A key U.S. Food and Drug Administration official who oversees vaccines and biotech treatments will step down from the agency following 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 on Friday. It is his second departure from the position: He briefly left the post in July following backlash over his regulatory decisions, and returned only two weeks later in August.
In a post on X, FDA Commissioner Marty Makary said the FDA will appoint a successor before Prasad returns next month to the University of California, San Francisco, where he taught before taking the FDA position last year. Makary said Prasad “got a tremendous amount accomplished” during his tenure at the agency.
Prasad’s decision to step down comes after mounting criticism of the FDA within the biotech and pharmaceutical industries and among former health officials. In the past year, the agency has denied or discouraged the approval applications of at least eight drugs, according to RTW Investments, after taking issue with data the companies used to support their applications. The FDA initially refused to review Moderna’s flu shot, but later reversed course.
All of those companies accused the FDA of reversing previous guidance on the evidence they could use to support their applications, sparking industry criticism that an unreliable regulatory process could stifle the development of drugs for hard-to-treat diseases.
A former FDA official who spoke to CNBC on the condition of anonymity to speak freely on the issue called the reversals the worst kind of regulatory uncertainty because companies say they are being told one thing and then experience another.
In a statement earlier Friday, an FDA spokesperson said there was “no regulatory uncertainty,” adding the agency “makes decisions based on the evidence, but does not make assurances about outcomes.” The spokesperson said the FDA is “conducting rigorous, independent reviews and not rubber-stamping approvals.”
The most recent controversy arose after the FDA discouraged UniQure from applying for expedited approval of its experimental treatment for Huntington’s disease.
The agency, which underwent staff cuts and an overhaul under Health and Human Services Secretary Robert F. Kennedy Jr., has faced broader backlash for its drug and vaccine approval process. Critics have worried that the agency could stifle the development of new treatments and risk the safety of patients.
Criticism of Prasad had been growing and reached a fever pitch when the FDA’s Makary, in an interview with CNBC’s Becky Quick last week, appeared to criticize UniQure’s gene therapy for Huntington’s disease. Makary didn’t name UniQure but described its treatment.
Calls for a shakeup grew even louder at a CNBC Cures event this week.
The Wall Street Journal first reported Prasad’s departure.
