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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

Hey @kshulist As per the principles noted in Q&A 508, if the published paper conveys a statistically significant improvement in the absolute risk reduction for the response rates (with multiplicity adjustments performed when required to manage risk of type I error), the NNT may be calculated.

Hey @tk2022 Q&A #763 refers to just one scenario which could render a piece exempt. The tool outlines other factors/scenarios that may or may not render a piece exempt from PAAB pre-clearance. Can you please provide us with the flow you followed through the tool and the nature of the piece you’re thinking of (unbranded/branded, treatment/no treatment, company generated/independently generated, distribution, etc.)? This will help us better assess the question. (Note 6.6. in the document will be updated to 1.5D per the current code.)

Hey @kellyyefet We were unable to locate the quote “if it’s mean to be gated” in the above copy and therefore cannot comment on what is meant by it. The possible forms of gating are outlined in the gating guidance document which can be found on the PAAB website under resources. To clarify “Note that if the branded site URL is intended to be the gating mechanism…” in our previous response, we were referring to the context where de-indexing is the form of gating. If this de-indexed URL is acting as the gate for your brand it would not likely meet the requirements. Note that “soft gate” is not a term that PAAB or Health Canada use. A website which contains information which goes beyond what is allowable in the consumer space requires a gate which ensures access is limited to the intended audience.

Hello @gmc As per our response above, there are many aspects that would impact acceptability. It is highly probable that the proposed link above would present an issue because the patient would know certain things about the medication that was prescribed to them (i.e. the indication). By linking to a pre-gate page that has a second medication which the patient has likely not been prescribed, it may be considered direct to consumer advertising. This is because the patient could start drawing inferences/conclusions about that second medication, even if they only see the name of it on a pre-gate landing page. This would be assessed and discussed during the review process.

Hi @gmc It is acceptable to acknowledge the contribution from HCPs in the development of an APS. Note that the content within the piece would still be required to meet the standards for evidence (i.e. individual opinion that is not supported by evidence would not qualify as an authoritative source). The overall principle of not associating branded and unbranded should also be adhered to. Wording would be discussed during the review to ensure that it does not contravene advertising regulations. We’d encourage the sponsor to also check with HCP governing bodies and other trade associations to ensure there are no concerns with the activity.

Hey @ap An unbranded piece that speaks to products which the patient is not on, would be considered consumer advertising. The activity above appears to fall under “Medical condition and treatment awareness material” (formerly consumer brochure) and as such would have to meet the requirements outlined in the Distinction Between Advertising and Other Activities document under section “Medical condition and treatment awareness materials”. This outlines that all options must be included (pharmacological and non-pharmacological). The Product Monograph can be used as a reference for treatment formulation but would not support direct or implied comparative claims. The reference should not be listed in the piece as this would create a link between the brand and therapeutic use which is in violation of the Food and Drug Regulations.

Hello @lags This is a complex question that would be better suited as an opinion submission where details on the therapeutic area, class of products, proposed inclusion and exclusion criteria etc. could be provided. It is not possible to create an exhaustive list that would be clear enough to apply across all therapeutic areas. As a general response, any selection criteria that have eliminated other products from the presentation, should be clearly conveyed along with disclosure to the audience that this is a selective presentation.