Forum

Hello,
Can you please clarify for RWE study presentations, if the footnotes (e.g. for study design, etc.) need to appear within the grey box and hence, before the fair balance - or after the fair balance (which would place it outside the grey box?) We have received two slightly different directions from PAAB on the placement of RWE study footnotes. Thanks.

@jennifer-carroll said in Unbranded APS on clinical study summary:

ly likely that a study overview would at minimum create a link between the brand and its therapeutic use thus prompting s.2.10.1 and 2.4 (fair balance) for all three

Thanks for the clarification!

Hi Jennifer. I would like clarity on unbranded APS that serve to provide a balanced overview of a clinical study. If the clinical study involved the sponsored product, does this necessitate the piece to be branded with product name/logo - if it meets all other requirements of the PAAB code? I would understand that the piece would be reviewed in a promotional sense in light of the product, but as far as my understanding of the code, there is no requirement to 'brand' the piece. This also then triggers requirement for fair balance, etc. By that logic, for e.g. the study could be involving 3 of the sponsor's products, would the APS then need to be branded with all 3 brand names/logos?

@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!

@jennifer-carroll Hi, would appreciate some clarity on Q.716. I understand the response holds for prescription products, but for Schedule D vaccines (as referenced here) whereby there can be a link between drug name and therapeutic use, is it still not permissible to have a potential perceived link between a DTCA and DTCI message? By 'potential' I am referring to one of the statements in both advertisements being the same (different colors, appearance, image, medium, proximity, context, etc), would this still be considered a link?

@jennifer-carroll Thank you !

Re: [601 - I have a question regarding MOA and Code Section 3.1. Suppose a TMA states that Product-X targets receptors A & B](with no additional information/limitations. It is known that Product-X also targets receptors D & E)

Hello, could you please provide clarity regarding a product's MOA presentation in an unbranded editorial piece. If Drug X targets receptor A along a pathway as mentioned in the TMA, and it is now well-established through clinical papers that it also targets receptor B and C (although not in the TMA), can this be discussed in an editorial if there is no emphasis on any one individual receptor/pathway, and all are discussed with equal balance? Would it make a difference if there was another competitor product in the same category which targets all receptors A,B and C?

This is with reference to the previous question on "New HC Guidance and Help Seeking messages." I would like to ensure I have understood correctly. Hence, can you please confirm - does this mean that under the new HC guidance, DTCI help seeking messages for vaccines and schedule A diseases are now required to disclose the sponsor (e.g. company logo), as this was previously not allowed? Thank you.

@jennifer-carroll Thank you!

According to the code, is it permissible to develop a promotional piece that would be submitted for PAAB review that compared the sponsor's drug product to another product not available in Canada? As the individual molecules of the other combination product not available are used in Canadian medical practice. The fact that the specific drug is not available in Canada can be mentioned. Thank you.

@jennifer-carroll Thank you for the clarification!

Hi, I would appreciate clarity with regards to the area of consumer branded websites. I understand that we cannot exceed name/price/quantity, and no link to therapeutic use. What if we would like to upload a questionnaire on a branded website, with some general questions to ask your HCP (this would not allude to therapeutic use, and could be used for all/any treatment). Would this be permissible, or we cannot go beyond n/p/q in any respect? Thank you.

@jennifer-carroll said in International Conference Held In Canada - Confines of the Conference:

escribed in your questions, would likely be considered to fall “within the confines of the conference” EVEN if the HCP can cho

Hi Jennifer, I have a follow-up question to what is considered "confines of the conference". Can you please clarify if this extends to the conference website? Technically it can be considered within "the confines of the conference" but would like clarity.

@jennifer-carroll said in Sharing DTC info with HCPs:

he unbranded communication linking to it are exempt from PAAB preclearance when targeted

Thank you. That really helps aid in understanding. Have a great weekend.

@jennifer-carroll Thank you for the response. I had understood the above to be true when there is a discussion on 'treatments' in the disease awareness article (as per section 7.5 on editorial advertising and discussion on treatment in a balanced way). Also, to your second point, the unbranded communication to inform HCPs of the article would be an email with a link to the article (no claims/additional information), and hence PAAB exempt?

If a pharma company sponsors a third-party developed disease article to be published in print media for general public on disease awareness only (no mention of treatment by name/class/category) and has a help-seeking message, can reps share this article with HCPs in an unbranded communication? I would assume the article, and the unbranded HCP communication both, would not be considered advertising as per the 'Distinction between Advertising and other Activities' document and not need to undergo PAAB review?

@palanski @Jennifer-Carroll Thank you!

Hello, can you please provide clarity if a provincial formulary reimbursement form that was pre-filled with product name and coverage criteria only would be considered PAAB exempt? Thank you.

@jennifer-carroll Thank you for the quick response