The old Vinay Prasad never left. He just changed jobs

[lostincalifornia]

Drug reviews are a frustratingly opaque process, so absent subpoena power, one cannot fully discount the possibility that Regenxbio’s Hunter syndrome gene therapy data were weak, totally screwed up, or some combination of both. If that’s what happened, the Food and Drug Administration’s decision to reject the therapy was justifiable.

But it’s hard to ignore a broader and more troubling trend: The Regenxbio treatment, called RGX-212, joins a growing list of cell and gene therapies for rare diseases that have been rejected or delayed since the appointment of Vinay Prasad as the head of the FDA center that regulates them.

Prasad has also wrested control of vaccine regulation. This week, he refused to review a flu vaccine candidate from Moderna, overruling the agency’s staff who deemed the company’s submission acceptable.

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Prasad changed jobs but his conservative regulatory doctrine remains the same, particularly for cell and gene therapies. The approval bar is much higher than it ever was before. Constantly shifting FDA goal posts is going to kill investment in rare diseases. I said this three weeks ago in this space. I’m saying it again.

https://www.statnews.com/2026/02/12/prasad-takes-conservative-approach-rare-disease-drugs-adams-biotech-scorecard/