Vinay Prasad returns to lead vaccines and cell and gene therapy at the FDA

The US Food and Drug Administration (FDA) division that deals with biologics, including vaccines and cell and gene therapies, has had another abrupt change in its leadership.

Just two weeks after Dr Vinay Prasad’s surprise resignation as head of the Center for Biologics Evaluation and Research (CBER) he has now returned to its helm.

“At the FDA’s request, Dr Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research,” a spokesperson for the department of Health and Human Services (HHS) told the New York Times.

Dr Prasad’s initial departure from the CBER, after less than three months as its director, came the day after the FDA ruled that shipments of Sarepta Therapeutics’ Elevidys (delandistrogene moxeparvovec) could be restarted some patients.

Distribution of the cell and gene therapy for duchenne muscular dystrophy (DMD), about which he had been openly critical, was halted in the US after three deaths due to acute liver failure among patients treated with either Elevidys or Sarepta’s investigational gene therapy SRP-9004.

Dr Prasad’s ousting from the FDA had seemed to herald a slightly less rocky environment for cell and gene therapies. His interim replacement, Center for Drug Evaluation and Research (CDER) Director Dr George Tidmarsh, appeared to bring with him a softer stance on that element of the CBER’s remit.

Dr Prasad’s initial departure came in the wake of a sustained campaign from activist and President Donald Trump ally Laura Loomer, who had labelled him a “progressive leftist saboteur” who was undermining the FDA’s work.

Responding to his return to lead the CBER, Loomer decried Dr Prasad as a “progressive Marxist” and pledged to continue her campaign against “rabid Trump haters”.

However, after President Trump reportedly overruled HHS Secretary Robert F Kennedy Jr and FDA Commissioner Marty Makary to remove Dr Prasad, his return suggests a certain amount of autonomy could be returning to pharmaceutical policy decision-making.