Con­tro­ver­sial changes com­ing to FDA

Modern Healthcare - - NEWS - By Adam Ruben­fire and Shan­non Much­more

The 21st Cen­tury Cures Act, which over­whelm­ingly passed the House last week, opens new av­enues for com­pa­nies to win quicker Food and Drug Ad­min­is­tra­tion ap­proval. It con­tin­ues to draw fire from safety ad­vo­cates and wor­ried pay­ers, who foot the bill for ex­pen­sive new ther­a­pies and may suf­fer if drugs aren’t thor­oughly eval­u­ated.

Phar­ma­ceu­ti­cal Re­search and Man­u­fac­tur­ers of Amer­ica, the na­tion’s ma­jor drug lobby, hailed the leg­is­la­tion for “en­hanc­ing the FDA’s abil­ity to adapt to cut­ting-edge tech­nolo­gies uti­lized by Amer­ica’s bio­phar­ma­ceu­ti­cal com­pa­nies to bring new medicines to pa­tients and their health­care pro­fes­sion­als,” the trade group said in a state­ment.

Dr. Michael Carome, di­rec­tor of Pub­lic Cit­i­zen’s Health Re­search Group, said the Cures leg­is­la­tion poses risks. “What this will do is it will has­ten to mar­ket drugs and de­vices where there is not ad­e­quate ev­i­dence that they are safe and ef­fec­tive for their ap­proved uses, and that’s not good for pa­tients,” he said.

The bill al­lows for smaller clin­i­cal trials for new drugs that treat drug-re­sis­tant in­fec­tions and will give speedier re­views to new de­vices given “break­through” sta­tus by the agency. It also raises the pop­u­la­tion cap to 8,000 pa­tients from 4,000 on the hu­man­i­tar­ian de­vice ex­emp­tion, which al­lows the sale of de­vices that have not been demon­strated as ef­fec­tive in treat­ing the tar­geted dis­ease.

The pol­icy im­prove­ments would help strengthen the “in­no­va­tion ecosys­tem” and sup­port de­vice de­vel­op­ment, said Scott Whi­taker, CEO of the Ad­vanced Med­i­cal Tech­nol­ogy As­so­ci­a­tion, the de­vice in­dus­try trade group.

The FDA would also be re­quired to give more weight to pa­tient-ex­pe­ri­ence data and con­sider real-world ev­i­dence or data in mak­ing ap­proval de­ci­sions or eval­u­at­ing stud­ies re­quired after ap­proval. Th­ese changes “sub­stan­tially un­der­mine the process for ap­proval of drugs,” Carome said.

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