FDA user fee reau­tho­riza­tions turn in­to rare bi­par­ti­san love­fest at House hear­ing

Leav­ing any hint of par­ti­san­ship to the dust, the sub­com­mit­tee on health of the House’s en­er­gy and com­merce com­mit­tee came to­geth­er across both sides of the aisle to sup­port not on­ly the user fee reau­tho­riza­tions that pro­vide for the ma­jor­i­ty of FDA’s bud­get, but al­so the add-on bills that would re­form the agency’s ac­cel­er­at­ed ap­proval path­way among oth­er mea­sures.

On the ac­cel­er­at­ed ap­proval front, the bill, which ad­vanced to the full com­mit­tee next week by a unan­i­mous vote of 30-0, would al­low the FDA to re­quire con­fir­ma­to­ry tri­als to be un­der­way pri­or to grant­i­ng these ap­provals as part of re­forms to shore up com­pa­nies that drag their feet on such tri­als. It would al­so stream­line the FDA’s abil­i­ty to with­draw ac­cel­er­at­ed ap­provals when con­fir­ma­to­ry tri­als fail, and it re­quires the agency to ex­plain it­self when not re­quir­ing a con­fir­ma­to­ry tri­al.

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