New pro­vi­sion­al, time-lim­it­ed drug ap­proval path­way: House and Sen­ate rein­tro­duce bi­par­ti­san bill

Mem­bers of the House on both sides of the aisle joined with Sen­ate col­leagues late last month in rein­tro­duc­ing a bill that would al­low for ex­per­i­men­tal drugs for life-threat­en­ing dis­eases to win two-year, pro­vi­sion­al ap­provals at FDA.

The bill, known as the Promis­ing Path­way Act, which was pre­vi­ous­ly in­tro­duced in 2021, would al­low spon­sors of new drugs to re­quest these pro­vi­sion­al ap­provals, which would dif­fer from ac­cel­er­at­ed ap­provals that have to use a sur­ro­gate end­point, for up to a to­tal of eight years as long as the com­pa­ny agrees to par­tic­i­pate in reg­istries while full ap­provals re­main pend­ing.

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