UPDATE AS OF NOV. 1: OpenBiome, the nonprofit that provides FMT material to clinical sites around the U.S., announced they will continue operations through the end of 2024, if they can submit an investigational new drug submission for their Phase 2 dosing study by Nov. 30.
At the end of October, OpenBiome announced it would voluntarily suspend distribution. In addition, while the FDA’s enforcement policy regarding the use of FMT to treat C. diff not responsive to standard therapies remains in place, its future is unclear.
This is a step backward for C. diff patients. AGA is pushing to ensure continued access to conventional FMT for vulnerable C. diff patients, for whom newly FDA-approved therapies aren’t indicated.
- Working with infectious disease specialists and others, AGA recently organized a joint-society letter to the FDA urging the agency to allow for use of conventional FMT in patients where access to or efficacy of new FDA-approved gut microbial therapies may be limited.
- Read a member’s take – Dr. Neil Stollman published an op-ed in STAT: Fecal transplants are saving lives — but are now at risk.
- We will stay in touch on any developments. Learn more about how AGA is tracking the effectiveness of FMT and other gut microbial therapies through our national registry.
