In May, 2013 the FDA ruled that the use of fecal microbiota for transplantation (FMT) to treat Clostridium difficile (C. difficile) infection not responding to standard therapies would need to go through the investigational new drug (IND) application process which would delay administration of the therapy. The FDA has changed their stance somewhat. While they do intend to exercise enforcement discretion regarding IND requirements, the provisos to do so are as follows: (1) the licensed health care provider treating the patient obtains adequate informed consent from the patient or his or her legally authorized representative for the use of FMT products; (2) the FMT product is obtained from a donor known to either the patient or to the licensed health care provider treating the patient; and (3) the stool donor and stool are qualified by screening and testing performed under the direction of the licensed health care provider for the purpose of providing the FMT product to treat his or her patient. Note that the 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.
To read “Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies” released by the FDA in July, 2013 click here.
To read the Draft guidance developed in March, 2014 and when finalized, will supersede the original Guidance document click here.