With sales ris­ing and ef­fi­ca­cy ques­tions swirling, Gilead faces calls to re­lin­quish lu­cra­tive pri­or­i­ty re­view vouch­er

Thir­teen years ago, Con­gress en­act­ed an at­tempt­ed so­lu­tion to a long-run­ning phar­ma prob­lem. Al­though in­fec­tious dis­eases that af­flict­ed the de­vel­op­ing world or could trig­ger pan­demics pre­sent­ed one of the world’s most lethal dis­ease threats, they didn’t present any size­able mar­ket for drug de­vel­op­ers.

So, fol­low­ing a pro­pos­al laid out by aca­d­e­mics, leg­is­la­tors start­ed a pro­gram that gave com­pa­nies that suc­cess­ful­ly de­vel­oped prod­ucts for these dis­eases “pri­or­i­ty re­view vouch­ers,” which they could use to get an FDA de­ci­sion on one of their oth­er drugs ear­ly or, more like­ly, sell to a large phar­ma for tens of mil­lions of dol­lars. It cre­at­ed a back­door mar­ket, where­by Big Phar­mas de­vel­op­ing lu­cra­tive prod­ucts for can­cer or au­toim­mune con­di­tions would sub­si­dize un­prof­itable but glob­al­ly need­ed drugs and vac­cines — all with­out the gov­ern­ment spend­ing a pen­ny.

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