AGA is developing strong relationships with the FDA. In 2012, AGA was invited to join the FDA Network of Experts program, a vetted network of outside scientists, clinicians, and engineers who will provide the FDA Center for Devices and Radiological Health (CDRH) staff with rapid access to scientific, engineering and medical expertise when it is needed to supplement existing knowledge and expertise within the CDRH.
Building on the success of this program, the FDA Center for Drug Evaluation and Research recently invited AGA to help them pilot the Network of Experts program under their division. This program will facilitate the exchange of scientific understanding from sources outside of the federal government; this feedback will be critical when it comes to new and emerging drugs and pioneering technologies.
By identifying GI experts to provide feedback and information to the FDA through this program, AGA is playing a powerful role in shaping regulations that will impact the GI community. AGA looks forward to collaborating with the FDA in new ways, with the ultimate goal of advancing the science and practice of GI.
AGA confirms IND is required for fecal microbiota transplantation
Due to member inquiries and concerns and the lack of clear guidance on regulations surrounding fecal microbiota transplantation (FMT), 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 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.
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.
In May, Dr. Gary Wu, chair of the AGA Center for Gut Microbiome Research and Education, attended a FDA workshop on "Fecal Microbiota for Transplantation" where this decision was reaffirmed (see the related story in this issue about the workshop). 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 AGA, and intends to post a summary of this meeting as well as updates on its website.
AGA and the 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. Visit the center online at www.gastro.org/microbiome.
