US Food & Drug Administration classifies FMT an Investigational New Drug

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FDA PhasesIt’s been a glum week in the FMT facebook group this week following cancelled FMT procedures in the wake of the FDA’s classification of FMT as an Investigational New Drug (IND).  This decision was confirmed in a letter from the FDA to the American Gastroenterological Association.  The AGA is now providing guidelines to members regarding the IND procedures.

On May 2 the FDA held a workshop with interested practitioners to discuss FMT. A copy of this powerpoint presentation outlines the FDA position. The effect of this decision is that FMT is now in Phase 1 of a 3 phase approval process and is not to be used by physicians other than in life saving situations subject to a formal IND application. IND Application forms and more information is available on the AGA website. The AGA states:

Because FMT is not approved for any therapeutic purposes, an investigational new drug (IND) application is needed for the use of FMT to treat any disease including C. difficile infection. AGA will work with the FDA to help ensure patients who may benefit from FMT will be able to gain access to such treatments in a timely manner.  

 The post on the AGA website seems quietly optimistic about FMT and the AGA has undertaken to assist physicians with IND applications.  It has also recently established a Centre for Gut Microbiome Research & Education which I suspect will be the beginning of big re-think about the liberal anti-biotic use that has been a big part of most of our illnesses.

As frustrating as the cancellation of procedures is for the individuals concerned, overall the FDA decision is a significant step forward in the journey toward legitimacy and safe accessible FMT for all who need it. 

If you live in the US and you or a loved one are suffering from a life-threatening case of C Diff, rest assured there is still help at hand. If your doctor is unaware of the IND application procedure refer them to the AGA website

While FMT doctors may not be able to perform the procedure for you, they can still help with testing.  Dr David Shephard of RDS Infusions in Florida writes:

We are very disappointed with recent FDAs position on FMT. Our Success for C diff patients is 100% so far and for UC it is in the 70-80% range. Because of our success we will continue to offer the infusions in any way we can despite the FDA’s hurdles. Please visit our website at rdsinfusions.com and check out testimonial page. We are here to help!!

If your condition is soul-destroying but not life-threatening, don’t lose heart. There is still the DIY option and if you have the funds, clinics in the UK and Australia.  Remember that just because a doctor can’t perform the procedure doesn’t mean they won’t screen your donor. Most doctors understand the concept of harm minimisation, so if you are determined to do DIY FMT you will eventually find a doctor who sees the sense in helping you to avoid the risks of an untested donor. 

The key to persuasion is a calm, well-researched presentation in the context that you have already tried mainstream options without success.  If this kind of presentation is not your thing then recruit an ally within your social circle to help you or join the FMT Facebook group where you will find a smart, supportive bunch of people who will give you tips and help you develop a strategy. Whatever you do, don’t give up. You and your quality of life are worth fighting for. 

First they ignore you,

then they laugh at you,

then they fight you,

then you win.

Mahatma Gandhi

 

June 17 2013 – Update:  The FDA no longer requires an IND application for urgent cases of C Diff however its use is still limited.

 July 17, 2013 – Update: Regulatory Approach for Fecal Transplant Product Finalized in Abrupt Guidance Document

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