17 - If a reprint carrier is being produced, can the content be based on the paper even if some of the points to be made are not part of the product monograph? For example, if data pertaining to subgroup and multivariate analyses were not included in the product monograph but are discussed in the article, can they, i.e., subgroup and multivariate analysis, be part of the text highlighted on the reprint carrier?

  • According to section 3.1 of the PAAB Code claims in advertising, including reprint carriers, should be consistent with the Health Canada approved product monograph and labeling. The PAAB would not approve distribution of a clinical reprint that focuses on off label claims. It may be acceptable to distribute the reprint as a whole if the off label claims are not the primary focus of the study. That is variable and subject to review for a definitive statement on specific cases. However, the off label claims should not be highlighted on the reprint carrier. The PAAB has had intervention by Health Canada regarding subgroup analysis claims that have appeared in advertising and did not appear in the product monograph. We would suggest submitting the data to Health Canada as part of an SNDS.