WASHINGTON — Vinay Prasad, a top official at the Food and Drug Administration who has been at the center of recurring public controversies, is exiting the agency for a second time.
Prasad will leave the FDA at the end of April, and his replacement has not yet been identified, FDA Commissioner Marty Makary told The Wall Street Journal.
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An FDA spokesperson confirmed Prasad’s departure. Prasad didn’t immediately respond to requests for comment from STAT.
His departure comes after a series of controversial agency decisions on rare disease drugs by the Center of Biological Evaluation and Research, which Prasad oversees. It also comes a day after the Health and Human Services Department, which oversees the FDA, held a press call in which a senior official bashed an experimental Huntington’s treatment — an unconventional step involving discussion of a therapy being considered by regulators.
Prasad, an oncologist by training who was also serving as the FDA’s chief scientific and medical officer, oversaw the regulation of vaccines, gene therapies, and blood products. Under his leadership, CBER has increased scrutiny of rare disease drugs at the same time Makary and others were publicly stressing regulatory flexibility.
Prasad’s center has recently rejected at least five cell and gene therapies that experts believe likely could have received approval under previous FDA officials.
In some cases, drugmakers have accused the agency of reversing previous agreements on clinical trial designs. A drug to treat a rare blood cancer, for example, was on the path to FDA approval last year before the agency rejected it last month, based on concerns about clinical data that the company thought had been previously addressed.
The decisions have spooked rare disease patient advocates, who have questioned whether the agency’s rhetoric on embracing flexibility for rare disease drugs matches up with its actions.
Prasad took over as CBER director in May of 2025, but was fired in July after he angered rare disease community advocates and far-right influencer Laura Loomer, who is close to President Trump, with his handling of a treatment for Duchenne muscular dystrophy. The administration changed course just a few weeks later, however, and hired him back after Makary vouched for him.
He did not return humbled, STAT previously reported. One of his first moves upon returning was to fire the person in charge of vaccine safety and surveillance, installing himself instead. Prasad has pushed at least seven leaders out of their positions. Eight agency officials told STAT in October that Prasad had created a work environment that was rife with mistrust and paranoia.
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During his tenure, Prasad, as a key ally of Makary’s, played a key role in some of the agency’s most important initiatives. He led the committee charged with evaluating drug submissions bestowed with a “Commissioner’s National Priority Voucher,” which guarantees a regulatory decision within one to two months. The role allowed him to weigh in on drug decisions outside his purview as CBER director.
He also sought to hold vaccines to a regulatory level that, according to 12 former FDA commissioners, might make it impossible for manufacturers to develop new products. Prasad and top drug regulator Tracy Beth Høeg have wrested control of vaccine surveillance from career staff. Most recently, Prasad overruled staff by refusing to review a new flu vaccine from Moderna. The agency ultimately agreed to review the product after White House pressure.
The FDA and other health agencies have taken a more vaccine-skeptical approach under health secretary Robert F. Kennedy Jr., a known vaccine critic.
Prasad, who lives in California, worked at the FDA’s Silver Spring, Md., campus just a few days a week. Still, staff members said he sought an unusual degree of control over staff from afar, requiring them to make their calendars completely visible to him despite his own calendar remaining private. He told staff not to notify their supervisors if he requested meetings with them.
Four officials told STAT at the time that several employees had filed complaints about Prasad’s management style with human resources.
This is a developing story and will be updated.
