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Aug 9, 06:42 PM
FDA Reinstates Vinay Prasad as Top Vaccine and Gene Therapy Regulator
US Gov Appointments
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FDA Reinstates Vinay Prasad as Top Vaccine and Gene Therapy Regulator

Authors
  • Reuters
  • The Washington Post
  • HuffPost
38

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.

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