148 - Can you provide an opinion on the use of reprints with information containing both within indication information and information outside of indication. The example would be a review article that has both, yet the direction to the sales force would be to highlight and promote the medical issue and the information consistent with the product's use and indication.
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It is our understanding that "use" of reprints refers to their distribution as part of the promotional mix. As per PAAB code section 3.1, reprints containing off-label content about drug therapy should not be distributed in a promotional context (e.g. through drug representatives). PAAB regards "off label" as content that is not supported by nor consistent with the Canadian Terms of Market Authorization (TMA). We would need to look at the study content (e.g. study population, dosages used, evaluated outcomes) in order to determine whether these parameters are in-line with the TMA or "off-label". Ask for an official PAAB opinion if you are unsure whether the paper is aligned with the product monograph. Drug promotion is regulated under the Food and Drugs Act; however, it is important to note that not all forms of distribution of reprints are considered promotional. Please refer to the Health Canada policy document "The Distinction Between Advertising and Other Activities". The section "Reference texts, Peer-reviewed Journal Articles" outlines the requirements for the distribution not be considered promotional. Your question mentions an example involving a review article. Note that these secondary references are not generally considered to meet the PAAB Code's standards for evidence for product claims (PAAB s3.1.1). As such, the published & peer reviewed paper should not be distributed in a manner directing the health care professional's attention to claims within the reprint in any way (e.g. through highlighting, insertion of sticky tabs, adding copy/summary or word of mouth). Finally, if distributed by drug representatives (or in any promotional context as per your question) the paper should not be off-label. Please call me at the PAAB office if you have any additional questions on this matter.
