Fecal microbiota transplantation: a tale of two regulatory pathways
Diane E. Hoffmann, Gail Javitt, Colleen Kelly, Josbert J. Keller, Simon Mark Dahl Baunwall, Christian Lodberg Hvas
Abstract
Fecal microbiota transplantation (FMT) is a procedure involving the transfer of intestinal microbiota from a healthy donor to a patient to restore a functional intestinal microbiome. First described in modern science in 1958, the use of FMT has been practiced for decades, but only during the past dozen years have clinical frameworks and legal regulations from competent authorities been developed. Future development of microbiota-derived medical therapies will be shaped by the regulatory frameworks of various jurisdictions. This review examines the historical development and status of FMT regulations in the United States and Europe, with particular attention to their respective approaches to ensuring the safety and quality of the therapeutic product and patient access.