Ensuring the Safe and Effective FDA Regulation of Fecal Microbiota Transplantation

Abstract

Scientists, policymakers, and medical professionals alike have become increasingly worried about the rise of antibiotic resistance and the growing number of infections due to bacteria like Clostridium difficile, which cause a significant number of deaths and impose increasing costs on our health care system. However, in the last few years, fecal microbiota transplantation (FMT), the transplantation of stool from a healthy donor into the bowel of a patient, has emerged as a startlingly effective means to treat recurrent C. difficile infections. At present, the FDA is proposing to regulate FMT as a biologic drug. However, this proposed classification is both under-regulatory and over-regulatory. The FDA’s primary goal is to ensure that patients have access to safe, effective treatments — and as such they should regulate some aspects of FMT more stringently than they propose to, and others less so. This Essay will examine the nature of the regulatory challenges the FDA will face in deciding to regulate FMT as a biologic drug, and will then evaluate available policy alternatives for the FDA to pursue, ultimately concluding that the FDA ought to consider adopting a hybrid regulatory model as it has done in the case of cord blood.