The Food and Drug Administration logo before a news conference at Health and Human Services Headquarters in Washington, April 22, 2025.
Natan Posner | Anadolu | fake images
A key U.S. Food and Drug Administration official who oversees vaccines and biotech treatments is leaving his post after multiple decisions that raised concerns within the industry.
Vinay Prasad, director of the Center for Biologics Evaluation and Research, will leave the FDA at the end of April, an agency spokesperson confirmed Friday. It is his second departure from office: He briefly left office in July after a backlash over his regulatory decisions, and returned just two weeks later in August.
In a post on X, FDA Commissioner Marty Makary said the FDA will name a successor before Prasad returns next month to the University of California, San Francisco, where he taught before taking the FDA job last year. Makary said Prasad “achieved a lot” during his tenure at the agency.
Prasad's decision to resign comes after mounting criticism of the FDA within the biotech and pharmaceutical industries and among former health officials. Last year, the agency denied or discouraged applications for approval of at least eight drugs, according to RTW Investments, after questioning the data the companies used to support their applications. The FDA also initially declined to review Moderna's flu vaccine before changing its mind.
All of those companies accused the FDA of reversing earlier guidance on what evidence they could use to support their applications, prompting criticism within the industry that an unreliable regulatory process could stifle the development of drugs for difficult-to-treat diseases.
A former FDA official who spoke to CNBC on condition of anonymity to speak freely about the issue called rollbacks the worst kind of regulatory uncertainty because companies say they are told one thing and then experience another.
In an earlier statement on Friday, an FDA spokesperson said there was “no regulatory uncertainty,” adding that the agency “makes decisions based on evidence, but makes no guarantees about results.” The spokesperson said the FDA is “conducting rigorous, independent reviews and not approvals by approval.”
The most recent controversy occurred after the FDA discouraged UniQure apply for accelerated approval of its experimental treatment for Huntington's disease.
The agency, which suffered staff cuts and overhaul under Health and Human Services Secretary Robert F. Kennedy Jr., has faced broader backlash over its drug and vaccine approval process. Critics worry the agency could stifle the development of new treatments and put patient safety at risk.
The Wall Street Journal previously reported on Prasad's departure.
