The FDA is set to classify fecal transplants
There is a new battle brewing among doctors, patient advocates and pharma companies over — believe it or not — human excrement.
Driving the news: The fight is over fecal microbiota transplants, a remarkably effective treatment for the bacterial infection Clostridioides difficile, the New York Times reports. The battle is over whether the treatment — which involves transplanting healthy fecal matter into the bowels of patients suffering from the infection — should be classified as a drug or as a procedure akin to organ, tissue and blood transplants.
The FDA is expected to make a final decision soon, although in 2013 it made a draft decision to regulate the procedure as a drug.
- The market for drug-based treatments for C. diff is expected to hit $1.7 billion by 2026, according to GlobalData.
- Following the success of the procedure, scientists are currently trying to come up with similar treatments for disorders like obesity, autism, ulcerative colitis, and Alzheimer’s and Parkinson’s diseases.
- Investors are pouring money into such endeavors.
One major concern for critics: Treating the therapy as a drug will give it a 12-year monopoly period upon approval.
- They say this could slow innovation and cause patients who can't afford the procedure to attempt to replicate it at home.
- And, of course, there's fear that this would lead to high prices for stool transplants.
- Drug companies say that regulating the procedure as a drug will help ensure its safety and efficacy.