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

Good morning @medwriter

If the context and audience are unchanged, addition of another publication would not prompt an updated submission. "Context" includes no change in targeting or placement (i.e. remains run-of-site) within the new journal and no linkages which were not presented in the initial submission. If unsure, PAAB can provide an opinion (which can proceed to full review if it is determined to be required).

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 @theodora32

The provisions of pre-printed prescriptions pads are not addressed specifically in the PAAB Code. As a company-sponsored service oriented vehicle, PAAB will review the content of submissions with a prescription pad to assess its consistency with the TMA. However, it is the sponsor’s responsibility (e.g. medical/regulatory or legal departments) to do their due diligence to ensure that this activity does not contravene the regulations and codes of the respective federal/provincial regulatory bodies, health professional governing bodies and industry associations.

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.

Hi @mimic909

A PAAB approved tool may not be linked to an exempt APS without PAAB review. The order of navigation does not make a difference. The email copy is intended to be consumed and is linked to the PAAB approved APS. As the messages are connected, both are PAAB reviewable.

Hello @shotk7

PAAB exemption criteria can be found in section 1.5 of the Code. At the root of this question is if this piece is advertising or not. The Health Canada policy document "The Distinction Between Advertising and Other Activities" is a valuable tool in determining whether materials are subject to the advertising regulations. The document poses questions and factors to consider (e.g. content/context, content creation, distribution, etc.) when determining if a message falls within the definition of advertising, including “Who sponsors the message and how?”. Whether the HCP piece would require PAAB preclearance also depends on the type of entity which is creating the piece and the relationship between the sponsor and that entity. In general, no single factor will determine if a particular message is promotional (e.g. third-party does not confirm that it is not advertising). Lack of mention of a specific product also does not render something “non-advertising”. Various possible scenarios and the corresponding answers are covered in the following document: Guidance on which HCP materials require PAAB review. Submit an opinion request if you have remaining questions about a particular tool or process (see the fee schedule on our website www.paab.ca)

Hi @georgian21

It is a requirement of the most recent Distinction Between Advertising and Other Activities document from Health Canada, that the sponsor is identified. This can be through the logo or copy.

Pg 8: Section: Medical condition and treatment awareness materials
“Declaration of sponsorship of such materials, by name or logo, is required and does not in itself render the material promotional.”

When a DTC ad is reviewed by PAAB the inclusion of the logo is preferred but not mandatory. Our logo is intended to be an indicator to the audience that the APS has undergone an independent review to meet high standards that help support the health and safety of Canadians. In text only pieces (where the platform does not allow for images), we can consider the copy “Reviewed by PAAB”. These should be rare exceptions and can be discussed during the review process. HCP and patient APS require inclusion of PAAB logo (or text when the platform does not enable inclusion of logos)