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Hi PAAB team, I understand that "Now Approved" is not compliant. However, is "Now Authorized" an approvable alternative?

Hey @kshulist Branded APS can present mortality/prognosis in general terms in the context of disease burden in an un-emphasized manner when there is no product data for mortality/survival, i.e. it is presented among a broad discussion of burdens including those that they have supporting product data for and there is a prominent disclosure included, indicating what the product has not demonstrated an effect in mortality/survival. Please see our disease burden document for additional information. This is generally correct. Please see answer to question 1 above. Yes, section 3 of the disease burden document provides the required references to establish the burden, e.g. authoritative consensus guidelines.

Hello @Username Is the product dual schedule or only “ethical”? Is it for the treatment of a schedule A disease? One would need to consider schedule A and dual scheduling to establish which DTC regs are applicable (and consequently the degree to which they differ from HCP regs). If we assume the product is not dual scheduled and its use is not on schedule A, it is likely that the same imagery and heading can be used. However, there are instances where that is not the case because the HCP looks at the ad from a different vantage point as the general public (I.e. the same message can convey different/additional meaning for the HCP). Also, the HCP piece may contain different content that impacts the context in which the image and heading is interpreted. One way to make sure the same image can be used is to submit an opinion to PAAB for the DTC along with the HCP piece.

Thanks, Jennifer. Love the dog, by the way!

Hi @HollyMed While this activity would be acceptable, the RMM/RMT requires PAAB review. MSLs are representatives of a company that has a vested interest in the health product. Having an MSL detail to an RMT renders the activity subject to advertising regulations. This amplification context differs from a reactive interaction, largely driven by the HCP, in which the MSL responds to an HCP’s one-on-one inquiries. As a reminder, Health Canada’s policy document “The Distinction Between Advertising and Other Activities” emphasizes that the determination of “advertising” versus “non-advertising/promotion” depends on the nature of the activity itself rather than on job titles assigned by the sponsor. Regarding the second part, data presentations are not automatically compliant with advertising regulations simply because they pertain to risk. Compliance depends on multiple factors including (but not limited to) completeness, significance, context, and selectivity. Even data presented in a neutral tone can mislead if not balanced or contextualized appropriately. While the activity itself can be permissible, the slides require PAAB preclearance per the PAAB Code.

Hey @kshulist Correct. You cannot speak to unmet need in a branded context. Even if the drug is the first treatment for a certain condition, discussing “unmet need” suggests that the product addresses that need in an absolute manner. There are still ways to convey treatments where no options were previously available without stating “ need”. PAAB may be able to assist with the direction of messaging. Please reach out for additional assistance in a forum that allows for more specifics to be shared.

Hello @Maryssa Great question as I can see where there might be some lack of clarity. The description of the “responsive ads” was intended to address the unique nature of these “small space ads”. Other parts of the Code and submissions guidance (including the Guidance document for Online Activities) continue to apply when there is targeting and/or keywords that cause the ad to surface. We have included the SEM and SEO in the same review efile as the Google responsive ads. This previous PAAB Q&A also covers some general principles which may be useful.

Hi there, PAAB can provide approval to APS with links to PAAB acceptable pre-proof articles (see also Code section 3.1.2). However, it is the responsibility of the sponsor to ensure that there are no restrictions to the distribution of the pre-proof article prior to full publication (Code section 3.3).

We appreciate this being discussed among the PAAB team!

This post was answered through our office earlier but we will post the answers here as well. No, only opioids are subject to the Health Canada terms and conditions for advertising. It is permissible to create promotional materials to HCPs for a controlled drug. However, note that direct to consumer advertising is not permitted.

This one is tough to answer in a general forum since there are a lot of considerations. First and foremost, the indication is the limitations for the Terms of Market Authorization and therefore sets the context of messaging within advertising. Code section 2.10 applies regardless of perception that terminology has changed. Next, this is a great opportunity for PAAB to remind clients that we do accept endpoints and terminology not listed in the TMA. What we look for is “consistency with the TMA”. Let’s look at a few examples of where it would not be acceptable. If the “new terminology” appears to expand the scope of the indication into a broader population than what is outlined in the TMA. If the “current medical practices” contradict the TMA, such as “use first line” when the TMA states “after failure on class Y”. The studies based on “newer disease terminology” result in the patient populations or outcomes being broader than those outlined in the Product Monograph. If a more specific assessment would provide more value, we invite you to submit for an opinion. You may also reach out to admin to set up a short billable consult meeting that would allow discussion of the specific example (more details to come about this service)

Per Health Canada guidance, PSPs are not a type of additional Risk Minimization Measure/Tool, therefore, there should be no mention of the PSP within the RMT. Participation in the PSP should not be seen as a part of conditions for receiving the drug. Given this, the enrollment form question would be moot. Please, let us know if any new questions come up given the response.

Thank you so much for your response!

Hey @dlew Coverage claims may be considered in HCP APS. Patient information should not contain promotional claims but formulary information may be considered. Please see our patient information guidance. HCP claims about “cost” should be factual and complete. A claim of “at zero additional cost for most patients” would be a hanging comparison and would need to clearly state versus what and be supportable across all public and private payers. Remember that formulary bodies have requested that messaging around coverage be limited to statements of coverage and not promotional messaging around “savings”. Additionally, messaging around cost should be clear about what costs (e.g. drug acquisition costs, mark-up, dispensing fee, etc.). Private coverage claims can be supported by independent third party data from an established company who assess’ market access.

Thank @Jennifer-Carroll , I will look into that and follow up if necessary. Hopefully a more simple question, can non-clinical characteristics of two schedule 2 products be compared in the DTC setting? E.g., Store Product X under conditions A, Store Product Y under conditions B?

Hey @ALee Please see Q&A 223 & Q&A 713. These were found by searching “ongoing”. If you select “in titles and posts” you may find additional past questions relevant to your question.