#DIA22: Re­vamp­ing the FDA's prized ac­cel­er­at­ed ap­provals

Zachary Bren­nan:

Hi, good af­ter­noon and wel­come to our DIA 2022 pan­el on FDA Over the Next Five Years. To­day, we are joined by Hol­ly Fer­nan­dez Lynch from the Uni­ver­si­ty of Penn­syl­va­nia, Mar­i­ana So­cal from Johns Hop­kins Uni­ver­si­ty and Kurt Karst, Di­rec­tor at Hy­man, Phelps & Mc­Na­ma­ra, who al­so pub­lish­es the FDA Law Blog. So thank you all for join­ing us. As an in­tro­duc­tion, I just want­ed to men­tion that every five years, the FDA in­dus­try and var­i­ous stake­hold­er groups come to­geth­er and ne­go­ti­ate their user fee deals, which typ­i­cal­ly means that the FDA has to hit cer­tain re­view mile­stones in ex­change for more mon­ey from in­dus­try. And Con­gress has un­til the end of Sep­tem­ber to reau­tho­rize this pack­age of leg­is­la­tion, and if Con­gress doesn’t meet that dead­line, then thou­sands of med­ical prod­uct re­view­ers that the FDA would like­ly be laid off. This year’s deal al­so in­cludes some new re­forms around the ac­cel­er­at­ed ap­proval path­way and some oth­er in­ter­est­ing de­tails around di­ver­si­ty in clin­i­cal tri­als and oth­er pro­vi­sions that the Sen­ate and the House have both yet to ful­ly agree on but we will talk about some of those dif­fer­ences right now.

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