Friday, October 22, 2021
Yaniv Heled (Georgia State University), Ana Santos Rutschman (Saint Louis University), Liza Vertinsky (Emory University), Regulatory Reactivity in FDA's Approval of the Alzheimer's Disease Drug Aducanumab (Aduhelm), Regul. Rev. (2021):
On June 7, 2021, the U.S. Food and Drug Administration (FDA) approved aducanumab, a therapy for the treatment of Alzeihmer’s disease sponsored by Biogen and set to be commercialized under the brand name Aduhelm. Aduhelm was the first treatment for Alzeihmer’s approved by the FDA since 2003. Yet, the approval of Aduhelm has generated widespread controversy and concern rather than celebration, as public health experts question both the validity of the approval process and the likely benefits of the resulting drug. Although much of the current debate is focused on the unique features of this particular drug and the consequences of its approval, we suggest that the approval can be best understood within a more general framework of what we define as regulatory reactivity that increasingly characterizes decision making by the FDA. Understanding this case as the result of regulatory reactivity can be used to isolate areas of regulatory weakness and support targeted institutional reforms. We conclude with some proposals for addressing reactivity both in the context of Aduhelm and beyond.