Embattled FDA regulator Vinay Prasad will leave the agency next month, an HHS spokesperson confirmed to POLITICO.
FDA Commissioner Marty Makary told The Wall Street Journal Friday that Prasad, director of the agency’s Center for Biologics Evaluation and Research, will depart at the end of April. In a post on X, Makary said Prasad would return to his teaching position at the University of California in San Francisco, framing his FDA work as part of a “one-year sabbatical” from academia.
On a call with reporters Thursday, a senior FDA official — speaking on condition of anonymity under ground rules set by HHS — said Prasad serves “at the pleasure of the commissioner and the secretary and the president” and would continue to do so.
Prasad’s exit — his second from the agency under Makary’s leadership — comes as he’s drawn sharp criticism in recent weeks about his handling of rare disease therapy candidates before the agency.
The most recent furor has surrounded the FDA’s interactions with Dutch biopharma Uniqure, whose Huntington’s disease gene therapy was dealt a setback after the agency said late last year that its earlier studies were inadequate to support a biologics license application.
The company said that contradicted the FDA’s 2024 feedback — an increasingly common complaint among several rare-disease drug companies trying to advance their therapy candidates through the agency under new leadership.
Uniqure executives said during a Monday earnings call that the FDA had “strongly recommended” the company conduct a randomized, double-blinded trial with a so-called sham surgery — in which control group participants were anesthetized. The development surprised financial analysts and patient advocates alike.
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