Aducanumab, Accelerated Approvals & the Agency: Why the FDA Needs Structural Reform

Abstract

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.

Note:

Funding Information: Research for this article was supported by a grant from the Canadian Institutes of Health Research (CIHR PJT 156256) and an award from the Commonwealth Fund.

Declaration of Interests: Matthew Herder is a member of the Patented Medicine Prices Review Board (PMPRB), Canada’s national drug pricing regulator, and receives honoraria for his public service. The PMPRB had no role whatsoever in the design or conduct of the research, or the analysis and writing of this manuscript.

Keywords: US Food and Drug Administration, Accelerated Approvals, Drug Regulation, Alzheimer’s Disease