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1h ago

Vinay Prasad Is Reinstated as FDA CBER Director After Brief Departure

HHS asked him to return to stabilize leadership at the biologics center once shipments of a scrutinized Duchenne muscular dystrophy therapy were allowed to resume.

In this undated photo provided by the US Food and Drug Administration, Vinay Prasad smiles for a portrait.
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
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Overview

  • Dr. Vinay Prasad resumed his role directing the FDA’s Center for Biologics Evaluation and Research at the request of the Department of Health and Human Services.
  • He steps back into the position less than two weeks after resigning under pressure from White House figures and activist Laura Loomer.
  • The FDA lifted its July 18 pause on shipments of Sarepta’s approved Duchenne muscular dystrophy gene therapy after safety reviews following multiple patient deaths.
  • Prasad’s May appointment by Commissioner Marty Makary had signaled a shift toward higher safety thresholds and randomized clinical trials for vaccine and gene therapy approvals.
  • The rapid leadership changes at CBER reflect broader personnel shake-ups under Health Secretary Robert F. Kennedy Jr. and ongoing debates over regulatory rigor.