FDA Biologics Chief Vinay Prasad to Depart Amid Industry Criticism Over Drug Approvals
Vinay Prasad, the director of the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER), will leave the agency at the end of April, an FDA spokesperson confirmed on Friday. His departure follows a period of heightened tension with the biopharmaceutical industry over what companies describe as unpredictable and shifting regulatory standards for drug and vaccine approvals.
Prasad’s exit is his second from the influential role. He briefly stepped down in July 2024 after facing significant industry backlash for several high-profile regulatory decisions, only to return to the post two weeks later in August. FDA Commissioner Dr. Marty Makary announced on the social platform X that a successor would be appointed before Prasad returns to his academic post at the University of California, San Francisco. Makary stated Prasad “got a tremendous amount accomplished” during his tenure.
Industry Backlash and Regulatory Uncertainty
The criticism centering on Prasad and the FDA has intensified over the past year. According to analysis from RTW Investments, the agency has denied or actively discouraged at least eight drug applications by taking issue with the clinical data submitted by companies. A prominent early example involved the FDA initially refusing to even review Moderna’s influenza vaccine application, though the agency later reversed that decision.
The core of the industry’s concern is that the FDA appears to be reversing previously communicated guidance on what evidence is acceptable for approval. Companies argue this creates an unreliable environment that could deter investment and slow the development of treatments for serious, hard-to-treat conditions. A former FDA official, speaking to CNBC anonymously to discuss internal matters, called these reversals “the worst kind of regulatory uncertainty,” explaining that firms are given one set of expectations only to face a different outcome.
The most recent flashpoint involved UniQure’s experimental gene therapy for Huntington’s disease. The FDA discouraged the company from seeking accelerated approval based on its existing data, a move that drew sharp criticism. Commissioner Makary amplified the controversy in a separate interview with CNBC’s Becky Quick, where he critiqued the design of UniQure’s clinical trial without naming the company or therapy.
In response to the criticism, an FDA spokesperson stated on Friday that there is “no regulatory uncertainty.” The agency maintains that “makes decisions based on the evidence, but does not make assurances about outcomes.” The spokesperson emphasized that the FDA is “conducting rigorous, independent reviews and not rubber-stamping approvals,” framing its actions as necessary to uphold scientific standards.
Broader Agency Changes Under Kennedy
Prasad’s departure occurs within a broader context of significant upheaval at the FDA and its parent agency, the Department of Health and Human Services (HHS). Under HHS Secretary Robert F. Kennedy Jr., the FDA has undergone staff reductions and a restructuring of its review divisions. Critics, including patient advocates and some former health officials, worry these changes could compromise the agency’s ability to efficiently and safely evaluate new therapies, potentially stifling innovation or risking patient safety.
Calls for leadership changes grew louder during this week’s CNBC Cures event, where stakeholders in rare disease and biotech research voiced their concerns about the approval climate. The Wall Street Journal was the first to report Prasad’s impending departure.
As the FDA prepares for a leadership transition in its biologics division, the biotech industry will be watching closely to see whether the next director provides more consistent regulatory pathways or continues a course that prioritizes stringent data requirements—a balance that sits at the heart of the agency’s mission to ensure safety while fostering medical innovation.
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