Prasad to depart CBER, again

Dr. Vinay Prasad will once again step down as director of the FDA’s Center for Biologics Evaluation and Research (CBER), FDA Commissioner Marty Makary announced to agency staff in an email late Friday.

According to Makary, Prasad would depart at the end of April, with plans to return to his academic job at the University of California, San Francisco.

Prasad has faced scrutiny in recent months over several high-profile regulatory decisions. In February, CBER informed Moderna it would not review the company's application for the first mRNA-based flu shot. The refusal-to-file letter, signed by Prasad, cited the lack of an "adequate and well-controlled" study with a comparator arm that "does not reflect the best-available standard of care." One week after Moderna publicly disclosed the decision, the FDA reversed course and assigned the vaccine a PDUFA date of August 5, 2026.

In March, the agency shifted its position on uniQure’s investigational Huntington’s disease gene therapy, telling the company that data from the phase 1/2 studies were not sufficient to support a marketing application and recommending a sham surgery-controlled study. In a conference call, uniQure leaders argued that the sham surgery would be unethical. 

Makary initially named Prasad, a hematologist-oncologist, CBER director in May 2025. In July 2025, Prasad resigned from CBER amid political controversy after becaming tangled in a public dispute with Sarepta, after the company refused to halt shipments of Elevidys despite an FDA request that cited recent patient deaths. Criticism of Prasad’s stance on Elevidys later drew significant political backlash. He returned to the role several weeks after stepping down.