Canadian Drug Licensing Probe Urged

11 November 1996

A call for an immediate inquiry into Canada's drug approval process has been made by a new public advocacy group, the Alliance for Public Accountability, in the wake of claims of deficient risk management at Health Canada's Health Protection Branch following its review of the calcium channel blocker nifedipine.

Federal regulator Michele Brill-Edwards resigned in "an act of conscience" after she said that the regulatory authority had failed to apply the precautionary principle in approving nifedipine for the treatment of angina and high blood pressure, and that it lacked the expertise to deal with complex drug regulatory issues. Although the HPB cannot approve a new drug until its manufacturer has provided conclusive proof of the product's safety, Ms Brill-Edwards said that this product had been classified as a second-line rather than a last-resort treatment because of deregulation and what she termed a "less rigorous approach to drug evaluation."

"More Transparency" Needed This, she said, has created a situation in which pharmaceutical manufacturers are able to continue producing and marketing their products "until there is conclusive scientific evidence of harm," according to a report in The Lancet. She also claimed that the assessment committee which reviewed nifedipine included members with "clear-cut associations" with the product's manufacturers, and called for far more transparency in the approval process. Canada's federal drug approval process is "in disarray," according to Ms Brill-Edwards.

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