Guidance on the Presentation of Burdens of Disease in Advertising
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Hi there,
I have a question related to the (soon-to-be-effective) guidance on disease burden (https://www.paab.ca/resources/guidance-on-the-presentation-of-burdens-of-disease-in-advertising/).Does this guidance still apply if a drug's indication is for a symptom of a disease?
For example, DrugX is indicated for symptomA associated with DiseaseZ. By default, everyone prescribed DrugX has DiseaseZ. In a branded patient piece, can we educate patients on DiseaseZ with mention of other associated symptoms (symptomB, C, D, E) in a disease info section (assuming these symptoms follow the general rules of the guidance, e.g., widely accepted, related to disease, etc)?
Thanks for your help!
Sorry I forgot to mention that DrugX has not demonstrated an effect for symptomB, C, D, E
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We are looking to leverage the Guidance on Presentation of Burdens of Disease in Advertising for a branded patient profile. Our interpretation of the new guidance document is that:
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Any disease-state information which is not supported by or aligned to the Product Monograph must be disclaimed accordingly and cannot be the sole focus of a tool/resource.
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Any inference to endpoints/data which are included in the Product Monograph must be included in the tool as support and referenced accordingly. Thereby, necessitating the inclusion of high-level fair balance.
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This is derived from the fact that the disclaimers for all examples included with this guidance document mention supporting data being found/available in the specific tool/resource.
In the development of a branded patient profile that includes disease-state information which is aligned to the indication only (thereby previously only necessitating low-level fair balance), would the addition of out-of-label disease-state information then trigger the need to include clinical data to support the profile? Or would we be able to substantiate the on-label information with the indication, reference out-of-label disease-state information with a guideline/medical text, and therefore maintain low-level fair balance?
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Hey @matt-s17
Under the new guidance on disease burdens, APS leveraging disease burdens upon which the product has not demonstrated an effect in a branded APS will require balance with burdens which it has demonstrated effect (section 4.2 relating to emphasis). This includes branded patient cases. Please also note that there should be no emphasis on burdens upon which the product has not demonstrated an effect. Repetition in multiple patient cases is also considered a form of emphasis. To clarify a point made in the original question, information on burdens upon which the product has not demonstrated an effect should be presented as part of a balanced presentation that includes burdens upon which the product has demonstrated an effect. Product results for burdens against which the product has demonstrated an effect must be included within the APS, thus necessitating highest level fair balance.
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Hey @kshulist
The guidance does apply in this scenario. In addition to the considerations identified in your question, section 4.2 of the guidance relating to emphasis is also applicable. There should be no emphasis on burdens upon which the product has not demonstrated an effect and it should be part of a balanced presentation that includes burdens upon which the product has demonstrated an effect. Clear and prominent disclosure as per section 5.2 of the guidance will be required and this may include clarification of the indication even if it has already been included elsewhere.
As a reminder, PAAB will be starting to review under the new guidance starting February 19th.
