In March, the FDA wrote to Human Microbes, a company that bills itself as “the world’s largest and highest quality stool bank” for fecal microbiota transplants (FMTs), after reviewing its website a months ago.
This text is a translation of an article from CTV News.
According to Health Canada, FMT is the transfer of bacteria from a healthy person’s stool to a patient’s intestine to reestablish a healthy microbiome, through enema, colonoscopy or other means.
A Health Canada spokesperson confirmed to CTVNews that this type of transplant should only be used as part of an authorized clinical trial, or to treat patients suffering from recurrent Clostridium difficile (also known as C. difficile), a bacteria that causes diarrhea and intestinal conditions, such as inflammation of the colon.
According to the Human Microbes website, FMT shows “promising results in clinical trials” for treating other conditions, such as irritable bowel syndrome, Parkinson’s disease, multiple sclerosis, and mental disorders like depression and anxiety, among others.
Human Microbes appears to sell fecal microbiota for transplantation purposes in capsule and enema form in the United States, Canada, and the rest of the world. The company appears to have sought out high-quality stool donors, offering US$500 per donation.
In its letter, the FDA states that to “legally market” these biologics, a valid biologics license application is required. Because these products are considered new, an FDA-approved application must be in effect to introduce and issue them. Additionally, an investigational new medicinal product marketing authorization application must be in place so that products can be distributed to people participating in clinical trials during the development phase.
According to the FDA, Human Microbes has not undergone any of the required applications, so what the company is offering is both “unapproved new drugs and unapproved biologics.”
The administration also notes that, according to its research published in November 2022, treatment with TMF for conditions other than C. difficile has more limited data, and that the study of this treatment for other uses does not is not included in the FDA’s discretionary enforcement policy.
Although your website recommends that patients “discuss their plans with their doctor,” it offers your products directly to patients, including for self-administration, the letter reads. “Therefore, there is no assurance that a healthcare professional will direct the screening and analysis of the stool donor and patient stool as described in the November 2022 guidance document.”
The letter also states that these particular products raise “significant potential health concerns,” due to insufficient screening.
The FDA has advised Human Microbes to review its website and materials to ensure they comply with federal food, drug and cosmetic laws. She asked the company to tell her what next steps it plans to take to correct any violations or to explain why its products are not infringing.
Rebyota and Vowst are currently on the FDA’s list of approved fecal microbiota products.
According to a blog post in response to the FDA letter, Human Microbes founder Michael Harrop said he intended to use the products in a clinical trial, “but all that I have been able to find, these are companies that ask for 1500 dollars to tell you if it is possible or not.
“I also contacted the FDA to get approval for an IND (Investigational New Drug) application, but never heard back. So I continued,” reads Mr. Harrop’s message. He acknowledges that Human Microbes should be regulated, but as a “source of stool donors” rather than as a drug developer.
“I am looking for people who are healthy enough to be stool donors. Researchers, doctors, clinical trials, etc. can then purchase stools from our donors. I am not sure of the exact requirements, but it is generally accepted that IND requirements are extremely onerous,” Mr. Harrop’s message reads.
Mr. Harrop told CTVNews by email that a meeting with the FDA is planned for next month, “after which I plan to publish a new blog on the major changes, regardless of the FDA’s decision.” But the blog will also cover what’s happening with the FDA.
What Health Canada thinks
In its guidelines published in 2015, Health Canada indicates that FMT can be used in the treatment of C. difficile bacteria that does not respond to conventional therapies. Authorized healthcare personnel may treat patients with this type of therapy without requesting a clinical trial if certain conditions are met, for example if the feces used come from a single donor known to the patient or health care practitioner. health and whether the donor has been screened for all relevant communicable diseases.
Outside of these circumstances, the use of fecal therapy must be carried out within the framework of an authorized clinical trial.
A Health Canada spokesperson said fecal therapy is considered a drug because it meets the definition under the Food and Drugs Act as any substance used for “the diagnosis, treatment, mitigation or prevention of disease.
“The active ingredient is the human microbiota contained in the stool, rather than the stool itself. “Researchers are only beginning to understand the important role of the human microbiota (i.e., bacteria that colonize the skin, gut, and other tissue surfaces) in human health,” reads the statement sent by email.
Thus, as with all new drugs, Health Canada has stressed the importance of conducting clinical trials to properly evaluate the safety and effectiveness of this treatment. By June 2024, Health Canada will have approved 68 clinical trials for fecal therapies.
Although Health Canada has not commented specifically on the Human Microbes case, the agency has stated that only authorized products can be advertised and sold in the country.
“The sale of unauthorized health products or making false or misleading claims regarding the prevention, treatment or cure of disease is illegal in Canada.”
