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FDA Rehires Controversial Biologics Chief Just Days After Trump Fired Him

FDA Rehires Controversial Biologics Chief Just Days After Trump Fired Him

Gizmodo2 days ago
The circus was performing at the Food and Drug Administration this weekend, apparently. The FDA has hired Vinay Prasad to oversee the Center for Biologics Evaluation and Research—less than two weeks after he left that same role.
Endpoints News was the first to report on Prasad's rehiring on Saturday. He was initially reportedly fired by President Donald Trump himself, following growing pressure from Laura Loomer and other conservative voices who criticized him over the agency's regulation of a gene therapy developed by Sarepta Therapeutics.
'At the FDA's request, Dr. Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research,' Andrew Nixon, communications officer for the Department of Health and Human Services, told Gizmodo.
Prasad is a hematologist-oncologist and epidemiologist formerly based at the University of California-San Francisco. He has also regularly written editorials, articles, and studies critical of the medical establishment and public health agencies like the FDA. While some of his critiques have enjoyed support from many in the public health field, such as calling for a stricter standard when approving new therapies, others have been more controversial. The often-combative Prasad has criticized the government's initial response to covid-19 as too restrictive, argued that many people didn't need the covid-19 vaccine, including children, and downplayed the health impacts of long covid, to name a few examples.
FDA Commissioner Marty Makary first hired Prasad to head CBER in early May. He was also additionally named the FDA's chief medical and scientific officer. But it didn't take long for Prasad to collect more enemies. Under his reign, the FDA butted heads with Sarepta Therapeutics over its Elevidys gene therapy treatment for the rare and life-shortening condition Duchenne muscular dystrophy (DMD).
Following the deaths of three patients linked to the drug, the FDA ordered Sarepta in mid-July to pause all shipments of the therapy until further notice. But 10 days later, the agency reversed course and recommended the drug to patients capable of walking. Days after that, Prasad left the FDA. Though the FDA stated officially that Prasad left of his own volition to 'spend more time with his family,' Politico soon reported that Trump had pushed for Prasad's firing over the objections of Health Secretary Robert F. Kennedy Jr. and FDA Commissioner Makary.
Prior to Trump's intervention, several right-wing influencers—most notably Laura Loomer—called for Prasad's head over his management of the Sarepta situation. Loomer and others also maligned Prasad as a 'progressive marxist' and saboteur to Trump and the 'Make America Healthy Again' agenda, pointing out that he had once insulted Trump.
Prasad's return isn't entirely surprising, though. Days after he left, FDA Commissioner Makary stated that he was working to bring back Prasad. At the time, Makary also called the reports of Trump firing him false, and HHS seems to now be sticking to a similar script.
'Neither the White House nor HHS will allow the fake news media to distract from the critical work the FDA is carrying out under the Trump administration,' Nixon said.
Whatever the exact chain of events, Prasad's comeback may signal that Loomer's influence over the White House isn't quite as ironclad as it's appeared. Or maybe it's just another sign that no one there really has any clue what is happening at any given time.
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