FDA Biologics Director Prasad to Depart End of April

Dr. Vinay Prasad, the director of the Food and Drug Administration's Center for Biologics Evaluation and Research, will leave the agency at the end of April, marking his second departure in less than a year amid ongoing controversies over vaccine and biotech drug approvals.

FDA Commissioner Marty Makary informed agency staff of the decision in an email sent late Friday. Prasad, an oncologist and former academic at the University of California, San Francisco, will return to that position. He assumed leadership of the center, which oversees vaccines and biological products, in May of last year.

Prasad's tenure has been marked by disputes involving the FDA's handling of gene therapies, vaccines and other specialized treatments for rare diseases. Pharmaceutical companies and patient advocates have accused the agency of inconsistent decision-making, including reversals that required additional clinical trials for products once deemed approvable. These tensions contributed to his latest exit, following a brief removal in July.

That earlier episode stemmed from clashes with biotech executives, patient groups and supporters of President Donald Trump. Prasad stepped down temporarily,...