Center for Biologics Evaluation and Research Director Vinay Prasad will exit the FDA for the second time after a controversial run that saw the oncologist butt heads with colleagues and ruffle feathers in biopharma after presiding over the rejection of several rare disease therapies.
After a stop—in July 2025—and a subsequent restart 10 days later, Vinay Prasad is now officially departing the FDA. The controversial Center for Biologics Evaluation and Research (CBER) director will leave the agency at the end of April amid growing criticism over recent regulatory decisions.
Prasad, an oncologist and epidemiology professor at the University of California, San Francisco, had only planned to remain at the FDA for the duration of his one-year leave of absence from the school, FDA Commissioner Marty Makary said in an interview with The Wall Street Journal on Friday.
Prasad will leave the FDA at the end of April, according to an internal email reviewed by Endpoints News, and a search for his replacement is underway.
“He’s really been successful and gotten a lot done in one year,” Makary told The WSJ, adding that Prasad had wanted to help implement a series of new policies at the FDA.
While Makary touted his longtime colleague’s success, Prasad has also generated his share of controversy since taking the CBER post in May 2025.
As of late February, Prasad was under probe by the FDA after complaints that he fostered a toxic workplace. The probe, being conducted with the help of outside investigator Professional EEO Services, is wide-ranging and has been going on for months, an anonymous FDA official told Endpoints News on February 26.
These complaints include “retaliation against subordinates and verbally berating staff,” The Wall Street Journal reported on February 11.
Prasad has held court for the past 10 months over an FDA that analysts and other market watchers view as increasingly stringent—and unpredictable.
Most recently, Prasad led the FDA’s issuance of a refuse-to-file letter to Moderna on February 10 for its mRNA-based influenza vaccine candidate mRNA-1010—a decision that was reversed a week later after the biotech submitted an amended application. That same week, he also had a hand in the rejection of Disc Medicine’s bitopertin. This case raised eyebrows as that application went through CBER’s sister division, the Center for Drug Evaluation and Research.
On Thursday, a senior FDA official held a briefing with reporters in which they refuted claims made by uniQure in a call earlier this week about a Phase 3 trial the agency requested for the biotech’s Huntington’s disease gene therapy, AMT-130. On Friday, Rep. Jake Auchincloss (D-MA) posted on X that the senior official was Prasad.
During his time at the FDA, Prasad reportedly butted heads with numerous colleagues, including Nicole Verdun, the former director of the office that reviews cell and gene therapies, and her deputy Rachael Anatol over an application for Capricor Therapeutics’ Duchenne muscular dystrophy (DMD) cardiomyopathy gene therapy, and former CDER director George Tidmarsh. Following his resignation from the post in November 2025, Tidmarsh told The New York Times he found the agency to be a toxic work environment—a situation he attributed to Prasad.
When Prasad was named as head of the biologics division in May 2025, the S&P Biotech ETF fell more than 5%.
While Prasad has spurred the most controversy—from the White House all the way down to his direct reports— Makary has also borne scrutiny. The chief regulator was called to the White House days after the agency refused to review Moderna’s vaccine over the objections of David Kaslow, review director at the FDA’s Office of Vaccines Research. A Type A meeting quickly followed, which “gave [the FDA] a public way to save face,” Politico reported on February 18, citing an anonymous source.
Top members of Congress have also spoken out about the current situation at the FDA. On February 19, Sen. Bill Cassidy (R-LA), chairman of the Senate’s Health, Education, Labor and Pensions Committee, published a report in which he said the FDA’s review processes can be a “black box,” adding that review teams typically “differ greatly” in what they ask of drug sponsors. This results in many companies reporting that they face a “reviewer lottery,” Cassidy wrote.
Prasad has been at the FDA for exactly 10 months.
