FDA Shake-Up: Vinay Prasad Exits Amid Tumult in Biologics Oversight

Resignation concept in a professional office setting | Image Credit: © Jane Kelly - stock.adobe.com

Vinay Prasad, MD, MPH, the controversial figure who briefly led FDAs oversight of vaccines, gene therapies, and blood products, has abruptly departed less than three months after his appointment (1). His sudden exit marks a sharp turn for the agency's biologics division at a time when regulatory stability is critical for biopharma stakeholders navigating complex approval processes.

Dr. Prasad’s tenure as director of the Center for Biologics Evaluation and Research (CBER) came at a pivotal moment. He had just begun advancing a regulatory overhaul that emphasized tighter standards for product review—especially around COVID-19 vaccines and cell and gene therapies (1). Prasad, a noted academic and critic of past US drug policies, also held the role of chief medical and scientific officer under FDA Commissioner Martin Makary, who appointed him on May 6.

"Dr. Prasad did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California to be with his family,” said Andrew Nixon, spokesperson for the Department of Health and Human Services in an email to Biopharma Dive (2). “We thank him for his service and the many reforms he was able to achieve in his time at the FDA.”

Shifts in drug review philosophy raise industry concerns

Dr. Prasad's leadership quickly drew attention from manufacturers and investors concerned about changes in the agency’s posture toward innovation. Unlike his predecessor, Peter Marks—who emphasized regulatory flexibility and oversaw the approvals of numerous COVID-19 vaccines and advanced therapies—Dr. Prasad signaled a stricter, more conservative approach (1). Within weeks, he began implementing tighter review standards and personally intervened in several high-profile decisions involving COVID-19 vaccines by Moderna and Novavax.

Industry watchers were particularly attuned to Dr. Prasad’s stance on gene therapies for rare diseases, where flexibility in clinical expectations has been essential for development (1). Attempting to clarify his position during a June FDA roundtable, Dr. Prasad said, “We understand that progress is not always made in a single leap. We will consider incremental steps forward, because those add up” (3).

Despite those assurances, FDA decisions during Prasad’s tenure were notably more conservative. In July, the agency rejected a Duchenne muscular dystrophy cell therapy from Capricor Therapeutics after heightened internal scrutiny (4). Around the same time, the FDA clashed publicly with Sarepta Therapeutics over its gene therapy Elevidys following patient deaths (5). Initially defying the agency’s order to pause shipments, Sarepta later complied—but only after the FDA demanded new safety data for continued distribution.

Resignation follows public and political backlash

The Sarepta episode fueled political criticism, with commentators from conservative circles accusing Prasad of overreach. A Wall Street Journal opinion piece labeled him a “one-man death panel” and criticized what the author saw as a rigid interpretation of risk-benefit decisions, also describing him as a “Bernie Sanders acolyte in MAHA drag,” intensifying public scrutiny (6).

Speculation mounted after the FDA partially reversed course and allowed limited resumption of Elevidys shipments. Some analysts inferred political intervention (2). “We wouldn’t be surprised to see a resignation in the short term,” wrote Baird analyst Brian Skorney in a note to investors on Monday.

Prasad’s departure was confirmed the following day. The implications for developers of cell and gene therapies—and for the regulatory tone at the FDA—remain uncertain, but the episode underscores the increasingly complex intersection of science, policy, and public opinion shaping product development timelines.

New CDER head Tidmarsh stepping in

To temporarily fill part of the void left by Prasad's departure, FDA has appointed new Center for Drug Evaluation and Research (CDER) head George Tidmarsh, MD, PhD, as the acting director of CBER also (7). Prasad's role as FDA's chief medical and scientific officer remains open. Tidmarsh just became the head of CDER last week, following years as a biotech executive.

References

1. Armstrong, D. Vinay Prasad Is Out at FDA, Following Sarepta Decision and Vaccine Controversies. EndpointNews.com. July 29, 2025.
2. Fidler, B. Vinay Prasad, Controversial FDA Official, Abruptly Departs Agency. BiopharmaDive.com. July 29, 2025.
3. FDA. Cell and Gene Therapy Roundtable (accessed July 30, 2025).
4. Cole, C. CMC and Analytical Gaps in CRLs: Why They Persist Despite FDA Guidance and How You Can Position Yourself for Success. PharmTech.com. July 25, 2025.
5. Lavery, P. FDA Investigates Pediatric Elevidys Death: 5 Things to Know. BioPharmInternational.com. July 28, 2025.
6. Finley, A. Vinay Prasad Is a Bernie Sanders Acolyte in MAHA Drag. WSJ.com. July 27, 2025.
7. Lawrence, L. FDA Names Drug Regulator Tidmarsh Acting Head of Biologics Center After Prasad’s Exit. STATNews.com. July 30, 2025.