Ask PAAB

Are there any limitations for using Phase II studies as support for therapeutic claims, apart from disclosing the Phase II nature?

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  Whether you are using a Phase II or a Phase III study to support therapeutic claims in advertising, the same standards apply:

  • Clinical or therapeutic claims must be based on published, peer-reviewed, controlled and well-designed studies with clinical and statistical significance clearly indicated. The study (and the claim you wish to base on the study) must meet all relevant criteria listed in the PAAB code and the PAAB guidances.

  and

  • The study must be consistent with and within the limitations of the TMA

  The PAAB code does not specifically differentiate between phase II and phase III studies. Having said, keep in mind that phase III studies are much more likely to meet all the criteria listed in the PAAB code and PAAB guidances than phase II studies. If unsure of the acceptability of a study as the evidentiary basis for a particular claim, consider submitting a opinion request (see the fee schedule on our website).

I understand that for international conferences held in Canada the following conditions need to be meet for being exempt for PAAB review according to (Health Canada policy document “The Distinction Between Advertising and Other Activities) I. the conference must clearly be an international event, e.g., a significant proportion of the conference delegates are from other jurisdictions, II. the material must emanate from the parent company of the manufacturer, III. the material must only be for use within the confines of the conference, and IV. the material is prominently identified as not being authorized for sale in Canada. The question I have is for the use of material that is non-branded and no product specific that makes reference to a therapy area/class for which several products are approved in Canada for sale by the local subsidiary. Would this non-branded, no-product specific material (banner), that talks about a therapy area/class would it be considered PAAB exempt for use at an international conference?

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  Are all 4 criteria you listed met? For example, I am unsure from your question whether the material emanates from the non-Canadian parent company. If all 4 criteria are indeed met, the material is exempt from Canadian advertising regulations and, consequently, outside of the scope of the PAAB code.  This is true regardless of whether or not the products are approved for use in Canada (i.e. available from the corresponding Canadian subsidiary).  This is also true regardless of whether the material is product branded or not.

  If, on the other hand, the material emanates from a Canadian manufacturer, the material would be subject to PAAB preclearance even if it is not product-branded.  After all, the material in question would be used in Canada, it would emanate from the Canadian manufacturer, and it would feature one or more products/classes in the context of a therapeutic area in which the manufacturer has a vested interest.  The material would therefore be subject to Canadian advertising regulations (including the PAAB code provisions).  It is easy to come to the flawed conclusion that materials that are not product-branded are not advertising.  Don’t fall into that trap.  Advertising is defined in the Food and Drugs Act as "any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device".  The definition matters because Canadian drug advertising is subject to Canadian drug advertising regulations.  For example, the provisions in the PAAB code apply to drug advertising directed to HCPs.  Whether materials emphasize/favor a specific brand does not in and of itself determine whether the materials are subject to advertising regulations.  In fact, the PAAB code has provisions that relate to unbranded editorial advertising such as section 7.5 (i.e. the PAAB code is not limited to product-branded advertising).  We’d need to review the piece to determine whether it is indeed editorial advertising or product-branded advertising but this does not impact whether review is actually required (it only impacts the nature of the review).  

If I have two clinical trials in slightly different patient populations, is it acceptable to present data from only one of the trials in an APS?  Both populations fall under the same indication.

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  The most relevant principles here appear to be that data presentations in advertising must be consistent with the TMA (s3.1), must not be overly-selective (s5.12), and must consider all relevant data (s. 5.5.i).

  Assuming both studies can be used in drug advertising (e.g. on-label, high-quality, etc.), you’d need to consider whether presenting data from only one study would be overly-selective (or misleading in some other way).  This could potentially depend on many factors. For example, the degree of similarity between the populations, the extent to which the outcome in question differs between both studies, the degree of consistency with outcomes in the TMA, …etc.

  If an HCP who modifies her behaviour/attitude based on something learned from an APS about study A is likely to feel misled after later learning about study B, the APS likely requires inclusion of study B so as not to be overly-selective.

Hi Patrick, I was wondering, after PAAB approves copy. Is it forbidden to make minor typography changes? I.e. spelling mistakes, punctuation, periods. As long the same message is there is that still considered an unsolicited change?

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  The document ‘Guidance on Submission Process’ on the PAAB website sets the boundaries for which post-approval changes made to an APS can be processed as “FYI” (versus changes that require reviewer assessment and approval in a new file).  The following can be processed as FYI:

  • corporate logo, trademark changes
  • French language grammar correction which does not alter the claim
  • directly proportional resize of APS that results in NO layout/flow/content/functionality changes.

  All other post approval changes to previously approved APS including any copy or layout changes are subject to further review and should be submitted in the form on a new eFile. While PAAB will consider it acceptable to correct spelling mistakes, they should still be submitted as an FYI to ensure that the most accurately copy is kept on file. It is possible to change the meaning of copy by changing the placement or type of punctuation, making it difficult to make a blanket statement of “all typography changes are acceptable”.  If you are uncertain if your grammatical change is acceptable as an FYI, please contact admin for further clarification.

Our company has an unbranded disease-focused app in the Apple/Google stores. As legally required, the manufacturers name must be disclosed in these stores. Can we make mention of this app in a separate DTCi Help-Seeking campaign (that itself does not mention the sponsor)? The campaign would not focus on the app, but mention it as one of many additional resources.

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  The Health Canada document “Distinction Between Advertising and Other Activities” states that materials that fall in the category “Help Seeking Announcements” must not include the manufacturer’s name. PAAB interprets that to mean that the piece must not identify the manufacturer by any means.  Providing a direct link to a corporate branded asset would identify the manufacturer.

  In your specific case, I have no way of knowing whether your piece is indeed a help-seeking announcement (for which this linkage issue would apply). Nonetheless, a simple solution exists if that is the case. You could direct the public to the app using corporate advertising as opposed to a help-seeking message.

  E.g. Company X created an app with features A, B, and C for patients with condition Y. This app can be downloaded at the app store: Click here. We are committed to helping you.

  You’ll note that I left out content relating to how a patient might know if he/she is afflicted with condition Y (e.g. symptoms, history…). I focused instead on the service that this company is providing to individuals afflicted with the condition through provision of the app. 

  I should also point out that there is an important exception to the linkage issue I discussed above.  A help seeking announcement may link to a document meeting all requirements of a consumer brochure. This is true even though the consumer brochure will identify the manufacturer. In that instance, the reader would learn about the identity of the manufacturer in the same context that he/she is exposed to presentation of the treatment options (drug and non-drug) and their respective risks and benefits discussed in an objective manner.    

We have a product indicated for the treatment of 'drug-resistant Condition-X'. Since this disease inherently links to drug therapy, I do not see how we can produce PAAB-exempt disease education materials. Does this seem like a fundamental limitation of the Code (6.6vii)? Could we produce exempt materials describing 'resistant' or 'refractory' Condition-X instead?

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  The interpretation that a piece describing a ‘resistant’ or ‘refractory’ condition is subject to PAAB review is correct. It would not be possible to create a disease information piece for this condition without alluding to drug therapy. The rationale for this however is more related to the PAAB scope of review then any specific preclearance exemption criteria.

  PAAB provides a preclearance review service related to promotional activities for healthcare products. Materials which are restricted to disease information (i.e. they do not allude to treatment in anyway) do not fall within the PAAB scope of review. Statements describing a condition as ‘resistant’ or ‘refractory’ suggest a prior treatment failure and as such would fall within the PAAB scope of review (as the disease material would not be required had treatment not occurred). This is necessary to ensure that discussion of drug therapy meets the PAAB code requirements. 

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 529, 626 and 585.