Background: Since the mid 1990's, Canada has introduced partial direct-to-consumer advertising (DTCA) of prescription drugs through administrative policy shifts. Little documentation exists on how regulation occurs in practice.
Objective: To evaluate Health Canada's response to complaints about DTCA.
Methods: We use case studies about DTCA spanning from 2000 to 2011 to examine the stringency of regulation by Health Canada. The aim was to identify key themes in Health Canada's approach to regulation from a public health perspective. All of the material related to the cases was independently read by each of the authors and any disagreements in interpretation were resolved through discussion.
Results: We identified six weaknesses in how Health Canada deals with DTCA: failure to act on concerns about promotion for unapproved "off-label" uses, possible financial inducements to use a product, advertisements perceived to stimulate unwarranted fear about disease risks, and advertising of products with serious safety concerns identified in Health Canada safety advisories; ineffective enforcement actions undertaken by Health Canada; and lack of transparency in Health Canada's decision-making.
Conclusions: There is an astonishing degree of discordance between public health priorities and regulation of DTCA in Canada. The current approach to enforcement is notable both for its lack of teeth and lack of accountability and transparency.
Keywords: Direct-to-consumer advertising; Health Canada; pharmaceutical industry; prescription drugs; regulation.