FDA Approval of Aducanumab for Alzheimer’s Disease

In this Oliver C. Schroeder, Jr. Scholar-in-Residence Lecture, Michael Carome, MD, director of Public Citizen’s Health Research Group (HRG), will describe the advocacy work of HRG over the past year opposing Food and Drug Administration (FDA) approval of the drug aducanumab for treatment of Alzheimer’s disease and seeking to hold the agency accountable for its reckless decision to approve the drug in June 2021. He will highlight the unprecedented and inappropriately close collaboration between the FDA and drugmaker Biogen before and after the submission of the company’s biologics license application (BLA) for aducanumab, a collaboration that dangerously compromised the independence and objectivity of FDA senior staff and clinical reviewers who were involved in the review of Biogen’s BLA for aducanumab and key data from clinical trials of the drug. In December 2020, Public Citizen’s Health Research Group first called for an independent investigation of the FDA-Biogen collaboration by the U.S. Department of Health and Human Services’ Office of Inspector General. Dr. Carome will explain why the FDA’s close collaboration with Biogen is emblematic of regulatory capture at the agency, which has been fostered by agency leadership over nearly three decades since the enactment of the Prescription Drug User Fee Amendments in 1992. Dr. Carome\u27s expertise includes drug and medical device safety, FDA regulations, and the protection of human research subjects. He is editor of Public Citizen’s Worst Pills, Best Pills News, a monthly newsletter that provides reviews of the safety of prescription and over-the-counter medications. Prior to joining Public Citizen in 2011, he was associate director for Regulatory Affairs, Office for Human Research Protections (OHRP), Department of Health and Human Services; staff nephrologist at the Walter Reed Army Medical Center’s Department of Medicine; and a Commissioned Corps officer in the U.S. Public Health Service. Earlier in his federal career, he served as director, Division of Compliance Oversight, OHRP; chief of the Compliance Oversight Branch in the Office for Protection from Research Risks, National Institutes of Health; and assistant professor of Medicine for the Uniformed Services University of the Health Sciences. Dr. Carome earned his MD at Case Western Reserve University. He is a fellow of the American College of Physicians