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After a tumultuous tenure marked by recent clashes with the biopharma industry, Vinay Prasad, M.D., will be departing his post as the FDA’s top regulator of vaccines and cell and gene therapies at the end of April, an agency spokesperson confirmed to Fierce Biotech.
A search is currently underway for Prasad’s successor. News of Prasad’s departure was first reported by The Wall Street Journal.
“Dr. Prasad came to the FDA to implement 4 major long-lasting reforms: 2-to-1 pivotal trial requirement, national priority reviews, a risk-stratified covid vaccine framework, & the new plausible mechanism framework for ultra rare diseases which we launched last week,” FDA Commissioner Marty Makary, M.D., wrote in a post on X. “He got a tremendous amount accomplished within his one-year sabbatical from UCSF and will be returning back to his academic home later next month. We will name a successor before his departure.”
Prasad has drawn the ire of the rare disease community throughout his time as director of the Center for Biologics Evaluation and Research. He was briefly ousted from the FDA last summer following a high-stakes regulatory dispute over Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy Elevidys. Back then, Prasad departed as Duchenne advocacy groups reportedly escalated their opposition to his restrictive policies all the way to President Donald Trump.
More recently, Prasad has come under fire for the FDA’s rejection of multiple rare disease therapies, most notably a Huntington’s disease gene therapy from Dutch biotech uniQure. The company said the FDA had previously agreed that its plan of using a single-arm trial based on external control was acceptable. CBER under Prasad has now seemingly reversed course, sparking a heated back-and-forth that has attracted numerous headlines.
Prasad’s signature also appeared on a letter telling Moderna that the agency was refusing to review the biotech’s application for a new mRNA-based flu vaccine. This call was quickly reversed after the White House reportedly intervened.