Authors
Maxwell Smith
University of Western Ontario
Abstract
Drug regulatory bodies aim to ensure that patients have access to safe and effective drugs; however, no matter the quality of pre-licensure studies, uncertainty will remain regarding the safety and effectiveness of newly approved drugs until a large and diverse population uses those drugs. Recent analyses of Canada’s post-market drug surveillance system have found that Canada is not keeping pace with international requirements for PMDS, and have noted that efforts must be improved to monitor and address the safety and effectiveness of approved drugs among vulnerable populations. Given the uncertainty that exists when drugs enter the market, some have suggested that the precautionary principle is relevant to guiding decision-making in this context. This paper responds to recommendations that the Canadian PMDS system should be responsive to the health needs of vulnerable populations by assessing the utility of deploying the precautionary principle to guide a post-market strategy for vulnerable populations.
Keywords Precautionary principle   Uncertainty   Vulnerable populations   Postmarket drug surveillance   Pharmaceutical regulation
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DOI 10.7202/1070232ar
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References found in this work BETA

The Moral Foundation of the Precautionary Principle.Karsten Klint Jensen - 2002 - Journal of Agricultural and Environmental Ethics 15 (1):39-55.
The Precautionary Principle and the Regulation of U.S. Food and Drug Safety.Ed Soule - 2004 - Journal of Medicine and Philosophy 29 (3):333 – 350.

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