Claims & Support/References for Claims
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Topics
422
Posts
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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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?
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423 - Definitions Section 1.8 of the PAAB code states: Use of the word 'new' or statements implying "new" in advertising should be restricted to 1 year after initial marketing. Can you please clarify what is meant by "initial marketing"? Is this the NOC date or when "marketing" activity is initiated etc.?
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404 - Hi Patrick, I am doing a slide kit for the reps based on our PM. In the PM it mentions a study with our drug against a non-approved drug, so I can use this info in my slide. New studies have come out on our drug vs the non-approved drug would I be able to use this new data in my slide deck for the reps.
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385 - Our client would like to produce a Canadian consensus statement in a disease area where there are currently no relevant guidelines. The publication would be peer-reviewed and cover all therapeutic options; we would ensure that any discussion of the sponsor's product was on-label. The intent would then be to distribute reprints through the sales force, and possibly also create an unbranded APS highlighting the availability of the consensus statement (no emphasis on a particular drug). Can you give us any guidance on how we should set up the consensus process and paper to be acceptable for these uses? Assuming the publication is peer-reviewed, would the fact that it has a single sponsor be an issue? Is endorsement by a medical association required or just recommended? Thanks in advance.
