title: Fecal transplant policy and legislation.
abstract: Fecal microbiota transplantation (FMT) has garnered significant attention in recent years in the face of a reemerging Clostridium difficile (C. difficile) epidemic. Positive results from the first randomized control trial evaluating FMT have encouraged the medical community to explore the process further and expand its application beyond C. difficile infections and even the gastrointestinal domain. However promising and numerous the prospects of FMT appear, the method remains limited in scope today due to several important barriers, most notably a poorly defined federal regulatory policy. The Food and Drug Administration has found it difficult to standardize and regulate the administration of inherently variable, metabolically active, and ubiquitously available fecal material. The current cumbersome policy, which classifies human feces as a drug, has prevented physicians from providing FMT and deserving patients from accessing FMT in a timely fashion, and subsequent modifications seem only to be temporary. The argument for reclassifying fecal material as human tissue is well supported. Essentially, this would allow for a regulatory framework that is sufficiently flexible to expand access to care and facilitate research, but also appropriately restrictive and centralized to ensure patient safety. Such an approach can facilitate the advancement of FMT to a more refined, controlled, and aesthetic process, perhaps in the form of a customized and well-characterized stool substitute therapy.
authors.affiliation: Dinesh Vyas, Apoorva Aekka, Arpita Vyas, College of Human Medicine, Michigan State University, East Lansing, MI 48912, United States.
authors.forename: Dinesh
authors.initials: D
authors.lastname: Vyas
authors.affiliation: Dinesh Vyas, Apoorva Aekka, Arpita Vyas, College of Human Medicine, Michigan State University, East Lansing, MI 48912, United States.
authors.forename: Apoorva
authors.initials: A
authors.lastname: Aekka
authors.affiliation: Dinesh Vyas, Apoorva Aekka, Arpita Vyas, College of Human Medicine, Michigan State University, East Lansing, MI 48912, United States.
authors.forename: Arpita
authors.initials: A
authors.lastname: Vyas
mesh_terms: D000818:Animals; D001691:Biological Therapy / Q000009:adverse effects / Q000379:methods*; D016360:Clostridioides difficile / Q000472:pathogenicity*; D004761:Enterocolitis, Pseudomembranous / Q000175:diagnosis / Q000453:epidemiology / Q000382:microbiology / Q000628:therapy*; D005243:Feces / Q000382:microbiology*; D006291:Health Policy; D006801:Humans; D007422:Intestines / Q000382:microbiology*; D064307:Microbiota; D061214:Patient Safety; D018570:Risk Assessment; D012307:Risk Factors; D016896:Treatment Outcome
keywords: Clostridium difficile; Fecal microbiota transplantation; Stool therapy; Toxin