Unbranded disease info + Guidelines (therapeutic categories)
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Content was created independently by a group of Canadian physicians where they provide information on how to differentiate between several disease states that closely resemble one another. They also included information from the consensus guidelines, which mentions all the therapeutic categories equally (no emphasis on any category, simply lists 1st line therapeutic category, 2nd line category, 3rd line category. My client was the sponsor for this project but the tool will remain unbranded (no product logo, no brand colours). Their sales reps will not be distributing the tool. A 3rd party will distribute the tool to Canadian physicians. Does this need to be reviewed by PAAB?
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Good Morning @natbourre
Please see Q&A 634, particularly the PAAB Advisory Guidance on which HCP materials require PAAB review, which contains a decision tree to describe the key elements in the assessment. To make an assessment, we would require further elaboration on the content, nature of the sponsorship and selection of the author group. We would also require elaboration on the “3rd party distribution”. If the sponsor has influence on choosing the topic and/or plays a role in the distribution by the 3rd party, we would recommend submitting for an opinion. The opinion would be to assess the influence of the sponsorship (as noted in the above guidance, examples of “influence” include control or input on the specific topic, content, author selection, audience, frequency, etc.) and the overall message of the piece. The standard litmus test is “could a reader identify the sponsor” and “would a competitor be equally as likely to promote this tool”.
