2016-06-01 17:51:48 UTC

AGA Submits Comments on Latest FMT Guidance

June 1, 2016

AGA provides feedback on regulation of stool banks and encourages FDA to allow practitioners to continue to offer FMT.

The AGA Center for Gut Microbiome Research and Education, with the support of the North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN), has submitted comments on the FDA recent draft guidance for industry regarding the applicability of investigational new drug (IND) requirements to fecal microbiota transplantation (FMT).

In the comments, which you can read here, AGA:

  • Agrees that stool banks should operate under an IND; their compliance with the IND requirements will help to ensure that the stool donor and stool are appropriately qualified by screening and testing and that centralized processing of FMT will adhere to appropriate current good manufacturing conditions. It will also mandate routine safety reporting, which is currently voluntary for stool banks and individual FMT providers.
  • Believes that all IND regulations should be waived for health-care providers using FMT product from stool banks (i.e., sub-investigators) except IND safety reporting of serious and unexpected suspected adverse reactions to the stool bank (i.e., IND sponsor)..
  • Believes that the requirement for assurance of institutional review board (IRB) review should be waived for sub-investigators when FMT is used to treat recurrent CDI not responsive to standard therapies. However, IRB review should be required when FMT is being used in the research setting for CDI, or for the treatment of disorders other than recurrent CDI.
  • Believes that the limitations for charging for investigational drugs under an IND should be waived for sub-investigators.
  • Believes that all health-care providers performing FMT should be required to record the donor stool used for each FMT recipient.
  • Believes that a national FMT registry must be established as a reporting vehicle for health-care providers performing FMT.

AGA thanks FDA for its interest in ensuring that FMT remains a safe therapeutic option for patients with recurrent CDI. As microbiome-based therapeutics continue to evolve, we encourage FDA to focus its immediate attention on ensuring gastroenterologists can continue current practice in using FMT as an effective treatment for recurrent CDI as we await the advent of new therapeutic options.

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