Patients Want Poop Transplants. Here's How to Make Them Safe


“The way the regulations are written now, everything is being done under enforcement discretion,” says Diane Hoffman, a professor of health law at the University of Maryland, and first author on the Science paper. The FDA is just choosing to bend the rules for C. diff. patients. But the agency could just as easily unbend them, whenever it wants. Which is why Hoffman and her colleagues are suggesting transplants used for C. diff be regulated as a “practice of medicine” rather than a drug, when the stool comes from someone the patient or physician knows, i.e. not a stool bank. Then it would only be subject to state, rather than federal regulation. More patients could then access the treatment—which has cure rates above 80 percent—regardless of market winds or agency whims. All other uses of FMT would still be subject to formal clinical trials overseen by the FDA.

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