Senior Food and Drug Administration official Vinay Prasad has reclaimed a role as the agency’s top doctor and scientist six weeks after his dramatic departure and one month after his surprising return to lead the regulator’s biologics medicine division.
On the FDA’s website, Prasad, a physician and prolific researcher, is now listed as the agency’s chief medical and scientific officer in addition to his role as director of the Center for Biologics Evaluation and Research, or CBER. A spokesperson for the Department of Health and Human Services, the FDA’s parent agency, confirmed via email Prasad’s reappointment to his former role.
Prasad had held both titles before he was embroiled in controversy over the FDA’s handling of safety concerns surrounding gene therapies developed by biotechnology company Sarepta Therapeutics. His role leading the agency’s hard-line response drew conservative criticism, and overlapped with a pressure campaign waged against him by right-wing activist Laura Loomer.
Prasad resigned in late July, but rejoined the FDA less than two weeks later after agency head Martin Makary and HHS Secretary Robert F. Kennedy Jr. reportedly advocated to the White House on his behalf.
As head of CBER, Prasad oversees the agency’s regulation of vaccines, cell and gene therapies and some blood products. On the former front, he’s played a major role in reshaping the FDA’s standards for approving COVID-19 shots. He’s also intervened to overrule staff in vaccine reviews and, according to Stat News, was involved in the agency’s decision to reject a therapy developed by Capricor Therapeutics.
Already a key deputy for Makary, Prasad will hold more power with the restoration of his additional title. His leadership page on the FDA website notes that, as chief medical and scientific officer, Prasad will advise Makary on “cross-cutting” issues and provide input on “trans-center” initiatives, medical policy and regulatory decisions.
