In a stunning reversal, Dr. Vinay Prasad is returning to his role as director of the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER), just days after his resignation.
The abrupt departure of the controversial figure, who had been a vocal critic of the biopharmaceutical industry and certain FDA approval pathways, sent ripples through the biotech world.
Now, his reappointment at the FDA’s request brings a new layer of uncertainty and raises questions about the future of vaccine and gene therapy regulation.
In May, FDA Commissioner Dr. Marty Makary named Dr. Vinay Prasad the next director of the U.S. Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER).
Dr. Prasad had stepped down on July 30.
“Dr. Prasad 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,” a spokesperson for the U.S. Department of Health and Human Services (HHS) had told CNN on his departure.
“At the FDA’s request, Dr Vinay Prasad is resuming leadership of the Center for Biologics Evaluation and Research,” a Department of Health and Human Services spokesperson told Reuters on Sunday.
Endpoints News was the first to report Dr. Prasad’s return.
Dr. Prasad had railed against a decision to approve Sarepta Therapeutics Inc.’s (NASDAQ:SRPT) drug for Duchenne muscular dystrophy known as Elevidys, arguing that there was little evidence favoring the gene therapy.
Earlier in July, the FDA requested that Sarepta halt shipments of the drug after a reported death in a young patient in Brazil.
Just one day before Prasad’s departure, the agency unexpectedly reversed its decision and allowed Sarepta to resume shipments for certain patients.
Laura Loomer, an activist and an ally of U.S. President Donald Trump, posted a blog in which she called Prasad a “progressive leftist saboteur” who was undermining the agency’s work.
William Blair noted that it is not clear whether Dr. Prasad will also still serve as the FDA’s chief medical and scientific officer.
A media report on Saturday backed FDA Commissioner Dr. Marty Makary’s statement that Dr. Prasad was not forced to leave but resigned voluntarily, and that the commissioner wanted him to return to the agency.
Dr. Vinay Prasad’s return as CBER’s head could reignite some volatility for the cell and gene therapy spaces. Dr. Prasad has openly criticized the biopharmaceutical industry and the FDA for using accelerated approvals broadly based on surrogate endpoints.
Analyst Sami Corwin on Monday said, “Since his departure was reportedly influenced by public backlash following FDA’s request to halt all shipments of Sarepta Therapeutics’ Elevidys, we think it is possible Dr. Prasad may be less heavy-handed this time around, especially regarding the regulation of products for rare diseases.”
Analyst Corwin writes that the companies developing therapeutics for rare diseases and relying more heavily on interim clinical data instead of surrogate biomarkers for accelerated approval may fare better under Dr. Prasad’s return.
This includes registrational trials for Neurogene Inc.’s (NASDAQ:NGNE) NGN-401, uniQure NV’s (NASDAQ:QURE) AMT-130, and Cabaletta Bio Inc.’s (NASDAQ:CABA) rese-cel.
In the broader vaccine landscape, William Blair has cautioned against expecting a loosening of rules for mRNA-based products, noting that Dr. Makary shares views similar to Dr. Prasad’s on evidence standards.
Sentiment toward mRNA vaccines has further soured within HHS and the current administration following Robert F. Kennedy Jr.’s cancellation of several Biomedical Advanced Research and Development Authority (BARDA) contracts tied to such programs.
Dr. Prasad’s return raises the stakes for both vaccine developers and investors. Without placebo-controlled studies, securing FDA approval for mRNA COVID-19 vaccines, and potentially other products, could become more challenging.
However, his previous tenure saw the agency approve Moderna Inc.’s (NASDAQ:MRNA) mNEXSPIKE and Novavax Inc.’s (NASDAQ:NVAX) Nuvaxovid. William Blair hopes his reinstatement will ensure that vaccine reviews remain grounded in science rather than politics.
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