[Governance of drug advertising control: assessment of misleading advertising penalties]

Background: Loyal promotion of the pharmaceutical industry has been challenged by stakeholders. Drug advertising is the easiest point to assess. Based on the agency theory, our objective was to describe the governance of advertising control when it was misleading and the terms of penalties within the framework of the contradictory process between the industry and the regulatory authorities.

Methods: We conducted a thorough analysis of the contents of the minutes of the Board of Control of advertising from April 2007 to May 2010. The amounts of penalties were analyzed according to three criteria: the timing of the examination procedure (first session versus second session), the nature of the penalty (ban versus notice of change) and the company's defense strategy (written response versus presence of company representatives).

Results: Thirty-nine reports involving 62 projects to ban advertisements were analyzed. The first two causes of penalties were off label promotion and non-objective use of study results to support claims. The Committee issued 47 advertising bans (76%) and 15 formal notices of change (24%). When the defense strategy of the company involved the presence of representatives, there was a significant reduction of votes in favor of a ban (68% versus 81%, P<0.000). However, overall, the company's defense strategy did not influence the nature of the penalty (Chi(2)=2.05; P=n.s).

Conclusion: These results should be put into perspective considering the fact that the qualitative composition of the commission was not free of potential conflicts of interest and that, moreover, only 10% of the penalty projects were reviewed. In addition, advertising control does not address the issue of the loyalty of the sales forces. Finally, our results open perspectives for research and managerial applications for the governance of advertising controls.