Claims & Support/References for Claims
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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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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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503 - We were granted a new indication based on a pivotal study. However, some datapoints in the published study, in a peer-review journal, are not found in the TMA. We would like to know if it is "off label" for our reps to speak to those data points since it is extra data points in our studied population for which we have an indication? Can they use the reprint and speak to those results?
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501 - The ASC's bulletin in April 2015 indicates that the statement "Product X is authorized for sale by Health Canada" is consistent with the Food and Drug Regulations and acceptable for use. Previous Ask PAAB questions 108 and 347 also address this issue and section C.01.007. We note that Health Canada's Consumer Advertising Guidelines for Marketed Health Products has precluded the use of statements that suggest authorization by Health Canada, and has not been updated since the ASC's bulletin. Can you please provide PAAB's position on the use of the statement above and also whether the use of "approved by Health Canada" or similar statements is acceptable?
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488 - What are the evidence requirements for case studies within an unbranded piece? The cases in question outline a patient's circumstances and presentation, and then provide faculty opinion/recommendations on appropriate courses of therapy (without specifying the results of the recommendations). In some cases, patients have previously failed to get symptom relief while taking other agents. (I've searched the PAAB website and haven't found this addressed anywhere. Many thanks in advance for any guidance.)
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451 - Dear PAAB. I understand pharmacokinetics is considered "non-clinical" information. Is "indication" and "dosing" considered non-clinical information? It would appear to me the condition in which a drug is studied and hence approved and also the dose at which safety and efficacy is determined is extremely clinically relevant and would be considered "clinical information". Thank you for your consideration.
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441 - There is a unique provincial situation in which the manufacturer has lowered the price of its drug to match the price of its generic substitute. Can we create an APS that speaks to this fact and claim that patients can continue to receive said drug "at no additional cost* compared to the generic version."? *Refers to the drug acquisition cost; dispensing fees not covered.
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440 - As a result of a recent PAAB approval I believe that a branded APS may contain corporate messages if - the messages are not contained on the same page as the branded material - this new page containing corporate messages does not contain any drug branding - this new page containing corporate messages appears after the fair balance My questions are: 1. would the same rules apply, with regard to corporate messages, to a branded drug manufacturing video? 2. If so, could corporate messages be included at the beginning of the video, before introduction of the product and its indication statement?
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430 - One of the pivotal trials for an advertised brand has a reference comparator (RC) arm (i.e., the trial has statistical analysis for the advertised brand vs placebo and the RC vs placebo, but no statistical analysis for the advertised brand vs RC). The Product Monograph mentions the RC as part of the design, but no RC data is included in the PM. Can the data for the RC vs placebo be shown in an APS?
