OpenBiome Voluntarily Suspends FMT Shipments

Share

On September 29, 2024, OpenBiome will voluntarily suspend the distribution of investigational Fecal Microbiota Transplants (FMT) for patients with recurrent Clostridioides difficile infection (C. diff). Until then, we will be limiting orders to confirmed cases only. We understand the impact of this decision and want to ensure that clinicians have ample time to explore alternative therapies for your patients, such as the use of FMT prepared by hospital laboratories, if available.    

Since 2013, OpenBiome, in collaboration with our clinical partners and the University of Minnesota, has provided over 70,000 rigorously screened and tested investigational FMT treatments for patients with recurrent C. diff not responsive to standard therapies. We commend the FDA for its willingness to apply a flexible regulatory framework, which has been instrumental in bridging the treatment gap as FDA-approved live-biotherapeutic products become widely available.   

 Recent interaction with the FDA has informed our decision to voluntarily suspend the distribution of all investigational FMT as we continue to seek clear direction on aligning our operations with the final Enforcement Policy published in 2022. Our commitment has always been to adhere to FDA regulations and guidelines for the manufacture and distribution of investigational FMT as a therapeutic option for patients with C. diff. Thus, this is not a safety or quality matter. Investigational FMT preparations provided by OpenBiome are manufactured and distributed in compliance with current good manufacturing practices (cGMP).    

We continue to hear from clinicians, our frontline partners, that despite the availability of FDA-approved therapeutics, there remain patients who do not respond to these treatments and, according to clinical guidelines, should have access to traditional FMT.   

As a nonprofit organization with a patient-driven mission, we firmly believe that we have a vital and continuing role to play in bridging the treatment gaps that remain in this patient population. Therefore, in addition to seeking clarity on how best to align our role under the revised final 2022 Enforcement Policy, we are preparing a new Investigational New Drug (IND) Application to conduct a well-controlled clinical trial on the safety and efficacy of FMT for severe and fulminant C. diff as a “last line” therapeutic for this life-threatening infection which remains the leading cause of death among hospital-acquired infections in the United States. Gaining this alignment with the FDA is our best opportunity to recommence distribution in the short term and collaborate with the FDA to ensure these patients have our support.   

In the interim, we are asking for help. We wish to advocate on behalf of the C. diff community, especially those who may require urgent treatment in the future. For those with fulminant C. diff, rigorously screened and tested investigational FMT may represent a last line treatment option.    

For now, we have four requests:    

  1. Contact us. If you have a patient suffering from severe or fulminant C. diff, please contact us at 617-575-2201 or info@openbiome.org to discuss options.
  2. Share your thoughts. We believe the FDA would benefit greatly from hearing directly from survivors and their advocates about the urgent need for continued access to rigorously screened and tested FMT. If you or your C. diff patients are willing, please submit comments to ocod@fda.hhs.gov with a copy to Dr. David Kaslow, director Office of Vaccines Research and Review, at david.kaslow@fda.hhs.gov, and Dr. Peter Marks, director of the Center for Biologics Research and Evaluation at peter.marks@fda.hhs.gov. Or you may share your experiences with us directly using this FORM.  
  3. Register for our virtual Town Hall. We will host a Virtual Town Hall on September 19th at 7:00 PM EST to provide updates and answer questions. Please register in advance HERE.   
  4. 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.     

 We wish to thank our clinical partners and patients for their unwavering support. Together, we have provided thousands of patients with access to a life-changing investigational product. We remain committed to C. diff patients and look forward to continuing to serve patients in the future.     

Scroll To Top