FDA vaccine head will step down in April after string of controversial decisions
The Food and Drug Administration’s logo is seen before a press conference at Health and Human Services Headquarters in Washington on April 22, 2025.
Nathan Posner | Anatolia | Getty Images
A key U.S. Food and Drug Administration official who oversees vaccines and biotech treatments will resign from the agency, following several decisions that have raised concerns in the industry.
Vinay Prasad, director of the Center for Biologics Evaluation and Research, will leave the FDA at the end of April, an agency spokesman confirmed Friday. This is his second departure from office: He left briefly in July following a backlash over his regulatory decisions, and returned just two weeks later in August.
FDA Commissioner Marty Makary said in a post on X that 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 “achieved tremendous success” during his tenure at the agency.
Prasad’s decision to resign follows growing criticism of the FDA from the biotech and pharmaceutical industry and former health officials. The agency rejected or discouraged applications for approval of at least eight drugs last year after handling the data companies used to support their applications, according to RTW Investments. The FDA initially declined to review Moderna’s flu vaccine, but later reversed course.
All of these companies accused the FDA of reversing previous guidance regarding the evidence they could use to support their practices; This has led to criticism in the industry that an unreliable regulatory process could hinder the development of drugs for difficult-to-treat diseases.
A former FDA official who spoke to CNBC on condition of anonymity and spoke freely on the subject said cancellations are the worst kind of regulatory uncertainty because companies say they are told one thing and then experience something else.
In a statement early Friday, an FDA spokesperson said there was “no regulatory uncertainty,” adding that the agency “makes decisions based on evidence but does not provide assurances about results.” The FDA “conducts rigorous, independent reviews, not blanket approvals,” the spokesperson said.
Latest controversy comes after FDA discourages UniQure From applying for accelerated approval of experimental treatment for Huntington’s disease.
Secretary of Health and Human Services Robert F. Kennedy Jr. The institution, which suffered staff cuts and was overhauled during the period, faced wider reactions due to the drug and vaccine approval process. Critics worry the agency could hinder the development of new treatments and put patients’ safety at risk.
The Wall Street Journal previously reported Prasad’s departure.
