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2w ago

Vinay Prasad Resigns as FDA’s Biologics Chief After Controversial Tenure

The agency named an acting director to steer operations during the search for a permanent successor after Prasad’s departure.

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 from his roles as director of the FDA’s Center for Biologics Evaluation and Research and as the agency’s chief medical and scientific officer.
  • He cited a desire to avoid distracting the agency’s work and to return to California to spend more time with his family.
  • During his tenure he implemented stricter COVID-19 vaccine guidelines and overruled career reviewers three times to narrow authorizations for Moderna and Novavax shots.
  • Prasad oversaw a safety-driven pause and partial resumption of Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy after reports of patient deaths prompted FDA investigations.
  • The FDA has named an acting director to manage CBER operations while it searches for a permanent successor against a backdrop of ongoing debates over biologics approval standards.