Dr. Carome will describe the advocacy work of Public Citizen’s Health Research Group 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. 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.
Michael Carome, M.D., is the Director of Public Citizen’s Health Research Group (HRG). His areas of expertise include drug and medical device safety, Food and Drug Administration 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 as the HRG’s Deputy Director in 2011, he was Associate Director for Regulatory Affairs, Office for Human Research Protections (OHRP), Department of Health and Human Services from 2002-2010; Staff Nephrologist at the Walter Reed Army Medical Center’s (WRAMC’s) Department of Medicine from 1992-2010; and a Commissioned Corps officer in the U.S. Public Health Service. Earlier in his federal career, he served as Director, Division of Compliance