WIKIMEDIA, CDCThe US Food and Drug Administration has decided that fecal transplants meet the definition of a biologic therapy, meaning that researchers and physicians who want to perform the procedure will now have to submit an investigational new drug (IND) application, MedPage Today reported last week (May 15).
Researchers performing the procedure—which has emerged as an effective way to treat resistant Clostridium difficile infection—were informed of the requirement in February. “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,” University of Chicago gastroenterologist David Rubin, who is involved in a trial of fecal transplant for ulcerative colitis, told MedPage Today.
Some researchers and clinicians are concerned that the new requirements, which involve lots of paperwork and a 30-day wait, will restrict access to a promising therapy. Michael Edmond, a researcher and physician at Virginia Commonwealth University, wrote on the Controversies in Hospital Infection Prevention blog that the ruling “imposes a huge bureaucratic hurdle to getting a much-needed therapy for patients with recurrent or intractable C. difficile infection.”
Infectious disease specialist Judy Stone agreed. Writing on her Molecules to Medicine blog, she argued that “the FDA [should] exclude non-academic/non-research centers from the IND requirement, or centers that want to perform less than X number of procedures per month. . . . Otherwise, physicians will increasingly give patients directions for home, do-it-yourself (DIY) treatments.”
But Herbert DuPont, a researcher at the University of Texas Medical School who is planning a fecal transplantation trial, told MedPage Today that while he was disappointed about the added expense and time, he understood the FDA’s desire to set safety standards for the procedure. “Am I disappointed? Yes,” he said. “Do I have problems with the outcome? Absolutely not.”