FDA's pathway for regulation of FMT: not so fraught

A recent article byRachel Sachs andCarolynEdelstein in the Journal of Lawand the Biosciences1 on regulation of fecal microbiota transplants (FMT) brought a welcome hard look at the difficulty of regulating an area that holds great promise but is often greeted by hoots and nervous laughter rather than comprehensive study. FMT has been given relatively little attention by legal scholars working in food and drug law.However, FMT and thebroader fieldof thehumanmicrobiome2 have enormouspotential for thedevelopment of new therapeutics.3 Already, FMThas been shown tohave greater efficacy for the treatment of recurrent Clostridium difficile infections (CDI) than traditional treatmentwith abroad spectrumantibiotic, vancomycin.4 Interventions thatmanipulate the human microbiota may also hold potential for the treatment of Inflammatory Bowel Disease5 and potentially a broader range of inflammatory, infectious, and metabolic diseases. Sachs and Edelstein take issue with FDA’s current approach to regulating FMT. FDAhas announced that fecalmicrobiotawill be regulated as a biological drug,6 but has † Professor of Law, Schools of Law andMedicine, University of Virginia ‡ Chief Executive Officer, Vedanta BioSciences 1 Rachel E. Sachs & Carolyn A. Edelstein, Ensuring the Safe and Effective FDA Regulation of Fecal Microbiota Transplantation, 2 J. LAW BIOSCI. 396, 415 (2015). 2 The humanmicrobiome is the population of microorganisms that resides on the skin, oral cavity, vaginal tract, and primarily, in the gastrointestinal tract, of human beings. 3 Bernat Olle,Medicines FromMicrobiota, 31 NAT. BIOTECHNOL. 309 (2013). 4 Els van Nood et al., Duodenal Infusion of Donor Feces for Recurrent Clostridium difficile, 368 N. ENGL. J. MED. 407 (2013). 5 Koji Atarashi et al., Treg Induction by a Rationally Selected Mixture of Clostridia Strains From the HumanMicrobiota, 500 NATURE 232 (2013). 6 Food & Drug Administration, Fecal Microbiota for Transplantation: Scientific and Regulatory Issues 309, May 2, 2013, http://www.fda.gov/downloads/BiologicsBloodVaccines/NewsEvents/WorkshopsMeetings Conferences/UCM352903.pdf (accessed Oct. 12, 2015).