The FDA’s biologics center faces another leadership shake-up as Vinay Prasad, MD, MPH, plans an exit in April, leaving questions over vaccine rules and gene-therapy approvals.
This story is developing and may be updated as more information becomes available.
Vinay Prasad, MD, MPH, the director of the FDA's Center for Biologics Evaluation and Research (CBER), will leave the agency at the end of April, FDA Commissioner Marty Makary, MD, MPH, confirmed Friday—marking the second time Prasad has departed the role in less than a year, though under strikingly different circumstances than the first.
According to a Wall Street Journal (WSJ) report,1 Makary said Prasad's exit is not a resignation under pressure but rather the conclusion of a planned, 1-year leave of absence from his faculty position at the University of California, San Francisco (UCSF), to which Prasad intends to return. "He's really been successful and gotten a lot done in 1 year," Makary told the WSJ. Federal health officials are now searching for Prasad's replacement, which Makary confirmed. Prasad declined to comment through the FDA, according to the WSJ.
Prasad's impending exit comes approximately 7 months after his first—and far more turbulent—departure from the same role.
This time, however, the circumstances appear to be more orderly. According to the WSJ, Makary framed Prasad's departure as the natural endpoint of a prearranged academic leave rather than a politically motivated exit and characterized his tenure as productive. Among the policy priorities Prasad was credited with helping implement are a new standard requiring only 1 major clinical trial for most drugs; a priority review program designed to accelerate promising treatments aligned with national health priorities; a revised framework for COVID-19 vaccines; and a new program intended to streamline approval pathways for bespoke therapies targeting rare genetic conditions.
A recent Contagion panel discussion series covered the ACIP’s new recommendations around pediatric vaccines, diving into the motivations behind the policy shifts, the updated approach to ACIP meetings, the supporting data, and more. This roundtable features clinicians including Jacinda Abdul-Mutakabbir, PharmD, MPH; Sharon Nachman, MD; Mary Koslap-Petraco, DNP, PNP-BC, CPNP; and William Schaffner, MD.
Whatever the terms of his exit, Prasad's time leading CBER has been among the most turbulent in the center's recent history. He was appointed to the role in May 2025, succeeding Peter Marks, MD, PhD, who was forced out in March of that year following a dispute with Health and Human Services Secretary Robert F. Kennedy Jr.4
Where Marks had championed regulatory flexibility—overseeing approvals of COVID-19 vaccines and dozens of cell and gene therapies during his nearly decade-long tenure—Prasad arrived with a reputation for evidence-based stringency and a skeptical view of many of those same decisions.
During his tenure, Prasad
The search for Prasad's permanent successor is now underway, according to Makary. The question of who leads CBER carries stakes for the infectious disease and broader biopharmaceutical communities. CBER's remit covers not only vaccines—including those for influenza, respiratory syncytial virus, COVID-19, and emerging pathogens—but also blood products, cellular therapies, and gene therapies, making it one of the FDA's most consequential divisions from both a public health and a market-access perspective.
Whether the next CBER director will continue, moderate, or shift the regulatory posture Prasad helped establish remains to be seen. Analysts at Jefferies raised the broader question in a research note reported by Pharmaceutical Technology in the wake of last summer's back-and-forth: "The FDA leadership turmoil amid the Prasad saga raises the question: how politically versus scientifically driven is the agency today?"5
That question—asked then in the context of Prasad's unexpected first departure—now hangs over the transition again, as the agency prepares to navigate yet another leadership change at one of its most scrutinized centers.
