CMS spent more than $18B in four years on ac­cel­er­at­ed ap­provals with in­com­plete con­fir­ma­to­ry tri­als, in­spec­tor gen­er­al finds

The bat­tle over whether and how to re­form the FDA’s ac­cel­er­at­ed ap­proval path­way is heat­ing up again, just as the Sen­ate punt­ed any talks un­til the lame duck ses­sion just be­fore the end of the year.

On Thurs­day, HHS’ in­spec­tor gen­er­al re­leased a new re­port re­it­er­at­ing con­cerns, al­so not­ed re­cent­ly by the FDA’s On­col­o­gy Cen­ter of Ex­cel­lence, about de­layed or slowed con­fir­ma­to­ry tri­als that are nec­es­sary to prove that the ac­cel­er­at­ed ap­provals were worth their salt in the first place.

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