Some comments in the recent thread on Scienceforums.org made me think to ask this question. It's relevant to how exactly FMT products can or cannot be marketed in the USA, and hence to how a successor to Human Microbes would need to operate.
People there were claiming that FMT is merely not approved, NOT actually banned, meaning that it can be prescribed off-label for almost any purpose, although not eligible for insurance coverage in most cases. This is not how I understand it--this is possibly how it worked during the "discretionary enforcement" period back when FMTs first started being performed, but I definitely understood that the FDA later came out with a very explicit, "bright-line" rule restricting use only to recurrent C. difficile.
Possibly, the posters on Scienceforums understood "FMT" as consisting solely of products like Rebyota or VOWST, i.e. manufactured, named drugs, as opposed to the more general procedure of collecting stool from a donor and administering it to a recipient. If this is the case, IS there a means by which something like Rebyota could be administered to a patient for something that FMT itself is not approved for, without the doctor who prescribes it and oversees the use risking sanction by a medical board?
Also along these lines, what would a business like Human Microbes have to do in order to NOT qualify as a prohibited product? Would it need to avoid using the acronym "FMT" entirely, and merely call itself a "stool source"? Is the main issue rather with donor testing and communication of the test results to potential recipients in a way that implies safety?
People there were claiming that FMT is merely not approved, NOT actually banned, meaning that it can be prescribed off-label for almost any purpose, although not eligible for insurance coverage in most cases. This is not how I understand it--this is possibly how it worked during the "discretionary enforcement" period back when FMTs first started being performed, but I definitely understood that the FDA later came out with a very explicit, "bright-line" rule restricting use only to recurrent C. difficile.
Possibly, the posters on Scienceforums understood "FMT" as consisting solely of products like Rebyota or VOWST, i.e. manufactured, named drugs, as opposed to the more general procedure of collecting stool from a donor and administering it to a recipient. If this is the case, IS there a means by which something like Rebyota could be administered to a patient for something that FMT itself is not approved for, without the doctor who prescribes it and oversees the use risking sanction by a medical board?
Also along these lines, what would a business like Human Microbes have to do in order to NOT qualify as a prohibited product? Would it need to avoid using the acronym "FMT" entirely, and merely call itself a "stool source"? Is the main issue rather with donor testing and communication of the test results to potential recipients in a way that implies safety?
