Scanning electron micrograph of Clostridium difficileWIKIMEDIA, 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 ...
