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.