Fecal transplants are to become regulated

Posted May 25, 2013 by Tim Sandle
Fecal therapy is a new method of treating people with infection. However, U.S. physicians and researchers will now have to get approval from the FDA before they can perform a stool transplant.
Earlier this year the Digital Journal reported that scientists had shown that fecal transplants, transferring the stool of a healthy person into the gut of someone with an antibiotic resistant microbe infection, have a high success rate.
According to one published study, the process of infusing a the stool of a healthy person into the intestines of another (fecal transplant) was successful in curing 15 out of 16 patients suffering from a recurrent diarrheal infection of the problem microbe Clostridium difficile. This bacterium is one of the so-called problem bacteria, noted for being resistant to many antibiotics.
Given that fecal transplants are being tried more often, the U.S. Food and Drug Administration (FDA) has stepped and has declared that the transplants require review and regulation. The FDA has declared that fecal transplants meet the definition of a biologic therapy. This means that researchers who want to perform the procedure will now have to submit an investigational new drug (IND) application, via the FDA.
This has not proved popular with all researchers. For example, Michael Edmond, a researcher and physician at Virginia Commonwealth University, has written on the Controversies in Hospital Infection Prevention blog that the FDA ruling will cause delays and it "imposes a huge bureaucratic hurdle to getting a much-needed therapy for patients with recurrent or intractable C. difficile infection."
Time will tell whether the regulation will slow down progress relating to this novel therapy.