Aside from creating a toxic work environment, CBER Director Vinay Prasad has also been accused of berating his staff and retaliating against reviewers who questioned his decisions.
The FDA is reportedly looking into complaints that Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, fosters a toxic workplace.
The regulator has enlisted the help of outside investigator Professional EEO Services, Endpoints News reported on Thursday, citing current FDA officials who requested to remain anonymous. The probe, according to one source, is wide-ranging and has been going on for months.
Aside from creating a toxic work environment, Prasad has also been accused of berating his staff and retaliating against reviewers who questioned his decisions.
In a statement to Endpoints, a spokesperson for the Department of Health and Human Services said that the reports form “part of a PR campaign against Dr. Prasad.” In an interview with CNBC on Thursday, FDA Commissioner Marty Makary expressed confidence in Prasad, calling him a “genius.”
It is unclear when the investigation will end, or if it will result in any consequences for Prasad. The director is expected to meet with the investigators soon, one source noted.
Since his appointment in May 2025, Prasad has consistently been a controversial figure for the FDA. At the time of his appointment, Mayo Venture Partner Audrey Greenberg called Prasad a “longtime critic of FDA policies” in a LinkedIn post, adding that he was “anything but a status quo appointment.”
In July 2025, Prasad was given the boot from the FDA—a move that analysts considered a plus for the industry. BMO Capital Markets said at the time that Prasad leaving “is a big positive for biotech in general and [cell and gene therapies] in particular.”
Just 10 days after his dismissal, however, Prasad was brought back “at the FDA’s request,” according to an HHS spokesperson. The exact reasons for his departure and return remain unclear.
The ongoing probe into Prasad is not the first time that his workplace behaviors were publicly criticized. After resigning from his post as director of the Center for Drug Evaluation and Research (CDER) in November 2025, George Tidmarsh told The New York Times that the FDA had been a toxic environment—something he attributed largely to Prasad.
Tidmarsh was succeeded by Richard Pazdur, whom Makary had to court extensively to take the job. As part of his demands, Pazdur reportedly asked for independence from Prasad, Endpoints reported in November last year. Pazdur also didn’t last long as Prasad’s counterpart at CDER, opting to retire just three weeks after agreeing to the job.
