Vinay Prasad abruptly departs from the FDA

Vinay Prasad has stepped down as head of the FDA's Center for Biologics Evaluation and Research (CBER), less than three months after taking on the role.

His departure – first reported by STAT and now confirmed by the Department of Health and Human Services (HHS) – comes after a series of controversial decisions about Sarepta's Duchenne muscular dystrophy gene therapy Elevidys, according to the news report.

An HHS statement gave little insight into the reasons for Prasad's departure, with a spokesperson merely saying that he "did not want to be a distraction to the great work of the FDA in the Trump administration and has decided to return to California and spend more time with his family."

The FDA's flip-flopping on Elevidys (delandistrogene moxeparvovec) – asking for a pause on shipments that was initially refused by Sarepta, and then recommending that distribution resume just a few days later – is cited by STAT as one of the factors behind Prasad's sudden exit.

Before joining the FDA, he had been a critic of the approval of the gene therapy, questioning its efficacy, and he drew criticism from the DMD community for suspending distribution. Meanwhile, public health experts have slammed the FDA's decision to scale back the use of COVID-19 vaccines, which also fall under CBER's remit.

The New York Times, meanwhile, reported that Prasad had fallen foul of a smear campaign led by the right-wing influencer and ardent Donald Trump follower Laura Loomer, which focused on past support for left-wing figures, including former president Joe Biden and independent Senator Bernie Sanders.

Loomer has also accused him of "defying" Trump administration objectives by allowing remote working for CBER employees, blocking efforts led by FDA Commissioner Marty Makary to deregulate the agency, and allowing various missed Prescription Drug User Fee Act (PDUFA) deadlines that have undermined Trump's push for faster drug approvals.

Similar rhetoric has emerged from former Republican Senator Rick Santorum and political commentator, who recently described Prasad in a social media post as "Bernie Bro [who] is using the socialist playbook of destroying innovation to save money for government health programmes."

Whatever the reason for his departure, it adds to the sense of chaos at the FDA as the regulator grapples with the impact of mass firings, the loss of scientific expertise, and the restructuring of specialist centres within the agency – which some consumer organisations claim have compromised its ability to regulate effectively.

Prasad - formerly a public health researcher at UCSF known as a critic of US health policy - was appointed CBER director in May. That followed the resignation of Peter Marks, reportedly before being pushed out, who warned that the HHS under Robert F Kennedy Jr was succumbing to "misinformation and lies."

He fit the mould of other senior health figures in the Trump administration in that he has been a sceptic about the use of COVID-19 vaccines in children, annual boosters, and the emergency authorisation of the shots, but now seems to have been undone after arousing the ire of the MAGA fan base.