Blog | Tuesday, July 2, 2013

Did the FDA soften its stance on stool transplants?

In June the FDA quietly posted an announcement regarding the requirement for submitting an investigational new drug (IND) application by physicians who perform fecal transplantation. In part, it says:

"Some health care providers have stated that applying IND requirements will make FMT unavailable and have suggested that an alternative regulatory approach is needed to ensure the widespread availability of FMT for individuals with C. difficile infection unresponsive to standard therapies."

"The agency acknowledges these concerns and intends to exercise enforcement discretion regarding the IND requirements for the use of FMT to treat C. difficile infection not responding to standard therapies provided the treating physician obtains adequate informed consent from the patient or his or her legally authorized representative for the use of FMT 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 while the agency develops appropriate policies for the study and use of FMT products under IND. The agency intends to issue guidance reflecting the agency's intention to exercise enforcement discretion."

"During this time FDA strongly encourages compliance with the IND regulations, and stands ready to work with sponsors who are interested in conducting clinical trials."

I've read this a couple of times, and I'm not sure exactly what this means. Can fecal transplantation now be performed without an IND as long as there is informed consent? It sounds as though further information is forthcoming. Nonetheless, it appears to be a step in the right direction. Kudos to the patients and their families for making their voices heard. Yesterday, one of my patients spoke about her experience here:

Michael B. Edmond, MD, FACP, is a hospital epidemiologist in Richmond, Va., with a focus on understanding why infections occur in the hospital and ways to prevent these infections, and sees patients in the inpatient and outpatient settings. This post originally appeared at the blog Controversies in Hospital Infection Prevention.