Claims & Support/References for Claims
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Topics
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The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB),
including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB
correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system.
Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly
prohibited. This prohibition includes, but is not limited to, use in machine learning or AI models.
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575 - Our question is related to question no 70 which was: "The PAAB codes allows side by side comparison of non-clinical data from 2 or monographs. Would it be acceptable to use a comparative table of non-clinical data (ie. pharmacokinetics) from a review article? Extract from 5.10.2: [Information from two or more Product Monographs on products' properties7 and on instructions for use or use limitations8 may be acceptable as side-by-side presentations and in text form.]". PAAB answer: "The PAAB Code (s3.1.1) does not regard "review articles" as high level evidence to support a drug specific claim because they reflect an opinion/ summary from an author rather than actual findings of a primary study. This also applies to non-clinical claims. Our question: Does PAAB regard "Guidelines" (such as CGA guidelines) as high and appropriate level of evidence for a side-by-side comparison of use limitations? Thanks
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572 - As part of our initial approval for a drug, we currently have an indication for the treatment of condition X. An additional trial has been published for cancer patients with condition X. The dosing remains consistent with the initial TMA. Can we promote our drug for cancer patients with condition X?
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570 - Hi, We would like to highlight specific market data for our brand. We seem to fall into the guidelines that PAAB has put together but the specific data we would like to highlight is the new patient share (this consists of naive and switch patients). It would be a "leader" or "#1" claim. This data is from the private payer database (RxDynamics). Is this type of data allowable? I've done leader market claims as it relates to the total prescriptions dispensed but have never tried this type of data. Thank you.
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567 - We would like to know if we can make a claim about the % of patients who would recommend a specific treatment to other patients. The % is published in a retrospective study done on patients who were taking this specific therapy. It is a patient reported outcome that is not in the Product Monograph. Please advise if there is any way to put such a claim through.
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564 - Based on advisory board recommendations for supportive tools, a company would like to create an unbranded "reference tool" which documents the metabolic pathways for drugs in a particular therapeutic area. This would be a service item distributed by the representatives. Information would be taken primarily from Product monographs and in a few cases, the literature. Is there any reason this would not be allowed? what would be the constraints?
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562 - Can we develop a sales aid where the user can select specific topics (efficacy, safety, cost) and then present these to a physician? The concept is to create a custom presentation based on the needs of the physician. So if a physician only wants to hear about efficacy and cost, those would be the only sections to appear. This would be like adding tabs to a print sales aid but since digital, we can create the sections that will appear based on the customers need
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548 - 1. Can a modified intent-to-treat (mITT) analysis be used in promotional materials? mITT analysis excluded patients who discontinued due to adverse event, lost to follow-up, or subject withdrawal. 2. If yes, would also need to show the primary endpoint analysis, ITT, as shown in the PM? 3. Are there any specific requirements on how the primary ITT and mITT analyses need to be displayed?
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547 - What type of reference is needed to claim absence of a specific excipient in a product? Would the fact that the specific excipient is not mentioned in the product monograph be enough to support this type of claim, or would some sort of certification of absence be required? For example, gluten free certification?
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531 - Re: Q#522 for use of Summary Basis Decision in advertising and you replied: "Yes. Provided the content referenced from it is not inconsistent with the product monograph", if data from the SBD does not appear in the PM, can we use it? It would not be 'inconsistent'. If PAAB considers the SBD the same weight as the PM, then it should be acceptable. Is this an accurate assessment?
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529 - Hi, I have a question about 3.1 specifically the section regarding claims consistent with the limitations of the Health Canada Terms of Marketing Authorization. There are some on our team that believe this means we are not able to use data that is not within the PM regardless. There are others that believe if a claim is based on a similar study population, endpoint and outcomes are consistent with the monograph, it appropriate. We seem to go back and forth on this a great deal and I like to hear PAABs thoughts. Thanks
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523 - Hello, I would like clarification on how efficacy data and mechanism of action data can be presented together in a promotional piece. My understanding is the MOA is considered non-clinical and therefore must be physically separate from efficacy or clinical claims. Is this assumption correct? I am not sure why this would be. Can you please explain why I cannot mention how a product works and how well it works together in a page? Thank you,
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516 - I am wondering if we are able to create stickers for our material to indicate that we have formulary however I would like to keep it simple and say something like "Now on formulary (special authorization) in your province" or "...in this province" without specifying the province itself. We would of course only place these stickers on tools where the province has received formulary and we would of course provide PAAB with an FYI as to what tools and where we would be placing the stickers. Is this doable?
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