IMPORTANT UPDATE: FDA Allows OpenBiome to Continue Investigational FMT Distribution Through October 31st

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On September 19th, the FDA agreed that OpenBiome may continue shipment of investigational FMT produced by the University of Minnesota through October 31st while we accelerate the timeline for our IND submission. This decision follows OpenBiome’s September 9th announcement of its intention to voluntarily suspend the distribution of investigational FMT.  

We commend FDA for its willingness to continue exercising enforcement discretion for OpenBiome in the interest of patient care, especially those for whom there are no approved options, such as pediatrics, and patients who are immunocompromised or struggling with severe or fulminant disease. 

Ordering guidance

Our current inventory is limited; therefore, shipments will be restricted to confirmed cases only. You may order for any identified patient with recurrent or fulminant C. difficile not responding to standard therapies, but not for the purposes of maintaining an internal inventory. When placing your order, please confirm that each requested unit is for a specific case and not for stock.  

Support ongoing efforts to increase patient access 

We appreciate the FDA’s consideration of patient well-being and thank the many clinicians and patients who advocate for FMT access. While this provides some immediate relief for clinicians and patients, much work remains.  

If you wish to support our efforts to continue safe FMT access for the most vulnerable patient populations, there are still ways you can help: 

  1. Support our clinical trial.  We invite you to participate as we prepare for a landmark clinical trial of FMT in severe and fulminant disease. If interested in learning more, please contact our Chief Medical Officer, Dr. Majdi Osman, at Science@OpenBiome.org.      
  2. Share your clinical experience. Use this form to tell us about your experience with FMT as a clinician. Sign up to help build a body of evidence to support continued access.   
  3. Lend your voice. We encourage patients to advocate for FMT access or share your story with the Peggy Lillis Foundation, the largest C. Diff patient education and advocacy organization.  

Read summary of September 19th Town Hall meeting and read frequently asked questions. 

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