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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?
• Jennifer Carroll -
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?
• Jennifer Carroll -
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?
• Jennifer Carroll -
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
• Jennifer Carroll -
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,
• Jennifer Carroll -
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• Jennifer Carroll -
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?
• Jennifer Carroll -
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?
• Jennifer Carroll -
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?
• Jennifer Carroll -
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.)
• Jennifer Carroll