Forum

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!

Hey @elena A message of “talk to your doctor” or “talk to your healthcare provider” or “talk to a healthcare professional” can all be considered in both branded patient information pieces and branded direct to consumer (DTC) pieces as they are broad and all encompassing. When you state a specialty, there are implications. For branded patient information pieces, there will be considerations about the specialty that the patient is being directed to in the context of the brand. For example, we’d likely question “talk to your urologist” in the context of a cardiovascular product. This would be assessed during the review process. For branded DTC pieces, it would not be acceptable to specify a specialty as this would suggest therapeutic use in violation of the Food and Drugs Act.

@jennifer-carroll Wonderful, thank you.

Hi @karen-taylor, A claim that references a vaccine product being publicly funded in a branded DTC APS can be considered. While claims would be assessed in the formal review of the piece, please note that “… free of charge …” may be potentially misleading. While it may not directly cost the patient any money, the vaccine would be paid for by the government (i.e. societal costs). Alternatively, claims such as “…may be publicly funded in your province. Speak to your doctor to see…” can be considered if it is accurate. Regarding the second example “… publicly available in Canada”, if certain provinces/territories do not cover the vaccine, then it would be misleading to state that it is publicly available in Canada overall. Please see the Food and Drugs regulations for DTC advertising and also ensure that this type of DTC-advertising is not linked to any DTC-information pieces (please see Q&A 716).

Thank you so much for your answer! @jennifer-carroll

Good Morning @kshulist In general terms, the linkage would have to be assessed to determine its acceptability. While it may appear to be less of a concern linking unbranded to unbranded, the linkage would be assessed during the review process where additional guidance could be provided in the context of the specific tool/message. There are scenarios where a deep link is fine and where it is not ok. For example, deep linking to a page which focuses on the sponsor’s product, even if it’s third party generated, from a sponsor generated unbranded APS, would not be acceptable. Apply general linkage principles to ensure that you are considering both the regulatory audience and content being linked.

Hello @kshulist This answer is provided with the understanding that the nominal p-value is not in the product’s TMA. The application of the above would depend on why the p-value was nominal. It can be from different reasons and the nominal p-value may become a meaningless number if the assumptions of the statistical model used to compute it do not hold. Violating any of the varying prerequisites of a significance test might render the nominal p-value not acceptable. As such, the ability to present the data and the potential types of claims in an APS would require consideration of the statistical analysis. For the example in question, if a statistically significant p-value is nominal simply because it was unadjusted, a claim neutral presentation could be considered per the prior Q&A.

@jennifer-carroll Thanks Jennifer, this is helpful!

Hey @llmktg The following response is provided as general guidance and should not be seen as an exhaustive list of considerations. Broadly speaking, when creating a branded patient experience video, remember that in a branded context, all content has implications for the brand. Also, keep in mind that patient-directed APS should be non-promotional, and HCP-directed APS should be supported by evidence meeting PAAB Code requirements. Subjective experience is often hard to qualify with blinded statistically significant data from randomized control trials. For a patient-targeted APS: Because a person’s experience is subjective, such a video may have promotional connotations, which would not align with section 6 of the PAAB code (see PAAB Q&A 450). It is possible to create a non-promotional video objectively highlighting the injection preparation + administration steps. A disclaimer should be added stating something similar to “Actual patient depicted. May not be representative of the general population.”. For an HCP-targeted APS: A patient’s experience with the injection process is considered similar to a testimonial (s3.1.3). Testimonials that are consistent with data supported by acceptable evidence (see PAAB Q&A 703), may be considered. A branded video for HCPs may be created depicting a patient injecting themselves with the product, so long as it is objective, accurate, and complete (s2.1). A disclaimer should be added stating something similar to “Actual patient depicted. May not be representative of the general population.”.

Hey @user123 Please see Q&A 674