FDA shifts toward informed consent for fecal transplants

After tightening its regulations last month regarding fecal transplants, the Food and Drug Administration has decided to shift from its investigational new drug application requirements to informed consent for the procedure.

In early May, the FDA announced that physicians who perform “fecal microbiota for transplantation,” or FMT, used to treat serious and unresponsive cases of Clostridium difficile infections, would be required to submit an investigational new drug application, or IND. During and following the announcement at a public workshop, led by the FDA's Center for Biologics Evaluation and Research and the National Institutes of Health's National Institute of Allergy and Infectious Diseases, doctors and scientists complained that the new requirements—including additional paperwork and a 30-day waiting period—would prevent them from sometimes being able to perform these potentially lifesaving procedures.

According to the Centers for Disease Control and Prevention, more than 14,000 deaths each year are related to C. diff infections. And while standard therapies, such as the antibiotic vancomycin, are not always effective, FMT has been reported to have a success rate upwards of 80%.

In response to the concerns of FMT proponents and their requests for alternate regulatory approaches, the FDA announced that it would consider other policies related to the use of FMT products under IND. In the meantime, the organization will shift away from the conditions issued last month, instead requiring physicians to secure informed consent from their patients or patients' representatives for the use of these products. According to the FDA, informed consent should include a statement that discusses the potential risks associated with FMT and the acknowledgement that it is an investigational procedure.

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