FDA Appoints Indian-American Hematologist-Oncologist Vinay Prasad as New CBER Head Amid Stock Declines

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Updated May 8, 2025, 11:03 PM

Dr. Vinay Prasad, an Indian-American hematologist-oncologist with over 500 peer-reviewed publications and two books, has been appointed as the new head of the FDA's Center for Biologics Evaluation and Research (CBER). The announcement was made by FDA Commissioner Dr. Marty Makary, who praised Prasad's appointment for enhancing scientific rigor, independence, and transparency within the agency.

Prasad, previously a professor at the University of California, San Francisco, has been a vocal critic of the pharmaceutical industry and the FDA's handling of the COVID-19 pandemic. He has questioned the FDA's decisions on vaccine approvals, particularly the authorization of COVID-19 boosters, advocating for more stringent clinical trials and expressing concerns about the efficacy and safety of certain vaccines, including those for children. His appointment comes after the resignation of Dr. Peter Marks, who led CBER during Operation Warp Speed.

The biotech industry has reacted to Prasad's appointment, with stocks of companies like Moderna and Sarepta Therapeutics experiencing declines. In his new role, Prasad will oversee the regulation of vaccines, gene therapies, and the blood supply, areas he has previously critiqued for lacking sufficient evidence-based practices.

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Sources

statnews.com(8)reuters.com(4)biopharmadive.com(2)latimes.com(2)

Rick Berke

@rickberke

5 burning questions about FDA’s ‘aggressive’ deployment of AI for scientific review https://t.co/eUfIkPrBy3 via @statnews @KatieMPalmer

Adam Feuerstein ✡️

@adamfeuerstein

Listen at 18' -- Makary and Prasad talk about wanting to bring more transparency to the FDA review process. Prasad mentions, specifically, how it's "unfair" that companies/drug sponsors can "spin" FDA letters "any way they want." And FDA "can't reply in the press, to clarify." https://t.co/pzCnWgycUg

Dan Elton

@moreisdifferent

I'm loving what I'm hearing and the general vibe here. Transparency! Flexible regulation based on unmet need and severity! They are using AI to help with their review! Prasad is not "anti-vax". He was extremely pro-vax at the start of the pandemic and then became anti-booster. https://t.co/7CvzLkOg2J