The Food and Drug Administration logo prior to a press conference at Health and Human Services Headquarters in Washington, April 22, 2025.
Nathan Posner | Anadolu | Getty Images
A key official at the U.S. Food and Drug Administration, which oversees vaccines and biotech treatments, is leaving the agency following several decisions that have raised concerns within the industry.
Vinay Prasad, director of the Center for Biologics Evaluation and Research, will retire from the FDA at the end of April, an FDA spokesperson confirmed Friday. This is his second resignation. He briefly stepped down in July following backlash over regulatory decisions and returned just two weeks later in August.
FDA Commissioner Marty McCulley said in a post on X that the agency will name a replacement before Prasad returns next month to the University of California, San Francisco, where he taught before taking the FDA job last year. Mr. McCurry said Mr. Prasad had achieved “tremendous accomplishments” during his time at the agency.
Prasad’s decision to resign comes amid growing criticism of the FDA among the biotech and pharmaceutical industries and former health officials. RTW Investments says regulators have rejected or blocked at least eight drug approval applications in the past year because of problems with the data companies used to support their applications. The FDA initially refused to review Moderna’s flu shot, but later changed its mind.
All of these companies accused the FDA of overturning previous guidance on what evidence can be used to support their applications, prompting industry criticism that an unreliable regulatory process could stifle drug development for hard-to-treat diseases.
A former FDA official who spoke to CNBC on condition of anonymity to speak freely about the issue said this reversal is the worst kind of regulatory uncertainty, as companies are told one thing and then experience another.
“There is no regulatory uncertainty,” an FDA spokesperson said in a statement early Friday, adding that the agency “makes decisions based on evidence but does not guarantee results.” A spokesperson said the FDA “conducts rigorous, independent reviews and does not issue intrusive approvals.”
The latest controversy arose after the FDA stopped recommending it. unicure From an application for accelerated approval of an experimental treatment for Huntington’s disease.
The agency, which was cut and overhauled under Health and Human Services Secretary Robert F. Kennedy Jr., has faced widespread opposition in its drug and vaccine approval process. Critics worry that authorities could stifle the development of new treatments and jeopardize patient safety.
Criticism of Prasad has been mounting, reaching a climax last week when the FDA’s McQuarrie appeared to criticize UniQure’s Huntington disease gene therapy in an interview with CNBC’s Becky Quick. McCurry didn’t mention UniQure by name, but he did explain its treatment.
This week’s CNBC Cures event reinforced the calls for reform.
The Wall Street Journal first reported Prasad’s resignation.
