FDA's OCE makes the case for ac­cel­er­at­ed ap­proval rid­er in user fee reau­tho­riza­tion

Four ex­perts from the FDA’s On­col­o­gy Cen­ter of Ex­cel­lence took to the New Eng­land Jour­nal of Med­i­cine yes­ter­day to make the case for not on­ly im­prov­ing the agency’s abil­i­ty to ex­pe­di­tious­ly pull dan­gling ac­cel­er­at­ed ap­provals when, on the rare oc­ca­sion, con­fir­ma­to­ry tri­als fail, but al­so bet­ter build­ing “qual­i­ty and ef­fi­cien­cy in­to the AA on-ramp.”

The time­ly per­spec­tive ar­rives as Con­gress has ex­act­ly one week left to draft, re­lease and sign off on the reau­tho­rized user fee deals be­fore lay­off no­tices will be sent to drug re­view­ers. That pack­age, which is like­ly to hitch a ride with the con­tin­u­ing res­o­lu­tion, may or may not in­clude sev­er­al pol­i­cy rid­ers (op­posed by Re­pub­li­cans), in­clud­ing one that would al­low the FDA to re­quire con­fir­ma­to­ry tri­als to be un­der­way be­fore an AA is grant­ed, and would im­prove the process by which FDA can with­draw AAs.

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