OpenBiome, a nonprofit supplying fecal microbiota transplantation (FMT) material, announced a voluntary suspension of its distribution this week, affecting many clinical sites across the U.S. Although the FDA’s current enforcement policy permits FMT use for C. difficile infections unresponsive to standard treatments, the future of this policy is uncertain.
The American Gastroenterological Association (AGA) is actively advocating to maintain access to conventional FMT for patients with severe C. diff infections who may not be eligible for recently FDA-approved microbial therapies. In collaboration with infectious disease experts and related organizations, AGA submitted a letter to the FDA, stressing the need for FMT accessibility in cases where newer treatments might be inaccessible or ineffective.