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Ousted FDA Vaccine Regulator Vinay Prasad Returns to Post

MONTGOMERY COUNTY, MARYLAND, AUG 11 – Vinay Prasad returns to lead the FDA's biologics center amid controversy over gene therapy regulation and political pressure linked to patient safety concerns.

  • Vinay Prasad has resumed leadership of the FDA division responsible for regulating biologics, returning less than two weeks after stepping down at the agency's request.
  • Prasad's removal on July 29 followed criticism from conservative figures, including Laura Loomer, who opposed his regulatory decisions and past political views.
  • Prasad’s tenure occurred amid intense scrutiny over FDA's regulation of gene therapies, highlighted by safety concerns linked to Sarepta Therapeutics’ product and related deaths.
  • HHS spokesperson Andrew Nixon confirmed Prasad’s return was at the FDA's request, while Loomer called the decision an 'egregious personnel decision' and vowed to investigate further.
  • Prasad’s reinstatement signals leadership continuity at a time of scientific, regulatory, and political pressures on the FDA’s biologics sector amid ongoing agency restructuring.
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Pharmaphorum broke the news in on Monday, August 11, 2025.
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