PAAB reviews the copydeck (in both English and French) and the layout before approval is provided. Layout is reviewed from a contextual perspective (as context helps shape meaning) while copydeck are reviewed from a copy perspective.
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Does PAAB review and approve both the copy & the layout before they issue a PAAB approval reference number? Or is it only the copy which is reviewed and approved? Thank you.
PAAB reviews the copydeck (in both English and French) and the layout before approval is provided. Layout is reviewed from a contextual perspective (as context helps shape meaning) while copydeck are reviewed from a copy perspective.
In an unbranded context, is it possible to use a guideline treatment algorithm that recommends drugs that are off label for the condition it pertains?
No. The editorial APS provisions of the PAAB code requires that “information on a specific drug is consistent with the current Product Monograph”. Editorial advertising is not the forum for off-label advertising of the sponsor’s product. Note also that the drug class in which the sponsor has a vested interest may not be promoted off-label (e.g. promoted in a manner which is inconsistent with the monographs of all products in that class).
In 7.1.2, regarding retaining a stakeholder to do speaking/chairing meetings, etc ---- slides/presentation of this stakeholder is not subject to PAAB review? Please confirm.
For everyone else’s sake, you are of course referring to section 7.1.2 of the Rx&D code. Not 7.1.2 of the PAAB code. I won’t speak to or clarify the Rx&D code, but I will respond to whether materials used in speaking events (e.g. slides, handouts) require PAAB review. I believe this is what you are asking.
The answer to your question hinges on whether this is advertising or not. If it is advertising, the materials are subject to the advertising regulations and PAAB review. To demarcate between advertising and non-advertising, the 7 factors listed in the Health Canada policy document “The Distinction Between Advertising and Other Activities” must be considered. Given that no single factor alone can determine whether material or activities are subject to advertising regulations, the fact that the creator and/or deliverer of the presentation is an HCP does not necessarily exempt the materials from the advertising regulations. It is important to consider aspects including (but not limited to):
Note that there are additional important Rx&D code and HCP association code (e.g. CMA) considerations to keep in mind in this scenario.
Hi Patrick, I am doing a slide kit for the reps based on our PM. In the PM it mentions a study with our drug against a non-approved drug, so I can use this info in my slide. New studies have come out on our drug vs the non-approved drug would I be able to use this new data in my slide deck for the reps.
Hi there. Use the following thought process to work through this scenario “The only reason the data is acceptable in spite of PAAB code 5.1 is that it appears in the PM”. As a deductive extension of this, other data from the same published study which is not found in the PM is not acceptable. As an additional extension, other similar data (e.g. from other studies) which is not in the PM are not acceptable.
Are the presentations/slides of our medical directors subject to PAAB review?
Under what circumstances can our medical director or medical scientific liaisons provide learning programs?
Must it be a solicited request for education?
Please read this answer in the context of the Health Canada policy document “The Distinction Between Advertising and Other Activities”. Whether materials/activities fall in the advertising realm is multifactorial.
An individual factor (e.g. having the title “Medical”) does not in and of itself eliminate the potential for materials/activities to be subject to the advertising provisions. When applying the principles of the aforementioned Distinctions document to presentations created & delivered by medical, it is helpful to incorporate the marketing concept of “push” vs “pull” into your thought process. Imagine that the information is a physical package. This package initially resides with the manufacturer. Is that package pulled by the HCP from the manufacturer (by a request that has not been solicited in any way by the manufacturer) or, is that package pushed by the manufacturer onto the HCP? Consider that analogy as you read the following scenarios:
Scenario 1:
Informational slide decks prepared by a pharmaceutical company’s medical department (or equivalent) which will be provided to HCPs only in response to unsolicited request are not subject to advertising provisions (and PAAB preclearance). In order to remain exempt from the advertising provisions and PAAB preclearance, the provided content must be limited to that which was requested (i.e. such that additional content is not “pushed” to accompany the requested/pulled content) and the content/tone must be non-promotional.
Scenario 2:
Similarly, if a particular institution makes an unsolicited request that staff from the manufacturer’s medical department (or equivalent) delivers an informational presentation for that institution’s staff, the presentation is not subject to advertising provisions (and PAAB preclearance). This is true even though the content is shared with an audience rather than an individual; however, that audience is exclusively comprised of staff/members from the institution mandating the session. Again, in order to remain exempt from the advertising provisions and PAAB preclearance, the presented content must be limited to that which was requested (i.e. such that additional content is not “pushed” to accompany the requested/pulled content) AND the content/tone must be non-promotional. Note that the non-advertising status would be compromised by incorporating or linking to promotional content/activities. Refer to the Rx&D code for additional considerations about the session.
Scenario 3:
If the manufacturer were to hold a session and invite HCPs to attend (i.e. manufacturer is “pushing” content/materials), the slidedeck would require a PAAB submission even if created and presented by staff from the medical department.
The same would apply if the presentation is prepared by and/or conducted by an external health care professional on behalf of the medical department at an unaccredited event. Note that there are additional Rx&D code and HCP association (e.g. CMA) considerations to keep in mind in this scenario. Bottom line, is that the 7 factors listed in the Health Canada policy document “The Distinction Between Advertising and Other Activities” must be considered. Given that no single factor alone can determine whether material or activities are subject to advertising regulations, the fact that the creator and/or deliverer of the presentation is from medical or is an HCP does not necessarily exempt the materials from the advertising regulations. It is important to consider aspects including (but not limited to):
If you have any additional questions, please call the PAAB office. </p>
Hi, I am looking for a ruling on the following scenario. If a sales rep is using a PAAB approved, Un-branded, Disease state promotional piece to engage an HCP in a non-product related discussion. If, during that discussion, the physician asks that representative a product specific question, i.e. "What is the clinical data for Product "X" in the disease state we are discussing?”. Is the rep allowed to answer the question and switch to a product based discussion that incorporates PAAB approved promotional pieces? What specifically can the rep do in a situation like this where the use of PAAB approved messaging and promotional pieces are strictly reactive?
The PAAB code relates to APS content. It does not govern specific rep activities. In order to stay in scope, I’ll refrain from discussing specifically when particular rep activities are appropriate or not.
Q&A # 232 should be interpreted as conveying the importance of not setting out to link branded and unbranded pieces in principle (this principle applies regardless of whether we are talking about journal placements, web contexts, rep detailing, etc…). Unbranded APS often have content which is off-label in relation to the sponsor’s brand (in fact, this is often why the piece is unbranded in the first place). Creating the link often equates to off-label promotion.
The Rx&D code has provisions against proactive/solicited off-label promotional activities.
Is there a PAAB mandate anywhere that states that the pharmaceutical companies corporate logo has to appear on all PAAB reviewed and approved APS materials? We have a situation there are high-priority approved APS materials requiring printing; however the corporate branding is changing and won’t be fully established for some time.
No. PAAB code requires that the company name be disclosed except in cases where this could contravene some other regulation (e.g. help-seeking messages). There is no need for the company logo.
Are promotional materials for class II medical devices required to go through PAAB clearance?
No. Please refer to PAAB code section 11 for the definition of healthcare product as used specifically within the PAAB scope.
We have an HCP-gated educational website/app containing endorsed medical education. We would like to post a program comprised of KOL-presented patient cases containing a video segment featuring one of that KOL's patients. What is the patient allowed to speak about on the video (e.g. their quality of life post-therapy...)?
First you have to decide if the case study presentation is advertising or not. If it includes mention of the sponsor's drug, it is usually advertising. Then all statements should be consistent with the Product Monograph and within the standards of the PAAB Code of Advertising Acceptance. You should also consult the Health Canada policy guideline "The Distinction Between Advertising and Other Activities".
In the current consultation by Health Canada on the Guidance Document: Product Monograph Release Part I: Health Professional Information and Part II: Scientific Information, Health Canada proposes to remove references, as per the response to Question #309 , what impact would removal of references have on the utilization of the study by companies if not listed in the PM?
Mention of a study in the PM bibliography has no influence on the PAAB review. Given this fact, the removal of the bibliography changes nothing from a PAAB review perspective. As a point of interest, PAAB code section 3.1.2 states that citation in the bibliography section of the Product Monograph does not indicate proof of acceptance by Health Canada.
Jennifer Carroll
Senior Reviewer Communications
Pharmaceutical Advertising