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The Food and Drug Administration has backed away from new rules requiring doctors to treat human stool as an unapproved drug, meaning fecal transplants used to treat life-threatening gut infections can continue as planned in the U.S.
FDA officials said this week that the agency will not enforce new requirements to obtain investigational new drug applications, or INDs, before doctors can perform the procedure that uses doses of donor stool to repopulate infected colons with healthy bacteria.
However, doctors must document that they’ve informed patients suffering from recurrent infections caused by a nasty germ known as C. difficile about the risks and benefits of the procedure.
“In short the physician, at minimum, must inform the patient that the procedure is investigational,” said Curtis Allen, a spokesman for the FDA.
The move came after pressure from groups like the American Gastroenterological Association, whose members said that the requirement to obtain time-consuming INDs would virtually stall the potentially life-saving therapy in the U.S.
AGA members praised the move in a letter to members this week.
“At this time, there are no negative consequences if a practitioner chooses not to obtain an IND provided they have informed consent and are using FMT (fecal microbiota transplantation) to treat their patients with recurrent C. diff,” the group wrote.
C. difficile infections strike more than 336,000 people in the U.S. each year and are linked to more than 14,000 deaths, according to the Centers for Disease Control and Prevention.
They typically occur when people take antibiotics that wipe out good bacteria in the gut along with the bad, allowing C. diff to flourish.
There are probably only about 20 doctors routinely performing fecal transplants in the U.S. now, experts say. Between 500 and 700 patients have received the procedure worldwide, according to doctors’ estimates.
FDA officials have always had authority to require INDs, but agency officials only recently decided to enforce the rule, in part to bring “regulatory clarity” to the growing field of fecal transplants, Allen has said.
But then came protests from doctors and patients eager to use the therapy that some studies show can cure 90 percent of C. diff infections quickly. The FDA still wants doctors to apply for INDs, but they agency will allow the procedures to continue in the interim.
That's a relief for patients like Nora Bagusky, 38, of Hanover Township, Pa., who is suffering from her fourth recurrent C. diff infection in 18 months, making her so ill she's been unable to work at her job as a rape crisis counselor. She feared she might have to wait up to six months for a fecal transplant under the rule.
“That's probably the best news I've heard in my entire life," Bagusky said. "I'm waiting for my doctor to call me back. Fingers crossed I will be having the transplant very soon."