A federal agency has changed course concerning an unusual therapy using fecal matter, and doctors may now use that treatment without going to the Food and Drug Administration for approval.
The FDA reported this week that doctors could proceed with the therapy as long as patients give informed consent and understand that it's an experimental treatment, with risks.
The therapy, sometimes called fecal transplantation, is typically used against a tough bacteria called Clostridium difficile, or C. diff. The bacteria invade the gut when antibiotics have wiped out a large portion of the normal bacteria population that lives in the intestines.
C. diff causes repeated bouts with bloody diarrhea and can severely weaken a patient, damage the colon and even kill a person.
C. diff sometimes can fight off antibiotics specifically used to kill them. Thus, physicians have learned to repopulate the normal bacteria population by infusing donated fecal matter in a watered-down form through a tube in the patient's nose or through the colon to help wipe out C. diff.
The FDA this spring expressed concern about the therapy and classified it as an “investigational new drug.” The FDA asked doctors to get federal approval for their methods using the therapy.
Dr. Ed Schafer, an Omaha gastroenterologist, said requiring FDA approval could have taken months, and the agency's change of course is good news. “They came to their senses,” Schafer said of FDA administrators.
He said there's plenty of evidence already that fecal transplantation has a high success rate — near 90 percent — among patients for whom medicines have failed. “This is not some iffy therapy.”