FDA Reverses Course On Fecal Transplant Requirement

Law360, New York (July 19, 2013, 6:47 PM EDT) -- The U.S. Food and Drug Administration on Thursday backed away from a short-lived requirement that doctors submit reams of data before using promising new fecal transplants to eradicate antibiotic-resistant infections, saying it recognized the mandate would be impractical and not in patients’ best interests.

In a guidance document, the FDA said that despite a lack of clinical studies showing effectiveness, it wouldn’t block uses of fecal microbiota — healthy bacteria — to treat tough cases of clostridium difficile, a bacterium that can cause severe diarrhea and...
To view the full article, register now.