Claims & Support/References for Claims

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  766 - Can you confirm if a CSR (Clinical Summary Report) is an acceptable document to support a data presentation from a published clinical trial. For example, the published clinical report presents pooled data results but the CSR captures this same endpoint by individual pivotal studies which garnered NOC for the drug. Additionally, can client share a portion of the document rather than the entire document given these reports are typically 2000+ pages. If it is possible to submit a partial version of the report, please confirm what parameters should be considered. thank you.
  • Jennifer Carroll  

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  762 - I am interested in the safety data for one of the products. Can i use data from a pooled analysis of 10 clinical trials (same indication and product) in our marketing materials. It contains data from pivot clinical trials as well. Can it be considered as a meta-analysis?
  • Jennifer Carroll  

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  Patient Satisfaction Claims
  • Danielle  

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  Hello @Danielle PAAB Q&A 387 and 338 cover patient satisfaction, surveys, perception of efficacy, safety, ease of use and preference claims. Please provide us with an example of a “non-subjective satisfaction measure” as satisfaction is inherently subjective (measures an individuals perceived fulfillment of expectations). The PAAB resource Marketing benefit claims: What are they and what level of support do they require? provides additional guidance.
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  721 - Can a patient survey be used to support claims of ease of use? Would it make a difference if the prescription product were administered through a Class-II medical device?
  • Jennifer Carroll  

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  751 - Similar to question #711, if we have unpublished patient survey data that was independently collected from a patient association, could it be used in an unbranded tool? If yes, what exactly would be required as the source document
  • Jennifer Carroll  

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  748 - Hello what kind of references are required to make a claim about number of patients treated with drug/device X worldwide? and about availability in x number of countries? Does Data on file suffice? if not what other references would be expected to approve this claim?
  • Jennifer Carroll  

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  COVID-19 Question Responses
  • lilymcneil  

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  @lilymcneil These questions may be acceptable if the content, context, and link aligns with the general guidance provided in our prior response. Of course, copy specific guidance would be provided as part of the review process. Questions and responses need to be assessed in the context of the entire piece and with assessment of the references.
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  Generic product launch announcement: can we mention the original brand name?
  • akar  

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  @akar Great question. Note that any of the proposed content would require review under the PAAB code. This is occasionally a point of confusion in the generic space. If the generic product’s TMA refers to the innovator brand as the reference product, the generic manufacturer may convey this fact in the APS. For example, “… generic version of Drug X [the reference product]”. In the unlikely event that the reference product is no longer authorized for sale, this should be conveyed through a cross-reference to the claim above. However, a manufacturer should only discuss the availability status of its own products. For example, it would be unacceptable to comment on a competitor’s drug shortage issues. Any messages relating to switching will require support from the TMA or standard setting organizations.
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  752 - Hi PAAB, I was reviewing my brands promotional pieces that will need to either be updated or be sent for rePAAB over the next few months. Since some of the pieces were approved, we have had a product monograph update. However, for certain pieces it does not change the Terms of Market Authorization and in some cases the copy in the piece wouldn't need to be changed. The only part of the piece which would need to be changed is the date of the Product Monograph (e.g. brochure) within the references. Since we have significant print inventory, is it permissible to have these submitted as a rePAAB to be valid for the next year until the next update or rePAAB without updating the date of the product monograph within the piece? Please advise. Many thanks.
  • Jennifer Carroll  

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  Real world evidence focused on patient compliance
  • NatBourre  

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  We’d need to assess the methodology through which the data was collected and analyzed through the third party research company. Ultimately, it's possible but unlikely since adherence is quite difficult to measure. It is important to distinguish between adherence and retention. Often when folks say the former, they are actually referring to the latter. PAAB interprets compliance/adherence as the extent to which patients administer the medication as instructed by the HCP. This is in contrast to persistence / retention which PAAB interprets simply as continued dispensing of the prescribed medication. It is inherently difficult to reliably measure patient adherence / compliance. We have yet to receive acceptable third party data that supports comparative adherence claims. However, PAAB regularly considers persistence / retention data from recognized or validated claims-based market data providers. The data may be comparative if it is less than 6 months old. Inferences (like “Drug X demonstrated higher retention rate vs drug Y”) may be made if supported by statistical significance.
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  745 - We have an 8 page print leave-behind detail aid that includes full dosing information. We are thinking of redoing this tool with a half page sized tear off flap that has key reminder information on the dosing. Does this flap have to contain all of the dosing information, or can it just contain e.g., the steps and an example calculation. Thanks.
  • Jennifer Carroll  

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  743 - Hi PAAB, I was wondering if expert guidelines for treatment option algorithms (first line, second line) are allowed to be included in branded pieces directed at HCPs. The goal would not be to compare treatments but to see under which situations / for what patients a therapy would be preferred. (Patient profile?) Thanks for your help!
  • Jennifer Carroll  

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  735 - Hello, If we want to do a video about the Mode of action of a drug, apart from the PM, what other references can we use?
  • Jennifer Carroll  

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  734 - In a company sponsored presentation, can a physician talk about off-label for another drug (not the sponsors drug) e.g. "In my practice I use Drug X to treat nausea", but Drug X is not indicated for nausea.
  • Jennifer Carroll  

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  713 - Can ongoing studies for a group of products (same therapeutic category) be discussed in a Corporate APS, or must this be done in individual branded APS? For example, a company has a portfolio of diabetes drugs that with ongoing research into weight loss indications, and would like to produce a single piece discussing all trials.
  • Jennifer Carroll  

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  711 - Can patient survey data from CADTH be used for an unbranded tool on current patient experience and behaviour?
  • Jennifer Carroll  

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  709 - For a product with two different administration formats (eg. syringe and pen), is it permissible to only advertise one format in APS (with no mention of the other device)?
  • Jennifer Carroll  

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  708 - If Product-A is a combination of Drug-B and Drug-C, can the mechanism of action information from the Drug-B and Drug-C Product Monographs be used in Product-A advertising? The Product Monographs for combination products usually contain less information regarding their components (for brevity), however mechanisms of action should be identical regardless of formulation.
  • Jennifer Carroll  

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  704 - If a product has two possible dosing schedules, with no specific requirements/recommendations on which HCPs can choose, are we permitted to just focus on one dosing schedule in APS? If both dosing schedules are required, are we permitted to focus on one over the other in terms of prominence?
  • Jennifer Carroll  

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  703 - Regarding the PAAB Guidance document "Tips relating to inclusion of expert commentary in drug advertising", would the same rationale and requirements apply to patient testimonials?
  • Jennifer Carroll  

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