Soon, the researchers who have been reporting success with the use of faecal transplant to treat resistant C. difficile will need an OK from the FDA to continue the treatment. The reason of FDA stepping involves the way in which the agency interprets existing regulations that cover biologic drugs.
Faecal microbiota meets the definition of a biologic product, which requires an IND before they are tested in humans. So far, there is no such rule to cover the faecal transplants, but going forward physicians will need an IND if they plan to use the treatment. According to FDA personnel, in an emergency situation, researchers can request to use faecal microbiota for transplant over the phone to which the FDA can respond immediately.
The purpose behind the regulation is ensuring that patients are not exposed to unreasonable risks; however, FDA’s interest in regulating the procedure has nothing to do with any adverse events.
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