Forum

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?

@jennifer-carroll Thank you for your quick reply. Would it be acceptable to disclose this endpoint in an APS when discussing study design, as it would be consistent with the TMA?

Hello,
If a pivotal trial has a secondary endpoint that is predefined and included in the trial description in the monograph, but the data is not included in the monograph due to a failed secondary endpoint higher up in the hierarchical testing structure, is it possible to present the data for this endpoint in a neutral way in an APS (knowing that significance could NOT be claimed for this endpoint)?

@jennifer-carroll My apologies as my question may not have been clear. The intent is not to show the device being used in any way, simply showing the device in the setting of a home (e.g., bathroom cabinet, kitchen table). Would this change your opinion? Thanks for your speedy reply.

Hello, knowing that some self-injectable medications must be administered under the supervision of a physcian, and others may be done at home, it is permissible to depict a self-injection device at home/work, or would this considered a promotional claim?

Given that "Now available" can only be used in the first year of a products' availability, it is acceptable to say "Available in Canada" after the first year, or would this be considering implying that the product is new?

Hello, what sort of wording would be permitted in a promotional piece concerning the resolution of a drug shortage? The drug was "unavailable" in that there was no supply due to a voluntary recall, but it was still listed in the Drug Product Database as "Marketed." Would "Back in Canada" or "Available again to Canadians" be permitted?

Hello, I was hoping you could provide some clarity on why the claim "Proven efficacy" can appear without the direct association of supporting data, and why this is not considered an unsubstantiated claim when it appears with the indication, and if this would also apply to claims of "Proven safety".