Vinay Prasad on Approving Drugs After Failed Trials: warns against

What Prasad says

Dr. Vinay Prasad warns against approving drugs whose pivotal trials failed. Of Sarepta’s Elevidys, he says former CBER director Peter Marks “overruled 3 review teams and pushed this product on the market despite a failed trial,” calling the approval “one of the most costly drugs throughout history.” The statement comes from his 2024 letter co-authored with Timothée Olivier, reported by Pharmaceutical Technology.

His stated reasoning

Prasad’s stated reasoning is that when regulators override their own review teams to approve a product after a failed trial, the evidence standard collapses and patients are exposed to $3.2-million-per-dose therapies with unproven benefit. His later actions at FDA — halting Elevidys shipments in July 2025 after patient deaths — put this criticism into enforcement practice.

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