Sunday, February 5, 2023
Aducanumab, Accelerated Approvals & the Agency: Why the FDA Needs Structural Reform
Matthew Herder (Dalhousie University), Aducanumab, Accelerated Approvals & the Agency: Why the FDA Needs Structural Reform, J. L. Med. & Ethics (Forthcoming):
The US Food and Drug Administration’s controversial decision to grant accelerated approval to aducanumab (Aduhelm), a therapy for Alzheimer’s disease, has motivated multiple policy reforms. Drawing upon a case series of other drugs granted accelerated approval and interviews of senior FDA officials, I argue that reform should be informed but not defined by aducanumab. Rather, structural reforms are needed to reshape FDA’s core priorities and restore the regulatory system’s commitment to scientific rigor.
https://lawprofessors.typepad.com/healthlawprof_blog/2023/02/aducanumab-accelerated-approvals-the-agency-why-the-fda-needs-structural-reform.html