The FDA has named oncologist Vinay Prasad, MD, as the director of its Center for Biologics Evaluation and Research.
In that role, Dr. Prasad, a frequent critic of the pharmaceutical industry, will oversee the regulation of costly and complicated biologic drugs, including vaccines, gene therapies, and blood supply. He succeeds Peter Marks, MD, who oversaw the approval of COVID-19 vaccines.
Dr. 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')," noted Tsai.
In a recent blog post on the Substack platform, Dr. 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 in children.
In another post, Dr. Prasad criticized media coverage of Dr. 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 Dr. 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 Dr. Prasad has been particularly critical of Dr. Marks' support of Sarepta Therapeutics' gene therapy treatment for Duchenne muscular dystrophy.
The FDA's commissioner, Marty Makary, MD, announced Dr. Prasad's appointment in an email to staff. “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."
Dr. 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," said Walid Gelland, MD, of the University of Pittsburgh.
Dr. 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.
