Interest in fecal transplants as a way to replace gut microflora to treat recurrent Clostridium difficile infections has been piqued in recent years, and a study published in the New England Journal of Medicine about a year ago showed that fecal microbiota transplants were more effective than vancomycin therapy for treating recurrent C. difficile infections
Shortly after that, the US Food and Drug Administration moved to regulate FMT procedures, indicating that it considers it a biologic. The agency later said it was exercising enforcement discretion, thus allowing FMT to be used to treat recurrent C. diff. without doctors having to file an Investigational New Drug application.
Still, a trio of researchers argues in Nature this week that FDA should regulate feces as a tissue, rather than as a biologic, or give it its own category.
"Although treating it as a drug creates strict requirements to protect patients, it limits access to care," say Mark Smith from MIT, Colleen Kelly at Brown University, and MIT's Eric Alm. "Reclassifying stool as a tissue product or giving it its own classification, as the FDA does for blood, would keep patients safe, ensure broad access, and facilitate research."
Smith, a PhD candidate, is a co-founder of OpenBiome, a feces biobank.
Regulating feces as a tissue will also enable further study of fecal transplants for conditions beyond C. diff., the researchers say. FMT has been floated as a possible treatment for inflammatory bowel disease and obesity.
"I think regulating it as a tissue product would both provide access as needed and the research that could bring some pretty exciting new treatments on the scene," Smith tells LiveScience.