A federal program that has sped hundreds of new drugs to cancer patients and others is facing the biggest makeover of its three-decade history as Congress considers ways to avoid approval of drugs that don’t work.
Congress is poised to amend the Food and Drug Administration’s accelerated-approval program to address complaints that it has sometimes led to the use of costly, ineffective drugs. Proposals in the House and Senate would give the FDA more authority to make sure companies conduct the large follow-up studies needed to confirm that a fast-tracked drug works, and to pull from the market any therapy that doesn’t.
