The FDA recently formally announced that it would exercise “enforcement discretion” for its rule that an Investigational New Drug (IND) permit be approved before fecal transplants could be used to treat Live-threatening infections with Clostridium Difficile bacteria. While not changing written policy guidelines the FDA’s existing policies, the announcement gives doctors an opportunity to treat patients who have granted their consent after being informed about the possible risks of the procedure. This decision effectively reverses the decision that was made before which decided to more tightly regulate any use of fecal microbiota transplants without first applying for an IND, a process which would effectively make use of this treatment very difficult for most doctors to use.
Fecal transplants are widely regarded as the only effective treatment option for recurrent Clostridium difficile infection which comes back in spite of treatment with antibiotics. Making it easier for doctors to use this treatment approach can possibly save many lives with low estimates for deaths related to c. diff of at least 14,000 a year in the United States. Before this decision, patients and their families faced an illness with no approved treatment while doctors hands were tied when it came to performing this procedure.
While the FDA’s guidance is addressed specifically toward the use of fecal transplants to treat Clostiridium Difficile, and does not cover its use for other illnesses it may also encourage more exploration as a treatment option for Inflammatory Bowel Diseases such as Ulcerative Colitis and Crohn’s Disease where there have been encouraging individual stories and there is also ongoing research. In fact Clostridium Difficile infections are sometimes found in patients who already have Ulcerative Colitis and / or Crohn’s Disease.
Here is the text of the decision from the Federal Register listing which is also available at this link. http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/ucm361379.htm?source=govdelivery
Guidance for Industry: Enforcement Policy Regarding Investigational New Drug Requirements for Use of Fecal Microbiota for Transplantation to Treat Clostridium difficile Infection Not Responsive to Standard Therapies