Where Stool is a Drug: International Approaches to Regulating the use of Fecal Microbiota for Transplantation

Scheeler, Alexandra

doi:10.1177/1073110519897729

Cited by 20 publications

(25 citation statements)

References 58 publications

(61 reference statements)

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“…In 2018, the stool bank’s protocol was designed principally to improve the safety and accessibility of FMT for treating C. difficile infection in a specific regulatory environment, 37 using donors from a limited geographic location, and guided by the scientific and medical understanding of FMT at the time. The protocol described here would require modification if implemented in a different regulatory environment 23,32 or geography 47 . Furthermore, as the field’s understanding of the safety profile and molecular mechanisms of FMT improves, there will be further opportunities to optimize human-derived microbial therapies in general and stool banking protocols in particular.…”

Section: Discussionmentioning

confidence: 99%

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Stool banking for fecal microbiota transplantation: methods and operations at a large stool bank

Zaman

Ramakrishna

Team

et al. 2020

Preprint

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Objectives: Fecal microbiota transplantation (FMT) is a recommended therapy for recurrent Clostridioides difficile infection and is being investigated as a potential therapy for dozens of microbiome-mediated indications. Stool banks centralize FMT donor screening and FMT material preparation with the goal of improving the safety, quality, convenience, and accessibility of FMT material. Although there are published consensuses on donor screening guidelines, there are few reports about the implementation of those guidelines in functioning stool banks. Methods: To help inform consensus standards with data gathered from real-world settings and, in turn, to improve patient care, here we describe the general methodology used in 2018 by OpenBiome, a large stool bank, and its outputs in that year. Results: In 2018, the stool bank received 7,536 stool donations from 210 donors, a daily average of 20.6 donations, and processed 4,271 of those donations into FMT preparations. The median time a screened and enrolled stool donor actively donated stool was 5.8 months. The median time between the manufacture of an FMT preparation and its shipment to a hospital or physician was 8.9 months. Half of the stool bank's partner hospitals and physicians ordered an average of 0.75 or fewer FMT preparations per month. Conclusions: Further knowledge sharing should help inform refinements of stool banking guidelines and best practices.

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Section: Discussionmentioning

confidence: 99%

“…Although there are differences between stool banks, in part due to variation in FMT regulation between countries, 32 stool banks generally adhere to a common-six part methodology, shown below. 5,21,[23][24][25]31,33,34 In some banks, these six elements are joined together by rigorous quality systems.…”

Section: Introductionmentioning

confidence: 99%

Stool banking for fecal microbiota transplantation: methods and operations at a large stool bank

Zaman

Ramakrishna

Team

et al. 2020

Preprint

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“…Importantly, the FDA's enforcement discretion policy has allowed the practice of FMT without mandated systematic collection of safety data in the vast majority of patients. Therefore, this opinion is based on limited observational case series, several carefully conducted open-label trials, a few randomized controlled trials, 32 as well as collective experiences of many individual physicians using FMTs in their clinical practices.…”

Section: Development Of Microbiota-based Therapeuticsmentioning

confidence: 99%

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

Khoruts¹,

Hoffmann²,

Palumbo³

2019

J. Law. Med. Ethics

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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.

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“…Arguments for using FMT as a treatment for rCDI were initially based on observational studies, such as case series, and data from small, unblinded trials. 43 These studies were not designed to produce evidence of efficacy for FDA approval of stool as a treatment for rCDI and were not regulated by the FDA. Results from these initial studies indicated that FMT led to resolution of rCDI symptoms in 89% to 94% of patients.…”

Section: Microbiota Transplants Lack High-quality Evidencementioning

confidence: 99%

FMT and Microbial Medical Products: Generating High-Quality Evidence through Good Governance

Ossorio¹,

Zhou²

2019

J. Law. Med. Ethics

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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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Where Stool is a Drug: International Approaches to Regulating the use of Fecal Microbiota for Transplantation

Cited by 20 publications

References 58 publications

Stool banking for fecal microbiota transplantation: methods and operations at a large stool bank

Stool banking for fecal microbiota transplantation: methods and operations at a large stool bank

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

FMT and Microbial Medical Products: Generating High-Quality Evidence through Good Governance

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