Lawmakers dropped provisions opposed by the pharmaceutical industry from a bill that makes it easier for the Food and Drug Administration to withdraw drugs that were approved under an accelerated timeline, according to three drug lobbyists.
The legislation was spurred by the fracas over the Alzheimer’s drug Aduhelm, which received a so-called accelerated approval. Nearly every member of an FDA advisory panel voted against approving the Biogen drug, though many advocates for patients with debilitating conditions praised FDA for the approval. Medicare officials subsequently refused to pay for the drug outside of clinical trials.
The FDA uses accelerated approvals to speed availability of promising drugs for serious conditions. In return, companies agree to conduct clinical research that confirms drugs extend lives, but companies often miss deadlines by years. Under the bill, those missed deadlines can now be ground for the FDA to withdraw approval.
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