March 01, 2016
2 min read

FDA proposes greater oversight of stool banks distributing FMT for C. difficile infection

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The FDA has released a revised draft guidance on its enforcement policy regarding investigational new drug requirements for fecal microbiota transplantation intended to treat refractory Clostridium difficile infection. The document proposes that enforcement discretion would no longer be extended to the IND requirements of stool banks.

The FDA’s official guidance on the matter remains the July 2013 version, in which the agency enacted an enforcement discretion policy that does not require an IND application for FMT treatment of refractory CDI, as long as the physician informs the patient of the treatment’s risks and investigational nature.

“The draft guidance is indeed a draft, so it won’t alter prevailing enforcement discretion policy; the prevailing guidance is still the July 2013 version,” Carolyn A. Edelstein, MPA, director of policy and communications at the non-profit stool bank OpenBiome, told Healio Gastroenterology. However, she added that “the draft does nullify previous draft guidance.”

Carolyn A. Edelstein

In the previous draft guidance, issued in March 2014, the FDA proposed that a stool donor must be known by the recipient or physician, but this was never officially enacted.

The new draft guidance proposes “to modify the conditions of the July 2013 guidance so that the use of material obtained from a stool bank would no longer fall under enforcement discretion,” Edelstein said. “Instead, it proposes that stool banks sponsor an IND application, and it notes that the stool bank sponsor can request that certain obligations pertaining to the investigators and sub-investigators (those who would be using the material to treat recurrent CDI patients) be waived. The FDA is soliciting feedback on which parts of the IND would be appropriate to waive.”

The FDA developed this as an interim policy so that patients with refractory CDI have access to FMT therapy while the agency addresses the potential risks associated with centralized manufacturing of FMT products in stool banks, according to the document. “These safety concerns include transmission of infectious agents and potentially other unidentified risks related to changes in the microbiome,” the agency wrote. “The sponsor’s compliance with the IND requirements will help to ensure that the stool donor and stool are appropriately qualified by screening and testing and that centralized processing of FMT adheres to appropriate current good manufacturing conditions.”

“In general, I consider this draft a positive step forward,” Edelstein said. “We have long supported greater regulatory oversight of stool banking, and the draft suggests that the FDA is seeking to tailor its guidance on the use of FMT to differentiate between stool banking and small-scale directed donation. We hope to see an outcome in which there is appropriate oversight of stool banking practices, without undue burdens imposed on physicians and healthcare facilities and, by extension, patient access.”

The FDA will continue to evaluate the enforcement discretion policy while working with sponsors who will submit IND applications for FMT treatment for refractory CDI, according to the document. The agency does not currently extend enforcement discretion to other indications for FMT due to limited data. – by Adam Leitenberger


FDA. Enforcement policy regarding investigational new drug requirements for use of fecal microbiota for transplantation to treat Clostridium difficile infection not responsive to standard therapies: Draft guidance for industry. Accessed March 1, 2016.

Disclosure: Edelstein is an employee of OpenBiome.