Update from 2018 FDA Public Workshop

This is modified from a letter sent to OpenBiome partners on September 25, 2018.

On September 17, 2018, the FDA held a public workshop on the regulation of live microbiome-based products. The event was a great opportunity to hear some of the leaders in the field discuss the complexities surrounding the regulation of fecal microbiota transplantation (FMT).  

No policy updates were announced, and the regulatory policies for FMT have not changed.

While this means that there have been no changes at this time to OpenBiome's operations, it is important to highlight that FMT is not approved by the FDA, and is currently permitted through a provisional policy for clinical care to treat recurrent C. difficile infection.

During the workshop, I raised the question of how OpenBiome can better support rigorous trials in pursuit of an FDA-approved microbiome-based product for C. difficile, while maintaining critical access to FMT for patients when existing treatments have failed. 

I welcome your thoughts on this question. You may reach me directly at carolyn@openbiome.org or by submitting comments through this form.

For patients: I encourage you to learn more about clinical trials for which you may be eligible, and to consider enrolling, as we look towards ensuring access to treatment for patients in the future.

For clinicians: I encourage you to provide information to your patients about clinical trials for which they may be eligible, especially those investigating new drugs for C. difficile. 

For industry: I welcome your perspectives on how OpenBiome can better support enrollment into the evaluation of new drugs for C. difficile.

We will be sharing more information about these trials through our website and in future communications. We continue to work closely with patient advocacy groups, physicians, researchers, industry, and the FDA to support safe access for patients now and in the future.

I look forward to continuing to engage with you on this important conversation, and on our work together to advance this new field of medicine. 

Warm regards,

Carolyn

Carolyn Edelstein

Executive Director

OpenBiome