The 21st Cen­tu­ry Cures Act is here to stay. Now what?

There’s some­thing for just about every­one in the 21st Cen­tu­ry Cures Act, which will now be­come law once it lands on Pres­i­dent Oba­ma’s desk. There’s more mon­ey for can­cer re­search, an ini­tia­tive on the opi­oid epi­dem­ic. There are even a num­ber of ini­tia­tives re­lat­ed to men­tal health that drew strong sup­port from the ad­vo­ca­cy com­mu­ni­ty.

But it’s the pro­vi­sions de­signed to ease the reg­u­la­to­ry bur­den of proof around new drug in­di­ca­tions that has the few re­main­ing crit­ics ran­kled. In par­tic­u­lar there’s a pro­vi­sion al­low­ing for “re­al-world” ev­i­dence of ef­fi­ca­cy to back a broad­er la­bel, re­plac­ing clin­i­cal da­ta with da­ta sum­maries. The change could be worth bil­lions in added rev­enue. And the small num­ber of leg­isla­tive op­po­nents left to fight the bill tried, com­plete­ly un­suc­cess­ful­ly, to make that a stick­ing point that would bring the whole thing down.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER