Ask PAAB

Hi PAAB. Can you advertise a drug to the general public if it is indicated for a condition/disease not listed in schedule A.

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  It’s not quite that simple. You also need to consider the Federal schedule of product. If the product is a Narcotic or controlled drug, advertising to the general public is prohibited (even if the ad contains nothing more than the stylized product name). For other products, yes, advertising is possible within the restrictions that relate to the product’s Federal schedule. For example, advertising for a product in the “Prescription” schedule would be limited to name, price, and quantity as per C.01.044 of the Food and Drug Regulations. 

  Note that even a drug for the treatment of a schedule A disease can technically be promoted to the general public (as long as it’s not a narcotic or controlled drug), you simply can’t convey (or link to or allude to) the therapeutic use

Code s6.6(i) states that materials independently prepared with industry involvement limited to sponsorship/distribution are exempt from review. Can you confirm if 3rd party influencer/blogger social media posts are therefore exempt from review, if industry involvement is limited to paid sponsorship?

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  No.  A blog is NOT independently prepared if the manufacturer (or it’s agent) is sponsoring the influencer/blogger. A pharma sponsored blog about drug therapy is therefore likely subject to advertising regulations. Consequently, if it is targeted to HCPs it would fall within the scope of PAAB preclearance. If it is open to the general public, DTC regulations would apply (PAAB offers an advisory opinion for such pieces).

Just wondering how long it would take to receive a response to a question submitted through Ask PAAB?

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  Good question. AskPAAB provides us with a mechanism to provide answers to anonymous questions in order to educate the entire industry about general aspects of our Code, our guidances, and the regulatory framework.  It is not intended to be a mechanism for providing time-sensitive responses related to current/imminent projects as the anonymity makes it impractical for us to ask clarifying questions or engage in two-way dialogue.  For time sensitive questions about matters relating to imminent submissions, the optimal platform is the written opinion submission over eFiles (four business day turnaround time).  For time sensitive questions relating to general questions you can submit call-back requests over our eFiles system (1 business day turnaround time). Call-back requests are also set up through our eFiles system for questions about ongoing submissions. We respond to questions received through AskPAAB as expediently as we can but we prioritize responding to questions through the eFiles system as those are triggered by ongoing or imminent projects.  

Would the use of a publication for a clinical trial evaluating two different head-to-head treatment comparisons be allowed in promotional materials if only one of the head-to-head comparisons is in alignment with the TMA? More specifically:

• The comparison of Product A versus Product B is in alignment with the TMA for Product A i.e, a comparison versus another product in the same therapeutic class as Product B is included in the TMA; the primary endpoint in the publication is the same as a secondary endpoint included in the TMA for a pivotal study; same patient population.
• The comparison of Product A versus Product C is not in alignment with the TMA indication for Product A.
• Would the comparison of Product A versus Product B be allowed in promotional materials for Product A?

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  Before reading this answer, please take some time to look at the other Ask PAAB questions around “off-label” content in references, specifically 336, 175 and 45. Off-label promotion would contravene section 9.2 of the Food and Drugs Act.

  If, in your described study, we were to assume that all other aspects of the code are met around the quality of the study, it may be possible to present the on-label findings in a restricted manner that does not include the off-label comparisons. Note that distribution of a study reprint would most likely not be acceptable (as it would be deemed promotion of off-label use).  In other words, the information you’ve provided alone would not preclude use of the study (except as a piece accompanied by the study such as a reprint holder).  Of course, our final ruling will not be based only on these stated factors.  For any study, many study-specific factors influence whether it is acceptable as the evidentiary basis for a particular claim/presentation. This is particular true for a complex study like the one you’ve described. The written opinion service (see fee schedule on our website) would provide you with a more robust assessment of whether the particular study which inspired this question can be used for the intended purpose and in the intended context.

We are currently embarking on a help seeking announcement for a prescription product. The help seeking message will follow the criteria as outlined in Health Canada's policy, The Distinction Between Advertising and Other Activities. We wish to additionally inform HCP’s of this campaign through promotional systems such as a detail aid to ensure full transparency to the HCP regarding the campaign. • Are we able to identify the help seeking campaign in promotional systems directed to HCPS? • Are we able to include additional promotional product messages in the promotional material? • If not permissible in the same promotional system, are the two allowed in the same sales call?

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  A tool meeting the requirements of a help-seeking announcement as outlined in the Health Canada policy document “The Distinction Between Advertising and Other Activities” is not considered to be promoting the sale of a drug and therefore is not subject to advertising regulations. However, informing HCPs of the help seeking campaign through the use of promotional systems or activities (i.e. sales calls) creates a link between the non-promotional help-seeking content and the promotional advertising campaign. This would render all content subject to the advertising regulations. The help-seeking message for consumers would have to be unbranded. If communications to an HCP created a link between the help-seeking message and a brand, the help-seeking message would have to be reviewed and approved in the context of the brand. If the message did not meet the limitations of the brand, a link could not be made. 

Can a claim of "Proven efficacy" appear over a presentation of clinical data, if that data was the basis for the product indication?

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  When clinical trial data is presented in advertising it should be clear that the results are based on past study findings. The data should not be presented in a manner which suggests that the results can be expected, or extrapolated beyond the study setting. This applies to all data presentations, including data that Health Canada reviewed as the basis for the product indication. By positioning the term “Proven efficacy” above clinical data it suggests that the results are guaranteed and can be expected by all patients. This would not be accepted over any type of clinical trial data. 

For APS having only two surfaces (i.e. a double-sided card), can you confirm if market benefit claims can appear on side 1, with the indication appearing on side 2?

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  The two surfaces of a two-sided card are generally considered to be equally prominent surfaces if the card is not appended to anything dictating a “front” or “back” side. In this scenario, the indication would be acceptable on either side, regardless of the positioning of marketing benefit claim. If the card is appended to something or formatted in a way that dictates a front/back designation (i.e. a letter), then the indication is required to appear on the front side if it contains a marketing claim other than those listed in section 1.5 of the PAAB code.  

Hi PAAB, If a pharma company who markets a vaccine sponsors a 3rd party vendor for the writing of an independently written article on adult vaccines in which all treatments are discussed and this vendor distributes this article to HCP through their channels is this considered advertising and would the article require PAAB review? The Pharma company would not review the article. If the distribution by the vendor is to consumers does it require pre-clearance by PAAB? Could the sponsorship be identified at the article “This independently written article was sponsored by XYZ Pharma Co”? Given that the topic is vaccination and it is Schedule D, could we link an ASC approved ad with the consumer article as you mention in Question 153? Would this PAAB require pre-clearance? Thank you.

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  The Health Canada policy document "The Distinction Between Advertising and Other Activities" is a valuable tool in determining whether materials are subject to the advertising regulations. The complete distinction document can be found at: http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/actv_promo_vs_info-eng.php. The document poses 7 questions to consider when determining if a message falls within the definition of advertising, including “Who sponsors the message and how?”.

  Whether the HCP piece would require PAAB preclearance depends on the type of entity which is creating the piece and the relationship between the sponsor and that entity. Various possible scenarios  and the corresponding answers are covered in the following document: http://code.paab.ca/pdfs/advisories/Guidance-on-which-HCP-materials-require-PAAB-review.pdf

  Submit an opinion request if you have remaining questions about a particular tool or process (see the fee schedule on our website www.paab.ca)

  With respect to your second question, you are not required to submit an APS for review if it is destined for the general public (provided that it won’t also be disseminated in a manner which is targeted to HCPs or to patients through their HCP).  Nonetheless, the PAAB offers an opinion service to DTC communications.  We can provide assurance that your consumer pieces are in alignment with the Health Canada regulations & guidances. See the fee schedule on our website www.paab.ca.

  Q&A 153 deals with linkage between independently generated editorial content about a disease and a branded ad. Such linkage in the DTC realm is technically “possible” for a vaccine as regulatory provisions restricting linkage between name and therapeutic use do not apply for these products. However, it is unlikely acceptable as the editorial would typically include content that is off-label with respect to the linked product. With respect to the tool in your particular question, it sounds as though it would be a consumer brochure. Linking such document to a product ad would render it subject to advertising regulations. From your description of the tool, this execution would be particularly problematic as the piece would now be viewed as comparative advertising in the DTC realm. For example, the document would likely be inconsistent with Health Canada’s policies on therapeutic comparisons in DTC advertising.  Short answer: It would generally be advisable to avoid such link, and this is especially true when dealing with a consumer brochure.

I would like to send an email to verified healthcare professional, that email would not exceed Price, Name, Quantity, would include no claim and have a deep link to access the product monograph of this schedule A product. Do I need to submit such email to PAAB approval if ... 1- the product monograph is only accessible via this email ? 2- the product monograph is hosted on our corporate website (ungated website) ? 3- the product monograph is hosted on a gated hcp website ?

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  I will assume that the proposed HCP email meets the exemption criteria per section 1.5D of the PAAB code. The question then becomes, do any of the proposed links render this content subject to PAAB review. There should not be an issue linking an exempt email directed to healthcare professionals to the complete, unedited product monograph. This applies whether linking to a product monograph on the corporate website or on an HCP gated website. The key message here is that to remain exempt from PAAB review, it must be a direct link to the product monograph.

No question: Just a thank you for posting these questions and responses. I know it is time consuming, but I have found it to be a great start in my project planning prior to PAAB submission and consultation. Thank you! 

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