The head of the Food and Drug Administration office, overseeing vaccines and gene therapy, Vinay Prasad leaves the FDA after taking over his job just three months before.
Department of Health and Human Services spokesperson, Andrew Nixon, confirmed his departure in an emailed statement on July 29, 2025. Dr. Prasad did not want to be some kind of a distraction to the great service that the FDA under Trump administration is doing and has decided to return to California in order to be with his family, said the statement. Nixon went on to write that he thanks him for his service and many reforms that he was able to attain in his time at the FDA.
It is well to be noted that as Vinay Prasad Leaves the FDA, it marks a sudden end to his shaky time as the director when it comes to the Center for Biologics Evaluation and Research at the FDA, in addition to vaccines as well as some genetic medicines that also review certain blood products.
Prasad, who has been a prolific academic and a longtime critic of US drug policies, had been appointed as the head of CBER on May 6 this year. At that time, Commissioner Martin Makary called his hiring a prominent step forward for CBER since Prasad brought significant rigor, transparency, and independence that the office required, claimed the commissioner at that time.
Later, Makary went on to name Prasad as the chief medical and scientific officer of the FDA, apart from his role at the CBER. It is worth noting that Prasad was quite a vocal opponent of Peter Marks, his predecessor, who went on to run the CBER for almost a decade before putting in his resignation in March 2025, following a dispute with Robert F. Kennedy Jr., the HHS secretary. It is well to be noted that Marks was the one behind the regulatory flexibility. Being the FDA and as the CBER head, he oversaw the review as well as approvals when it comes to the COVID-19 vaccines along with dozens of cell and gene therapies. Prasad had in the past criticized numerous of those decisions and, interestingly, had castigated Marks for overruling the FDA reviewers when it comes to clearing the Duchenne muscular dystrophy gene therapy named Elevidys by Sarepta Therapeutics.
Interestingly, the appointment of Prasad had raised questions among many biotech companies as well as investors that FDA standards might be transitioning. After joining the FDA, Prasad swiftly worked with Makary in order to establish stringent approval guidelines for COVID-19 vaccines. He also thrice stepped in to overrule the other agency reviewers when it came to issuing narrower-than-requested clearances for Covid shots that were developed by Novavax and Moderna.
Apparently, at a round table meeting that was hosted by the FDA in early June, Prasad attempted to ease the concerns that CBER might be less flexible.
Under his watch in terms of regulating gene therapy for rare conditions. He had said that they do understand that progress is not always made with a single leap and shall consider incremental steps forward because those do add up.
After a month, the FDA went on to reject a Duchenne cell therapy from Capricor Therapeutics, which Prasad had reportedly scrutinized. Shortly thereafter, the FDA also engaged in an unusual public standoff with Sarepta when it came to its Duchenne gene therapy – Elevidys. Due to the death of two Elevidys recipients, as well as the death of a study volunteer who had received a different gene therapy, the agency asked Sarepta to hold all the shipments of its treatment. After initially defying the request, Sarepta later agreed and published reports, suggesting that the company might require new safety data before the FDA might allow Elevidys back into the market.
However, in the days that followed, Prasad was targeted by Laura Loomer, the right-wing influencer, as well as other conservative commentators and in op-eds published in the Wall Street Journal. One Journal op-ed went on to criticize him as being a Bernie Sanders acolyte in MAHA drag and a one-man death panel. Another went on to argue that his decision-making suggested that he believes people cannot be trusted in order to make their own decisions when it comes to risks and benefits.
When the FDA suddenly went on to allow Sarepta to go ahead with its few shipments of Elevidys on 28th July, some Wall Street analysts did speculate that the higher-ups in the Trump administration had indeed stepped in.
At that time, Brian Skorney, the Baird analyst, had pointed out that they won’t be surprised to see a resignation in the short term.
