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georgian21

@georgian21
Agency
PAAB Notice
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. This prohibition includes, but is not limited to, use in machine learning or AI models.
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Recent Best Controversial

  • DTC Ads on Google Responsive Ads Platform
    G georgian21

    Our clients are looking to run a DTC campaign on the Google Responsive Ads platform with ads that direct consumers to a PAAB approved DTC website (disease information only, not branded) where the sponsor company logos/legal copy are always visible in the footer (per Health Canada "Guidance on distinction between advertising and other activities for health products").

    Is it a PAAB and/or Health Canada requirement that the sponsor company logos or names must also appear in the Ads themselves? As this platform functions by having Google’s AI find the best-performing ad combinations to maximize results, we can’t always control whether all logos will appear (especially with text only ads which don’t allow for any logos).

    Additionally, as we will be submitting the ads content for PAAB approval, does the PAAB logo always need to displayed?

    Guidance on DTCA / DTCI Regulations

  • PAAB Code 3.2.3
    G georgian21

    Reference to research or ongoing studies may be made in a non- promotional context with no prominence on information that has not been authorized by Health Canada. A study involving off-label use, which has been completed, has undergone an interim analysis, or has been presented at a medical meeting, and incorporates information that is not included in the Health Canada TMA, must not be mentioned in advertising.

    In the Oncology space, one drug can, overtime, get studied in other completely different diseases (or tumour sites). If a TMA exists for disease A and is currently being studied in disease Z (completely unrelated), are the studies considered off-label or pre-NOC (not yet authorized by Health Canada)? I feel it is the latter given that it is a distinct disease (and indication) but wanted to double check

    PAAB Code

  • 3rd Party Unbranded Videos
    G georgian21

    We would like to provide patients (via Physicians or via DTC) or send patients to a video hosted on a 3rd party Patient-focused website (an association). The video discusses a class of drugs where there are a handful of agents. The video was produced independently with no sponsorship or grant. There is no mention of any one specific drugs.

    Can a company promote this video (meaning send patients to it)? Does the video need to be reviewed by PAAB? Can the company sending patients to the video put their logo on the materials used to disseminate or promote the video?

    PAAB Code

  • DTC Website Review
    G georgian21

    How long PAAB take for the 1st round of review of a DTC website (unbranded, help seeking)?

    DTCA/I, consumer secondary audience

  • Sharing International Guidelines links
    G georgian21

    When sending email communication to a HCP, is it allowable for a manufacturer to include a link to US or European Guidelines (the entire PDF, not to specific content within the document) - if there are also Canadian Guidelines in place for the same therapeutic area? The intent is to direct the HCP to the US or European Guidelines for information only and not to make any link to brand communication/claims.

    Claims & Support/References for Claims

  • Sodium comparison
    G georgian21

    Let’s say product A contains mg of sodium. We are finding that HCPs have little context to assess whether this amount is high or low. Would PAAB accept a sodium comparison based on the labels of the various products – these drugs being OTC and/or Rx – if they are from different categories and have different indications

    PAAB Code

  • Branded and Unbranded APS in Conference Setting
    G georgian21

    @jennifer-carroll Thank you.

    Just to clarify, Drug A (unbranded) and Drugs B/C (branded) would belong to different disease areas.

    Would that change the PAAB ruling?

    Non-product branded APS, pre-NOC teasers

  • Branded and Unbranded APS in Conference Setting
    G georgian21

    In a conference setting, is it possible to display unbranded Disease State advertising (helping educate about the disease prior to the launch of Drug A) along with branded content for Drugs B and C (which are already in the market)?

    Non-product branded APS, pre-NOC teasers

  • Sending Presentations to Doctors
    G georgian21

    When submitting materials to PAAB, you have to select various options to describe the APS: Leave Behind, Presentation, Email etc. Then PAAB reviews in that particular context.

    Are there any limitations in providing a copy of a PAAB-approved Presentation to a doctor directly following the actual presentation of the content.

    PAAB Code

  • Emailing Guidelines to HCPs
    G georgian21

    56c764a1-aaf0-447f-9c94-ddeb0e19419a-image.png Is the following Rep email considered as PAAB exempt? The email contains no brand logo, has an open field for the Rep salutation and 1 line of copy: “Here is the link to the complete Guidelines that we discussed today”.

    Here are 4 different scenarios:

    1. Guidelines are Canadian and fully aligned with TMA of product. The link in the email points to the first page of the Guidelines.

    2. Guidelines are International, endorsed by a Canadian authoritative source and fully aligned with TMA of product. The link points to the first page of the Guidelines.

    3. What changes if the link points to a specific page within the Guidelines vs. the first page?

    4. What changes if these same Guidelines contain data or information not reflected in the TMA of another product in a different therapeutic category that is promoted by the same Rep (target audience would also be different)?

    Miscellaneous
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