Article Summary:
Vinay Prasad, an oncologist and former critic of U.S. COVID-19 vaccine and mask mandates, is returning to his role overseeing vaccine, gene therapy, and blood product regulation at the U.S. Food and Drug Administration (FDA). Prasad had left the agency just over a week ago after being named the director of the Center for Biologics Evaluation and Research in May.
The FDA’s handling of a gene therapy for Duchenne muscular dystrophy from Sarepta Therapeutics, which played a role in the death of two teens, was a source of criticism during Prasad’s brief tenure. After a third death in a separate experimental gene therapy from the company, the FDA asked Sarepta to stop all shipments of the approved DMD therapy, citing safety concerns. However, the FDA later changed course and allowed shipments to the main group of patients to restart.
The return of Prasad to the agency has been met with mixed reactions, with a far-right activist labeling him a “progressive leftist saboteur” who was undermining the FDA’s work. Prasad, who has had stints at the National Cancer Institute and the National Institutes of Health, is a physician who joined the FDA from the University of California, San Francisco.
The FDA and other health agencies have seen multiple shake-ups in recent months under the leadership of U.S. Health Secretary Robert F. Kennedy Jr.