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.
