The U.S. Food and Drug Administration on Saturday reinstated oncologist Vinay Prasad as director of the Center for Biologics Evaluation and Research, returning him to the role that oversees vaccine, gene-therapy and blood-product regulation less than two weeks after his abrupt departure. “At the FDA’s request, Dr. Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research,” Department of Health and Human Services spokesperson Andrew Nixon said in an emailed statement. The agency did not clarify whether Prasad will also keep the separate title of chief medical and scientific officer that he received earlier this summer. Prasad was appointed in May by FDA Commissioner Martin Makary but resigned on July 29 after political pressure from the White House and criticism from conservative activist Laura Loomer. His exit followed a public dispute over Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy, Elevidys, whose shipments the FDA briefly paused amid safety concerns before allowing them to resume. George Tidmarsh has been serving as acting CBER chief during Prasad’s short absence. The swift reversal highlights internal turbulence at the FDA as it reassesses standards for novel biologics and leaves drugmakers uncertain about the agency’s regulatory stance heading into a busy review calendar.
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