Vinay Prasad is once again set to depart from his role at the US Food and Drug Administration (FDA), after just eight months back at the helm of the agency’s biologics department.
Prasad’s FDA exit was confirmed by a social media post from commissioner, Marty Makary, who praised the “tremendous amount” Prasad accomplished as the head of the Center for Biologics Regulation and Evaluation (CBER) within his one-year sabbatical from academia.
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A year ago, Dr. Prasad came to the FDA to implement 4 major long-lasting reforms: 2-to-1 pivotal trial requirement, national priority reviews, a risk-stratified covid vaccine framework, & the new plausible mechanism framework for ultra rare diseases which we launched last week.…
— Dr. Marty Makary (@DrMakaryFDA) March 6, 2026
In the X post, Makary noted that Prasad will return to his role at the University of California, San Francisco, where he is a professor of epidemiology and biostatistics and medicine, as well as a practicing haematologist-oncologist at the San Francisco General Hospital. The FDA is due to announce who will replace Prasad before he leaves the agency at the end of April 2026.
Prasad’s exit comes shortly after he first resigned from the FDA amid backlash on his conservative approach to cell and gene therapy approvals – particularly around his regulatory approach to Sarepta’s Duchenne muscular dystrophy (DMD) gene therapy, Elevidys (delandistrogene moxeparvovec). He was then reinstated as CBER head just two weeks later at the request of the FDA.
During his time at the agency, Prasad has been embroiled in several controversies, including the CBER’s request that UniQure conduct another study on its Huntington’s gene therapy involving a sham surgery control group, and the agency’s initial refusal to review Moderna’s seasonal flu jab, mRNA-1010.
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By GlobalDataAccording to William Blair analyst Matt Phipps, Prasad’s departure is “likely a tailwind for the biotech sector, particularly in cases of regulatory flexibility for companies developing novel therapies for rare diseases”. However, Phipps warns that the recent plausible mechanism and single clinical trial pathways were led by Prasad, meaning there could be an element of uncertainty around these programmes under the new appointee.
Unrest at the FDA
Prasad’s FDA exit comes in a volatile period for the regulator, as several high-profile officials have either resigned or been ousted from their positions in recent months. This includes seasoned oncology regulator, Richard Padzur, who left the FDA after less than a month as head of the Center for Drugs Regulation and Evaluation (CDER). Padzur was later replaced by Tracy Beth Hoeg, who became the fifth person to lead CDER in 2025.
Before Padzur came George Tidmarsh, who resigned after being placed on administrative leave in November after concerns were raised around his personal conduct.
Within CBER, Prasad was appointed to run the division after previous lead, Peter Marks resigned after he and Robert F Kennedy Jr (RFK Jr) disagreed on vaccine policy. At the time, Marks said that RFK Jr did not desire “truth and transparency”, but rather “subservient confirmation of his misinformation and lies”.
Alongside high-profile leadership changes, the agency has also been grappling with drug review delays, which some are attributing to mass layoffs, while also contending with accusations of its politicisation from ex-FDA staffers.
