FDA vaccine head will step down in April after string of controversial decisions

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.

In an interview with the Wall Street Journal, FDA Commissioner Marty Makary said Prasad had only planned to stay in the role for as long as his one-year leave from the University of California at San Francisco, where he taught before taking the FDA role.

Prasad’s decision to step down comes after criticism of the FDA mounted within the biotech and pharmaceutical industry 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 also refused to review Moderna’s flu shot before it reversed course.

All of those companies accused the FDA of reversing previous guidance about the evidence they could use to back their applications, sparking criticism within the industry that an unreliable regulatory process could stifle 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.”

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