Investigating pharmaceutical marketing in Canada using American prosecutions.

BACKGROUND Pharmaceutical companies are prohibited from marketing medications for off-label uses in both the United States and Canada. In the United States, there have been several recent multi-billion dollar settlements with pharmaceutical companies based, partly, on off-label promotion. Health Canada has not publicized any investigations into, or prosecutions of, pharmaceutical companies for off-label promotion in Canada even though many of the same medications are marketed here. The prohibition on off-label promotion is largely directed at preventing pharmaceutical companies from circumventing the drug licensing process and attendant safety checks. OBJECTIVE To determine if sanctions for off-label pharmaceutical promotion in one jurisdiction can be used to regulate marketing in another. METHODS We reviewed and compared the laws and regulatory bodies in Canada and the United States to determine if Canadian regulators could use the findings of American regulators. RESULTS There were no important differences in the laws and regulatory bodies in Canada and the United States related to off-label promotion. CONCLUSIONS Canadian regulators can use the findings of American regulators to investigate off-label promotion in Canada. All countries should consider using sanctions in other jurisdictions to direct the deployment of limited regulatory resources.