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YOUR QUESTIONS? ALL ANSWERED

Ask PAAB is a question-and-answer system that allows you to ask questions anonymously to PAAB. They then post their answers in this archive on a periodic basis. If your question requires more immediate attention, we encourage you to contact PAAB directly. Please ensure that you ask your question in English. To view the PAAB Code of Advertising Acceptance, please click here.

Questions updated to: October 4, 2021

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784

When constructing Fair Balance, under "Other relevant warnings & precautions," are we required to include caution in use within certain patient populations where no/limited safety or efficacy data are available? In this situation, patients with certain medical conditions were excluded from the clinical trials, as is standard with other brands in the category.

When it comes to product specific questions, it is best to speak to the reviewer as they will be familiar with the brand and therapeutic area, and there may be other considerations within the TMA that determine if it is required. As a general rule of thumb, this type of statement from the warnings and precautions section would be required if implications/consequences are conveyed such as "not recommended" or "lower the dose".

783

Hello, I am the author of the Clinical Guide to Probiotic Products Available in Canada (and In the US). This is a resource independently reviewed by a group of experts in the field and published annually online and in print. Our project is supported by the unrestricted educational grant provided by the Alliance for Education in Probiotics, a group comprised of industry members. The Guide is designed as a practical tool to assist health care professionals when recommending evidence =based probiotics to their patients. My question is if this kind of product would be subject to PAAB review? I would appreciate any information you provide. Thank you!

Independent third party publications do not fall within the scope of PAAB. Content taken from the publication, or distribution activities by a manufacturer may render the activity advertising. This would not fall within the purview of the publications responsibilities. If the publication supports advertising content throughout, the advertising content may be subject to PAAB review. See PAAB resource: Guidance on which HCP materials require PAAB Review for additional information.

782

We have a product with a complex indication, requiring previous treatments, biomarkers, etc. We would like to create an algorithm that depicts the approved indication within a diagnostic/treatment framework. Can we utilize Guideline pathways (not recommendations) in order to put the indication in a larger clinical context? For example, we would depict the entire Guideline pathways for all possibilities, but only highlight/emphasize the approved indication portions leading to our product use.

Guideline recommendations and pathways, must be consistent with the TMA for the brands mentioned. When a treatment pathway or algorithm contains content which exceeds the TMA copy, it can be rendered unacceptable in advertising.

781

We have a product with an open indication (Product X for the treatment of Condition Y). Guidelines now suggest the use of Product X in combination with another product. Can we promote this combination in the context of Guideline recommendations (ie. not showing clinical data/claims)?

The presentation would be assessed to evaluate consistency with the TMA for both products.

780

If a third party group (e.g. patient advocacy) develops a DTC piece with mention of a brand- would it be subject to HC regulations? The message is by no means sponsored by the manufacturer, and no involvement from the manufacturer. Would this meet the definition of advertising?

Independently created and controlled content is not subject to advertising regulations. See the "Distinction Between Advertising and Other Activities" for additional clarification.

779

For how long can the word "new" or saying "now approved" can be used in promotion to announce a new prescription drug ?

Please see question 423.

778

The product I'm working on can be self-administered by the patient. Part 3 includes the steps for self-administration, however nurses have created their own instructions for patients to self-administer. The nurse instructions don't adhere exactly to the product monograph (their instructions include more details). Is there a way to support the nurses in producing a self-administration tool for them? Perhaps by a grant and the sponsor company would not influence the content, just add some design and print it for them?

As per the Health Canada Distinction Between Advertising and Other Activities document, who sponsors the message, delivers the message, content and context all impact the assessment of whether this would qualify as advertising. Providing sponsorship to nurses to create and disseminate content about the administration of your product would fall into the category of advertising. The manufacturer could provide sponsorship, however the final product would be subject to review. Note that it is possible to provide a more detailed administration guide than that provided in part III of the TMA. The review would ensure that the copy does not contradict or go beyond the recommended steps.

777

Hello PAAB! I'm working on an unbranded piece that's for HCPs. It discusses the impact that medication adherence can have on efficacy for a specific class of drugs. Being relatively recent, my brand's drug is not discussed in most of the trials that evaluated the link between adherence and efficacy for this class of drug. Given the unbranded context, can I include data from these trials that discuss the class of drug that my brand belongs to, even though my brand was not specifically included? Thank you.

There are two considerations here. The first is the use of a study that is specific to one or more brands (this is regardless of the sponsors product inclusion). In the context of an unbranded piece, the use of this type of study would effectively brand the piece to the products used within the study. It would not be acceptable for a manufacturer to create content which refers to brands which are not their own. Any discussion of other brands should be done in the context of RCTs which meet the rigors of the code. As such, it would not be possible to create an unbranded piece about the impact of adherence on efficacy within a specific therapeutic class. As an additional point of consideration, remember that single study findings cannot be extrapolated out to class claims.

776

Hi, Is it possible to do pre-NOL PAAB submissions for a product already on the market? We know there is a new product monograph coming by the end of the year, but only minor changes to the product monograph are expected. The regulatory department from the company would do an attestation letter confirming this. Thank you.

Yes. The process would follow the same flow and logic of a pre-NOC submission. Please see PAAB resource Administrative Guideline for the Review of Pre-NOC Advertising Submissions.

775

Hi PAAB, If a pharma company who markets a vaccine sponsors a 3rd party to commission the the writing of an independently written educational article on adult vaccines, in which all treatments are discussed and this vendor distributes this article to consumers through their channels, is this considered promotional? Would the article require PAAB review? The Pharma company would not review the article.

The evaluation of whether this falls under advertising should be based on the Health Canada "Distinction Between Advertising and Other Activities" document. There is a probability that by commissioning the production of the review, this would be perceived as advertising and therefore subject to the code, especially if the final report favors the sponsors product. The question also mentions "consumers" and therefore, the consumer regulations would have to be taken into consideration (cannot exceed name, price, quantity).

We would suggest submitting for an opinion to gather a more thorough evaluation of the proposed project.

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