As fecal matter transplants (FMTs) continue to be more widely adopted, it is critical to have an appropriate regulatory framework in place, authors of this Policy Forum emphasize. They go on to outline key areas for improvement, compared to current regulatory approaches. The transfer of stool from one healthy donor to a recipient for re­current Clostridium difficile infection (CDI) is considered by many to be standard-of-care therapy, and microbial transfers are increasingly being considered as treatment for other conditions as well. In fact, microbial transfers are gaining such popularity that some people are self-administering FMT us­ing unscreened stool samples, which - sourced from family or friends - have not been analyzed for disease. Such approaches further highlight the need for better access and regulation. However, common regulatory approaches could be hard to apply, say Diane Hoffmann et al., because the transplanted material is a community of highly dynamic and diverse organisms, many of which are challenging to culture in vitro. Each "batch" of product is very different. In stating its most recent stance, the U.S. Food and Drug Administration (FDA) published guidance that it would require stool banks to submit an inves­tigational new drug application (IND) to obtain and distribute stool to physicians, an approach that has been criticized for creating more barriers, and costs, associated with accessing FMT. The authors of this Policy Forum propose a different approach, where stool banks are required to report to a registry, allowing for ongoing capture of patient outcome data on safety and effective­ness, but are not required to file an IND to distribute stool treatments for CDI. They also recommend that doctors and laboratories retain the ability to distribute stool for CDI treatment at their discretion, but not for treatment of other, unproven therapies.

###