The FDA will require doctors to pursue an investigational new device exemption for fecal transplants, since the procedure's ... er, core ingredient ... is not approved for any use.
The American Gastroenterological Association reported on its website that it confirmed this in a letter from Karen Midthun, MD, ACP Member, the Director for the Food and Drug Administration's Center for Biologics Evaluation and Research.
Fecal transplants have captured the interest of many physicians seeking a definitive solution to recurrent Clostridium difficile infections. The procedure goes back in the literature as far as 1958. A few modern-day internists' experiences are reported here, here and here. Still want more proof? The Centers for Disease Control and Prevention are working on the issue, as well.
Finally, meet another doctor who is working on the issue, by donating the ... again, core ingredient ... to those in need who don't have family that can donate. Hunter Johnson, MD, an Emory University medical resident, describes why he likely has a high success rate for patients who use his samples for their treatments. He says the best donors are young, healthy, and at low risk for infections; don't eat exotically, travel a lot or use drugs; and essentially lead "a pretty boring life." His supervisor is working on the investigational new device exemption that would define his stool as medicine, reports NBCnews.com.