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Vinay Prasad, who was appointed as head of the U.S. Food and Drug Administration’s biologics division just three months ago, has left the agency, according to a government representative.
Prasad, a cancer specialist known for opposing U.S. COVID-19 vaccine and mask mandates, was brought on in May by FDA Commissioner Marty Makary. The two had pledged to reform regulatory processes and introduce new review models.
His brief tenure faced increasing scrutiny, particularly over the FDA’s handling of a gene therapy for Duchenne muscular dystrophy made by Sarepta Therapeutics. The treatment had been linked to the deaths of two teenagers with advanced disease. Following a third death involving another of the company’s experimental gene therapies, the agency halted all shipments of the approved treatment on July 18, citing safety concerns.
Public criticism also intensified, with some political figures labeling Prasad as ideologically driven and undermining the FDA’s mission. Opinion pieces published Monday accused him of focusing more on drug pricing than patient benefit.
Speaking to CNBC, Makary said Prasad chose to step down after seeing what he described as personal attacks, adding, “He didn’t want to be a distraction.”
George Tidmarsh, a recent appointee to lead the FDA’s drug review division, has been named interim head of the biologics center, according to the agency’s website. A permanent replacement has not yet been announced by the Department of Health and Human Services.
Prasad, who also served as the FDA’s chief medical and science officer, implemented several policy changes, including tighter rules for COVID-19 vaccine approvals. During his time, the agency also rejected therapies from companies such as Replimmune and Capricor Therapeutics. Following the news of his resignation, shares in Sarepta and Capricor rose, while Replimmune’s stock nearly doubled.
Prior to joining the FDA, Prasad was a professor at the University of California, San Francisco, with previous experience at the National Cancer Institute and the National Institutes of Health.
His exit follows several other leadership changes within the FDA and other health agencies under the current administration. Earlier this year, longtime vaccine official Peter Marks and gene therapy head Nicole Verdun also left their roles.
Some industry analysts view Prasad’s departure as a relief, with one noting that investor discussions had largely centered on regulatory uncertainty tied to his policies.
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