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Aducanumab, Accelerated Approvals & The Agency: Why The Fda Needs Structural Reform, Matthew Herder
Aducanumab, Accelerated Approvals & The Agency: Why The Fda Needs Structural Reform, Matthew Herder
Articles, Book Chapters, & Popular Press
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.
Denaturalizing Transparency In Drug Regulation, Matthew Herder
Denaturalizing Transparency In Drug Regulation, Matthew Herder
Articles, Book Chapters, & Popular Press
In the arena of pharmaceutical drug regulation, transparency is the favoured focus of many current policy initiatives. Transparency is predominantly understood in terms of information disclosure. Requirements to register clinical trials, publish summary results, share clinical trial data, and disclose physician-industry relationships as well as rationales behind regulatory decision making are each predicated upon this idea that imparting information will both inform and deter unwanted behaviours. In this paper, I argue that understanding transparency qua disclosure has clear limitations and suggest transparency can and should serve an additional function - namely, of enabling standard setting through a more participatory, public …