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@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.

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

@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!

@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.

Good Morning @alee What a great question. This one got us thinking. We see your point if the sponsor can confirm that the cookies are tied strictly to cellular phones, this would appear to be sufficiently targeted to HCPs. Tablets, ipads, and other such devices are much less likely to be tied in a 1:1 ratio with the user (HCP). There should also be explicit cookie approval by the HCP after they have been validated as an HCP. During the review, ALL targeting information would have to be provided. The standard practices for targeting should still be applied.

Hey @georgian21 This does give us pause to consider the nuance of the scenario. The main concern is separation. When we put unbranded content with branded, it creates an association that brands everything. Even if it is a separate therapeutic area, the question is, can we ensure that there is no suggestion that the product has implications (e.g. safety/efficacy) in that therapeutic area? We’d also have to consider the therapeutic areas as some are more closely related than others. Example: - Drug A (renal or CV drug); Drug B/C (diabetes) - Drug A (lipid drug); Drug B/C (HIV) This type of question might be more suited for an opinion so that we may assess the intricacies.

@donna Thank you for the clarification. We will set aside the banner ad for a moment and address the collection of accredited CHE on a gated section of a corporate sponsored website first. It is important that this method of distribution / dissemination of the CHE meets the accrediting body’s regulations (possibly including approval by the body). Also, if there is any content in addition to the accreditor-approved library of manufacturer-sponsored CHE on the website, that website likely requires PAAB review. At the very least, the website framework should be reviewed. With regards to the non-product branded banner ad, when understood that it meets the accrediting body’s regulations (possibly including approval by the body), it would not require PAAB review if the website did not require review. If there was any content in addition to the accreditor-approved library of manufacturer-sponsored CHE on the website, then the banner would be assessed as part of our review of the website framework. This sort of scenario is multi-factorial. If there are additional factors you’d like us to consider regarding this initiative, please submit an advisory opinion.

Good morning @keoca The inclusion of the brand logo and PM, as well as a corporate message, is likely subject to review (would not meet exemption per code section 1.5E).

Hey @keoca You are correct that the non-selective addition of tabs for each heading throughout the product monograph, would not require submission to PAAB. The addition of branding colours to those tabs, in the manner described in your question, would not cause the document to require PAAB review. Any further modification may require the submission. We recommend naming the document a Promotional/Clinical Monograph as it would appear from your description that the control number should be removed. Modification limited to the addition of non-selective tabs, would not prompt the inclusion of fair balance. Note that changing the cover (beyond the control number removal) such as adding branding colours, elements, logos, would prompt review.

Hey @username An image of the device may still suggest its route of administration and therefore may not be acceptable. The proposed home setting would also have to be assessed to determine if it fully aligns with the complete administration instructions from the TMA. Based on the nuances of the image and variables needed for proper assessment, it may be beneficial to submit for an opinion prior to creating the full campaign.

Hey @username In the context of a study design, with no additional weight that would emphasize the endpoint, it would likely be acceptable to mention the endpoint.

Hey @charlton No, a patient case is not required to be on a patient who actually participated in the PM trial.