Pharma wins changes in bill regarding FDA’s accelerated approval
A bill that makes it easier for the Food and Drug Administration to withdraw drugs that were approved under an accelerated timeline also dropped provisions the industry had opposed, 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.
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