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FDA Biologics Chief Vinay Prasad to Step Down at End of April

His exit follows a turbulent year of high-profile disputes over vaccine and gene-therapy reviews.

Overview

  • Health and Human Services and the FDA confirmed Prasad will leave at the end of April to return to UCSF, with Commissioner Marty Makary saying a successor will be named before he departs.
  • Prasad’s tenure included an unusual initial refusal to review Moderna’s mRNA flu vaccine application before the FDA reversed course and accepted it contingent on an additional study.
  • The agency engaged in a rare press call to defend its demand for a new study of UniQure’s Huntington’s gene therapy, with HHS later accusing the company of misleading the public about regulators’ requests.
  • In November, Prasad circulated a memo claiming COVID vaccines had killed at least 10 children, a statement for which he provided no evidence and which 12 former FDA commissioners publicly denounced.
  • He briefly left the post in July before being reinstated, and his planned departure comes during broader leadership turnover across federal health agencies.