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Regulatory Memory Loss: The FDA’s Road to Aducanumab
January 26th, 2022 @ 1:00 pm - 2:00 pm
Department of Epidemiology Seminar Series
Open to the public.
Speaker:
Steven Goodman, MD, MHS, PhD
Professor of Epidemiology and Population Health and of Medicine
(Primary Care and Population Health)
Associate Dean of Clinical and Translational Research, Stanford University
Abstract: The FDA’s 2021 approval of the Alzheimer’s drug aducanumab has attracted widespread criticism, both within and outside of the FDA. Most of this criticism is focused on the low evidential bar used to justify the decision under the accelerated approval pathway, and its inconsistency with previous criteria. This talk will focus on features of FDA structure and decision making that made this possible, demonstrated in an empirical study of drugs approved 2013-2018 that were initially disapproved. This study showed that the FDA’s failure to formally build upon its own precedents – routine in the legal world – set the stage for decisions like that for aducanumab, which weaken the FDA’s public trust. Possible remedies will be discussed.