Dr Benjamin Levy highlights key considerations that need to be answered for FMT-based research to make good on its considerable promise.
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Researchers and physicians have been studying dysbiosis (or alterations of the gut flora) and its relationship with many disease processes, including inflammatory bowel disease, irritable bowel syndrome, rheumatoid arthritis, depression, diabetes, metabolic syndrome, multiple sclerosis, Parkinson's disease, chronic fatigue syndrome, and heart disease. In recent years, much of this research has focused on fecal microbiota transplant (FMT) as a potential therapy for disease prevention and to treat numerous medical conditions beyond Clostridium difficile infection.
For those unfamiliar with FMT, stool can be transplanted by colonoscopy, enema, frozen pills, and nasoenteric tube.
Because several conditions can contribute to dysbiosis, as well as antibiotics and diet, our ultimate goal is to use FMT to improve the microbiome and cure a variety of disease processes.
Advantages, Disadvantages of FDA Regulation
Although we lack data about the long-term side effects of FMT, animal models have shown that it can unintentionally transfer disease phenotype, including metabolic disorders and obesity. Gut bacteria have also been accused of increasing the rate of both colon cancer and heart disease in patients, so it's very important that FMT be regulated properly.
The US Food and Drug Administration (FDA) works to ensure that patients have safe access to treatments that are proven effective through research and evidence-based medicine.
As explained in a recent editorial in [Clinical and Translational Gastroenterology], which I helped contribute to as a member of the American College of Gastroenterology's FDA Committee, "In the United States, drugs and bioactive agents including MBTs [microbiome-based treatments] used with therapeutic intent for specific disease states falls under the jurisdiction of the US Food and Drug Administration."
The Center for Biologics Evaluation and Research is the part of the FDA that regulates biologic products, which includes blood as well as blood products, vaccines, gene therapies, allergenics, and human cells and tissue products.
The FDA previously decided that FMT is both a drug and a biological product and should be regulated as a drug.
Interestingly, the Federal Food, Drug, and Cosmetic Act defines drugs as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and articles (other than foods) that are intended to affect the structure and function of the body of man or other animals. In addition, the Public Health Service Act says that a biological product is a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein, or analogous product applicable to the prevention, treatment, or cure of disease or condition in human beings. As such, biologic products in the United States can be regulated as drugs under the Federal Food, Drug, and Cosmetic Act, or as biological products under the Public Health Service Act, or under both laws.
Clinical trials of microbiome-based treatments require an investigational new drug application be submitted to the FDA for permission to give a potentially therapeutic microbiome donation to humans.
One of the advantages of having the FDA regulate FMT is that the industry can more easily navigate their medical-legal responsibilities through a uniform, organized process when bringing fecal microbiome products to market. The FDA can also help physicians more successfully treat patients by providing guidance.
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