Trump administration’s embattled FDA vaccine chief is leaving for the second time
Dr. Vinay Prasad's tenure involved demanding additional trials for vaccines and gene therapies, sparking disputes with drugmakers and criticism from industry and lawmakers.
- Late Friday, an agency email to staff said Dr. Vinay Prasad, FDA's top vaccine and biotech regulator, will leave in April to return to UCSF as a professor.
- Amid a month of backlash, Dr. Vinay Prasad faced criticism from pharmaceutical executives, investors, and members of Congress for tightening approval guidelines and reversing Moderna's mRNA flu vaccine review.
- The agency even held a rare press conference to criticize UniQure and defend its request for an additional study after staff raised concerns, while a senior FDA official called the original AMT-130 study 'stone cold negative' and Congressman Jake Auchincloss alleged unlawful disclosure of trade secrets.
- Shares of UniQure spiked Monday, and analysts called Prasad's planned exit a big win for biotech as more than a half-dozen drugmakers face costly extra-study requests.
- There's no replacement yet, and Prasad's departure follows a recent HHS leadership reshuffle with no named successor at CBER, according to Makary.
13 Articles
13 Articles
Trump administration’s embattled FDA vaccine chief is leaving for the second time
WASHINGTON — The Food and Drug Administration’s embattled vaccine chief, Dr. Vinay Prasad, is once again leaving the agency — the second time in less than a year that he’s departed after controversial decisions involving the review of vaccinations and specialty drugs for rare diseases. Read more...
5 lessons from Vinay Prasad's turbulent tenure at the FDA
Food and Drug Administration official Vinay Prasad self-destructed last week. The FDA announced Friday evening that he would step down next month after a series of controversial decisions about vaccines and gene therapies. His unique ability to attract criticism — even when his bosses, including the president, wanted him to keep his head low — did him in. Prasad’s defenders will present his arc as that of a heroic figure falling because he stoo…
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