Blog | Thursday, July 25, 2013

QD: News Every Day--FDA will allow fecal transplants after all


The Food and Drug Administration will back off its previous stance that fecal transplantations will require an Investigational New Device (IND) application.

The FDA said in a guidance for industry that it will not require physicians to apply through the regulatory process, "provided that the treating physician obtains adequate informed consent from the patient or his or her legally authorized representative for the use of FMT [fecal microbiota for transplantation ] products. Informed consent should include, at a minimum, a statement that the use of FMT products to treat C. difficile is investigational and a discussion of its potential risks. FDA intends to exercise this discretion on an interim basis while the agency develops appropriate policies for the study and use of FMT products under IND."

Fecal transplants have been widely discussed as a way to treat recurrent Clostridium difficile colitis, and the agency's decision was unpopular among internists.