336 - The data appearing in a product monograph is based on a pivotal trial. The same study also discusses 'off-label' endpoints. Can reps distribute the reprint of the study to support data that is in the PM?

  • Before reading this answer, please read Q&A numbers 175 and 45 as they provide important background reference to the Health Canada policy document "The Distinction Between Advertising and Other Activities" and the PAAB code. Distribution of materials through a sales representative is likely to be (or eventually become) a promotional activity. Off-label promotion would contravene section 9.1 of the Food and Drugs Act. The scenario in the current question differs slightly from that identified in question 45; however, in that the study is a pivotal trial which presumably has data presented in the clinical trial section of the product monograph. Given this nuance, it is PAAB's interpretation that it is possible to distribute this reference through the sales rep. BUT, you'd want to ensure that the reps are trained not to discuss any off-label (i.e. non-PM) content. You also want to ensure that the reprint is the complete and unedited published and peer-reviewed pivotal trial. Also consult the Innovative Medicines Canada code.