The FDA issued a statement Monday stating that it will not require filing and review of an IND for Fecal Microbiota Transplant procedures, so long as there is adequate informed consent. The agency still asserts its authority to regulate the procedure, and intends to issue guidance covering this "enforcement discretion".
This seems about right to me - adequate informed consent would be a part of any responsible practitioner's protocol at present anyway, so no one will be denied treatment. In the meantime there is an opportunity to have a conversation about how to ensure the procedure can be made safe and effective and part of the medical mainstream. The worst outcome would be to leave it unregulated and suffer the inevitable disaster that will discredit FMT.
Posted with Blogsy
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