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3w ago

Vinay Prasad Resigns as FDA Biologics Director After Politicized Tenure

His departure closes a brief tenure that saw him impose stricter COVID-19 vaccine guidelines under political scrutiny over a Duchenne muscular dystrophy gene therapy review.

WASHINGTON, DC - DECEMBER 06: Dr. Vinay Prasad is an Assistant Professor of Medicine at Oregon health and science university. His research is on health policy, cost of drugs, evidence based medicine. In his practice, he takes care of patients with cancer. He is one of the panelists attending the Chasing Cancer Summit in Washington, D.C. on December, 06, 2016. (Photo by Marvin Joseph/The Washington Post via Getty Images)
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 to avoid distracting from FDA work and return to California to be with his family, according to HHS spokesperson Andrew Nixon.
  • In his less than three-month stint as CBER director and chief medical and scientific officer, he tightened approval criteria for Moderna and Novavax COVID-19 vaccines, overruling agency reviewers three times.
  • He oversaw the FDA’s request to pause shipments of Sarepta’s Duchenne muscular dystrophy gene therapy Elevidys after patient deaths, followed by a partial resumption once safety concerns were clarified.
  • Right-wing figures including Laura Loomer and Rick Santorum launched vocal attacks against Prasad, and a person familiar with internal discussions said White House pressure contributed to his departure.
  • George Tidmarsh has assumed Prasad’s duties in an acting capacity while the FDA begins its search for a permanent CBER director.