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Hi @Jennifer-Carroll, I'm going to copy/paste 352 here for reference: @Jennifer-Carroll said in 352 - Can you please explain the rationale behind not being "promotional" in branded patient-directed material? Product claims would seem to promote adherence, and therefore be beneficial to the patient.: The PAAB code section you are alluding to is s6. This provision is intended to align with the federal advertising regulations for prescription products which only enable prescription drug advertising directed to HCPs and restricted consumer advertising (the latter being limited to name, price, and quantity). There are no enabling provisions for promotion to patients. Patient information must be consistent with part III of the product monograph (and this "information" is non-promotional). This information can support adherence by educating patients about how to use the product appropriately. However, the response doesn't quite touch upon my question. C.01.044 only prohibits advertising of prescription drugs to the general public. But patients are not considered part of the general public per the Distinction guidance document. Is this an oversight by HC, or can promotional advertising to patients really take place?

Hello @dmauri Yes, a fair balance sticker that replaces only the outdated fair balance with the updated version may be considered as a potential solution. The sticker must be limited to covering the existing fair balance only. Please note that if the sticker alters the original piece beyond the fair balance (e.g., obscures or impacts other copy or design elements), the material would be considered altered and would require re-PAAB review. This assessment can be made as part of the eFile submission for the sticker and would be communicated to the client at that time.

Hoping to receive a clarification per @Constance 's question!

Hello @ebailey A search of the term "company" on the forum will return Q&A 744 which should answer the above question.

Hello @Maha-Dogar Thanks for your question. Please note that this topic has been addressed previously. Searching “secondary endpoints” in the forum should provide the relevant guidance. Note that the response applies regardless of whether or not the study appears in the TMA.

Hey @kshulist This question reads as tactic- and copy-specific and therefore would not be considered a general question. A general question would be something along the lines of: “In general, how should consensus guideline recommendations that apply to multiple products within a therapeutic class be handled when referenced in branded promotional materials?” In response to such a general question, we would direct you to What Constitutes Current Medical Opinion?. Canadian guidelines may be used to support place-in-therapy claims relating to the sponsor’s product. It is important to note that where guidelines reference a therapeutic class without specifically naming the sponsor’s product, presenting class-level claims in a branded context may be considered misleading. In scenarios where the sponsor’s product is not explicitly reflected in the guideline recommendations, we recommend discussing the proposed approach with your PAAB reviewer to explore potential options that could meet your objectives while ensuring the guidelines are represented accurately and in context.

Hey @Maryssa The initial question related to self-directed digital advertising on an HCP website. The Q&A 199 language you referenced applies specifically to rep-directed materials and should not be relied upon for self-directed digital ads. For self-directed digital ads, we suggest reviewing the principles presented in guidance on fair balance and web-link destination examples (search “study parameters”). Required study parameters may be presented either within the same ad unit (including in a clearly labelled scrollable section immediately below the ad) or via a direct web-link destination, provided that: • it is clear on the face of the ad where the study design is located, • it is clear how to access the study design • access does not require additional effort beyond a single click or scrolling (i.e. the content is accessed without any barriers) Please note that where specific elements from the study parameters are required on the face of the ad (e.g., dose), those elements would not be acceptable solely as a web-link destination or scrollable section.

Happy New Year @dmauri This appears to be a specific question about a specific project and therefore would not qualify as a general question. As a general answer to a general question, we would advise that you should consider linkage principles and assess if linking to unacceptable content is occurring. By having the Canadian page as a subdirectory of the US site it looks like a link is being created. If you’d like to have an interactive discussion, please consider PAAB’s new short-call service which is a 20-minute billable session over the phone or web-conference where the specifics of the project can be discussed, and additional guidance can be provided. Please reach out to review@paab.ca to discuss options.

Hey @Joleen-Santos This would not qualify as a general question. Please see our website or reach out to info@paab.ca to explore billable options for consultation/written opinions and training.

Happy Monday @charlton No. This would not be an acceptable comparison. See Q&A 674 and Can we present a side-by-side comparison of the trial design of our product's pivotal trial vs. the trial design of our competitor?.

Hello @Maryssa Q&A 501 is exactly the one we would have pointed to @dmauri . However, the copy "Now authorized" alone is incomplete (authorized how? for what?) it should be restricted to "Authorized for use in..." or "Authorized for sale in ...".

Hello @support If we are to assume that this is in an HCP gated space, we would advise that claims should not directly/indirectly highlight things like the shortage of competitor(s). Instead, the message may focus on reminding the audience about the sponsor’s product and availability in the market. You correctly identified that it would not be exempt. The piece would be subject to the Code and would require lowest level fair balance if restricted to a product availability message.

Hey @Username In the consumer space, a standalone message such as “Get Brand X” can be acceptable when used strictly as a DTC reminder ad. However, a URL is rarely a standalone message. Its acceptability depends on the entire ecosystem around it, including: • the content that drives traffic to the URL • the content on the landing page • any content linked after the landing page If those connections change the overall impression or strengthen the implied message beyond a reminder ad, the URL may no longer be acceptable. Because of this, it’s essential to share all current and planned linked content during the review process. With the full context, the reviewer can guide you on whether the URL maintains an appropriate attitude of caution and meets PAAB requirements. It’s also important that any new materials that will link to this URL clearly communicate that a linkage will occur, so PAAB can assess the combined effect.

Good Morning @MondayMover In general, what people do is upload the “track changes” version between the original and updated PM. When there are multiple version updates, they provide (upload) the sequential PM track changes PDFs. You do not need to annotate each version of the TMA to the APS, only the most recent PM. In the case described, it sounds like there would be no annotations within the PM as no copy is referenced back to it. If that is the case, it’s likely sufficient to upload the most recent clean PM with an explanation of why the new TMA with annotated changes may not be necessary. Please feel free to reach out to admin for support during the submission process.

Hey @kshulist Branded APS can present mortality/prognosis in general terms in the context of disease burden in an un-emphasized manner when there is no product data for mortality/survival, i.e. it is presented among a broad discussion of burdens including those that they have supporting product data for and there is a prominent disclosure included, indicating what the product has not demonstrated an effect in mortality/survival. Please see our disease burden document for additional information. This is generally correct. Please see answer to question 1 above. Yes, section 3 of the disease burden document provides the required references to establish the burden, e.g. authoritative consensus guidelines.