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.

Fecal Microbiota-based Therapeutics for Recurrent Clostridium difficile Infection, Ulcerative Colitis and Obesity

“…Another issue raised by the IDSA and others is the urgent need to establish a national FMT registry in order to monitor safety and long-term adverse events of FMT (Hecht et al, 2014, Vyas et al, 2015). Earlier this year, the American Gastroenterological Association (AGA) received funding from the National Institutes of Health (NIH) for creation of the first national registry for patients receiving FMT (AGA, 2016).…”

Gleaning Insights from Fecal Microbiota Transplantation and Probiotic Studies for the Rational Design of Combination Microbial Therapies

“…FMT is currently designated a biological agent by the FDA, and physicians must submit an investigational new drug application to administer FMT for any indication other than recurrent CDI (13). Uncertainty about the potential long-term effects of FMT and how to appropriately regulate this treatment has limited its use (14). In contrast, development of treatments containing only the effective components of FMT by using combinations of specific microbial strains would alleviate many of these drawbacks that result largely from the undefined nature of fecal preparations.…”

Microbiome engineering: Current applications and its future

“…In contrast, FMT treats CDI by restoring beneficial Firmicutes and Bacteriodetes, thus re-establishes the healthy microbiome to effect high cure rate and low recurrence [13], and exemplifies the advantage of FMT over antibiotic therapy for CDI treatment. Owing to its benefits, FMT rapidly gained popularity as an Investigational New Drug (IND) when the US Food and Drug Administration (FDA) exempted the need for an IND application in 2013 to employ FMT under enforcement discretion to treat severe recurrent CDI although FDA has since imposed stricter regulations on FMT in order to ensure long-term safety of the treatment [14]. In addition to CDI, FMT has shown promise in treating IBD and insu- Figure 1.…”