Investigating pharmaceutical marketing in Canada using American prosecutions

Abstract

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.