In­dus­try groups, CVS pick apart FDA's pro­posed path­way for gener­ics to carve out OTC in­di­ca­tions

Phar­ma in­dus­try groups like the As­so­ci­a­tion for Ac­ces­si­ble Med­i­cines (AAM) and PhRMA are rais­ing point­ed ques­tions about an FDA plan to cre­ate a new path­way for mar­ket­ing pre­scrip­tion drugs with an ad­di­tion­al con­di­tion for non­pre­scrip­tion use (AC­NU), which would re­quire more safe­guards than the cur­rent OTC path­way but es­sen­tial­ly carve out new OTC us­es for some gener­ic drugs.

Chief among the con­cerns were: In­sur­ance com­pa­nies drop­ping cov­er­age for the Rx ver­sion, new AC­NU patents to block com­pe­ti­tion, and in­dus­try es­sen­tial­ly gov­ern­ing the path­way.

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