Cures 2.0: Bi­par­ti­san House bill would al­low RWE to sat­is­fy con­fir­ma­to­ry tri­al re­quire­ments for ac­cel­er­at­ed ap­provals

Reps. Fred Up­ton (R-MI) and Di­ana DeGette (D-CO) on Tues­day un­veiled the sec­ond it­er­a­tion of their mam­moth 21st Cen­tu­ry Cures Act, a wide-rang­ing, most­ly pro-phar­ma law signed by for­mer Pres­i­dent Oba­ma that pushed the FDA in cer­tain di­rec­tions on re­al-world da­ta and oth­er hot but­ton is­sues.

This time around there’s a pro­vi­sion to fund a $6.5 bil­lion (on par with Biden’s re­quest) re­search cen­ter at NIH to speed new treat­ments and make riski­er in­vest­ments. Sim­i­lar to DARPA, the new NIH di­vi­sion to be known as ARPA-H, would be run by a small group of pro­gram man­agers with more lat­i­tude to pur­sue high-risk, high-re­ward projects.

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