The Impact of Regulatory Policies on the Future of Fecal Microbiota Transplantation.

Autor: Khoruts A; Alexander Khoruts, M.D., is Professor of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, Director, Luminal GI Section, and Medical Director of the Microbiota Therapeutics Program, Center for Immunology; BioTechnology Institute; Cancer Center; MICaB Graduate Program, University of Minnesota. Diane E. Hoffmann, J.D., Sc.M., is Jacob A. France Professor of Health Law and Director, Law & Health Care Program University of Maryland Francis King Carey School of Law. Francis B. Palumbo, Ph.D., J.D., is Professor and Executive Director, Center on Drugs and Public Policy, University of Maryland School of Pharmacy., Hoffmann DE; Alexander Khoruts, M.D., is Professor of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, Director, Luminal GI Section, and Medical Director of the Microbiota Therapeutics Program, Center for Immunology; BioTechnology Institute; Cancer Center; MICaB Graduate Program, University of Minnesota. Diane E. Hoffmann, J.D., Sc.M., is Jacob A. France Professor of Health Law and Director, Law & Health Care Program University of Maryland Francis King Carey School of Law. Francis B. Palumbo, Ph.D., J.D., is Professor and Executive Director, Center on Drugs and Public Policy, University of Maryland School of Pharmacy., Palumbo FB; Alexander Khoruts, M.D., is Professor of Medicine, Division of Gastroenterology, Hepatology, and Nutrition, Director, Luminal GI Section, and Medical Director of the Microbiota Therapeutics Program, Center for Immunology; BioTechnology Institute; Cancer Center; MICaB Graduate Program, University of Minnesota. Diane E. Hoffmann, J.D., Sc.M., is Jacob A. France Professor of Health Law and Director, Law & Health Care Program University of Maryland Francis King Carey School of Law. Francis B. Palumbo, Ph.D., J.D., is Professor and Executive Director, Center on Drugs and Public Policy, University of Maryland School of Pharmacy.
Jazyk: angličtina
Zdroj: The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics [J Law Med Ethics] 2019 Dec; Vol. 47 (4), pp. 482-504.
DOI: 10.1177/1073110519897726
Abstrakt: In this article, the authors explore the impact of a potential future regulatory decision by FDA whether or not to continue its enforcement discretion policy allowing physicians to perform, and stool banks to sell, stool product for fecal microbiota transplantation as a treatment for recurrent Clostridium Difficile infection without an Investigative New Drug (IND) application. The paper looks at the Agency's regulatory options in light of the current gut microbiota based products that are in the FDA pipeline for drug approval and the potential impact and repercussions of their approval on FDA action. In laying out FDA's options we consider the implications of market exclusivity and off-label use of newly approved drugs. Ultimately, we explore the potential impact of FDA's decision on patients, research, and innovation.
Databáze: MEDLINE