Vinay Prasad, the Food and Drug Administration’s director of the Center for Biologics Evaluation and Research who has overseen regulation of vaccines and gene therapies, will leave the agency at the end of April, according to FDA Commissioner Marty Makary.

Prasad’s departure marks the second time he has left the FDA and concludes a turbulent tenure marked by controversial decisions affecting rare disease treatments and multiple staffing changes at the agency’s highest levels.

The oncologist-turned-regulator took over as CBER director in May 2025 but was fired in July after angering rare disease advocates and far-right influencer Laura Loomer over his handling of a Duchenne muscular dystrophy treatment, according to previous reports. The Trump administration rehired him weeks later after Makary vouched for him.

An FDA spokesperson confirmed Prasad’s departure to news outlets. Makary told The Wall Street Journal that Prasad’s replacement has not yet been identified.

In a social media post, Makary credited Prasad with reducing clinical trial requirements for drug approvals, limiting Covid vaccine approvals to those over 65 or with risk factors, developing pathways for individualized medicines, and launching a speedy drug review program.

“He got a tremendous amount accomplished within his one-year sabbatical from UCSF and will be returning back to his academic home later next month,” Makary said in a note to staff. “We will name a successor before his departure.”

Prasad’s center has recently rejected at least five cell and gene therapies that experts believe likely would have received approval under previous FDA officials, according to industry observers. Under his leadership, CBER increased scrutiny of rare disease drugs despite public statements from Makary and others emphasizing regulatory flexibility.

The decisions have created tension with drugmakers, some of whom accused the agency of reversing previous agreements on clinical trial designs. One drug treating a rare blood cancer was on track for FDA approval last year before the agency rejected it last month over clinical data concerns the company believed had been addressed.

These rejections have alarmed rare disease patient advocates, who questioned whether the agency’s stated commitment to flexibility for rare disease treatments matches its regulatory actions.

Prasad’s departure follows a series of controversial decisions by his center and comes one day after the Department of Health and Human Services held a press call where a senior official criticized an experimental Huntington’s treatment under regulatory review — an unusual step involving public discussion of a therapy being considered by regulators.

The departure continues a pattern of dramatic exits by top FDA officials under the Trump administration. The Center for Drug Evaluation and Research had five different directors in 2025 alone. Richard Pazdur, a longtime cancer drug regulator, retired from the CDER director position in December, citing concerns that political officials were corrupting the agency’s scientific process.

George Tidmarsh, who held the role before Pazdur, left amid allegations that he used his regulatory position to advance a personal vendetta against a former biotech colleague. Tidmarsh denies these allegations, according to reports.

Agency leaders at lower levels have also left at a steady pace, either pushed out or departing voluntarily for other opportunities.

Prasad, who also served as the FDA’s chief scientific and medical officer, previously taught at the University of California San Francisco, where he gained recognition as a healthcare provocateur for criticizing clinical trial designs and relationships between regulators, doctors, and industry.

His center oversees regulation of vaccines, gene therapies, and blood products — critical areas affecting patient care and drug development timelines.

Makary indicated that the agency would name Prasad’s successor before his April departure, though no timeline was provided for the announcement.