Vinay Prasad will leave his position as director of the FDA’s Center for Biologics Evaluation and Research (CBER) at the end of April, following a period marked by controversy and criticism over regulatory decisions. Prasad, an oncologist and professor at the University of California, San Francisco, had intended to stay at the FDA only during his one-year leave from the university.
FDA Commissioner Marty Makary told The Wall Street Journal, “He’s really been successful and gotten a lot done in one year,” noting that Prasad aimed to implement new policies during his tenure.
However, Prasad’s time as CBER chief has been contentious. Since May 2025, he has faced scrutiny for regulatory moves seen by some as strict and unpredictable. In February 2026, reports emerged that Prasad was under investigation after complaints about workplace conduct. An anonymous FDA official told Endpoints News on February 26 that the probe—conducted with help from outside investigator Professional EEO Services—was wide-ranging and ongoing. According to The Wall Street Journal on February 11, complaints included “retaliation against subordinates and verbally berating staff.”
Prasad oversaw several high-profile decisions in recent months. In early February, he led the FDA in issuing a refuse-to-file letter for Moderna’s mRNA-based influenza vaccine candidate mRNA-1010—a decision reversed a week later after an amended application was submitted. He also played a role in rejecting Disc Medicine’s bitopertin application through another division within the agency.
On Thursday prior to his announced departure, a senior FDA official briefed reporters to dispute claims made by uniQure regarding requirements for its Huntington’s disease gene therapy trial. Rep. Jake Auchincloss (D-MA) identified this official as Prasad.
During his tenure, Prasad reportedly clashed with colleagues including Nicole Verdun and Rachael Anatol over Capricor Therapeutics’ Duchenne muscular dystrophy gene therapy application, as well as former CDER director George Tidmarsh. After resigning in November 2025, Tidmarsh told The New York Times he believed toxicity at the agency stemmed from Prasad’s leadership.
The S&P Biotech ETF dropped more than 5% when Prasad was named head of CBER in May 2025.
The controversies have extended beyond CBER leadership. Commissioner Makary himself faced White House scrutiny following the agency’s initial refusal to review Moderna's flu vaccine despite objections from David Kaslow at the Office of Vaccines Research. Politico reported on February 18 that a Type A meeting allowed the agency to publicly resolve tensions surrounding this decision.
Congressional leaders have weighed in on perceived unpredictability at the FDA. On February 19, Sen. Bill Cassidy (R-LA), chairman of the Senate Health Committee, released a report criticizing inconsistent review processes at the agency and described sponsor experiences as akin to facing a “reviewer lottery.”
Prasad's departure comes exactly ten months after he joined the FDA.
