In a U-turn that caught many in the industry off guard, Vinay Prasad is back at the US Food and Drug Administration (FDA).
On 29 July, Prasad stepped down from his role as head of the FDA’s Center for Biologics Evaluation and Research (CBER), the department responsible for regulating medical products such as vaccines and gene therapies.
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Though not much was known at the time of the resignation, it has since emerged that his exit was amid a slew of social media attacks against him from controversial conservative activists, including Laura Loomer and former senator Rick Santorum. They took issue with Prasad’s handling of Sarepta’s Duchenne muscular dystrophy (DMD) gene therapy, Elevidys.
At the request of the FDA, Prasad is now back at the agency. The move likely means FDA commissioner Marty Makary is willing to test political backlash to bring his ally back into the fold. Prasad and Makary align on many healthcare views from a regulatory standpoint.
“At the FDA’s request, Dr Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research. Neither the White House nor the Department of Health & Human Services (HHS) will allow the fake news media to distract from the critical work the FDA is carrying out under the Trump administration,” HHS communications director Andrew Nixon told Pharmaceutical Technology in a statement.
Prasad was a critic of the mask mandates and quarantines during the Covid-19 pandemic. There were also adjustments to Covid-19 immunisations, such as restricting booster jabs in children and pregnant women, during his tenure. While a supporter of cell and gene therapies (CGTs), Prasad was against using surrogate endpoints as evidence for accelerated approvals in CGTs, leading to uncertainty in the field for biotechs using this approach in clinical trials.
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By GlobalData“Prasad, being a statistician, took issue with that practice, leaning toward more certainty regarding drug outcomes, even at the cost of delayed treatment,” says Michael Abrams, managing partner at Numerof & Associates.
Prasad’s departure and almost immediate reinstatement have brought further volatility to a CGT space that has lacked regulatory stability in the US in recent times. Shares in many CGT developers – including Sarepta – fell following the news. Stocks had originally risen when his departure was first reported by Endpoints on 29 July.
Abrams said that upon rejoining the FDA, Prasad “may moderate his actions and pursue change in the way effective change agents typically succeed – incrementally”.
Abrams added: “While he may consider his return to the FDA a ‘win’, there is no question that he is ‘on the radar’. Rightly or wrongly, his actions are being interpreted within a political framework, and if he continues to act ‘the barbarian’, he will find himself on the street once again.”
Investment bank Jefferies said in a research note: “The FDA leadership turmoil amid the Prasad saga raises the question: how politically versus scientifically driven is the agency today?”
Meanwhile, William Blair analysts said Prasad’s return could “reignite some volatility for the CGT spaces given that he had previously been critical of the use of surrogate endpoints for accelerated approval”.
“We think it is possible that Dr Prasad may be less heavy-handed this time around, especially regarding the regulation of products for rare diseases,” the analysts added in a research note.
For vaccines, William Blair analysts say they are hopeful the reappointment means the risk/benefit profile of new and existing vaccines is “based on scientific evidence and not on political influence”.
