The FDA appears to have to come to its senses, at least temporarily. Yesterday the agency officially published guidance revoking a May, 2013 requirement that the procedure known as fecal bacteriotherapy will not be allowed unless physicians submit a investigational new drug application (IND) prior to the procedure. Given that the procedure is offered only to patients who are chronically infected with Clostridium difficile that has not responded to standard therapies, the original FDA decision was viewed by many as an impediment to the public’s health.
Here’s the timeline:
In May of 2013, the agency announced that fecal transplants would now fall under the category of a ‘biologic’. As a result, researchers and physicians would now be required to submit an investigational new drug application (IND) before performing the treatment on humans. During that workshop, and in subsequent communications, physicians and scientists expressed concern to FDA that FMT is not appropriate for study under the agency’s IND regulations. Some health care providers stated that applying IND requirements will make FBT unavailable and suggested that an alternative regulatory approach is needed to ensure the widespread availability of FBT for individuals with C. difficile infection unresponsive to standard therapies.
In an apparent change of heart, FDA has announced that it would exercise ‘enforcement discretion’ regarding FBT. As long as the treating physician obtains adequate informed consent from the patient or his or her legally authorized representative for the procedure, FDA will not require submission of an IND. 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. It will exercise this discretion on an interim basis while the agency develops appropriate policies for the study and use of FBT products under IND.
This guidance is to be implemented immediately without seeking prior comment because the agency has determined that it deals with an urgent issue affecting patients with life-threatening infections with Clostridium difficile. However, during this period of enforcement discretion, FDA will continue to work with any sponsors who wish to submit INDs for this use of FMT.
FDA invites comments on this guidance here. FDA will review any comments it we receive and revise the guidance when appropriate.