Man­u­fac­tur­ers count on faster prod­uct ap­provals un­der Cures Act

Modern Healthcare - - NEWS - —Adam Ruben­fire

2017will be a year of chal­lenge and op­por­tu­nity for the phar­ma­ceu­ti­cal and med­i­cal de­vice in­dus­tries thanks to the 21st Cen­tury Cures Act, which passed with their vig­or­ous lob­by­ing sup­port.

The law prom­ises $500 mil­lion in new fund­ing for the Food and Drug Ad­min­is­tra­tion over the next 10 years to speed up prod­uct ap­provals, in­clud­ing ex­pe­dited pro­cesses for in­no­va­tive drugs and de­vices or prod­ucts that serve a rare need.

The leg­is­la­tion likely will spur reg­u­la­tors to look be­yond the lengthy, costly clin­i­cal tri­als that de­fine the cur­rent ap­proval process, said David Rosen, a for­mer FDA of­fi­cial who now heads the FDA prac­tice group at law firm Fo­ley & Lard­ner. The law calls for reg­u­la­tors to give more weight to pa­tient in­put and data that re­flects the ex­pe­ri­ence of pa­tients in re­al­world set­tings.

Whether the FDA ac­tu­ally will be able to speed up ap­provals de­pends on the suc­cess of its lead­ers in bol­ster­ing the agency’s in­fra­struc­ture and work­force, said Marc Scheine­son, an­other for­mer FDA of­fi­cial who heads Al­ston & Bird’s food and drug prac­tice. Agency lead­ers have noted the dif­fi­culty of at­tract­ing qual­i­fied staff; there is a large back­log of un­filled po­si­tions.

Although reg­u­la­tors will be busy in the com­ing year im­ple­ment­ing the law, there likely won’t be any no­tice­able changes to FDA pro­cesses in 2017, Scheine­son said. But the in­dus­try is likely to see a jump in prod­uct ap­provals over the next five years, he said. The FDA has ap­proved only 19 new medicines so far in 2016, down from 45 in 2015 and 41 in 2014.

Im­ple­men­ta­tion of the law may be in­flu­enced by whom Pres­i­dent-elect Don­ald Trump chooses to lead the FDA. Per pro­to­col, Dr. Robert Califf, the cur­rent com­mis­sioner, will of­fer his res­ig­na­tion. Jim O’Neill, a ven­ture cap­i­tal­ist and for­mer HHS of­fi­cial, and Dr. Scott Got­tlieb, a for­mer FDA deputy com­mis­sioner, re­port­edly are un­der con­sid­er­a­tion for the job.

O’Neill pre­vi­ously has said he would like the FDA to fo­cus on mak­ing sure new drugs are safe while pay­ing less at­ten­tion to ef­fec­tive­ness.

Rosen ex­pressed con­cern about hav­ing a com­mis­sioner who’s not a physi­cian or sci­en­tist. “I think you re­ally need to un­der­stand the un­der­ly­ing med­i­cal as­pects of these sit­u­a­tions to fully un­der­stand the de­ci­sion­mak­ing in the ap­proval process,” he said.

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