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@jennifer-carroll Thank you kindly for the response

Hey @maryssa We’re not sure of the specifics to the case that you’re referencing in the beginning of the question so we cannot confirm your understanding. We can provide general guidance on place in therapy claims. Place in therapy can be supported by guidelines when it’s consistent with the indication. The PAAB document “What constitutes current medical opinion & practice” states “PAAB has received requests from consensus groups to ensure that the proprietary drug name [brand name] is not included within a claim directly referring to the guideline if the guideline recommendation only cites the non-proprietary drug name [generic name]”. We refer you to the examples in the above-mentioned document. Therefore, a claim that a product is recommended first-line per guidelines X, would require that the brand name be specifically mentioned in the guideline recommendation. Otherwise, the generic name should be used. For the second scenario (“BRAND NAME X has an indication in its PM, in combination with generic name Y. Could we have a header in an APS that says "BRAND NAME X + BRAND NAME Y" supported by the combined indication from BRAND NAME X's product monograph?), the answer is no, as per the principle outlined above (consistency with the authorized indication). We are also aware of cases where Drug Y does not have an authorized indication for combination with Drug X. If the question was intended to be in reference to guidelines, the above response (direct mention by brand name in the guidelines) would also be required.

Hello @tk2022 The feature of being phase 3b/4 does not in and of itself disqualify a study from either RWE or study duration.

Hey @sabrinab Minimal changes such as those mentioned, would not void “direct pick-up”. We’d ask that you identify in the submission letter and highlight (versus shade) the specific instances. This can appear overtop of the shading. In this example it would not be considered direct pick-up. For efficiency sake, we’d ask that you identify the previously approved file, the content removed, and for extra support, providing the rationale can help.

Hey @copycallosum It’s difficult to capture all aspects that may make this activity exempt versus an advertising/promotion system (APS) subject to pre-clearance review without seeing all the tools and how they are used. The general response is that when you link advertising (APS) and non-advertising, everything becomes advertising (this is regardless of whether it is branded or unbranded). If HCPs are being encouraged to link disease state information to a consumer campaign, all aspects of the consumer campaign should be considered in the context of the dual audience (HCP and consumer). We’d suggest submitting for opinion as mention of management can be implicit or explicit and is broader than just mention of a product/brand.

@Agency and @Manufacturer We invite you to participate in our annual client survey, where your feedback will directly inform our future improvements. About the survey: • This quick, 10-minute survey is for everyone who works with PAAB, whether directly or indirectly. • Your responses are entirely anonymous, all insights will be presented in aggregate via our research partner, CreateHealth.io. To thank you for your input, you’ll receive a digital $10 CAD gift card (Visa and select store cards) upon completion. Please note, to receive the $10 honoraria, you must provide your work email at the end of the survey, and it must be associated with your forum registration, eFiles records, or PAAB email list. Share you views here today Thank you in advance for your feedback! PAAB

Hey @afpjjim The principle to consider is in the “Dissemination” section of the document referenced. The copy reads “If the intent is for the email template to be used across many brands (and therefore not contain fair balance), the document naming convention should not trigger the addition of fair balance. This means that it should not contain claims or copy that links the brand to therapeutic use.” If the brand name appears in the piece and there is a study name, this would create that link (see Attachment of clinical reprints in an RTE). During the submission process, you would define the naming convention as “Study acronym_study_safety_data” and convey that studies across multiple brands could be attached in the same email. The reviewer would assess if indication and fair balance are required.

@jennifer-carroll thank you so much!

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 @NatBourre When images are presented they must be aligned with the indication. If they present an outcome, data to support this effect must be presented within the APS. A letter from medical/regulatory should be provided to confirm that the demonstrated effect in the image is aligned with/representative of the effect demonstrated in the trial (i.e. the average not the best-case scenario). It would not be acceptable to use the same images in both branded and unbranded advertising as when you link branded and unbranded, everything becomes branded. The images and their presentation in the unbranded pieces would have to be different.

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.”

Hello @jdilly11 PAAB code section 3.1.1 requires that clinical claims are based on published, peer-reviewed, controlled and well-designed studies with clinical and statistical significance clearly indicated. Unpublished data would not be considered sufficient. If a study has been accepted for publication and completed the peer-review process (i.e. final manuscript is approved and awaiting official publication), PAAB can accept a letter from the editor confirming the future publication of the manuscript as presented in the submission.

@jennifer-carroll thank you for clarifying! That's very helpful.

Hi @natbourre There is the ability to link to an unbranded survey questionnaire. However, as it is linked to a branded patient APS, the questionnaire would be subject to the PAAB code. As a reminder, linking unbranded to branded renders everything branded, so please be mindful that unbranded materials should not contain content which would not be accepted in a branded context. In addition, depending on the questions and if the answers/results are not intended for internal use only, the subsequent distribution of the results to patients or HCPs may be subject to advertising regulations as well.

Hi @rlevit1 The PAAB does not have a single guidance document dedicated specifically to defining “consistent with the TMA”. While many of the principles of the CFL guidance can be considered analogous to PAAB requirements, we suggest referring to and applying only Canada-specific guidance, as ultimately this is the only guidance describing compliant advertising in Canada. Familiar principles such as scientific accuracy (Code Section 2.1), restriction to the approved use and population (s3.1), and appropriate communication of risk-benefit profile (s2.4) are all required by the PAAB code, among others; however, consistency with the TMA as a whole depends on the type of claim and/or evidence posited. Some resources describing consistency with the TMA relevant to certain contexts include: Guidance on Subgroup Analysis (https://www.paab.ca/resources/guidance-on-subgroup-analysis/) , Noninferiority Trials (https://www.paab.ca/resources/guidance-on-noninferiority-trials/), and Secondary Endpoints (https://www.paab.ca/resources/guidance-on-secondary-endpoints/) all describe consistency with the TMA specific to these analyses. Guidance on Real-World Evidence/Data (https://www.paab.ca/resources/guidance-on-real-world-evidencedata/). Section 1.1 describes consistency with the TMA with respect to Real-World Evidence/Data; points 1.1.1-1.1.4 can generally be applied to any randomized controlled trial. Guidance Regarding Duration of Clinical Trials Used as Reference Support in Advertising (https://www.paab.ca/resources/guidance-regarding-duration-of-clinical-trials-used-as-reference-support-in-advertising/). Some principles in this guidance originate from the CFL guidance. Guidance on Advertising for Drugs with Notice of Compliance with Conditions NOCc (https://www.paab.ca/resources/guidance_on_advertising_for_drugs_with_notice_of_compliance_with_conditions_nocc_feb_2018_typofix_docxpdf/), which precludes inclusion of any studies or data not found in the TMA.

Hi @maryssa From the description in the question, the ads are visible to the general public but they are designed for HCPs. As such, the primary audience are HCPs and the general public is the secondary audience. Consequently, the provisions of the PAAB Code apply, including the need for PAAB Preclearance. Because of the secondary audience, our assessment would also include the need to adhere to federal regulations pertaining to consumer advertising. Please ensure the submission letter conveys that the banner ad will be placed in pre-gate environments.