FDA’s Pathway for Regulation of FMT: Not So Fraught
A recent article by Rachel Sachs and Carolyn Edelstein in the Journal of Law and the Biosciences 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 the broader field of the human microbiome have enormous potential for the development of new therapeutics. Already, FMT has been shown to have greater efficacy for the treatment of recurrent Clostridium difficile infections (CDI) than traditional treatment with a broad spectrum antibiotic, vancomycin. Interventions that manipulate the human microbiota may also hold potential for the treatment of Inflammatory Bowel Disease and potentially a broader range of inflammatory, infectious, and metabolic diseases.