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The slides are approved only in the order in which they have been reviewed. Preclearance is most effective as a regulatory mechanism when promotional tools are used in the precise way in which they were reviewed. Please refer to Q&A # 198 for a solution on how to leverage some of the functionality you are describing.
Content of a previously approved piece may only be re-purposed into a different medium so long as no copy, layout, flow, visual, or functionality changes are made as a result of the re-purposing. Therefore, in response to your specific question, any rearranging of content as a result of resizing will require further review (i.e. the new medium should be submitted in the form of a new eFile). Furthermore, all PAAB code requirements must be maintained in the new medium. For example, if the approved APS was employing middle fair balance on the surface of the journal ad to direct to highest fair balance elsewhere in the publication, simply digitizing the journal ad would not meet the fair balance disclosure requirements. The new medium ad will require either a change in copy (e.g. use of the highest fair balance on the surface of the new medium ad) or a change in functionality (e.g. addition of an electronic link to the highest level FB). Either of these changes would trigger the need for PAAB review.
It is reasonable to provide latitude for slight deviation between English and French keywords (i.e. the English and French keywords don't have to match 100%) provided that the overall theme is the same. However, if the gap between English and French is so wide as to essentially represent two different reviews, our admin team will simply instruct you to separate the two languages into to submissions (i.e. two $390 base fees rather than one $450 base fee). Note that although the rationale you provided could be argued to apply to many other types of APS, this latitude would not apply more broadly. The nature of the keywords assessment simply lends itself quite well to this flexibility. Note that the generated description should be a direct translation.
You'll see that there is an association between opinions and latter submissions of same/similar content. This is best described as a correlation (which is indicative of consistency) rather than a causative relationship. For example, if XYZ is not acceptable, it will be questioned whether it is submitted as an opinion or a full submission. However, the fact that something was questioned earlier does not in and of itself render it unacceptable (what renders it unacceptable is likely whatever triggered the comment in the first place). Note that this correlation is not absolute. On occasion, something is questioned in an opinion submission, but is accepted in the following complete submission because the client addressed the concerns (e.g. by providing acceptable evidence to support the claims and/or by adjusting the context). Submitting an opinion does not impact the PAAB timelines associated with the eventual complete submission. However, the line by line review during the complete submission process may run smoother if PAAB feedback from the opinion is incorporated onto that complete submission.
The indication is indeed a claim. But it is sufficiently "balanced" with lowest level fair balance general statement (i.e. complete indication with the statement to consult the PM for contraindications, warnings...). The piece you've described is not exempt. Per the document cited in your question, product advertising is only exempt there are absolutely no messages other than drug name +/- claims explicitly listed in the PAAB code s6.6.
Pieces targeted to HCPs and groups which may be comprised of HCPs in addition to other specialized individuals responsible for making decisions about drug therapy which effect affect Canadians (e.g. Private drug plan managers) would fall within the scope of the PAAB code. Content factors will therefore be pivotal in determining whether the content should be submitted for PAAB review. Here are some key considerations:
Messages/announcements aligned with the "Clinical Trial Recruitment" section of the Health Canada policy document "The Distinction Between Advertising and Other Activities" are not subject to the advertising provisions in the PAAB code. Having said that, PAAB offers an advisory opinion based on the aforementioned Health Canada document. This opinion provides the assurance of an objective external review that the message/announcement is indeed aligned with that Health Canada document. Note that, in some cases, a Telecaster number may be required for broadcasting media (e.g. television and/or radio) and receipt of that number may be contingent on demonstration of a "no further comments" letter from PAAB or ASC. Note that HCP advertisements require PAAB review whether they contain Clinical Trial Recruitments or not. Please refer to the Rx&D Code of Ethical Practices for guidance on activities related to retaining the services of a stakeholder and communication with stakeholders involved in post registration clinical studies.
Yes, it is acceptable to co-promote products in one APS. Content will be reviewed in the context of all the promoted products. Attachments, if any, should be submitted as separate APSs but please advise that they are associated with the email. They will be reviewed in the context of the email.
"How to use the product" can mean a couple of different things. Nonetheless, if the video is about the sponsor's product, the advertising provisions would appear to apply (in which case, in the non-gated context you've described, the video would be subject to section C.01.044 for the Food and Drug Regulations if it relates to an Rx product). Discussion of the how/who/when/where/why relating to administration/use of the product would appear to be in excess of the name, price, and quantity restriction. Note that this is not a PAAB code issue. It is an opinion based on PAAB's interpretation of the Food and Drug Regulations.
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?
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
Jennifer Carroll
Senior Reviewer Communications
Pharmaceutical Advertising
