As politicians debate the priority review voucher program, the FDA is rooting for its demise
Sarepta’s regulatory win on eteplirsen this week came with a big bonus. The approval delivered a rare pediatric priority review voucher that the company now plans to sell — potentially for hundreds of millions of dollars. And if the FDA’s internal war over an OK had gone on longer, the biotech may have missed that big score.
Congress will likely have until the end of the year now to decide the fate of the priority review voucher program at the FDA, moving past a September 30 deadline if a compromise extension built into a continuing resolution bill on government funding is passed, as RAPS’ Regulatory Focus Managing Editor Zachary Brennan explains in a wonderfully detailed review of the situation. Congress, though, has been wrangling over what to do. And agency officials are crossing their fingers and hoping to see the whole thing disappear.
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