Notice on FDA draft guidance on FMT, released March 1, 2016

The FDA has released new draft guidance on fecal microbiota transplantation (FMT). This document is a draft for discussion purposes, and does not alter current enforcement discretion policy.

The prevailing FDA guidance, published in July 2013, states that physicians may perform FMT outside of an Investigational New Drug (IND) application to treat C. difficile infection (CDI) that is not responsive to standard therapy, so long as they obtain informed consent. 

OpenBiome continues to provide treatments to our clinical partners for recurrent CDI.  No IND is necessary. 

 

What does the draft propose?

This draft proposes that stool banks (including OpenBiome) sponsor an IND application to provide treatments for recurrent CDI. It notes that the stool bank sponsoring the IND can request that certain obligations for the clinicians who would be using the material to treat recurrent CDI patients (the “investigators” and “sub-investigators”) be waived. 

The FDA is using the draft to solicit feedback on this general proposal, and on which parts of the IND application would be appropriate to waive. The comment period is open here until May 31st, and we encourage all interested parties to share their perspectives. 

This draft is a revision of an earlier version that the agency published two years ago (in March 2014). It replaces that version.

 

What is OpenBiome's response to the draft?  

We consider this draft a positive step toward enhanced regulatory oversight of stool banking. We will be responding to the guidance to propose an outcome that affords appropriate oversight of stool banking practices without placing undue burdens on physicians, healthcare facilities, and patients.