Good Morning @HollyMed Pooled data is not acceptable even if part of a pre-planned long-term extension study.

Hello @tk2022 It appears that you are asking for an exempt review over the forum. Please note that this is not the intention of the forum. From a search it appears that you are taking the term “simple sample” from Question 47 or 58. If this is the case, please ask the question under the relevant Q&A in the future to help maintain the usability and clarity of the Forum. Q&A Solicit product samples should provide sufficient information along with the referenced questions within that response, to assess “simple”. When unsure, please be invited to submit for an opinion.

@jennifer-carroll Thank you!

Good morning @caitlinbyrne While “now available” as a stand-alone message is exempt, when it is paired with another marketing claim (route of administration), the piece is no longer exempt. This piece appears to require lowest level fair balance if restricted to the copy noted above.

Hello @jennifer_cm An attestation letter from Med/Reg confirming that only sites which have been approved will be listed is sufficient. When submitting, provide a standardized template of how the sites will be listed. This will allow sites to be added and removed without a need to re-review as this becomes an administrative feature.

Hey @mimic909 This is a specific review question about specific pieces. It should be submitted for an opinion. You can request an opinion for exemption with a note that you’d like to proceed to review if not exempt, as per the PAAB Policy and Procedure for Reviewing Exemption Request eFiles. As general guiding principles, when you direct branded advertising to HCPs or branded patient information to patients through HCPs, it is subject to the PAAB Code and all other advertising regulations. This also applies to APS that promote a corporate service (e.g. co-payment) (s7.4). Payment to a site to include your brand in their space is “control” as the brand would not exist there without the sponsors interaction. While you may not control the copy in this space, it is still the manufacturers responsibility to ensure it meets advertising regulations.

Hey @costeap We are working on cleaning up a final draft document that will help to provide additional guardrails when developing creative. We hope to have this draft back in front of the committee by the end of the month and posted shortly there after Note that PAAB guidance documents are not permitted to be integrated into training material for AI per the following disclaimer on our website and the forum: “The responses, guidance, and advisories provided by the Pharmaceutical Advertising Advisory Board (PAAB), including but not limited to those available through the PAAB Forum, the PAAB website, and any PAAB correspondences, are specifically intended to assist individuals navigating the PAAB preclearance system. Repurposing or reproducing this content without written consent from the PAAB Commissioner is strictly prohibited.”

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.

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.

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.

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.

Hi @hrj2021, Yes, efficacy and safety data that meets PAAB requirements may appear together in APS.

@jennifer-carroll Thanks so much. This is most helpful.

@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.

Hello @username Let’s begin by setting a common understanding of what is market research (and what isn’t market research). Market research has the sole purpose of pointing out and defining marketing opportunities and issues; generating, refining, and evaluating marketing programs; monitoring marketing performance; identifying patient and prescriber needs and improving understanding of the marketing process. The planning, implementation, evaluation, and utilization of market research should reflect that sole purpose. The activity is not considered market research if the purpose includes promotion of a health product (or the features/properties of that product). The content, its context and tone should reflect these facts as should the type and number of participants (and the nature of the agreement/contract where applicable). We invite you to refer to the “General Principles” section of the Distinction Document to determine whether the activity is potentially subject to advertising regulations (and consequently subject to PAAB preclearance if targeting HCPs). The IMC Code of Ethical Practices is an additional resource for standards/factors pertaining broadly to market research and for some specific examples of market research. True market research is generally not considered subject to advertising regulations. And consequently, the PAAB Code standards and preclearance are not applicable. However, please note that some activities that are believed to be market research are actually promotional in nature. If there is any doubt, you are welcome to use the PAAB advisory opinion service to confirm whether any particular activity is indeed exempt from advertising regulations (see our fee schedule for more information). Please note that communication of market research findings in advertising is subject to preclearance.

Hello @reed-wigs Theoretically it is possible, however there are several considerations. For example, if the PSP is therapeutic area specific, it would create a link to the other brand for which patients only on one product are not on and would not be acceptable. If the PSP is not therapeutic area specific, it would require verification that the patient was on both products and within the PSP, the content would need to have been reviewed and approved in the context of both products. If it was therapeutic area specific, the content would still require review in the context of both brands. If the products are in different therapeutic areas and the content is different based on the product, there would need to be clear delineation between therapeutic content. These are just some considerations. We would suggest that you submit for an opinion so that we may assess and provide direction in the context of the specific program and application.

@gmc In PAAB’s view, Canadian medical/regulatory review of international conference materials is an appropriate mechanism for determining whether the sort of disclosure statement outlined in the fourth bullet of the Distinction document’s section on international conferences is required to be affixed to the ad. However, tailoring the ad for Canadian HCPs (beyond simply affixing the aforementioned sticker) would likely render it subject to all applicable Canadian Federal advertising regulations, regardless of whether the revisions are implemented by the parent company or the Canadian subsidiary. Given that the ad was generated from a non-Canadian label, its deviations from the Canadian regulations likely go beyond the product’s local naming/branding conventions and risk disclosures. The course proposed in the question would therefore appear to render ad subject to Canadian advertising regulations while falling short of achieving full adherence with those regulations. The resulting ad would likely also deviate from the regulations that are applicable in the jurisdiction from which it originates. In our opinion, based on the limited information provided, it would be best to EITHER: • Make no modifications to the ad itself, and instead affix a sticker conveying that the product is not authorized for sale in Canada or that the product is authorized under a different name for different indications in Canada (if applicable). Canadian HCPs should be invited to refer to the Canadian monograph. • Revise the ad so as to fully bring it into adherence with all applicable Canadian regulations (and confirm this through the PAAB preclearance mechanism).

Thank you for the information!