The Food and Drug Administration logo is seen before a press conference at the Health and Human Services headquarters on April 22, 2025 in Washington, DC.
Nathan Posner | Anadolu | Getty Images
A key U.S. Food and Drug Administration official who oversees vaccines and biotechnology treatments will resign from the agency after several decisions that 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. It is his second resignation from the position: He briefly left the post in July after backlash over his regulatory decisions, and returned just two weeks later in August.
In a post on Makary, Prasad said “achieved tremendous things” during his tenure at the agency.
Prasad’s decision to resign comes after criticism of the FDA grew from the biotech and pharmaceutical industries, as well as from former health officials. According to RTW Investments, the agency rejected or discouraged approval applications for at least eight drugs last year after delving into the data the companies used to support their applications. The FDA also refused to review Moderna’s flu shot before changing course.
All of these 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 hamper the development of drugs for hard-to-treat diseases.
A former FDA official, who spoke to CNBC on condition of anonymity to speak freely on the topic, called the retractions the worst kind of regulatory uncertainty because companies say they are told one thing and then experience another.
In a statement earlier Friday, an FDA spokesperson said there is “no regulatory uncertainty,” adding that the agency “makes decisions based on the evidence but makes no representations about the results.” The spokesperson said the FDA “conducts rigorous, independent reviews and does not agree with the approvals.”
The latest controversy came after the FDA advised against it UniQure disqualified from applying for accelerated approval of its experimental treatment for Huntington’s disease.
The agency, which made staff cuts and reorganization under Health and Human Services Secretary Robert F. Kennedy Jr., has faced broader backlash for its approval process for drugs and vaccines. Critics fear the agency could hinder the development of new treatments and endanger patient safety.
The Wall Street Journal previously reported Prasad’s departure.
