CBER chief Vinay Prasad to leave FDA once again
Vinay Prasad.
For the second time in less than a year, Vinay Prasad has departed from the FDA, after controversial decisions relating to the review of vaccines and rare disease therapies.
Prasad was first appointed head of the FDA's Center for Biologics Evaluation and Research (CBER) in May 2025 – after his predecessor Peter Marks resigned, reportedly before being pushed out by HHS Secretary Robert F Kennedy Jr – but stepped down the following July, only to return to the role just a few days later.
His second departure was revealed in an email from FDA Commissioner Marty Makary to staff late on Friday, according to the Wall Street Journal, which indicated he would leave the agency at the end of April, and was later confirmed by Makary in a social media post.
In the message, Makary said Prasad's intention is to return to his former job as a professor of epidemiology and biostatistics at the University of California, San Francisco (UCSF), describing his time at the FDA as a "sabbatical."
There's no news yet on a replacement at CBER, although Makary said someone will be in place before Prasad leaves the agency.
Prasad's first departure came after a period of FDA flip-flopping over Sarepta's Duchenne muscular dystrophy gene therapy Elevidys (delandistrogene moxeparvovec), asking for a pause on shipments – which was initially refused by the drugmaker – and then recommending that distribution resume just a few days later.
The last few months have seen a series of other decisions by CBER that have spooked biopharma companies, including changing previously agreed protocols and/or controls in clinical trials, and making claims about fatalities in children who received COVID-19 vaccines without providing substantiating data.
The agency refused to accept a filing for Moderna's combination flu and COVID-19 vaccine, saying it had not used an appropriate control group, then allowed it to be submitted a few days later with a truncated label claim.
Then, in the past few days, a major row has erupted over uniQure's experimental AMT-130 gene therapy for Huntington's disease, after the FDA demanded that the biotech conduct another clinical trial, on the grounds that a previously agreed protocol for its main supporting study, which used an external control, was no longer acceptable.
Since that revelation, there have been media reports of a 'senior FDA official' – who asked not to be identified – making the unusual decision to discuss the shortcomings of the gene therapy with reporters on a call, calling it a "failed therapy."
In a social media post on Friday, Congressman Jake Auchincloss (D-MA) identified the FDA official as Prasad and alleged that "disclosing trade secret information without legal authorisation is a prohibited act under the FDCA & a criminal violation under the Trade Secrets Act."
Prasad's departure is the latest reshuffle at HHS and its agencies, coming shortly after NIH director Jay Bhattacharya was put in charge of the CDC following the departure of Jim O'Neill. O'Neill's predecessor, Dr Susan Monarez, was fired after refusing to resign after 29 days in the job.
Meanwhile, there have been five heads of the Center for Drug Evaluation (CDER) in a year, with the latest incumbent – Tracy Beth Høeg – taking the role following the short tenures of Richard Pazdur, who retired, and George Tidmarsh, who stepped down amid concerns about his personal conduct.
