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

Alexander Khoruts, Diane E. Hoffmann, Francis B. Palumbo

Research output: Contribution to journalArticlepeer-review

14 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)482-504
Number of pages23
JournalJournal of Law, Medicine and Ethics
Issue number4
StatePublished - Dec 1 2019

Bibliographical note

Publisher Copyright:
© 2019 American Society of Law, Medicine & Ethics.


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