295 - Hi there, I was wondering if your review procedure for DTCA and DTCI advisory opinions occurs in accordance with chapter 8 and s 9.8 of the PAAB Code. More specifically, do you have the same rights to clarification by telephone or correspondence, meeting, escalation to the Chief Review Officer, and appeal? Thanks in advance for your answer.
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Although the PAAB code is not the basis of review for DTC (i.e. the review is based on Health Canada guidance documents), section 8 of the PAAB code relates to the administrative aspects of PAAB review and much of these are consistent between DTC and other submission types. The key exception relates to turnaround time. Our mandate is to provide a first response for DTC submissions within 4 business days (as opposed to 10 business days for HCP advertising & patient information). As with any PAAB submission, if you disagree with a PAAB correspondence received after having discussed that particular issue with the reviewer and responding to PAAB in writing with your position, you may set up a call involving the Senior Reviewer Preclearance Services , the reviewer, the manufacturer, and the communication agency. However, with regards to appeal to a panel as described in section 9.8, things are very different in the DTC realm. The nuance here is the difference between a PAAB ruling based on the PAAB code (i.e. HCP advertising and patient information) and a PAAB advisory opinion on DTC messages. The DTC 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 will therefore consult directly with Heath Canada when there is disagreement on how to interpret these documents. For clarity and completeness, I should point out that 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
