Rep. Frank Pallone (D-NJ) (Photo by Michael Brochstein/Sipa USA)(Sipa via AP Images)

Over­haul­ing FDA's ac­cel­er­at­ed ap­proval path­way: Key House com­mit­tee chair pens new bill

House En­er­gy & Com­merce Com­mit­tee Chair Frank Pal­lone (D-NJ) late Mon­day in­tro­duced new leg­is­la­tion that would re­vamp the way the FDA can tight­en its reigns around ac­cel­er­at­ed ap­provals, which have seen ris­ing num­bers over the years, but no re­al way for the agency to quick­ly pull ones that have failed to con­firm clin­i­cal ben­e­fit in a time­ly man­ner.

Specif­i­cal­ly, the bill pro­vides the FDA with a lot more dis­cre­tion on how it can man­age the ac­cel­er­at­ed ap­proval pro­gram. The FDA’s On­col­o­gy Cen­ter of Ex­cel­lence, which re­views the bulk of the ac­cel­er­at­ed ap­provals that come in­to the agency, held an ad­vi­so­ry com­mit­tee meet­ing last spring and has been work­ing to move for­ward on ei­ther pulling or re­quir­ing fur­ther stud­ies for some of these “dan­gling” ac­cel­er­at­ed ap­provals.

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