WASHINGTON – Lawmakers are facing off over the future of the Food and Drug Administration’s so-called accelerated approval pathway, with Biogen’s controversial Alzheimer’s drug Aduhelm front and center in the debate.
The very first minutes of a Thursday hearing, originally billed as an opportunity to highlight roughly 20 different health policy measures, focused on the future of accelerated approval, which allows the FDA to approve drugs without clear evidence they prolong patients’ lives.
One of the bills, favored by Republicans, makes it easier for the FDA to use the controversial pathway. The other, from a Democrat, would more likely limit it, by making it easier for the FDA to crack down on companies that don’t quickly follow up their initial, accelerated approvals with studies proving the drug’s benefit.
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