FMT Happens: Regulating Fecal Microbiota Therapy in Canada; What You Need to Know

AuthorShahad Salman,Denise Avard,George Vardatsikos,Nicole Palmour,Ken Dewar,Ma'n H. Zawati
Published date01 March 2016
Date01 March 2016
DOIhttp://doi.org/10.1002/wmh3.174
FMT Happens: Regulating Fecal Microbiota Therapy in
Canada; What You Need to Know
Shahad Salman
, George Vardatsikos
, Denise Avard, Nicole Palmour,
Ken Dewar, and Ma’n H. Zawati
By disrupting normal gut microbiota, antibiotic therapies pose a major risk to the treatment of
Clostridium diff‌icile infection (CDI), a debilitating and potentially fatal intestinal infection.
Consequently, there is a pressing need for the development of an effective, novel, nonantibiotic
treatment. One such treatment is fecal microbiota therapy (FMT), which restores gut microbiota in
CDI patients and has gained popularity in recent years due to its high eff‌icacy rate. Health Canada
has recently proposed to regulate FMT as a “biological drug” following the U.S. Food and Drug
Administration’s approach. Moreover, as an interim policy, Health Canada proposed to exercise a
risk-based interpretation regarding the clinical trial requirements for FMT used in treating CDI,
limited to patients unresponsive to conventional therapies. This article f‌irst discusses important
considerations for an alternative classif‌ication of FMT and stresses the need to develop a policy
dependent upon scientif‌ic developments in the f‌ield, away from a one-size-f‌its-all approach. Second,
it brief‌ly explores some concerns related to the recourse to this provisional interpretation to guide
the use of FMT in the treatment of patients with CDI unresponsive to conventional therapies
subject to Health Canada’s recent policy.
KEY WORDS: fecal microbiota therapy, Health Canada, regulation
Introduction
Clostridium diff‌icile infection (CDI) is a major cause of antibiotic-associated
nosocomial diarrhea and colitis worldwide (Ghose, 2013). Antibiotic treatments for
CDI, such as metronidazole and vancomycin, are usually successful (Petrella et al.,
2012). However, recent studies have demonstrated a decrease in patients’ response
to such treatments alongside a continued high disease recurrence rate (Aslam,
Hamill, & Musher, 2005; Petrella et al., 2012). Moreover, the economic burden of
CDI is staggering, with estimated costs of over $280 million in Canada and $1–3
billion in the United States (Levy et al., 2013; McGlone et al., 2012). Antibiotic
resistance is becoming such a problem that a 2014 report by the World Health
Co-f‌irst authors.
World Medical & Health Policy, Vol. 8, No. 1, 2016
95
1948-4682 #2016 Policy Studies Organization
Published by Wiley Periodicals, Inc., 350 Main Street, Malden, MA 02148, USA, and 9600 Garsington Road, Oxford, OX4 2DQ.

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