FDA ap­proved? Yes, but quite a few phar­mas leave out the messy de­tails on ac­cel­er­at­ed ap­proval

Com­pa­nies that win ac­cel­er­at­ed ap­provals for new drugs of­ten don’t ad­ver­tise them di­rect­ly to con­sumers in the same way, the FDA found. In fact, more than one quar­ter (27%) of on­line DTC ads for drugs re­ceiv­ing ac­cel­er­at­ed ap­provals didn’t even dis­close that the prod­ucts won ap­proval through this faster path­way that still re­quires con­fir­ma­to­ry da­ta.

The same FDA analy­sis found that on­ly about half (47%) of the web­sites men­tioned these con­fir­ma­to­ry tri­als, al­though 84% of these ac­cel­er­at­ed ap­proval dis­clo­sures on DTC web­sites men­tioned the ap­proval ba­sis, and 68% men­tioned un­known out­comes.

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