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.