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yesterday

Vinay Prasad Abruptly Resigns as FDA Biologics Director

He said he did not want to distract the FDA’s work during its rollout of stricter COVID-19 shot guidelines following safety reviews of Sarepta’s Elevidys

FILE - The Food and Drug Administration seal is seen at the Hubert Humphrey Building Auditorium in Washington, Tuesday, April 22, 2025. (AP Photo/Jose Luis Magana, File)
Dr. Vinay Prasad, a prominent critic of the pharmaceutical industry and the Food and Drug Administration, has been named to oversee the health agency’s program for vaccines and biotech drugs.
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Overview

  • Prasad stepped down on July 29 after less than three months overseeing CBER and serving as FDA chief medical and scientific officer.
  • A spokesperson for Health and Human Services said Prasad chose to return to California to be with his family and avoid distracting the agency as it faced intensified White House scrutiny.
  • He implemented tighter approval criteria for Moderna and Novavax COVID-19 vaccines, limiting authorizations to seniors and immunocompromised groups.
  • He paused shipments of Sarepta’s Duchenne muscular dystrophy therapy Elevidys after patient deaths, a restriction the FDA has since eased pending more safety data.
  • Prasad’s emphasis on scientific rigor drew acclaim from transparency advocates but provoked criticism from biotech investors, FDA career staff and conservative commentators.