298 - We have a DTC/I campaign moving forward (disease awareness, unbranded). In the treatment section, there will be an outline the different medication options indicated for treatment of this disease. A listing of the benefits and risks associated with medication will also be listed. Because this is a DTC/I content and it contains a listing of ALL indicated products with no links to branded sites, we believe this to be PAAB exempt. What is your recommendation?
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The concept of "Exemptions" does not apply to DTC as PAAB provides advisory opinions for DTCA/I (i.e. manufacturers have the option to seek a DTC opinion or not). PAAB should review the content if it is created for use by HCPs or patients. Note that PAAB's advisory opinions are assessments as to whether materials, based on Health Canada's policy The Distinction between Advertising and Other Activities, are promotional, in which case they must be in accordance with the F&DAandRegulations, CDSA, and associated policy and guidance documents. PAAB provides advisory opinions on messages directed to consumers for prescription drugs (e.g., reminder ads), material discussing a medical condition or disease (e.g., help seeking messages, consumer brochures), Schedule D drug (biologics, including vaccines) advertisements, and other messages or materials (e.g., clinical trial recruitment announcements, press releases, institutional messages, etc.). PAAB has been providing objective review of DTC since the 1990. I refer you to the following link which outlines the roles of pre-clearance agencies and Health Canada: http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/role_apa-pca-eng.php
