USFDA picks oncologist Vinay Prasad as top vaccine official
Dr Vinay Prasad, an oncologist and outspoken critic of the FDA leadership and COVID-19 mandates has been named as the new director of U.S. Food and Drug Administration's Center for Biologics Evaluation and Research.
In his new role, Dr Prasad will oversee the regulation of complex and high-cost biologic products—including vaccines, gene therapies, and the blood supply. He succeeds Peter Marks, who oversaw the agency’s COVID-19 vaccine approvals and exited the post in March.
Prasad could raise the bar for companies to get approval for new drugs, including what are known as Accelerated Approvals for new potential treatments of serious conditions for which there is no standard alternative, Jefferies analyst Andrew Tsai wrote in a research note.
"We suspect he will require sponsors to produce more supporting clinical evidence (taking less 'shortcuts')," Tsai wrote.
In a recent blog post on the Substack platform, Prasad said the CDC "should ABSOLUTELY remove COVID-19 from the Childhood Immunization schedule. If it stays, it shows the United States is a corrupt country," citing the lack of randomized trial evidence for use of the vaccines in children.
In another post, Prasad criticized media coverage of Marks' departure and called him "one of the most dangerous , pro-pharma regulators of the 21st century."
In a note to clients, RBC Capital Markets analyst Brian Abrahams called Prasad an "anti-establishment physician" who has been vocal on a broad range of matters, "including COVID-19, oncology studies, and randomized clinical trial designs in general."
Abrahams noted that Prasad has been particularly critical of Marks' support of Sarepta Therapeutics' gene therapy treatment for Duchenne muscular dystrophy.
Prasad is not without supporters, however.
The FDA's commissioner, Marty Makary, announced Prasad's appointment in an email to staff, as per Reuters.
“He brings a great set of skills, energy, and competence to the FDA, and I know that he is eager to begin immersing himself in the important work of CBER and the agency as a whole,” Makary wrote.
Walid Gellad, a physician from the University of Pittsburgh, said Prasad is "a brilliant guy with remarkable experience understanding evidence and data on drugs. He has a difficult task ahead but an opportunity to bring those talents to positively impact FDA and the American public."
Scott Steele had been serving as acting head of CBER.
Prasad comes to the FDA from the University of California, San Francisco. He holds a medical degree from the University of Chicago, and has had stints at the National Cancer Institute and the National Institutes of Health.
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