FDA responds to provider pressure, backs off stricter control of fecal transplants for C. diff
Individuals with treatment-resistant Clostridium difficile can undergo fecal transplants after giving informed consent, the Food and Drug Administration recently announced. This is a victory for providers, who pushed back after the FDA recently announced it would tighten regulations around the transplants.
Fecal microbiota transplants (FMTs) treat C. diff by repopulating the gut with necessary bacteria that was wiped out by antibiotics.
Arguing that transplants been well-established as an effective and safe means of treating serious cases of C. diff, healthcare providers and groups such as the American Gastroenterological Association pushed back vigorously against FDA efforts to require investigational new drug (IND) approval to do transplants. They said IND approval requires an arduous process, and would prevent patients from obtaining needed transplants in a timely manner.
“The agency acknowledges these concerns and intends to exercise enforcement discretion regarding the IND requirements for the use of FMT to treat C. difficile infection,” the FDA announced Tuesday. Physicians can provide these transplants after sharing potential risks and obtaining informed consent from the patient or a patient's legal representative.
Colleen R. Kelly, M.D., Clinical Assistant Professor of Medicine, Warren Alpert Medical School of Brown University, is a principal investigator for the first U.S. clinical trial of FMTs to treat relapsing C. difficile infection. Doctors had been performing FMTs for decades before studies like this one drew the FDA's attention to transplants, she told McKnight's.
Providers should not be scared off by the administration's scrutiny of the procedure, she stressed.
With rigorous donor screening protocols and other precautions in place, fecal transplant has proven to be a safe C. diff treatment, Kelly said. A quarter to a third of her patients are from long-term care facilities, she estimated.
The FDA's main concerns are with fecal transplants used to treat more complicated conditions than C. diff, such as Crohn's disease, Kelly surmises. The agency is likely also concerned about for-profit transplant providers, who will do the procedure on practically anyone for a fee, she said.
The FDA will remain cautious about transplants, but the latest announcement is “as much of a green light as you're going to get from them,” she said.