An ongoing dialogue on HIV/AIDS, infectious diseases,
June 19th, 2013
FDA, IND, FMT: Nine Letters, Some Common Sense, and a Real Video Link
Good news here — the FDA has reconsidered their requirement for an IND for fecal microbiota transplantation (FMT) for C diff:
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.
This approach certainly makes sense.
Still, on reading the statement, one might wonder about the phrase “exercise enforcement discretion”. What precisely does this mean?
If I had to guess, they will choose to go after the clinicians who are using FMT for indications where the evidence for benefit is much weaker (thus far) than for C diff — e$pecially tho$e who $eem to be offering FMT for the wrong rea$on$.
And FYI, there are LOTS of those (still unproven) indications out there, as any brief internet search will reveal — as one site notes, they include “Ulcerative Colitis, Crohns, IBS, Constipation, Autoimmune disorders, Obesity, Parkinsons, Multiple Sclerosis, Anxiety and Depression.”
Will FMT work for some of these? As the cliche (and grant proposals) note, “more research is needed…”
Meanwhile, some were disappointed that the video I linked last time this topic was reviewed was a fake — you wanted the real thing.
Ask and you shall receive.
Paul E. Sax, MD
Contributing Editor
NEJM Journal Watch
Infectious Diseases
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