Vinay Prasad, the chief medical and chief scientific officer at the US Food and Drug Administration and director of its biologics’ drug division, is to leave the FDA at the end of April. Dr Prasad’s departure was announced on 6 March by Marty Makary, the FDA Commissioner, and follows a period of disquiet within industry and patient advocacy groups about the way decisions have been made on new drug applications.
In one instance the FDA refused to review a candidate mRNA vaccine for influenza, only to reverse its position a week later. More recently, it unexpectedly requested a Phase 3 trial for a gene therapy for Huntington’s disease having earlier indicated the product could proceed to regulatory submission based on Phase 1/2 data. According to the Wall Street Journal, Dr Prasad also emailed his staff in November 2025 saying that the deaths of 10 children were linked to a Covid-19 vaccine without backing up this claim with data. Dr Prasad’s upcoming departure will be his second exit from the agency since his appointment in May 2025. In July of that year he was forced out by a right-wing political activist, but quickly returned after Dr Makary and Robert F Kennedy Jr, head of the Department of Health and Human Services, made an appeal to the White House.
Dr Prasad will return to the University of California at San Francisco where he has a position as professor in the Department of Epidemiology and Biostatistics.
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