707
Hi, For the balance copy requiring a direct link to the Product Monograph - the guidelines state that a link to the Health Canada database along with DIN number would work in lieu of a corporate URL. If going this route, is it sufficient to say: "Search the Health Canada Drug Product Database and search DIN XXX for...." OR must the database URL be written out? It is quite long: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html) Much thanks!
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Voir réponse [+]
The guidance document state “the manufacturer could have used a URL leading directly to…the Drug Product Directory search page on the Health Canada website”. There are no requirements to provide the DIN, as a search can be conducted simply using the product name.
The link to the TMA in the fair balance may be either the complete url, which is required in the case of a print tool, or an electronic link (i.e. “Please click here to consult the Product Monograph…”) which directs the user to the Health Canada Drug Product Database. As a courtesy, please note that the shorter link below (valid at time of post) would be acceptable:
English TMAs: https://health-products.canada.ca/dpd-bdpp/index-eng.jsp
French TMAs: https://produits-sante.canada.ca/dpd-bdpp/index-fra.jsp
706
Can sales representatives provide information on a drug's reimbursement criteria in response to a question from a HCP if the reimbursement criteria are not aligned with the TMA. For example, the approved Health Canada indication is for use as 2nd line therapy but the drug is only reimbursed for use in 3rd line. Could the sales representative respond to the question and provide information on reimbursement if not aligned with the TMA. Thank you.
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Voir réponse [+]
While verbal correspondence between the sales representative and the healthcare professional does not fall under the PAAB scope of review, it is a promotional activity and as such it is subject to advertising regulations. Per section C.08.002 of the Food and Drug Regulations, promotion of a drug and/or indication, prior to market authorization is not permitted. We suggest advising sales representatives to direct HCPs to call the manufacturer’s Medical Information Department in response to these unsolicited questions.
705
Can a non promotional website that is not subject to review and is only available to verified Canadian HCPs link to a post-gate landing page for a PAAB approved branded website?
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Voir réponse [+]
Let’s assume that “non promotional website that is not subject to review” is referring to a 3rd party website that has a verification process in place to restrict access to HCPs. In this scenario there are two main considerations. Is there an issue linking the branded/unbranded website and is it acceptable to bypass the gating mechanism on the branded website. With respect to the websites, the unbranded website content would need to be acceptable in the context of the brand product, otherwise the link may contravene advertising regulations. With respect to the gating mechanism, if the unbranded site has a valid verification process in place, the HCP is not required to validate their identity a second time. However, keep in mind that the HCP must be directed to the landing page with the respective fair balance copy to ensure they are exposed to the appropriate level of safety information.
704
If a product has two possible dosing schedules, with no specific requirements/recommendations on which HCPs can choose, are we permitted to just focus on one dosing schedule in APS? If both dosing schedules are required, are we permitted to focus on one over the other in terms of prominence?
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Voir réponse [+]
There are a number of scenarios which could result in either requiring both dosing schedules in the APS, or allowing the focus on just one. These would depend on both the content in the TMA, and the claims which are being made in the APS. As an example, if the piece is promoting an indication where the product is used in combination with another drug, we would question the select inclusion of a monotherapy dosing schedule. As the answer to this question is dependant on the specific TMA and the claims made in the APS, we suggest submitting this to PAAB as an opinion request.
703
Regarding the PAAB Guidance document "Tips relating to inclusion of expert commentary in drug advertising", would the same rationale and requirements apply to patient testimonials?
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Voir réponse [+]
Similar to an expert commentary, a patient testimonial is basically a single person’s opinion. An individual’s opinion alone is not considered sufficient evidence to support product claims in advertising (PAAB Code section 3.1.3). As explained in the tips document, the caveat to this is if the individual’s opinion/patient testimonial is consistent with evidence or with consensus opinion from an independent, authoritative source that meets the standards of the PAAB Code. The supportive content must be presented prominently in close proximity to the individual’s opinion within the piece and the individual’s comment must meet the standards of the PAAB Code (e.g. must not be absolute, must not be disparaging, etc.).
702
Hello, If we are temporarily suspending a website while we update the contact (as the website's current content is set to expire), do we need to PAAB this temporary page? Or since there is not claims and no other pages can be accessed this step is unnecessary? Thanks
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Voir réponse [+]
Assuming that the temporary page on the website will not contain any product claims, images, or links to other content or websites, and the content will be restricted to a message about the temporary suspension of the site, then there doesn’t appear to be a reason to submit this page to PAAB for review. However, if you are unsure, the temporary page can be submitted to PAAB as an opinion file.
*One additional consideration is if this site is being used as a link to satisfy content requirements from any other pieces in circulation (i.e. safety information, study parameters, reference lists). (see guidance document: Fair Balance & Web Link Destination Examples – Section: Using middle level to lead to highest level fair balance and section 4.4 of the PAAB code). If this is the case, then disabling the website would cause the other circulating pieces to contravene the code.
701
Can HCP advertising and Patient advertising (not consumer) feature the same campaign visual, design and statement, with the understanding that the information within the campaign is in context for each audience. (Patient information driven from Part III of the PM)?
700
Can we present two different brands, (which are two different therapeutic areas) in one APS (i.e. in a LB) as long as the indication and balancing info is presented for both brands?
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Voir réponse [+]
The co-promotion of different products within a single APS is possible, even for different therapeutic areas. The key is that there is a clear separation of the content. For example, a two-sided card could promote drug A on the front, and drug B on the back. We can provide further direction on how to accomplish this during the review process.
699
A pharma company wishes to produce an Unbranded video that will be used by reps for a call with HCPs. The video will feature a patient campaign that has already been approved by PAAB. There are no claims being made in the video, and it just provides an emotional story behind the campaign. Would this be considered PAAB exempt?
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Voir réponse [+]
As this sounds like a specific example, we suggest submitting for an opinion. As a generally guiding principle, if the unbranded promotional piece is for a branded patient campaign, it should be reviewed in the context of the brand, regardless of whether or not the brand is mentioned within the rep directed piece or not. The thought process behind this is that if you link branded and unbranded content, all content becomes branded and therefore requires review in the context of the brand.
If the program or unbranded campaign speak to “treatment” in any way (even without direct mention of a product), it would fall under the purview of the PAAB code and be subject to review.
If the program is unbranded, the piece is unbranded, and there is no mention or implication of “treatment” in either, it is possible that the piece is exempt from PAAB review.
698
Could you clarify a few points for us: 1 - Is a product indication (verbatim from the product monograph) seen as a claim by PAAB? 2 - If a detail piece, journal ad etc., contains only branding colours, brand name and product indication, does PAAB need to review this or is it exempt? 3 - Per question 2 above, if the piece also contains imagery related to the indication, does that change the PAAB review requirement? Thanks for the clarification.
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Voir réponse [+]
Let’s assume that we’re talking about claims in HCP advertising. Pieces which include direct or implied claims (including the product indication) are subject to PAAB review. In fact including the indication would prompt the requirement for the lowest level of fair balance. This applies regardless of the imagery included in the piece (although imagery may result in middle or highest level fair balance being required if it alludes to other claims).
