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Hi Danika - A Rapid Access Consult or written opinion might be of most value here, given the specific manufacturer and associated restrictions. PAAB will be able to advise on corporate claims, potential linkage issues, and if your specific product has any other considerations (e.g. Class A OUD products vs. Class B opioids).

Hi Adelaide - A 'Sell Sheet' is a broad term, that doesn't appear to be defined in Health Canada guidance documents. Advertising is classified by intent not format, and defined as anything with "the purpose of promoting the sale or disposal of a drug." So if you're referring to a Pharmacy Order/Info Sheet (containing SKUs or prices not contained in the TMA), while this is still advertising, it may be treated differently if limited to logistical information alone. s3.2.3.2 of the Health Canada Guidance states that any HCP material regarding opioid use is expected to undergo preclearance, where your specific content will be reviewed. PAAB offers Written Opinion services, and now Rapid Access Consults, which may help guide development of your specific material.

Hi there, While standard setting organizations (i.e. reputable patient associations) may be used to support information in Patient Information APS as noted in Code section 6, acknowledgement from a standard-setting organization is not sufficient as endorsement for guidelines as they are not considered a recognized, Canadian, authoritative, medical body. However, PAAB will consider recognized, authoritative US consensus guidelines (when deemed acceptable), in the absence of Canadian guidelines, without need for endorsement from a recognized, authoritative Canadian medical body. Please refer to the PAAB document “What constitutes current medical opinion?” for further details.

Hi Danika - The RWE Guidance document does mention that Class B opioids and NOC/c products are not in scope, given APS for those products are limited to content from the TMA. However, other controlled drugs may be permitted to utilize RWE. Also see Q&A 4213

Hi there, Our regrets for the delay in responding. The answer to the above original question was provided in general terms based on PAAB code section 3.1.1 which states “…pooled data…are generally regarded as not being evidence to support claims in drug advertising. Data included in the TMA may be acceptable”. Even when the original trials are in the TMA, this does not confer acceptance for their pooled analysis in advertising. Q762 provided the general PAAB position as well but expanded to provide the narrow scope where PAAB has considered pooled data which is dependent on a multitude of factors. Q762 provided the starting point for consideration. As there are varying and specific factors that determine the acceptability of a pre-planned pooled analysis, it is beyond the scope of this forum to address. If there is a pre-planned pooled analysis where the study designs are identical or nearly identical, then we suggest consideration of our opinion service to determine if it may be acceptable for use in advertising.

Hi @QnC The original question on why can't patient-directed APS for prescription/controlled/targeted drugs be promotional was intended to be addressed in PF Q&A 352 where it was noted that PAAB code section 6 applied to patient directed information and its rationale. The HC Distinction document does not cover patient information, i.e. information to individuals that have already been prescribed the drug. PAAB s6 is applicable to patient information and indicates that “Company controlled or prepared branded patient information is information that contains non-promotional material…All health product information must be consistent with the Terms of Market Authorization (TMA), and should not contain promotional claims.”.

Hey @Username No. Real or fictitious, a manufacturer should not be promoting patient treatment flows that are not reflective of guideline recommendations as per Code section 3.2.

Thank you for clarifying this!

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.