Ensuring the Safe and Effective FDA Regulation of Fecal Microbiota Transplantation

Journal of Law and the Biosciences, Vol. 2, p. 396, 2015

19 Pages Posted: 27 May 2015 Last revised: 21 Jan 2016

See all articles by Rachel Sachs

Rachel Sachs

Washington University in Saint Louis - School of Law

Carolyn Edelstein

OpenBiome

Date Written: May 26, 2015

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.

Suggested Citation

Sachs, Rachel and Edelstein, Carolyn, Ensuring the Safe and Effective FDA Regulation of Fecal Microbiota Transplantation (May 26, 2015). Journal of Law and the Biosciences, Vol. 2, p. 396, 2015. Available at SSRN: https://ssrn.com/abstract=2610738

Rachel Sachs (Contact Author)

Washington University in Saint Louis - School of Law ( email )

Campus Box 1120
St. Louis, MO 63130
United States

Carolyn Edelstein

OpenBiome ( email )

196 Boston Avenue
Suite #1000
Medford, MA 02155

Register to save articles to
your library

Register

Paper statistics

Downloads
255
Abstract Views
1,884
rank
120,706
PlumX Metrics