How a phar­ma com­pa­ny bought 2 ac­cel­er­at­ed ap­provals — nev­er ran con­fir­ma­to­ry tri­als — and cashed in un­til FDA said stop

The whole premise of the FDA’s ac­cel­er­at­ed ap­proval path­way rests on the idea that clin­i­cal ben­e­fit will be es­tab­lished af­ter the ap­proval, via a con­fir­ma­to­ry tri­al, prov­ing the drug was worth au­tho­riz­ing ear­ly on.

In many cas­es, the con­fir­ma­to­ry tri­al does just that, con­firm­ing the ben­e­fits that seemed promis­ing at first, while in oth­ers — 112 of the 253 drugs au­tho­rized un­der the ac­cel­er­at­ed path­way have not been con­firmed as clin­i­cal­ly ef­fec­tive, per this BMJ in­ves­ti­ga­tion — still need to ful­fill their promise.

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