665 - We would like to produce a non-branded APS that highlights the current medical practice on using a specific class of medication. The most recent Canadian consensus guidelines (updated in 2017) support the message that this class of medication should now be offered as an option to patients undergoing continued maintenance treatment (this is a big change vs the last consensus guidelines publication from 2003). 2 Questions: 1) We assume it would be acceptable to make a claim in an APS that outlines this recommendation, given that this is from an approved, authoritative source, correct? 2) This guideline document also provides context around why their position has changed. They provide details about how this class of medication was used historically, and also outline some of the evidence that supports their new recommendation...
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continued ... which included reviewing 3 RCTs among other sources (note: they communicate that there is data that supports the classes superiority, but also data that challenges it). Would it be permissible to also include a balanced presentation of these additional details in our APS? If not, why? Wouldn't a consensus guidelines document be an acceptable reprint that a company sales rep could distribute to HCPs? And if so, then why would be ok for them to distribute the document that includes this information, but it wouldn't be permitted to use the content on its own in an unbranded APS if referenced accordingly and presented in a balanced and objective manner?
Response: I can only speak in general terms as I don't know the particulars of your specific case. In general, Canadian guidelines can be used to support place in therapy recommendations that are aligned with the product's TMA. However, the basis for the recommendation tends to touch on topics such as comparative efficacy, safety, tolerability, adherence, cost-effectiveness, and so on. Guidelines are not an acceptable evidentiary basis for claims pertaining to these parameters. Please refer to the following document highlighting the evidentiary requirements for different types of messages in advertising: http://code.paab.ca/resources/Marketing_benefit_claims._What_they_are_and_what_level_of_support_is_required.pdf
There are several differences between consensus guidelines and a detail aid. Arguably the most germane to your question is that consensus guidelines are created independently of the manufacturer and are therefore exempt from PAAB preclearance (provided that it is the complete and unedited document). The detailing aid is advertising which is subject to advertising regulations. You can also refer to the section "Reference texts, Peer-reviewed Journal Articles" in the Health Canada Policy Document "The Distinction Between Advertising and Other Activities.
