636
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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View Answer [+]
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.
635
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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View Answer [+]
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.
634
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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View Answer [+]
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.
633
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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View Answer [+]
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.
632
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!
631
We have a Enrollment Form for a PSP program that has been previously approved by PAAB. We have a PDF writeable format which we would like our PSP Field Case Managers ( Nurses) to send to our HCPs via email. Could you please provide any limitations or requirements to this, if any?
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View Answer [+]
A direct transfer of a print APS to an electronic platform does not in and of itself, render the piece subject to re-review. Allowing the form fields that were intended to be filled out by the physician to be open text fields would be acceptable. However, having a drop down menu with options would render it subject to a new review. Consider if there are formatting changes required to meet the specifications of the new platform. Reformatting a print APS onto an electronic platform often means there is new functionality added to the piece (i.e. links, modifiable fields, etc.). The PAAB should be informed of any electronic functionality which is added to the Enrollment Form. Also, in this particular example, as the Enrollment Form will be distributed by email, a subject line is required. These additions/revisions to the previously approved piece require PAAB review of the electronic format.
630
We have a question regarding controlled distribution/gating of a website containing information intended for HCPs. We understand that options for creating an acceptable barrier include "URL of a website which is not indexed" (as presented during Jennifer Carroll's talk "From Email to Virtual Reality" during PAAB's 2017 National Workshop). However, we are unable to find any further information from PAAB or from Health Canada regarding what "not indexed" means in this context. Can you please elaborate, or point us to guidance documentation outlining what "not indexed" means for a site's URL, in order to create an acceptable barrier for the site?
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View Answer [+]
Please see ask PAAB question 418. As additional guidance, keep in mind the url should be something that is NOT easily guessed (i.e. www.productname.ca) and is submitted to PAAB as part of the website review. Please contact your IT department for specific instructions on how to de-index your website.
629
Hi there, Can the wording "NOW APPROVED IN CANADA" be PAAB exempt for a 2nd indication? Thanks
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View Answer [+]
The following guidance is provided under the assumption that this is the entire content of the piece. The Food and Drug Regulations prohibit discussion of the approval process within advertising. If we were to reframe the question to a message of “Now available in Canada”, while the message itself would be considered exempt from PAAB review, it is still advertising and subject to the standards of the PAAB code. Messages of “new” are restricted to one year post marketing. Stating that the product is “now available” without limiting the claim to the new 2nd indication, would be misleading. The 2nd indication would need to be included to accurately limit the ”new” claim and this would render the piece non-exempt. See code section 1.5D for a list of exempt messages.
628
Hi, we have a new product in our pipeline that is currently undergoing an approval process with Health Canada and is targeting a specific biomarker. We would like to do a campaign to HCPs regarding this specific biomarker and to raise the physician's awareness of this biomarker as an emerging target for a particular disease. Is such campaign acceptable, considering that no mechanism of action nor information on the pipeline will be discussed?
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View Answer [+]
The intent of a pre-launch editorial APS should be to increase health care professional awareness and understanding of a specific therapeutic area, or in this case a specific biomarker. These APS should not contain the message that a new product (or indication) is coming soon as this could be construed as pre-NOC advertising and contravene section C.08.002 of the Food and Drug Regulations. Discussion of how an exogenous compound may modulate a pathway would be rejected as it alludes to a new drug coming to market. Likewise, we would question the message that this biomarker is an emerging target for the disease, this would be construed as pre-NOC advertising. As this APS is targeting HCPs, it should be submitted for PAAB review.
627
We would like to make non-clinical comparisons between products that are specifically indicated for different subtypes of a disease state (eg. phenotypes of COPD). Would this be acceptable, given the common umbrella disease state?
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View Answer [+]
No. The specific indication for each product must be the same. If the products are indicated in different subtypes, they are not considered to have the same indication and therefore should not be compared. See code section 5.1 and 5.2
