Lecture: Fecal Microbiota Transplantation: Ethical Challenges and Regulatory Hurdles

Presented by Prof. Stacy A. Kahn, MD, of the Transitional Inflammatory Bowel Diseases (IBD) Clinic at the University of Chicago's Comer Children's Hospital. Fecal Microbiota Transplantation (FMT) has emerged as an important yet controversial therapy for Clostridium difficile (C. difficile), a painful and sometimes life-threatening form of colitis. While there is a great deal of enthusiasm about the treatment, there remain many unanswered questions. Dr. Kahn describes her pioneering work using FMT with pediatric patients and outlines critical ethical, social, and regulatory issues, including implications of the FDA’s decision to designate FMT as both a biologic and a drug. The lecture was introduced by Susan M. Wolf, JD, chair of the University of Minnesota's Consortium on Law and Values in Health, Environment & the Life Sciences, and moderated by Prof. Alexander Khoruts, MD, medical director of the Microbiota Therapeutics Program at the University of Minnesota. After Prof. Kahn's talk, a commentary was provided by Prof. Byron Vaughn, MD, also of the Microbiota Therapeutics Program.