Vinay Prasad, the FDA's controversial director of the Center for Biologics Evaluation and Research (CBER) and a key ally of FDA Commissioner Marty Makary, is leaving the agency at the end of April 2026 — his second departure in less than a year.

Prasad's tenure has been turbulent by any measure. He was appointed CBER director in May 2025, fired in July 2025 over his handling of a Duchenne muscular dystrophy treatment decision, then rehired just weeks later in August 2025. During his time leading CBER, the center rejected at least five cell and gene therapies, and rare disease drug approvals declined.

The leadership instability at CBER is part of a broader pattern at FDA. The Center for Drug Evaluation and Research (CDER) experienced five director changes in 2025 alone, including the retirement of longtime oncology review chief Richard Pazdur in December 2025. The cumulative effect: a regulatory agency responsible for approving vaccines, biologics, and gene therapies is operating with a revolving door of senior leadership.

For pharmaceutical companies, biotech firms, and healthcare systems planning around FDA approval timelines, the instability creates material uncertainty. Sponsors preparing CBER submissions should build longer regulatory timelines into their planning and monitor leadership changes closely.

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