Just got done reading this: Policy: How to regulate faecal transplants : Nature News & Comment by Mark Smith, Colleen Kelly and Eric Alm. I was pointed to it by a Tweet from Marc Pallen
Policy: How to regulate faecal transplants @NatureNews http://t.co/HOCrFuYg7l
— Mark Pallen (@mjpallen) February 20, 2014
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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.
