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Hey @mef Yes, direct to consumer information (DTCI) help-seeking messages for vaccine-related diseases would require disclosure of the sponsor.

@jennifer-carroll Thank you!

@jennifer-carroll Thanks for clarifying! I understand now

Hi @jennifer-carroll, That answers any lingering questions I had, thank you so much for taking the time to explain!

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.

@Jennifer-Carroll Thank you kindly for the response. This helps provides our team with some starting points to consider. Should we need further response, we will be sure to submit an opinion, or arrange a consult meeting as suggested.

@kshulist No, it would not be acceptable to include a study that does not meet PAAB requirements for evidence in branded or unbranded APS. Please note that in general, a study for the sponsor's product would not be considered unbranded, even without the brand name or branding elements.

Good morning, @Username Comparative data remains subject to the guidance for evidentiary basis to support comparative claims. As noted above, consideration may apply when the study can be demonstrated to be the basis for approval of the biosimilar. A study that is NOT part of the basis for approval and completed post approval, should meet the standards for high quality evidence (i.e. pre-defined statistically significance endpoints).

@jennifer-carroll thank you for clarifying! That's very helpful.

Thank you @Jennifer-Carroll. This is very helpful!

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.

Hi @QnC The original question on why can't patient-directed APS for prescription/controlled/targeted drugs be promotional was intended to be addressed in PF Q&A 352 where it was noted that PAAB code section 6 applied to patient directed information and its rationale. The HC Distinction document does not cover patient information, i.e. information to individuals that have already been prescribed the drug. PAAB s6 is applicable to patient information and indicates that “Company controlled or prepared branded patient information is information that contains non-promotional material…All health product information must be consistent with the Terms of Market Authorization (TMA), and should not contain promotional claims.”.

Hello @Maryssa Q&A 501 is exactly the one we would have pointed to @dmauri . However, the copy "Now authorized" alone is incomplete (authorized how? for what?) it should be restricted to "Authorized for use in..." or "Authorized for sale in ...".

@jennifer-carroll Thank you !

@jennifer-carroll said in 716 - Hello, I'm looking for where to find guidance regarding regulations for executing a 'help seeking' DTC campaign for vaccines at the same time as a branded DTC vaccine campaign. Given the DTC nature, pre-clearance would likely be through ASC. I've reviewed the guidance from Health Canada at length and am well aware of the criteria for help seeking. My understanding is that the help seeking and branded campaigns must be different (ie: in colour, tag lines etc) and not linked in any way, but I'm unable to find specific direction. I'd like to be more clear on how the campaigns must be different, assuming they are not linked in anyway (visually or otherwise), and if/how they may be executed concurrently. ie: can a vaccine help seeking TV ad be on during the same time a vaccines DTC branded banner ad or social media campaign is running (again, assuming not linked in any way). Thank you in advance for your assistance.: he same statement in DTCI, used in the DTCA may be considered a link depending on the balance of the APS, e.g. It is the only statement in the APS + p Thanks so much for the clarification, Jennifer!

Thank you for clarifying this!

@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.

@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.

@SKW If independent third party content on COVID-19 is being provided to a patient through a branded patient support program, an assessment of the linkage should be performed to ensure the acceptability of the content within the context of the brand. This remains true even if being sent without the brand logo (i.e. they are being sent the content because they are part of the branded patient support program). PAAB would do an assessment of the linkage to the content which could be done through an opinion file and would be subject to the four day turn around time.

Hey @hannah Please see Q&A 338 listed above.