Fecal microbiome transplants have shown success in treating recurrent C. difficile infections and researchers are examining whether they might also give relief to a range of other conditions like ulcerative colitis and Alzheimer's disease. But as the New York Times reports, the US Food and Drug Administration has not yet issued a final determination on whether FMTs should be considered a drug or more like a blood transfusion, a designation that could shape how the treatment is regulated as well as its cost and patient access to it. The agency did, though, issue a draft decision in 2013 to treat FMTs as drugs.
If deemed a drug, the Times notes that FMT would have to undergo testing to ensure their safety and efficacy — an expensive process — and could give drug companies exclusive rights to FMTs for a dozen years. This, some doctors tell the Times, could price some patients out of the treatment or lead them to seek out DIY versions.
"It is very frustrating to see hyperregulation again ruining a good thing in health care," Colleen Kelly, a gastroenterologist at Brown University, tells the paper.