AGA Confirms IND is Required for Fecal Microbiota Transplantation
AGA to develop FMT resources for clinicians and patients
Due to member inquiries and concerns and the lack of clear guidance on regulations surrounding fecal microbiota transplantation (FMT), the AGA, ACG, ASGE and NASPGHAN have sought clarification about regulatory issues dealing with FMT from the FDA. The Center for Biologics Evaluation and Research (CBER) has determined that the fecal microbiota falls within the definition of a biological product and drug that is regulated by the FDA.
Because FMT is not approved for any therapeutic purposes, an investigational new drug (IND) application is needed for the use of FMT to treat any disease including C. difficile infection. Read the letter from FDA.
AGA will work with the FDA to help ensure patients who may benefit from FMT will be able to gain access to such treatments in a timely manner.
Last week, Dr. Gary Wu, chair of the AGA Center for Gut Microbiome Research and Education, attended an FDA workshop on “Fecal Microbiota for Transplantation” where this decision was reaffirmed. Based on the active interchange between basic and clinical researchers, clinical practitioners, as well as patients and participants from industry at this meeting, the FDA will hold internal discussions to further refine the regulatory issues surrounding this modality of treatment. The FDA will seek input from various societies, including the AGA, and intends to post a summary of this meeting as well as updates on its website.
- IND form and instructions.
- Emergency use IND: The AGA and FDA recognize that there may be critical clinical situations where FMT for the treatment of C. difficile infection may require urgent action. The FDA recommends calling 301-827-2000 (after hours 866-300-4374) to obtain information about an “emergency use” IND (part of an expanded access IND).
The gut microbiome is one of the most exciting and promising areas of science today. The AGA Governing Board has made a major commitment to the gut microbiome through the ?AGA Center for Gut Microbiome Research and Education. Go to www.gastro.org/microbiome to access a list of invited speaker sessions and abstracts lined up for DDW(R) 2013.
May 6, 2013