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  1. Introduction: The Promise and Challenges of Microbiome-Based Therapies.Diane E. Hoffmann - 2019 - Journal of Law, Medicine and Ethics 47 (4):476-481.
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  • FMT and Microbial Medical Products: Generating High-Quality Evidence through Good Governance.Pilar N. Ossorio & Yao Zhou - 2019 - Journal of Law, Medicine and Ethics 47 (4):505-523.
    This article argues that current data for the safety and efficacy of fecal microbiota transplants as a treatment for any indication, including recurrent Clostridioides difficile infection, is low-quality. It develops a governance proposal that encourages production of high-quality evidence by incentivizing well-designed RCTs of stool and stoolderived microbial products. The proposal would require that FDA change its current enforcement approach, but it would not require any change in statutes or regulations.
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  • The Impact of Regulatory Policies on the Future of Fecal Microbiota Transplantation.Alexander Khoruts, Diane E. Hoffmann & Francis B. Palumbo - 2019 - Journal of Law, Medicine and Ethics 47 (4):482-504.
    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 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 (...)
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