The Food and Drug Administration is moving to tighten regulations around fecal transplants, which research has shown to be an effective treatment for Clostridium difficile infection.
The FDA has not issued a formal rule, but researchers and healthcare professionals performing fecal transplants have been told they need to file an Investigational New Drug (IND) application and receive approval before performing the procedure.
Fecal microbiota fall under the FDA’s classification for biologic products, which are regulated through the IND process. Emergency approval for transplants can be obtained over the telephone, but non-emergency procedures must be approved through the agency’s usual process, an FDA spokesman told MedPage Today. Further instruction from the FDA is expected to be forthcoming, following a recent meeting on this topic.
Fecal transplants, which can be less expensive and more successful than surgery, are being done in hospitals to cure Clostridium difficile, with one Netherlands study showing a success rate of curing 15 out of 16 people. But researchers are also exploring the use of synthetic fecal matter.