Ask PAAB

In order to discuss switching patients from Product-A to Product-B within an APS, what is required for substantiation: a specific mention in the TMA/indication, Guideline recommendations, a head-to-head study? Also, does this substantiation need to appear in the APS itself?

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  According to section 3.1 of the PAAB Code, claims in advertising should be consistent with the Health Canada approved product monograph and labeling. This applies regardless of the specific reference provided to support the “switch” message. The acceptability of the “switch” message and the requirements for substantiation depend greatly on the type of claim made in the APS. Here are some examples that come to mind:

  • For a plea to consider using Product B in patients who were previously treated with Product A: If the indication specifies use in patient who were previously treated with Product A, then the indication alone would be adequate substantiation for this claim. If the indication is for a broader condition but does not specify use in patients previously treated with product B, then data would be required in the APS to quantify the product’s magnitude of effect in this specific patient population. Although a well-designed randomized controlled trial may be acceptable support if it meets all the evidentiary requirements in the PAAB code, the patient population studied, and data must be consistent with the TMA. If the subgroup exceeds the information in the TMA, we would suggest submitting the data to Health Canada as part of an SNDS.
  • For claims related to efficacy or safety of Product B in patients who were previously treated with Product A: Data would be required in the APS to quantify the magnitude of effect and must be consistent with the data/patient population in the TMA.
  • For claims related to place in therapy (i.e. Product A is recommended as first line therapy, Product B as second line therapy): This claim would require support from Canadian consensus guidelines and must be on-label (i.e. cannot exceed the product indication).

  In all cases, it is important to remember that the presentation should never disparage or unfairly attack a competitor’s product.

I recognize that consumer help seeking campaigns cannot disclose the manufacturer's name. In the event of a DTC disease awareness website, that is seeking to allow users to opt in to receive future communications (all unbranded, disease related in nature), we're challenged by CASL regulations which appear to conflict with Health Canada's guidance. CASL regulations indicate the name of the sender must be included. If the sender of the communication is indeed the manufacturer, is the manufacturer's name, allowed for inclusion in the website copy in this circumstance, presumably with minimal prominence in order to solely meet CASL guidance? Or, can you provide examples, guidance, or a recommendation on how a manufacturer may meet CASL and Health Canada guidance in this situation? Thank you.

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  No. The solution is not to engage in activities for which you cannot meet all applicable regulations. This currently means not engaging in help seeking activities that trigger the CASL requirement.

Hello PAAB! Can sales representatives distribute a tool that was approved by PAAB as DTC to physicians to provide to potential patients? Would this tool need to be re-submitted through PAAB as unbranded patient material? Thank you!

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  Yes. To avoid this in the future, you can inform us that the piece will be viewed by both audience types during our initial review. The rationale is that materials viewed by the different regulatory audiences (i.e. consumers vs patients vs HCPs are subject to different regulations.     

Hi, I wanted some clarity on the rule below. Essentially, we are allowed to use peer reviewed resources, etc. to support claims, as long as the claim made references a clinical endpoint already captured in our monograph? Specifically, if my label mentioned confirmed disability worsening, but I also have long term data that discusses confirmed disability improvement (diff metric), I would not be allowed to use this? -- 3.2.2 Literature used to support claims contained in the APS must be consistent with the indications, dosage regimens, and efficacy and safety information contained in the Health Canada TMA.

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  Two issues jump out here. Firstly, the outcome appears as though it is quite different from the label (level of disability increases in the label vs the level of disability improving in the study). Secondly, even if we change the outcomes to match each other qualitatively, I note that the study outcome is longer term data than the label.  It appears from this limited information that it would not be possible to make an argument of consistency with the TMA. Please see questions Question #529, Question #626 and Question #585.

If a DTCI Consumer Brochure closes with a 'help-seeking' message, would it still be considered a Consumer Brochure, or would it be reviewed as a Help-Seeking Announcement (or a combination of the two)?

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  A message to go see the doctor does not necessarily render a DTC piece (i.e. a consumer brochure) subject to the provisions of a Help Seeking Announcement (particularly referring to the provision to remove company logo’s). You are likely fine if the piece meets all the requirements of a consumer brochure as listed in the Health Canada document “The Distinction Between Advertising and Other Activities” as this piece would primarily be a consumer brochure.  If you are unsure, we suggest submitting the piece to PAAB for further clarification.

Is an unbranded conference booth display targeting HCPs, that leverages creative from a help-seeking DTC campaign exempt from review? There is no mention of product or treatment options, just disease info only. However, other APS that are part of the DTC campaign (same branding) do contain mention of treatment options, however in a balanced presentation.

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  Unbranded HCP targeted disease information materials which meet all of the following criteria are exempt from PAAB preclearance:

  • makes no mention of medication by name, class, or category
  • does not discuss or allude to medication or to medication issues (e.g. adherence, societal cost burden of drug coverage…)
  • does not linked to product/class/category advertising in any way (e.g. contextually, proximity, through hyperlinks, appearance…)

  It’s easy for you to tell whether there is mention of a product.  Where clients sometimes struggle is in determining whether the piece relates to a drug issue or whether the piece somehow links to drug advertising.  Our written opinion service can help you determine that for any particular tool (see fee schedule on our website). 

  Please note that basing an HCP piece on DTC materials does not, in and of itself, render a piece exempt. Content which has no (or limited) meaning to consumers may take on more concrete meaning to a specialized audience such as HCPs.

  Also note that utilizing the same creative concept across multiple pieces essentially creates a link between those pieces. Whenever linking separate materials/activities, always pause to examine whether the linkage would change the regulatory status of those materials. PAAB could also help you with that assessment through our opinion service.

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.