21st Cen­tu­ry Cures Act could use a sec­ond look; It's time for the FDA to open up

End­points as­sess­es the big bio­phar­ma R&D sto­ries of the week, with a lit­tle added com­men­tary on what they mean for the in­dus­try.

  The 21st Cen­tu­ry Cures Act would ben­e­fit from a clos­er look be­fore it’s passed

A slight­ly mod­i­fied 21st Cen­tu­ry Cures Act has been gain­ing mo­men­tum in the lame duck Con­gress, with De­moc­rats and Re­pub­li­cans com­ing to­geth­er in a rare kum­baya mo­ment to back a bill in­dus­try lob­by­ists have been push­ing hard for the past two years. It’s not hard to see why. There’s some­thing in here for every­one, with plen­ty to rile the left in the form of an even warmer wel­come for drug de­vel­op­ers. One of the biggest plums is an of­fer to con­sid­er “re­al world ev­i­dence” in ap­prov­ing drugs. It should not au­to­mat­i­cal­ly be as­sumed that the FDA will willy-nil­ly ig­nore long es­tab­lished guide­lines on clin­i­cal da­ta in ap­prov­ing drugs, but the agency has al­ready gone a long, long way to ac­com­mo­dat­ing de­vel­op­ers and speed­ing ap­proval time­lines. To a fault. Per­haps rather than just rolling this out, the Sen­ate should make some thought­ful ad­just­ments. But it is clear that the mood in Con­gress is cal­i­brat­ed to sup­port­ing the in­dus­try, rather than pun­ish­ing it. That kind of fair wind has been blow­ing in biotech’s fa­vor for 5 years now. We’re hap­py to see the sails that have been filled. We just hope it doesn’t end up with many of these ships, and the pa­tients that board them, on the rocks.

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