Mar 4, 2019

The FDA is set to classify fecal transplants

Poop emoji cookies in piles

Photo: Steve Russell/Toronto Star via Getty Images

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.
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