By Kamal Choudhury and Michael Erman
March 6 (Reuters) – The controversial head of the U.S. Food and Drug Administration’s vaccines and biologics unit, Dr. Vinay Prasad, will leave the agency at the end of April.
FDA commissioner Dr. Marty Makary posted about the departure on social media platform X, saying Prasad would return to the University of California San Francisco School of Medicine, where he is a professor, and that he had accomplished much during his one-year sabbatical.
The news was first reported by the Wall Street Journal.
Makary said a successor will be named before Prasad’s departure.
Prasad, an oncologist, was an outspoken critic of U.S. drug and vaccine policies, particularly around COVID-19 mandates, before joining the agency. His tenure included a series of high‑profile disputes over product reviews for vaccines, including Moderna’s COVID shot, gene therapies and other rare disease drugs.
He was appointed as the director of the FDA’s Center for Biologics Evaluation and Research in May last year. Shortly after, he stepped down over questions of his handling of a muscular dystrophy treatment before returning to the role just weeks later.
UNIQURE SHARES JUMP 57%
Most recently, Prasad’s division at the FDA engaged in a back-and-forth tussle with Dutch drugmaker UniQure over disagreements about the path forward for the company’s gene therapy for Huntington’s disease.
The U.S. drug regulator called for a new study to support the approval of the company’s gene therapy for the rare brain disorder, but the company and patient advocates argued that what the FDA was asking for was too lengthy and onerous on patients.
The U.S. Department of Health and Human Services, which oversees the FDA, has accused the company of misleading the public about what regulators were asking for.
U.S.-listed shares of UniQure jumped 57% in extended trading, following the news of Prasad’s departure.
An opinion piece in the Wall Street Journal on February 24 said the FDA had torpedoed several rare disease drugs under Prasad, contradicting Makary’s stated goal of flexible reviews for such treatments and raising questions about the management of the health regulator.
The piece cited the latest rejection of Disc Medicine’s treatment, which had received the Commissioner’s National Priority Voucher, a program launched by Makary to help fast-track breakthrough treatments.
Disc had said that the agency concluded that the trials did not show a clear link between biological improvement and clinical benefit.
Shares of Disc rose about 10% in after-market trading.
Prasad’s departure is the latest reshuffle at the health department, which recently put National Institutes of Health head Jay Bhattacharya in charge of the U.S. Centers for Disease Control and Prevention following the departure of Jim O’Neill.
(Reporting by Christy Santhosh and Kamal Choudhury in Bengaluru; Michael Erman in New York; Editing by Sriraj Kalluvila, Shinjini Ganguli, and Caroline Humer)
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