WASHINGTON D.C. – Dr. Vinay Prasad is returning to his role as the director of the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER), the division responsible for regulating vaccines, gene therapies, and blood products. His return comes just over a week after his departure from the agency.
The move was confirmed by the U.S. Department of Health and Human Services (HHS). “At the FDA’s request, Dr. Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research,” HHS spokesperson Andrew Nixon said in a statement. Dr. Prasad had left the agency on July 30 after a brief but eventful tenure that began in May.
Dr. Prasad, an oncologist from the University of California, San Francisco, with prior experience at the National Cancer Institute and the National Institutes of Health, was appointed by FDA Commissioner Marty Makary. He is known for being a fierce critic of U.S. COVID-19 vaccine and mask mandates.
His short time as director was marked by intense scrutiny, particularly surrounding the agency’s handling of a gene therapy for Duchenne muscular dystrophy (DMD) from Sarepta Therapeutics. Following the deaths of two teens who had received the FDA-approved therapy and a third death related to a separate experimental gene therapy from the company, the FDA acted on safety concerns. On July 18, the agency asked Sarepta to halt all shipments of the DMD treatment.
However, in a reversal on July 28, the FDA announced that shipments to the main patient group could be restarted.
During this period, Dr. Prasad also faced public criticism. Far-right activist Laura Loomer described him as a “progressive leftist saboteur” in a blog post, accusing him of undermining the agency.
The leadership change at CBER is the latest in a series of shake-ups at the FDA and other health agencies under the leadership of U.S. Health Secretary Robert F. Kennedy Jr., highlighting a period of significant transition in the nation’s public health institutions. The news of Dr. Prasad’s return was first reported by Endpoints News.
