
FDA Reinstates Vinay Prasad as Top Vaccine and Gene Therapy Regulator
The U.S. Food and Drug Administration said Saturday that Dr. Vinay Prasad is re-assuming leadership of the agency’s Center for Biologics Evaluation and Research, the office that regulates vaccines, gene therapies and blood products. “At the FDA’s request, Dr. Vinay Prasad is resuming leadership of CBER,” Health and Human Services spokesperson Andrew Nixon confirmed. It is unclear whether Prasad will also retake the separate post of chief medical and scientific officer. Prasad’s return comes just 11 days after he resigned under pressure from the White House. The oncologist, appointed in May by FDA Commissioner Marty Makary, stepped down on 30 July after conservative activist Laura Loomer highlighted past social-media comments criticizing President Donald Trump. His brief exit was the latest personnel shake-up at the FDA and HHS, which have seen multiple senior changes since Robert F. Kennedy Jr. became health secretary. The dispute unfolded amid scrutiny of Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy Elevidys. In mid-July the FDA asked the company to halt shipments following three patient deaths, then lifted that request a week later. Prasad had previously questioned the drug’s approval, and critics of his approach argued that tighter oversight could slow patient access. His reinstatement restores continuity at CBER as the agency prepares for several high-profile vaccine and gene-therapy decisions later this year.
Sources
- Kevin Bass PhD MS
People might wonder why I cared so much about Vinay Prasad being ousted. Scientists getting ousted by political mobs is evil. If it is allowed, science will become purely political. Above all, it's personal. I will go bare knuckles on this every time. Long live The Prasad.
- San Francisco Chronicle
Dr. Vinay Prasad had resigned as the FDA’s chief medical and scientific officer in late July after influential Trump allies accused him of being too liberal. https://t.co/uRGwSGBN9E
- Markets Today
Dr. Vinay Prasad returning to #FDA weeks after leaving role Dr. Vinay Prasad will return to the Food and Drug Administration after being forced out two weeks ago, resuming his role overseeing vaccine, gene editing and blood product regulation, according to an HHS spokesperson.
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