(Reuters) -Vinay Prasad is returning to his role overseeing vaccine, gene therapy and blood product regulation at the U.S. Food and Drug Administration a little more than a week after he left the agency. “At the FDA’s request, Dr. Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research,” U.S. Health and Human Services spokesperson Andrew Nixon said in an emailed statement to Reuters. Prasad left the agency on July 30 after just a few months as director of the center. STAT News first reported the return of Prasad. Prasad, an oncologist who was a fierce critic of U.S. COVID-19 vaccine and mask mandates, was named the center’s director by FDA Commissioner Marty Makary in May. Criticism of Prasad’s tenure intensified around the agency’s handling of a gene therapy for Duchenne muscular dystrophy from Sarepta Therapeutics. The FDA-approved therapy played a role in the death of two teens who had advanced DMD. After a third death in a separate experimental gene therapy from the company, the FDA asked Sarepta on July 18 to stop all shipments of the approved DMD therapy, saying it had safety concerns. The FDA changed course on Sarepta on July 28 and said shipments to the main group of patients for the drug could restart. Laura Loomer, a far-right activist and an ally of U.S. President Donald Trump, posted a blog on July 20 in which she called Prasad a “progressive leftist saboteur” who was undermining the agency’s work. Prasad was a physician who joined the agency from the University of California, San Francisco. He has had stints at the National Cancer Institute and the National Institutes of Health. 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.
(Reporting by Rishabh Jaiswal and Ananya Palyekar in Bengaluru; Editing by Mark Porter)
Comments