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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 Unpublished data would not be considered sufficient.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.

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)

Hey @dmauri Section 7.3 of the PAAB Code states “Advertising with Product Claim Link to Terms of Market Authorization: One of the following must appear prominently within the main advertising message of the APS: Electronic link(s) to the current TMA (and Health Canada endorsed risk communications issued since approval of the TMA, if relevant) URL(s) for a webpage containing the current TMA (and Health Canada endorsed risk communications issued since approval of the TMA, if relevant) accompanied by a statement that these documents are also available upon request through a stated phone number. The definition of “Terms of Market Authorization” can be found in the Code and reads as follows: Information in the Product Monograph, labeling and product license and the document that assigns a Drug Identification Number (DIN), Natural Health Product number (NPN) or homeopathic product number (DIN-HM), including related product labeling material and prescribing information, authorized by Health Canada. When a Product Monograph is the basis of authorization, it should be linked. If authorization was granted based on a Product License, providing a link to that document would meet the requirements of section 7.3. The TMA document would be the basis for review of the ad.

Hey @smurcar It is not possible to know if the piece would qualify for a minor update from the description. The content structure remaining the same is not what will determine eligibility for a minor update. Significant new presentations may be added within a content structure that would extend beyond the spirit of a minor update. For example, a new data set within a pre-existing ‘Efficacy’ content section. An eligible minor update is an update to an existing presentation. The copy “existing presentations is updated with more recent information of the same type” was generally written to reflect updated formulary coverage, updated distribution numbers etc. A patient case is more complex as content within it may prompt additional support to be included in the piece. Additionally, the stacking of patient cases can create emphasis on particular characteristics which may not have existed as a stand-alone patient case. We would suggest submitting for consideration as a minor update, with the understanding that it may prompt broader change in the piece which would incur a revision to the fee. Hope that helps.

Hi @dmauri Hashtags can be considered in consumer spaces. It is important to note that if a sponsor creates or propagates a hashtag, they are responsible for all content linked to its use. This means that they take on all of the regulatory risk associated with the unrestricted use of the hashtag. In the context of a disease awareness campaign which is not linked in any way to a brand, there may be low regulatory risk. However, linking to the company increases the risk and should a post or link to the sponsor’s brand occur, it may prove difficult for the sponsor to remove this link. We would encourage a discussion with regulatory and legal to assess the appetite for regulatory risk. Similarly, the same risks occur when you have the hashtag #CompanyATherapeuticAreaX as the sponsor has no control over the hashtags use.

Hello @tk2022 Could you please provide additional information on what aspect of “inclusion of patient cases in a branded HCP tool” you are looking for clarity on? In advance, please note that there are a number of forum posts which address the use of patient cases. We suggest searching “patient case”.

Hey @boram The level of fair balance will be dependent on the exclusivity claim and any additional copy required to support it. For the exclusivity claims discussed in the above document, highest level fair balance would likely be required as these are indication comparisons. See Question 1 in Guidance on Fair Balance Level Selection and Placement

Hi @gmc This would be considered a review question. Please submit for opinion or full review. Note that other copy and content on the page impacts the acceptability of a message. As a general guiding principle, content on the described landing page would need to meet patient, HCP, and DTC regulations (i.e. it would be subject to the applicable sections of the Food and Drugs Act and Regulations, Health Canada policy documents pertaining to consumer advertising, and the PAAB Code).

Hi @natbourre Please see Q&A 214. For anything discussing disease burdens, please also see our recent guidance document Guidance on the Presentation of Burdens of Disease in Advertising, specifically section 5.3.

Hello @natbourre An unbranded APS can be considered exempt if it discusses only disease information without any mention of or allusion to drugs/medications/pharmacotherapy. Because the tool would be alluding to medication/pharmacotherapy via discussion of MoA, the APS would not be considered exempt.

Hey @maryssa The relevant standards of the PAAB Code of Advertising Acceptance are applicable to APS directed at HCPs and APS directed at patients when there is HCP involvement. This remains true regardless of how else the APS may be used. In questions 1 and 2, leaving physical copies of APS in an HCP's practice constitutes distribution involving the HCP. The HCP maintains full control over which materials are allowed to remain in their practice. It would be prudent, as a best practice, to seek permission from the HCP before leaving such materials in their practice. In question 3, the messaging is directed specifically to the HCP. The fact that the messaging is about a consumer campaign does not exempt it from the applicable provisions of the PAAB Code for the message itself. If inclusion of the DTC website/material is for awareness only, it would not subject to PAAB review. However, should there be copy that suggests the material is intended for consumption by the HCP or disseminated to patients through the HCP, e.g. “Tools and resources…”, “Learn more at…”, then the website/material would be subject to PAAB review. Conversely, in question 4, the HCP is receiving the message as a member of the general public. Therefore, the PAAB Code does not apply. While the question may be framed humorously (I would hope), the general public includes individuals from all walks of life, even HCPs. Don't forget the Advisory - APS in Patient Interaction Areas as well.

Hello @cchristopoulos The primary reason for the implementation of the RWE guidance document was to provide some flexibility around presenting evidence that was not previously accepted, in order to allow additional clinical data. Code section 3.1.4 states “Claims based upon laboratory or animal testing reports should be separated and cannot be used to imply clinical significance, unless there is evidence of a valid clinical correlation”. Unless the PK/laboratory-type data are unequivocally shown to have clinical relevance reflected by widely-accepted medical opinion and practice (e.g. authoritative consensus guidelines) and determined to be a valid endpoint (an example of this would be viral load in HIV), then a PK presentation would also not fall under the scope of the RWE guidance document.

Good afternoon @dmauri Please see the PAAB Advisory on Disclosure of APS Placement Details. The answer will be dependent on the ad and where it is being placed. A general question you could ask yourself is, “Am I creating a link between the brand and articles which may be considered off-label by virtue of exclusive placement?”. Note that the concern is the potential for placement to create a notable link between the brand and articles/content on the page(s) which could exceed the federal advertising regulations. This potential is amplified by exclusivity of ad placement.