By Kristina Fiore, Staff Writer, MedPage Today
Published: May 15, 2013
http://www.medpagetoday.com/InfectiousD ... 2013-05-15
Researchers who have been reporting success with the use of fecal transplant to treat resistant C. difficile are likely to need an OK from the the FDA to continue that treatment.
The reason the FDA is stepping into the "poop" involves the way in which the agency interprets existing regulations that cover biologic drugs. Fecal microbiota, it said, meets the definition of a biologic product and such products require an IND before they are tested in humans.
FDA spokesperson Curtis Allen told MedPage Today that the FDA has not issued a new rule covering the fecal transplants, but going forward physicians will need an IND if they plan to use the treatment.
In an emergency situation, the agency said, researchers can request to use fecal microbiota for transplant over the phone or by "other rapid means of communication," to which the FDA can respond immediately.
In a non-emergency situation, however, the IND for use in individual patients must be reviewed by the FDA before the transplant can begin.
Researchers at centers performing fecal transplants said they were informally notified by the FDA about the need for IND approval relating to their work in February, and that they should expect further direction following a 2-day hearing, which was convened 2 weeks ago.
"The FDA has been clear for some time now that for fecal transplantation, ... it is necessary to have an IND for some type of regulation and oversight," said David Rubin, MD, of the University of Chicago, who is involved in a trial of fecal transplant for ulcerative colitis. Rubin attended the FDA hearing.
Many researchers and clinicians expect the rule will have a significant impact on their practice or research.
Herbert DuPont, MD, of the University of Texas Medical Center in Houston, who is gearing up for a major fecal transplantation program there, said he already had his protocol approved by the center's Institutional Review Board (IRB).
"Am I disappointed? Yes," DuPont told MedPage Today. "Do I have problems with the outcome? Absolutely not."
DuPont, who also attended the hearing, said he understood the FDA's concerns about needing to set standards for safety and efficacy with procedures such as fecal transplant.
William Schaffner, MD, an infectious diseases expert at Vanderbilt University, said the requirement for an IND will likely increase the cost burden on researchers.
"Just putting [an IND] together and carrying it out and managing data to the level of sophistication required by the FDA, just running it all costs a lot of money," he told MedPage Today.
The FDA's Allen said he did not immediately know the cost of an IND.
The purpose of the IND is to ensure that patients aren't exposed to any "unreasonable risks," the agency said. It noted, however, that its interest in regulating the procedure has nothing to do with any adverse events.