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4mo ago

FDA Brings Back Vinay Prasad to Lead Biologics Unit After Brief Exit

His reinstatement underlines tensions as political influence clashes with regulatory independence at the agency’s biologics center.

In this undated photo provided by the US Food and Drug Administration, Vinay Prasad smiles for a portrait.
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
Dr. Vinay Prasad, a prominent UCSF oncologist and outspoken critic of the U.S. government’s past pandemic policies, has been reinstated at his senior post at the Food and Drug Administration less than two weeks after resigning under pressure.
Laura Loomer is seen outside the U.S. Capitol on Thursday, June 12, 2025.

Overview

  • Dr. Vinay Prasad resumed leadership of the FDA’s Center for Biologics Evaluation and Research on August 9 at the agency’s request, less than two weeks after his July 30 resignation.
  • His July resignation followed controversy over tighter COVID-19 vaccine rules and the FDA’s pause and restart of Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy.
  • George Tidmarsh served as acting director of the biologics center during Prasad’s absence.
  • Commissioner Marty Makary had appointed Prasad in May to enforce stricter standards for vaccines and gene therapies as FDA chief medical and scientific officer.
  • The rapid reversal highlights ongoing debates over political pressure and the FDA’s scientific autonomy.