No longer ‘dead or just hi­ber­nat­ing,’ drug­mak­ers re­turn to heart med­i­cines

In 2015, now-FDA Com­mis­sion­er Robert Califf joined in­dus­try, aca­d­e­m­ic and reg­u­la­to­ry rep­re­sen­ta­tives in Wash­ing­ton to dis­cuss why more drugs weren’t in de­vel­op­ment for car­dio­vas­cu­lar dis­eases, the lead­ing US cause of death and once a main­stay of phar­ma­ceu­ti­cal in­dus­try block­busters.

The group point­ed to many rea­sons. Clin­i­cal tri­als could take years and test­ing was ex­pen­sive. Wide avail­abil­i­ty of gener­ic drugs made the com­mer­cial prospects un­cer­tain. Their pa­per ti­tle summed up the mood: “Car­dio­vas­cu­lar Drug De­vel­op­ment: Is it Dead or Just Hi­ber­nat­ing?”

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