Regulating Prescription Drugs For Patient Safety: Does Bill C-17 Go Far Enough?

Canada was the last developed country in the world to remove thalidomide from the market, and doing so required an Act of Parliament. At the request of Health Canada’s then Food and Drug Directorate, thalidomide’s two manufacturers voluntarily withdrew the drug from the market on Mar. 2, 1962. However, most of the drug’s distribution was in the form of free samples to medical professionals, which the directorate had no legal authority to control. Therefore, to avoid similar situations in the future and to stop sales of thalidomide, on Dec. 4, 1962, the Parliament of Canada amended the Food and Drugs Act, allowing the distribution of drug samples only under “prescribed conditions” and prohibiting the sale of any drug listed in Schedule H of the act, including thalidomide. The legislation stopped short of granting legal authority to the directorate to unilaterally recall drugs, even though officials recognized that “the cooperation of the manufacturer to recall a drug from the market could not be solely relied on.”

More than 50 years later, this gap in Canada’s Food and Drugs Act remains: the regulator, Health Canada, cannot order a drug recall. Instead, it must negotiate drug recalls with manufacturers. Negotiation invites delay and may precipitate harm to patients that could have been avoided. Several recent examples, including the acne drug cyproterone acetate–ethinyl estradiol (Diane-35), the diabetes drug rosiglitazone (Avandia), the pain-relief drug propoxyphene (Darvon-N), the gastroesophageal reflux drug cisapride (Prepulsid), and the anti-inflammatory drug rofecoxib (Vioxx), illustrate the adverse consequences that may flow from manufacturers’ indecision about whether and when to issue a recall, and the regulator’s inability to compel one. ( Table 1 lists drugs withdrawn for safety reasons from the Canadian market after Aug. 1, 2004.) Drug withdrawals are relatively rare in Canada. However, the fact that some of those withdrawn had been very widely prescribed means that tens of thousands of Canadians were exposed to potential harm after safety issues first arose but before market withdrawal.