Openbiome Sep-Dec 2024 updates. Distribution will cease on Dec 31, or when their IND Phase 2 protocol is cleared to proceed. FMT

[Michael Harrop]

This article reported "OpenBiome No Longer Distributing FMT For Recurrent C. difficile Infections":
https://www.gastroendonews.com/PRN/Article/12-24/OpenBiome-No-Longer-Distributing-FMT-For-Recurrent-C-difficile-Infections/75606

The decision, which went into effect Sept. 29, was prompted by guidance issued by the FDA in 2022 and finalized in November, which advised that its discretionary enforcement policy related to investigational FMT would not include stool banks.

When the FDA approved Rebyota in 2022, Dr. Vaughn said he “knew what that meant for OpenBiome. Their license to distribute investigational FMT would be rescinded, but we didn’t know exactly when it would be. Now we do.”

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We are pleased to share that the FDA has agreed to permit OpenBiome to continue distributing investigational FMT under enforcement discretion for patients with severe and fulminant C. difficile infection (CDI), including pediatric cases. This temporary continuation is valid until December 31st, 2024, or until our IND Phase 2 protocol is cleared to proceed. https://openbiome.org/fmt-distribution-through-december-31/

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Medscape article with more info:
Easy Access to Conventional FMT Continues — for Now https://archive.ph/ZSbNF


Earlier notices from September 2024:

IMPORTANT UPDATE: FDA Allows OpenBiome to Continue Investigational FMT Distribution Through October 31st https://openbiome.org/feature/important-update-fda-allows-openbiome-to-continue-fmt-distribution-through-october-31st/

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.

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OpenBiome Voluntarily Suspends FMT Shipments https://openbiome.org/feature/openbiome-voluntarily-suspends-fmt-shipments/

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.

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They want people to contact the FDA:

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 [email protected] 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 [email protected] with a copy to Dr. David Kaslow, director Office of Vaccines Research and Review, at [email protected], and Dr. Peter Marks, director of the Center for Biologics Research and Evaluation at [email protected]. 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 [email protected].    

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They first said they were winding down operations in 2021:

Phasing out FMT in favor of FDA approved drug/preparation (Feb 2021): OpenBiome’s goal for the next year is to continue providing investigational FMT until patients have access to an FDA-approved treatment for recurrent C. difficile. https://www.openbiome.org/press-releases/2021/2/22/openbiome-announces-new-direct-testing-for-sars-cov-2-in-fecal-microbiota-transplantation-fmt-preparations-and-release-of-new-inventory

OpenBiome to wind down stool bank operations (Feb 2021) https://www.statnews.com/2021/02/23/openbiome-to-wind-down-stool-bank-operations/

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[SFBayFMT5]

Interesting, I thought they had stopped shipping back in 2021 as you'd said. Not that it matters for most of us who don't have C. diff. I will definitely consider writing to the FDA, telling them about my excellent experience with FMT from OpenBiome (which addressed much more than just C. diff).