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FDA reverses fecal transplant regulations, eases restrictions on doctors treating C. Diff patients

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c diff (wikipedia)
c diff (wikipedia)

Despite the fact that the rather experimental fecal transplant procedure has been recognized through a number of studies as a reliable cure for the rare and debilitating disease known as Clostridium difficile, or C. diff, FDA regulations made it difficult for doctors to reliably perform the operation. However, now the organization says that it will "exercise enforcement discretion" and no longer require doctors to receive agency approval before performing the procedure. Earlier this year, the FDA introduced a policy that classified fecal transplants as an "investigational new drug," which meant that doctors needed to submit an extensive application to the agency and wait up to 30 days for a response — as a result, many doctors chose not to perform the procedure at all.

Fortunately for the 3 million people affected by C. diff in the US every year, the FDA is changing course. Thanks to the doctors who protested this new regulation, the FDA now says that it won't require doctors to receive its approval before performing the fecal transplant procedure. However, the agency also notes that it is only lifting that requirement when the fecal transplant is performed on C. diff patients who have not responded to other treatment methods; the patient must also have a discussion with the doctor about "potential risks" and acknowledge that the treatment is "investigational." But while the FDA hasn't fully embraced fecal transplants, its at least making things easier for those that might benefit from the treatment.