Prime Highlights
- Vinay Prasad resigns as FDA’s top vaccine and biologics official after less than three months as a top official.
- He resigned due to political pressure and criticism for restricting gene therapy approvals.
Key Facts
- Prasad began at the FDA in May 2025, replacing Peter Marks as director of vaccine and biologics regulation.
- His stepping down has been regarded by analysts as a potential shot in the arm for biotechnology and gene therapy companies.
Key Background
As a professor at UCSF and a hematologist-oncologist, Dr. Vinay Prasad was named in May 2025 to lead the FDA’s Center for Biologics Evaluation and Research (CBER) and as chief medical and science officer of the agency simultaneously. His job was to streamline regulatory processes and rebrand surveillance of vaccines.
Though president for a brief time, Prasad gave a series of contentious decisions. He delayed approvals for COVID‑19 vaccines, rejected high-profile requests for gene therapy, and put on hold temporarily the distribution of Sarepta Therapeutics’ Duchenne muscular dystrophy drug after safety issues were reported. Although some of the limits were later relaxed, his cautious approach was roundly condemned by scornful industry critique.
Political fallout was also responsible for his exit. Conservatives and right-wing activists criticized him for undermining previous policies and discrediting his skepticism towards rapid vaccine rollouts. Ongoing pressure from conservative allies based on reports mostly encouraged his resignation, even though he had internal support from FDA leaders.
FDA Commissioner Marty Makary valued Prasad’s ability but conceded his presence had politicized and media-driven distraction. Prasad put down his resignation to a desire to work closer to home with family and to trim controversy over the agency’s activities.
In response to his resignation, the FDA named acting director of CBER, George Tidmarsh, an experienced drug industry executive. Analysts regard his resignation as likely to bring regulatory clarity to gene therapy and vaccine biotech firms, citing share rebounds for firms that had been damaged by his stringent policies. Industry watchers regard this transition as a potential inflection point for gene therapy and vaccine innovation in a less contentious regulatory environment.
