For the past several years, the U.S. Food and Drug Administration has been trying to figure out how to regulate human feces.
Fecal transplants are an almost miraculously effective cure for a gut infection called C. diff. The microbes in the stool of a healthy donor repopulate the gut microbiome of a sick patient. But some of those microbes could be dangerous. This month, hypothetical concerns became real when the FDA issued a warning: An immunocompromised patient died after acquiring drug-resistant bacteria from a stool donor.
The death was the first of its kind ever recorded, out of tens of thousands of fecal transplants, and it could very well become a flash point in the battle over regulation. “This is an unintended consequence that the FDA’s really been waiting for, because they’ve had concerns for a long time,” said Colleen Kraft, a microbiologist at Emory University. Kraft spoke on a panel at Aspen Ideas: Health, which is co-hosted by the Aspen Institute and The Atlantic.
The FDA’s concerns have been evident since it originally proposed to regulate fecal transplants like drugs. Back in 2013, the agency suggested that doctors performing the procedure would need to file an Investigational New Drug Application—a step that critics said would be so burdensome that it would prevent doctors from offering the life-saving procedure and drive desperate patients to do it themselves with a blender and enema bottle.