FDA: Human Poop Is Not a Drug

The FDA is on the verge of deciding the future of fecal microbiota transplants (FMT), a promising new treatment that harnesses the power of the gut microbiome to fight illness. The agency is poised to regulate FMT as new drugs, which means patients will be paying thousands of dollars for human poop. This is yet another example of why medicine is so expensive in this country: the FDA takes affordable, natural treatments—as natural and humble as human feces!—and gifts them to Big Pharma to reap mega-profits.

Write to Congress and the FDA, telling them not to regulate FMT like drugs!

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Don't regulate FMTs like drugs

Dear [Decision Maker],

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I'm very concerned that the FDA is on the verge of regulating fecal microbiota transplants (FMT) like drugs. This is yet another example of why medicine is so expensive in this country: the FDA takes affordable, natural treatments--as natural and humble as human feces!--and allows Big Pharma to monopolize them and drive up the price.

FMT has proven incredibly effective at treating a bacterial infection known as C diff. that hits 500,000 Americans a year and kills 30,000. FMT has an 80% success rate at treating C diff. But there's potential for FMT to treat a number of debilitating chronic diseases including ulcerative colitis, Crohn's Disease, Parkinson's disease, multiple sclerosis, childhood regressive autism, metabolic disorders, diabetes, and others. FMT could lead to the next generation of medicines that utilize the trillions of microbes living within us to heal.

The agency should decide to apply a regulatory scheme similar to blood or HCT/P products, which are regulated under the Public Health Service (PHS) Act to ensure safety through restricting the donor pool and requiring testing of donated samples.

But the FDA has a history of allowing Big Pharma to take beneficial natural compounds that are widely and cheaply available and turn them into monopoly drugs costing thousands of dollars. CBD oil is becoming a $32,500-a-year drug; L-glutamine has been turned into a $40,500-a-year drug. This isn't good for patients who rely on these medicines.

As long as the safety of FMT can be ensured by regulation solely under PHS, without drug regulations, this is the path the FDA must pursue to ensure that consumers can continue to access this treatment affordably.

Please do not regulate FMT like drugs!

Sincerely,
[Your Name]
[Your Address]
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[Your Email]