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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:

• 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.

• 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.

• 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?

We are looking to develop a patient resource that focuses on a treatment regimen made up of multiple therapies. Our client's product is indicated for use in this regimen in conjunction with these therapies, however, Part III of the Product Monograph only provides an overview (e.g., side effects, dosing guidance, etc.) of our client's treatment. What is the PAAB's opinion on leveraging Part III from the Product Monographs of the other treatments (NOTE: our client is not the DIN holder for these treatments) to develop a patient brochure or similar resource? The main driver behind this is a significant patient and stakeholder demand for a "one-stop-shop" brochure/resource, especially considering many of the additional treatments are genericized and not actively promoting—ultimately there is a gap/unmet need for patients to be comprehensively informed of all treatments and expectations that are associated with this regimen. An overview of any alternative paths forward for this type of resource would be greatly appreciated.

@jennifer-carroll Hi Jennifer. Just a quick clarification on this response. If a product has multiple indications, but a warning & precaution is only specific to one of those indications, does that warning & precaution need to be incorporated to the fair balance of ALL indications or just when that particular indication is mentioned/promoted? Many thanks!

We are looking to highlight before and after patient images (i.e., before and after treatment) in a branded context. Specifically, these would be real patients from a clinical trial that is included in the Product Monograph, and the results they are demonstrating would be consistent with outcomes from the specific trial. The images themselves are not in the Product Monograph and may or may not be in the trial publication—some may be leveraged from data on file. Our question is two-pronged:

1. What degree of evidence (beyond a signed Med/Reg letter confirming the accuracy of the images) would be needed to support the inclusion of these images in a branded APS?
2. Are there any stipulations regarding the context to where these images must be placed in an APS?

Thank you!

Hello! We are working on developing a consumer-facing institutional message campaign with our clients. The objective of this campaign is to reiterate the aspiration of our client—Company X—in being committed to curing/ending suffering from Condition Y. Our client’s portfolio includes multiple treatments for Condition Y as well as other diseases. Messaging on these APS might include statements like "We all play a role in ending the suffering caused by Condition Y. Forever." or "Company X, together with the healthcare community, is committed to putting an end to Condition Y." The banners and/or posters associated with this message would directly link to videos which highlight Company X’s commitment in supporting healthcare institutions that treat Condition Y. Given that this campaign would not explicitly highlight one treatment in particular and does not include a help-seeking message, we are hoping to gather the PAAB’s opinion on the degree of pre-clearance that would be needed for this type of communication.