The FDA has approved two microbial therapies to prevent recurrent Clostridioides difficile infection (CDI), limiting access to conventional fecal microbiota transplantation (FMT). The FDA guidance issued in November 2022 targets stool banks, affecting OpenBiome, a major provider. Stakeholders, including the AGA, objected, leading to a reprieve until the end of the year. CDI affects 500,000 annually, with 30,000 resulting in death. Conventional FMT is still recommended for patients with severe CDI. Physicians can still access FMT through directed donors or hospital systems. AGA supports the FMT National Patient Registry for real-world data on FMT efficacy and safety.
Source link
Easy Access to Conventional FMT Continues — for Now
