Forum

Hi, I am working in a therapeutic area that currently has no Canadian guidelines. A relevant standard-setting organization, on their website, acknowledges that there are no Canadian guidelines and directs HCPs to the US guidelines. Could this constitute adequate endorsement? Thanks!

Hello PAAB, wondering if a fictitious, unbranded patient would need to follow guidelines in terms of their treatment journey? In real life, HCPs do not always follow guidelines.
i.e., if guidelines recommend Product X as first-line treatment, then Product Y as second-line treatment in refractory patients; could an unbranded patient profile show a patient being initiated on Product Y? Thank you!

Hoping to receive a clarification per @Constance 's question!

Hi, wondering if there are any limitations on the URL for a product's DTC website (landing page, gating for pt/HCP content)? i.e., would a URL of "GetProductX.ca" be considered to be lacking an attitude of caution or be a problem, as patients should speak to their HCP about Product X and see it is it right for them, not just "get" the product?

Thanks @Jennifer-Carroll . To be more specific, the product falls under the "Ethical" schedule. Would this affect your response? Thanks!

Hi PAAB, is there a clear regulation that would forbid DTC and HCP from having the same visual/headline for a schedule 2 product, if the creative & assets are approved by the respective agencies for the appropriate audience?

Thank @Jennifer-Carroll , I will look into that and follow up if necessary. Hopefully a more simple question, can non-clinical characteristics of two schedule 2 products be compared in the DTC setting? E.g., Store Product X under conditions A, Store Product Y under conditions B?

If there are two randomized controlled trials that support a comparative therapeutic claim for a schedule 2 product (not for a schedule A condition), can the therapeutic claim be mentioned in the DTC setting (e.g., Product A was superior to Product B)?

This seems to be the case according to the "Data Requirements to Support Comparative Claims Related to Therapeutic Aspects of Nonprescription Drugs Used in Consumer-Directed Advertising and Labelling" section of the "Therapeutic Comparative Advertising: Directive and Guidance Document" but it's also a very confusing document and 20 years old, so I maybe misinterpreting the text?

This document also stipulates that "Statements that compare the side effect and safety profiles, of drug products or ingredients, may be made in consumer-directed advertising provided the general provisions of the Directive, this Guidance document and this section are met," is this the case for schedule 2 products?

Hello @Jennifer-Carroll, would this mean that safety data from a comparative clinical trial would be permitted in a promotional piece (knowing that there is typically no p-value for safety endpoint), or would comparative trials still be subjected to the "Guidance on secondary endpoints" as other trials outside the PM? And, would it change if the study was NOT the basis for the approval, but was carried out subsequently? Thank you!

Hi, if we are renewing an iterative submission, would the yellow shading for previously approved copy or the blue shading for iteration be preferred?

Hello,
I recently submitted a piece with an approved claim of "X years in Canada across indications," and found out that PAAB is now requesting that the year of each indication's NOC be added to the claim. Would it be possible for PAAB to provide an explanation of why this change happened, why the code was previously considered in accordance with the code, and also would it be possible for PAAB to provide notices when general changes on how PAAB decides to interpret and apply the code are made? It is difficult for us to explain to clients on why PAAB suddenly feels that the content violates the code, as no explanation is provided on the change.

A similar example is that directing HCPs to pre-gate websites now requiring a disclaimer, no notice was given to agencies prior to receiving response letters requiring this disclaimer. These changes in how the code is interpreted and applied creates a lack transparency.

Hello,
Regarding the limitations of name/price/quantity, are there any guidance documents that provide insights on the scope of where the logo can be placed? Does placing it on a "usable" item create a promotional claim that would extend beyond name/price/quantity? And, would these limitations apply to experiential events, e.g., "Concert brought to you by Brand X", "Wifi sponsored by Brand X"?

Hi, I have a question regarding schedule 2 (nonprescription, but regulated by Heath Canada) products, specifically a biologic. Is it permissible to link from a DTC site (ungated) to the complete, unedited product monograph? Also, does the 2023 Guidance on the distinction between advertising and other activity, which now specifically mentions biologics, affect the review of this type of product?

Hello, would a video discussing a manufacturer's quality standards and processes, which mentions product by name only, be considered exempt as a corporate message? If so, would it still be exempt if it was displayed on a corporate website (and thus "linked" to product monographs)?

Hello,
My understanding is that market research materials are not subject to PAAB review. Is this true for market research that is done informally, or is there formal guidance around what is considered market research?

Hello,

A client would like to include a link to a medical device brochure in a branded piece. Is the medical device brochure now subject to PAAB review?

Hello,
Would it be acceptable to create a piece comparing the trial design of two product's pivotal trials, from their respective PMs? The comparison would include only design details, no results.

Are products with NOC/c subject to regulations beyond the "usual" name, price, quantity for DTC advertising?

Hello,

is it possible to use a PSUR as support for a safety claim (incidence of AE's)?

Hello, what kind of support would be required to support the instructions for a demo device (e.g., inhaler or self-injector)? Would a letter from medical confirming that these instructions are accurate for the demo deice suffice?