or the Agency) that may affect the Agency′s structure and stakeholder interactions. This week′s updates:
- The Return of CBER Director Prasad
- FDA Announces Its Choice for FDA Counsel
- FDA Budget Watch
CBER Leadership Update: Dr. Prasad Returns as CBER Director
In last week′s Pulse, we discussed the July 29 resignation of the Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad, M.D., M.P.H., from FDA, following mounting political criticism and disagreement with his handling of Sarepta Therapeutics′ gene therapy drug. In a rapid development, on August 9, the U.S. Department of Health and Human Services (HHS) confirmed to Endpoints News and other news outlets that Dr. Prasad has returned to serve as CBER director. Dr. Prasad′s return comes just days after FDA Commissioner Marty Makary, M.D., M.P.H., made comments suggesting Dr. Prasad could return to the Agency. It is unclear whether Dr. Prasad will resume his roles as FDA chief medical and scientific officer, which he also held prior to his resignation.
FDA Announces Its Choice for FDA Counsel
On August 4, FDA announced Sean Keveney as the Agency′s next chief counsel. The position of chief counsel had been vacant since Hilary Perkins resigned in March 2025. According to the press release, Keveney was most recently the acting general counsel of HHS. Robert Foster, who currently serves as HHS′s principal deputy general counsel and FDA chief counsel for Food, Research, and Drugs, will replace Keveney as the acting general counsel. The press release notes that the U.S. Senate held a hearing for the Trump administration′s nominee for general counsel of the HHS, Michael Stuart, on July 31, 2025.
FDA Budget Watch: Recent Developments
Earlier this month, the U.S. Senate passed an amendment that would provide roughly $7.02 billion in funding for FDA. By comparison, in June, the U.S. House of Representatives Appropriations Committee allocated $6.69 billion for the Agency in its Fiscal Year 2026 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act. We will monitor the Senate′s legislation as it moves through Congress and report any key changes that occur during that process.
Venable will continue to monitor all changes regarding the FDA and report any critical developments. If you have questions about how the contents of this article may impact you or your business′s interactions with the FDA, please contact the authors today.