Here are four insights:
1. Because of its reported risks, the FDA has said it will regulate fecale microbiota transplants.
2. The agency released a draft guidance last month that would exclude stool banks from the enforcement discretion it is currently exercising over fecal microbiota transplants for treating C. difficile.
3. If enacted, the guidance would require stool banks like OpenBiome and AdvancingBio to have an investigational new drug application in place before they can distribute samples.
4. The stool banks are unsure how these requirements would affect the physicians to whom they provide samples and their patients, but researchers in the field have said the draft guidance shouldn’t affect research into fecal microbiota transplants and might even encourage it, if enacted.
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