FDA program that hurried hundreds of new medicines to patients is facing a makeover after criticism that it allowed the sale of some costly drugs that don’t work
House and Senate proposals would give the agency added authority to make sure drugs submitted for fast-track approval undergo follow-up studies
Biogen’s Aduhelm is the first approved treatment for early stage Alzheimer’s patients that may be able to slow the disease. WSJ explains how the drug interacts with brain cells, and why some doctors aren’t ready to prescribe it yet. Illustration: Jacob ReynoldsA 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.
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