According to a story from NBC News, the death of a patient following a fecal transplant procedure has finally prompted the US Food and Drug Administration (FDA) to take more stringent steps in regulating the approach. The death of the patient (as well as another that was made extremely ill) was linked to the presence of drug resistant bacteria in the fecal sample used for the operation.
What is a Fecal Microbiota Transplant?
A fecal transplant is primarily used to treat severe cases of Clostridiodies difficile (often referred to as C. diff) infection, which can cause life threatening symptoms, though it may have utility for other medical problems as well. The procedure appears to be effective because it restores a healthy population of bacteria in the digestive tract, which prevents harmful species from continuing to survive and cause problems for the patient. Fecal microbiota transplant may not be that well known, but it is actually not a brand new treatment method. In fact, fecal transplants have been conducted as far back as the 1950s. For much of that time, they were entirely unregulated.
Following the incidents, the FDA has released new guidelines for fecal microbiota transplant which specifically require the testing of stool samples and donors for the presence of drug resistant bacterial strains. To the disappointment of doctors and researchers, the agency has released very few details about the specific circumstances of the cases, and the announced guidelines raised just as many questions as they answered.
How Should it be Regulated?
Part of the reason the fecal microbiota transplants have remained untouched by the FDA for so long is because of questions of classification. Is it a drug? Is it an operation? Something else? With difficulties surrounding its definition, it was difficult for it to fit into any of the agency’s typical frameworks. In 2013, the agency was leaning towards designating the transplants as a drug, but many specialists said that it shared a stronger resemblance to organ transplants and treating it like a drug could cause soaring prices and limit access.
For the time being, these transplants are being treated more like a drug and fecal transplants are currently being tested for a variety of diseases in clinical trials.
