Policy: How to regulate faecal transplants @NatureNews http://t.co/HOCrFuYg7l
— Mark Pallen (@mjpallen) February 20, 2014
And, well, I rarely says this, but it kind of blew my mind. First, i should note that the authors (who include the cofounders of OpenBiome which I wrote about a few weeks ago. Anyway, they argue that - especially in light of the use of stool transplants for various purposes - human stool should be considered as a tissue not a drug. I have written and talked about the FDA getting involved in regulating fecal transplants quite a bit and confess this idea had never occurred to me. Now - I don't work directly on fecal transplants, but I have been promoting the idea on and off that the human microbiome is in some ways akin to an organ and Smith et al. reference a similar argument in their article. And it follows in a way that one could view the microbiome / stool as a tissue. But I am not aware of anyone promoting this idea to the FDA in terms of regulation until this article (correct me if anyone knows any differently).
Anyway - just wanted to make people aware of this essay and add in my 1st impressions.
Post a Comment