The Food and Drug Administration logo is seen before a news conference at Health and Human Services headquarters in Washington, DC, April 22, 2025.
Nathan Posner | Anadolu | Getty Images
A key official at the U.S. Food and Drug Administration, which oversees vaccines and biotechnology treatments, will resign from the agency following several decisions that have 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. This is his second departure: he briefly left his post in July following backlash over his regulatory decisions, and only returned two weeks later, in August.
In an article on Makary said Prasad “accomplished a tremendous amount” during his tenure at the agency.
Prasad’s decision to resign comes after criticism of the FDA grew within the biotechnology and pharmaceutical industry and among former health officials. Over the past year, the agency has denied or discouraged applications for approval of at least eight drugs, according to RTW Investments, after challenging the data the companies used to support their applications. The FDA also refused to review Moderna’s flu vaccine before changing course.
All of these companies accused the FDA of overturning previous guidance on what evidence they could use to support their applications, sparking criticism within the industry that an unreliable regulatory process could stifle drug development for difficult-to-treat diseases.
A former FDA official who spoke to CNBC on condition of anonymity to speak freely on the issue called these reversals the worst kind of regulatory uncertainty, as companies say they are told one thing and then endure another.
In a statement released earlier Friday, an FDA spokesperson said there was “no regulatory uncertainty,” adding that the agency “makes decisions based on evidence, but makes no assurances about outcomes.” The spokesperson said the FDA “conducts rigorous, independent reviews and does not endorse approvals.”
The most recent controversy arose after the FDA discouraged UniQure to seek accelerated approval of its experimental treatment for Huntington’s disease.
The agency, which has undergone staff reductions 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 fear the agency will stifle the development of new treatments and endanger patient safety.
The Wall Street Journal earlier reported Prasad’s departure.