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Accelerated Approval: How The Aduhelm Probes Will, And Won’t, Impact The Debate

 
• By Sarah Karlin-Smith

Even as the US FDA can expect to be put through the ringer with the congressional and HHS Inspector General probes, the process could have some upsides for the agency, according to former officials who have been through such scrutiny.

FDA under OIG microscope (design by Nielsen Hobbs)
FDA is undergoing two reviews related to its controversial approval of Biogen’s Aduhelm. • Source: Nielsen Hobbs; the Pink Sheet | Alamy image

The US Food and Drug Administration’s accelerated approval of Biogen, Inc.’s Aduhelm (aducanumab-avwa) has been the most controversial event in the Rx policy sphere – until the Centers for Medicare and Medicaid Services’ effort to essentially undo it through a national coverage determination impacting even traditional approvals of Alzheimer’s drugs.

The locus of outrage may now be shifting towards CMS, and that agency’s time in the stocks may be coming soon. (See sidebar

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