If human feces is used to cure a disease, then is it a drug or a bodily tissue?
That’s a question the FDA has to answer in order to regulate fecal microbiota transplants (FMT), a treatment in which feces is transferred from a healthy donor to one suffering from Clostridioides difficile, also known as C. diff, in order to introduce healthy bacteria into the gut of the patient.
In 2013, the FDA drafted a decision to regulate FMT like a drug, while continuing to analyze the situation. The decision is expected to come down shortly. As reported by the New York Times, the FDA’s decision will have bearing on how the treatment is regulated, as well as how much it costs.
Currently, the treatment, which involves transferring fecal matter via colonoscopy or enema, has a success rate of over 80 percent. Though the FDA hasn’t approved the therapy, it can be tried in situations where other therapies have failed. Concurrently, drug companies have been investing resources into figuring out a different way to deliver the benefits of FMT -- including via pill.
Some pharmaceutical voices and doctors have said that the drug model will mean a safer development of this treatment. But other doctors fear that if FMT is regulated like a drug, then pharma will make the treatment expensive and inaccessible. Still, others think that the FDA should create a new regulatory category for developments in microbiota therapies.
Which regulatory framework would work best for patients, as well as research and development?
With guest host Libby Denkmann
Colleen Kelly, M.D., a gastroenterologist and associate professor of medicine at the Brown University medical school, where she has been doing fecal microbiota transplants for over 10 years
Leigh Turner, associate professor at the Center for Bioethics, School of Public Health and College of Pharmacy at the University of Minnesota