Remember when the FDA said to quit doing fecal transplants without an IND permit? Yeah, it was just a few weeks ago. (I wrote about it here.) Well, last week they changed their mind. The AGA comments. Since trials of FMT had to be stopped early because it was unethical to withhold the treatment from the control group, many doctors and patients said that it’s illogical to prohibit FMTs from patients who could benefit. The FDA’s announcement was quiet, but it sounds like the transplants are back on, and doctors’ only requirement is to make sure patients understand what the treatment is, and that it’s unapproved.
The next big thing?[*]
Meanwhile, one of the first companies trying to commercialize poop, Rebiotix (they aim to make a somewhat standardized “intestinal preparation” to make docs’ lives easier) got Fast Track status for FDA approval. This shortens the process somewhat, but the final product will likely be many years in the making. (This company is not the only one working on such a product: another is Monarch Labs, better known as the supplier of Medical Maggots and purveyor of maggot-shaped mint candies. At least they have a sense of humor about their work.)
[*] Yes, I knitted a turd. I have a sense of humor about my work too.