Ac­cel­er­at­ed ap­proval re­forms make the cut in year-end gov­ern­ment spend­ing bill

Con­gres­sion­al ne­go­tia­tors have de­cid­ed to in­clude re­forms to the FDA’s ac­cel­er­at­ed ap­proval path­way in its year-end spend­ing pack­age af­ter the agency’s top lead­ers called for tighter con­trols on con­fir­ma­to­ry tri­als and an eas­i­er process for with­draw­ing dan­gling ac­cel­er­at­ed ap­provals that failed their con­fir­ma­to­ry tri­als.

The text of the bill, known as the om­nibus, had been float­ed ear­li­er this sum­mer but it was un­clear what it might at­tach to. Now, the AA re­forms, re­leased late last night, ap­pear to be ready for show­time, stip­u­lat­ing that mov­ing for­ward, FDA “may re­quire, as ap­pro­pri­ate, a [con­fir­ma­to­ry] study or stud­ies to be un­der­way pri­or to ap­proval, or with­in a spec­i­fied time pe­ri­od af­ter the date of ap­proval.”

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