DTCA/I | consumer secondary audience

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Can a skincare clinic advertise promotion, such as Botox/ laser promotion, providing off-label treatment, claiming 100% effective as well as encouraging immune IV drip to the customers? No. Please see the following Health Canada issued Q&A.

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If an independent third party (e.g. patient advocacy group) runs a DTCA campaign, would it need to comply with DTC regulations even if they are not the sponsor or manufacturer of the drug? Yes. An advertising campaign directed to consumers must comply with the DTC regulations regardless of if it is produced by an independent […]

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Dear PAAB reviewers, I have a question regarding the “Clarification regarding digitization of APS: Helping healthcare product manufacturers plan for the evolving COVID-19 operational context” guidance – several of our clients have pulled back on rep visits to HCPs in-person in light of COVID and have asked us how they can disseminate DTC waiting room […]

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I am new to the world of PAAB and I am wondering what the code allows in terms of non-product branded advertising on social media, targeted to HCPs. For example, videos of HCPs speaking about a disease and how it’s important to treat/vaccinate against, without mention of a specific drug, being shared as sponsored ads […]

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In the context of a Consumer Brochure, is it permissible to provide DINs for a balanced list of medication options? I’d advise against doing so as DINs tend to be used as the gating mechanism for patient information websites. i.e. promoting the DIN of your products in the consumer realm would likely invalidate the gating […]

614

Is it acceptable to advertise a statement that says something along the lines of: “Drug X is the only drug containing active ingredient Y that is approved from clinical tests?” assuming that this statement is true? Would that change if the statement is more specific, such as “Drug X is the only epidural drug containing […]

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Hi, I have a question regarding receiving pre-clearance from PAAB regarding promotional material related to a new product that has been approved under the NOC/c (Notice of Compliance with conditions) policy, as stated in the Qualifying Notice received from HC? Is this mandatory, or optional? Thank you! If this was a “requirement” stated in the […]

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The Guidance document 'Claims Based on Non-Inferiority Trials' states that “In the event the non-inferiority study failed to demonstrate superiority in the primary endpoint, one should not use secondary endpoints to suggest superiority.” Does this still apply if the primary/secondary endpoints are unrelated (eg. primary endpoint is an efficacy measure, secondary endpoints are safety measures)? […]

608

If we pay for a beauty expert to talk about one of our OTC products live on a tv show like Breakfast Television (on City TV), should the beauty expert mention live on the show that they are being paid by a pharmaceutical company? OTC advertising which is broadcasted to the general public does not […]

602

What is PAAB position on the use of the word NEW in the claim New in Canada. I know that NOW in Canada with only the brand (no other claim) is PAAB exempt, would NEW in Canada be too? Please see Q&A 476.

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Hi, We were thinking of providing our reps with iPad covers that have images from a campaign that we intend to launch. The iPad covers will be solely for the reps and won't have any sort of messaging on them, but will have the names of our brands. Do we need to put the covers […]

604

What are the requirements/limitations for emailing of Enrollment Forms to HCPs for the purpose of enrolling their patients in a PSP? We have developed an Enrollment Form (approved by PAAB) of which we have a version that is a writeable PDF (text fields can be filled out on the computer) to then be printed and […]

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Hi, We are a health clinic interested in running a publicly funded flu shot campaign for the public. We want have free coffee cards and lollipops to give to anyone who comes in and gets a flu shot. Are we allowed to advertise in a flyer and emails to the neighbourhood businesses specifying that anyone […]

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Hi! We would like to know what the role of PAAB is? Do you support innovation or the pharmaceuticals? This is not meant to be prejudiced in anyway. We've tried to work with pharmaceuticals to put a product that could eventually replace vaccines, replace the current international immunization plans, prevent outbreaks and epidemics.These are just […]

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Seeking some clarification on the response to Question #273. Can you confirm that the answer “It may be exempt if all the treatments are balanced” applies only if the piece in question is consumer-directed? We're assuming that HCP-directed exempt material (s6.6) can never mention treatments (balanced or not), otherwise it would be considered Editorial (s7.5). […]

599

Suppose a Product Monograph contains pooled data presentations (demographics, efficacy, safety, etc), but the individual data sets are from separately conducted and published studies, with no planned pooling. Would it be acceptable to report the individual data in APS, or would PAAB require it to remain pooled (and subject to the associated limitations). Traditionally pooled […]

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Regarding Code s3.1.1, does PAAB distinguish between different types of “pooled data”? For example a post-hoc pooled analyses of unrelated trials (low evidence), vs. a pre-specified pooled analyses of replicate trials (higher evidence)? Such pre-specified pooled analyses are commonly used in registration trials for certain therapeutic categories, and therefore interpretation of s3.1.1 could potentially be […]

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I have a question regarding MOA and Code Section 3.1. Suppose a TMA states that Product-X targets receptors A & B, with no additional information/limitations. It is known that Product-X also targets receptors D & E, although this information does not explicitly appear in the TMA (as it is not intended to be a repository […]

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