Vinay Prasad, a controversial oncologist and former director of vaccines and genetics at the U.S. Food and Drug Administration (FDA), has been reinstated to his previous role less than two weeks after resigning amid pressure from biotech executives, patient groups, and conservative allies of former President Donald Trump. Prasad oversees vaccine, gene therapy, and blood product regulation at the FDA's Center for Biologics Evaluation and Research (CBER). His abrupt departure and subsequent return have caused volatility in biotech stocks, with shares rising upon news of his resignation and falling after his reinstatement. The decision to bring Prasad back reportedly involved internal agency dynamics and external influences, including input from Marty Makary and political figures such as Susie Wiles. The FDA has not provided clear communication to staff regarding his reinstatement or changes in leadership roles within CBER. Prasad's return raises questions about the agency's regulatory approach, particularly concerning vaccine and gene therapy approvals, amid ongoing debates over the influence of Big Pharma and public health policy. This development highlights broader challenges within the FDA, including political oversight and internal discord affecting scientific and regulatory processes.
Small biotech gets a full approval for a rare disease with data from a tiny study, after seeking accelerated OK. You've got to wonder which end goes up at the @FDA. From where I'm sitting, it looks like a loose association of warring clans. https://t.co/At1w9A2a6C
"The final steps in approving research grants, previously routine and rapid after scientific review panels signed off, has become a bottleneck." @AnilOza16, @MeganMolteni & @angRchen on the politicization of #NIH. https://t.co/YFRzIVZDKA
One Year After FDA’s MDMA Rejection: Insiders and Observers Reflect @Josh__Hardman spoke with a former Lykos exec, MAPS founder Rick Doblin, members of the FDA Advisory Committee that panned the program, and others for this deep-dive. https://t.co/C13R5LqiPk