Blog The FDA and FMT regulation. (Mar 2024, HumanMicrobes.org)

[Michael Harrop]

https://www.humanmicrobes.org/blog/fda-fmt-regulation

Response to FDA warning letter, proposal for FMT regulation, and some background of this project.

I wasn't planning on posting this yet, but the FDA letter has been publicly released and news organizations are already picking it up and contacting me about it, so I think it needs to be posted now. I may still make changes to it.

 

[Michael Harrop]

A related forum discussion: Is human microbes getting shut down?

It includes discussion of the FDA Expanded Access program https://www.fda.gov/news-events/expanded-access/expanded-access-information-patients that allows patients to try non-licensed drugs: https://forum.humanmicrobiome.info/threads/is-human-microbes-getting-shut-down.261/post-690.

As well as FDA Enforcement Discretion and EUAs (Emergency Use Authorization): https://forum.humanmicrobiome.info/threads/is-human-microbes-getting-shut-down.261/post-739

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2015 paper discussing how to regulate FMT:
Ensuring the safe and effective FDA regulation of fecal microbiota transplantation https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5034381/. One of the authors is from Openbiome.

Standards for fecal microbiota transplant: Tools and therapeutic advances (Mar 2024, meeting report). Includes commentary by an FDA employee.