OpenBiome has suspended its distribution of investigational fecal microbiota transplantation due to FDA guidance. This may impact patients with recurrent C. difficile infections. The FDA’s new policy no longer extends to stool banks, leading to concerns about access to FMT for severe cases. The AGA and other organizations have urged the FDA to reconsider and maintain access to FMT for patients who do not respond to current therapies. The FDA has approved new FMT therapeutics, but conventional FMT from known donors or stool banks is still considered essential for certain patients. The AGA will continue to support the FMT National Patient Registry for real-world data.
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AGA urges continued access to conventional FMT for C. difficile patients
