@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.