FDA Biologics Chief Vinay Prasad to Leave Agency in April Amid Policy Disputes

Dr. Vinay Prasad, the controversial director of the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER), will step down from his role at the end of April, according to FDA Commissioner Dr. Marty Makary. Makary announced the departure on social media platform X, confirming that Prasad will return to the University of California, San Francisco School of Medicine, where he serves as a professor. Makary also noted that a successor to lead the FDA’s vaccines and biologics division will be appointed before Prasad leaves the agency.

Prasad, an oncologist and prominent critic of U.S. drug and vaccine policies, joined the FDA in May last year. Prior to entering the agency, he was widely known for challenging federal COVID-19 vaccine mandates and questioning certain regulatory decisions related to drug approvals. His time at the FDA was marked by several high-profile debates involving vaccine approvals, gene therapies, and treatments for rare diseases.

Shortly after assuming the role as head of CBER, Prasad briefly stepped down following scrutiny over his handling of a muscular dystrophy treatment review. However, he returned to the position only weeks later. During his tenure, disputes between the FDA and biotechnology companies became a recurring theme, particularly regarding the approval process for innovative therapies.

One of the most notable disagreements involved Dutch biotech company UniQure and its gene therapy designed to treat Huntington’s disease. The FDA requested additional clinical studies to support the therapy’s approval, while the company and patient advocates argued that the agency’s requirements were too burdensome and would delay treatment for patients with the rare neurological disorder. The U.S. Department of Health and Human Services, which oversees the FDA, later accused UniQure of misrepresenting the regulator’s requests to the public.

Following news of Prasad’s departure, UniQure’s U.S.-listed shares surged approximately 57% in extended trading. Shares of Disc Medicine also climbed around 10% after-hours. The biotech firm recently faced a rejection from the FDA for a treatment that had received the Commissioner’s National Priority Voucher, a fast-track initiative launched by Makary to accelerate breakthrough therapies. The agency concluded that the clinical trials failed to demonstrate a clear connection between biological improvements and measurable patient benefits.

An opinion column published in the Wall Street Journal in February criticized the FDA’s handling of several rare disease drug applications under Prasad’s leadership, arguing that the decisions conflicted with Makary’s stated goal of more flexible regulatory reviews for innovative treatments.

Prasad’s exit is part of a broader leadership reshuffle within the U.S. Department of Health and Human Services. The department recently placed National Institutes of Health director Jay Bhattacharya in charge of the Centers for Disease Control and Prevention after the departure of former CDC head Jim O’Neill.