Ask PAAB

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?

• View Answer [+]

  ---

  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.

• View Answer [+]

  ---

  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?

• View Answer [+]

  ---

  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?

• View Answer [+]

  ---

  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.

• View Answer [+]

  ---

  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!

• View Answer [+]

  ---

  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.

• View Answer [+]

  ---

  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.

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)?

• View Answer [+]

  ---

  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.

• View Answer [+]

  ---

  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.

• View Answer [+]

  ---

  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