Forum

Hello @natbourre An unbranded APS can be considered exempt if it discusses only disease information without any mention of or allusion to drugs/medications/pharmacotherapy. Because the tool would be alluding to medication/pharmacotherapy via discussion of MoA, the APS would not be considered exempt.

Hey @maryssa The relevant standards of the PAAB Code of Advertising Acceptance are applicable to APS directed at HCPs and APS directed at patients when there is HCP involvement. This remains true regardless of how else the APS may be used. In questions 1 and 2, leaving physical copies of APS in an HCP's practice constitutes distribution involving the HCP. The HCP maintains full control over which materials are allowed to remain in their practice. It would be prudent, as a best practice, to seek permission from the HCP before leaving such materials in their practice. In question 3, the messaging is directed specifically to the HCP. The fact that the messaging is about a consumer campaign does not exempt it from the applicable provisions of the PAAB Code for the message itself. If inclusion of the DTC website/material is for awareness only, it would not subject to PAAB review. However, should there be copy that suggests the material is intended for consumption by the HCP or disseminated to patients through the HCP, e.g. “Tools and resources…”, “Learn more at…”, then the website/material would be subject to PAAB review. Conversely, in question 4, the HCP is receiving the message as a member of the general public. Therefore, the PAAB Code does not apply. While the question may be framed humorously (I would hope), the general public includes individuals from all walks of life, even HCPs. Don't forget the Advisory - APS in Patient Interaction Areas as well.

Hello @cchristopoulos The primary reason for the implementation of the RWE guidance document was to provide some flexibility around presenting evidence that was not previously accepted, in order to allow additional clinical data. Code section 3.1.4 states “Claims based upon laboratory or animal testing reports should be separated and cannot be used to imply clinical significance, unless there is evidence of a valid clinical correlation”. Unless the PK/laboratory-type data are unequivocally shown to have clinical relevance reflected by widely-accepted medical opinion and practice (e.g. authoritative consensus guidelines) and determined to be a valid endpoint (an example of this would be viral load in HIV), then a PK presentation would also not fall under the scope of the RWE guidance document.

Good afternoon @dmauri Please see the PAAB Advisory on Disclosure of APS Placement Details. The answer will be dependent on the ad and where it is being placed. A general question you could ask yourself is, “Am I creating a link between the brand and articles which may be considered off-label by virtue of exclusive placement?”. Note that the concern is the potential for placement to create a notable link between the brand and articles/content on the page(s) which could exceed the federal advertising regulations. This potential is amplified by exclusivity of ad placement.

@jennifer-carroll that makes sense, thank you for clarifying!

Hey @mimic909, @palanski is correct that if there is proper gating, the ad may appear on the site. Be careful not to apply this to the entire site, as we can see that there is advertising on the journal website referenced in your question prior to gating/before the paywall.

Good Morning @charlton The information provided must be non-promotional and it must not exceed that which would normally be required to support their role. The formulary kits/packages section of the Distinction Document is relevant to your question as well.

Hey @laraholmes Assuming that all aspects of the code are met (prominence and clarity of messaging, balanced, complete, non-promotional to patients, etc.), this may be possible. Given the variety of factors that would need to be considered for assessment, including the size/dimensions of the piece, we suggest either submitting for an opinion and/or providing a preliminary mock-up of the piece when submitting for review to determine the plausibility of the proposed APS. Final ruling would be pending an official review.

Hey @natbourre This would be an opinion for exemption. We suggest submitting with additional details around the therapeutic area, talks, sponsorship, influence over content, relationship with the speaker, etc. in order for PAAB to make an assessment.

Hello @zsivo It’s important to remember that the forum responses are written as general responses to general questions. Responses should not be viewed as an exhaustive explanation of the code and regulations. The above summary is not complete or exhaustive. We would suggest reviewing the questions and responses provided above in their entirety. Please note that bullet point three is inaccurate and does not reflect guidance in 175 or 419. For bullet four, we’d note that a sales call is an advertising activity, regardless of a “reactive” discussion to a distributed paper. As a reminder, the Health Canada Guidance on distinction between advertising and other activities for health products states that for “Responses to inquiries,” the information provided to an individual or organization about a health product by a manufacturer in response to a request for information may be considered promotional if the inquiry has been encouraged in any way by the manufacturer of the health product or the response to an inquiry regarding unauthorized products or indications (off-label) is communicated by sales or marketing personnel. For bullet five, per Q&A 419 “Although rep activities do not fall under the PAAB code, advertising/promotional systems (APS) are indeed covered by this code. This means that although a published and peer reviewed clinical trial which has NOT been modified in any way wouldn’t require preclearance, using the study as a rep detailing tool would render it subject to the provisions in the PAAB code.” One should not assume that all lone-standing peer-reviewed papers are aligned with the Code.

Hello @maryssa Our understanding is that you are asking in reference to the “Renewal Management Dashboard" and a piece needing to be 100% pickup . In this context, yes, it would be acceptable to update the date to match the new TMA. Note that review to ensure that the piece is not affected by the TMA update would be required. If additional copy change is required to address the TMA update, additional fees and a new timeline may be applied.

@jennifer-carroll ok that clarifies things, thank you very much!

Hello @starship1 Please keep in mind that it is the sponsor’s (manufacturer’s) responsibility to ensure a robust validation mechanism for gating access to information that is intended for Canadian HCPs. An individual self-declaring that they are an HCP (without any additional verification) is not considered a valid gating mechanism. LinkedIn does not validate users’ information and therefore cannot be used as a mechanism for validation. It may be possible to target unbranded content to HCPs on LinkedIn, however it would require a dual review for a DTC audience and an HCP audience as the users would not be validated. In this case, any “linked” content which exceeds the consumer regulations would still require the user to be validated as an HCP. See the document Guidance on Gating Mechanisms for Healthcare Professional Targeted Digital Assets.

Good morning @starship1 A third-party website validation alone may not always be considered as a “robust gating mechanism”. Not all users of Medscape are validated HCPs. The sponsors should verify with the third-party platform, their validation mechanism and ensure ads are only placed in spaces which meet the outlines stated in the document Guidance on Gating Mechanisms for Healthcare Professional Targeted Digital Assets. Links from ads in a space that meets the requirements for HCP validation, are not required to revalidate the HCP.

Hello @abhi-patel While consumer advertising for Schedule D health products (e.g., vaccine), and ethical schedule health products fall within the scope of PAAB services, consumer advertising for OTC and NHP products does not. Please note that Health Professional directed advertising of these products falls within the scope of the PAAB Code.

Good morning @mhouzer Yes, this falls within the PAAB Code’s scope for pre-clearance. The submission should include the functionality (e.g. prompted questions, user-generated, pre-populated). If user generated, how will they be linked to an answer (% match, list of terms, etc.), access, linkages, audience, content (utterances and responses), layout, and safety information. This may not be an exhaustive list and the reviewer may have additional questions. If you require additional information, please reach out to info@paab.ca and we’ll help in the context of your specific case.

Hey @smurcar We cannot provide a review over the forum. Claims around the approval process are generally restricted to factual statements about the current state of the approval. Note that it is not acceptable to promote the approval process in branded advertising per Food and Drug Regulations C.01.007. See this previous Q&A. In reference to the sticker approach, we suggest submitting an opinion with the content you intend to use and the positioning on pieces (with examples) so that we may assess in the context of a complete picture. Given the outlined copy provided, it appears it may be appropriate to use a sticker to update pieces. The full review would cover the requirements for the copy on the sticker and the copy which would become covered on the revised pieces. We’d also need to assess if anything else changed in the TMA that may affect the piece beyond just the NOC status change.

@jennifer-carroll I will do that. Thank you for your help!

@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!