This has been around for a while and basically is the last resort for anyone suffering from CDiff, but it works. I wrote about it back in 2007 so the transplant I guess is a “new drug”? The feces for transplant of course would be new (grin) and there’s no guarantee the FDA will approve the process. Then you have insurance companies not covering the donor testing, what a hassle.
So if you are unfortunate enough to pick this up in a hospital and need the last resort treatment, here’s more red tape. BD
he US Food and Drug Administration has decided to bring the semi-outlawed — but very safe and very effective — procedure called “fecal transplant” under its auspices, ruling that to perform it, physicians must have applied for an “investigational new drug application,” or IND. This requires a lot of advance paperwork, 30 days of consideration, and does not return not a guaranteed yes. For the transplants, which have been performed informally but carefully by a growing number of physicians as a treatment (and often cure) for devastating C. difficile infection, it may improve safety, but it can’t help but impose obstacles and delay.