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- W2290141279 abstract "If the aim of federal regulation of prescription drugs is to protect public health and to promote safe, effective and informed medicine use, the first five years’ experience with Diane-35 (cyproterone acetate and ethinyl estradiol) in Canada is a case study in regulatory failure. An examination of how and why this failure occurred provides an example of why changes are needed to federal drug regulation in Canada. This paper covers the period from pre-market application to the first five years postlicensing, late 2003. A systematic review of the studies provided to Health Canada to obtain regulatory approval was conducted, as well as a review of subsequent published studies, in order to examine the evidence supporting regulatory decisions both pre- and post-approval. Regulatory approaches to Diane-35 changed dramatically over time, with initial caution during the pre-marketing stage replaced by a laissez-faire approach during the initial post-market stages, and a renewal of caution following public and media criticism. Health Canada initially refused to approve the product because of safety concerns, and later limited the approved use in the hope of restricting population exposure. The limited criteria for approved use failed to limit population exposure due to a lack of monitoring and enforcement. Health Canada compounded the regulatory failure by failing to adequately enforce restrictions on advertising of Diane-35. Diane-35 has been widely advertised to the Canadian public, despite laws explicitly prohibiting such advertising." @default.
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- W2290141279 date "2004-01-01" @default.
- W2290141279 modified "2023-09-23" @default.
- W2290141279 title "Drug regulatory failure in Canada The case of Diane-35" @default.
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