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13h ago

FDA Reinstates Biologics Director Vinay Prasad Less Than Two Weeks After Resignation

His return has triggered sharp biotech stock declines for firms targeted by his earlier enforcement moves

Ousted FDA Vaccine Chief Vinay Prasad Is Returning to the Agency
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© Marvin Joseph/The Washington Post via Getty Images
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Overview

  • At the FDA’s request, Vinay Prasad resumed his role as director of the Center for Biologics Evaluation and Research on August 11, less than two weeks after resigning.
  • The reinstatement was publicly endorsed by FDA Commissioner Marty Makary and HHS Secretary Robert F. Kennedy Jr.
  • Prasad’s initial departure followed his order to halt shipments of Sarepta’s $3.2 million Duchenne muscular dystrophy therapy Elevidys after two patient deaths.
  • News of his return sent shares of Sarepta, Capricor and Replimune down sharply in premarket trading.
  • Some CBER staffers have voiced incredulity over the swift reversal while the agency grapples with low morale and high turnover following early-year layoffs.