The transfer of stool from one healthy donor to a recipient, known as faecal matter transplants (FMT), is considered by many to be standard-of-care therapy for recurrent Clostridium difficile infection (CDI), and microbial transfers are increasingly being considered as treatment for other conditions.
However, writing in a Policy Forum paper in Science, a team of experts emphasised that as FMT continues to be more widely adopted it is ‘critical’ to have an appropriate regulatory framework in place.
Led by Professor Diane Hoffmann, director of the Law and Health Care Program at the University of Maryland, USA, the team warn that 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 analysed for disease.
“Although some physicians are practicing FMT using stool from donors known to the physician or patient, stool is inconsistently screened for infectious pathogens,” noted the experts. “The use of prescreened stool obtained from a stool bank and shipped to the physician is increasing, but the stool banks are not regulated.”
However, Hoffmann and her colleagues added that common regulatory approaches ‘could be hard to apply’ because the transplanted material is a community of highly dynamic and diverse organisms, many of which are challenging to culture in vitro.
“In consideration of these and other particular characteristics and challenges of MT, and the nascent regulatory landscape, we convened human microbiome researchers, legal experts, and others to explore regulatory pathways for MT,” they said.
A less poopy solution?
In its most recent stance on FMT, 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, noted the team, who added that such an approach has been criticised for creating more barriers, and costs, associated with accessing FMT.
Hoffmann and her colleagues 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.
“We believe our proposed approach is an improvement on the U.S. Food and Drug Administration's (FDA) current and proposed scheme and could provide a model for other countries that are contemplating regulatory frameworks for FMT,” said the team.
Vol. 358, Issue 6369, Pages 1390-1391, doi: 10.1126/science.aaq0034
“Improving regulation of microbiota transplants”
Authors: Diane Hoffmann, et al