Article Summary:
Vinay Prasad, a fierce critic of U.S. COVID-19 vaccine and mask mandates, has left his position as the Director of the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) after just three months in the role. Prasad, an oncologist, was appointed to the position in May by FDA Commissioner Marty Makary, with the aim of speeding up regulatory action and piloting new review pathways.
However, Prasad’s tenure has been marked by criticism, particularly around the agency’s handling of a gene therapy for Duchenne muscular dystrophy developed by Sarepta Therapeutics. The FDA-approved therapy was linked to the deaths of two teens, leading the agency to ask Sarepta to stop all shipments of the approved therapy due to safety concerns.
Far-right activist Laura Loomer and the Wall Street Journal’s opinion section have criticized Prasad, with one piece describing him as a “Bernie Sanders acolyte in MAGA drag.” Makary said Prasad’s departure was due to him not wanting to be a “distraction” after seeing these “smear pieces.”
Prasad’s departure comes amid a series of shakeups at the FDA and other health agencies under the leadership of U.S. Health Secretary Robert F. Kennedy Jr. His predecessor, Peter Marks, and the head of gene therapy, Nicole Verdun, were also ousted earlier this year.
While Prasad’s departure adds to the uncertainty, some analysts view it as a positive for the pharmaceutical sector, as his presence had raised concerns about regulatory risk.