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Healthcare
Business Fortune
12 August, 2025
Dr. Vinay Prasad is reinstated as director of the FDA’s Center for Biologics Evaluation and Research after stepping down last month.
Vinay Prasad is set to resume his position as the head of vaccine, blood product regulation, and gene therapy at the U.S. Food and Drug Administration just over a week after leaving the agency. In an email, Andrew Nixon, spokesperson for the U.S. Health and Human Services confirmed that Dr. Prasad is returning to lead the FDA’s Center for Biologics Evaluation and Research at the agency’s request.
After only a few months as the center's head, Prasad departed the organization on July 30. Prasad's return was first reported by Endpoints News. In May, FDA Commissioner Marty Makary named Prasad, an oncologist known for his strong criticism of U.S. COVID-19 mask mandates and vaccines, as the center’s director.
The agency's handling of Sarepta Therapeutics' gene treatment for Duchenne muscular dystrophy sparked increased criticism of Prasad's tenure. Two teenagers with advanced DMD died as a result of the FDA-approved treatment. On July 18, the FDA requested that Sarepta halt all shipments of the approved DMD therapy due to safety concerns following a third death in a different experimental gene therapy from the business.
The FDA declared on July 28 that deliveries of Sarepta to the main group of patients were allowed to restart. In a July 20 blog post, Laura Loomer, a far-right activist and supporter of US President Donald Trump, referred to Prasad as a "progressive leftist saboteur" who was undermining the agency's efforts.