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\t\t\t\t An FDA spokesperson confirmed Prasad\u2019s departure. Prasad didn\u2019t immediately respond to requests for comment from STAT.<\/p>\n In a social media post<\/a>, Makary thanked Prasad for his work at the agency, highlighting Prasad\u2019s role in reducing the number of clinical trials required to approve a drug, limiting Covid vaccine approvals to those over 65 or with risk factors, developing a new pathway for individualized medicines, and helping launch a new speedy drug review program. Makary said the same in a note to staff, viewed by STAT.\u00a0<\/p>\n \u201cHe got a tremendous amount accomplished within his one-year sabbatical from UCSF and will be returning back to his academic home later next month,\u201d Makary said. \u201cWe will name a successor before his departure.\u201d<\/p>\n 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 Department of Health and Human Services, which oversees the FDA, held a press call<\/a> in which a senior official bashed an experimental Huntington\u2019s treatment \u2014\u00a0an unconventional step involving discussion of a therapy being considered by regulators.\u00a0<\/p>\n Prasad is only the latest in a series of dramatic departures by top officials at the Trump administration\u2019s FDA. The Center for Drug Evaluation and Research had five different directors in 2025. Richard Pazdur, a longtime cancer drug regulator, retired from the CDER director post<\/a> in December due to concerns that political officials were corrupting the agency\u2019s scientific process. George Tidmarsh, who held the role before Pazdur, left amid allegations<\/a> that he had used his regulatory perch to advance a vendetta against a former biotech colleague. Tidmarsh denies these allegations. Agency leaders at lower levels have been pushed out, or voluntarily left for other opportunities at a steady clip<\/a>.\u00a0<\/p>\n Prasad, an oncologist by training who was also serving as the FDA\u2019s chief scientific and medical officer, oversaw the regulation of vaccines, gene therapies, and blood products. Previously, he taught at the University of California San Francisco and was known as a health care provocateur<\/a>, criticizing clinical trial designs and the relationships between regulators, doctors, and industry.<\/p>\n Under Prasad\u2019s leadership, CBER has increased scrutiny of rare disease drugs at the same time Makary and others were publicly stressing regulatory flexibility.\u00a0<\/p>\n Prasad\u2019s center has recently rejected at least five cell and gene therapies that experts believe likely could have received approval under previous FDA officials.\u00a0<\/p>\n 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.\u00a0<\/p>\n The decisions have spooked rare disease patient advocates<\/a>, who have questioned whether the agency\u2019s rhetoric on embracing flexibility for rare disease drugs matches up with its actions.\u00a0<\/p>\n Prasad took over as CBER director in May of 2025, but was fired in July<\/a> after he angered<\/a> 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<\/a> just a few weeks later, however, and hired him back after Makary vouched for him.\u00a0\u00a0<\/p>\n 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<\/a>.\u00a0<\/p>\n \t\t\t \t\t\t\t During his tenure, Prasad, as a key ally of Makary\u2019s, played a key role in some of the agency\u2019s most important initiatives. He led the committee charged with evaluating drug submissions bestowed with a \u201cCommissioner\u2019s National Priority Voucher,\u201d<\/a> 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.<\/p>\n He also sought to hold vaccines to a regulatory level that, according to 12 former FDA commissioners, might make it impossible<\/a> for manufacturers to develop new products. Prasad and top drug regulator Tracy Beth H\u00f8eg have wrested control of vaccine surveillance<\/a> from career staff. Most recently, Prasad overruled staff<\/a> by refusing to review a new flu vaccine from Moderna. The agency ultimately agreed<\/a> to review the product after White House pressure<\/a>.\u00a0<\/p>\n The FDA and other health agencies have taken a more vaccine-skeptical approach under health secretary Robert F. Kennedy Jr., a known vaccine critic.\u00a0<\/p>\n![\"\"\/](\"https:\/\/www.statnews.com\/wp-content\/themes\/stat\/images\/home\/statplus.svg\")
\n\t\t\t\tSTAT Plus: Under Vinay Prasad, employees at a key FDA center fear speaking out, look for the exits<\/a><\/p>\n![\"\"](\"https:\/\/www.europesays.com\/news\/wp-content\/uploads\/2026\/03\/VP_COLLAGE-768x432.jpg\")
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\n\t\t\t\tSTAT Plus: Inside the fall of Vinay Prasad at the FDA<\/a><\/p>\n