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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.
  • 0 Votes
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    A
    As a follow-up to Q&A 577, we understand inclusion of the written statement “See Formulary listing for more information” would still be exempt for a simple “Now on Formulary” Email. Can you please advise if an indirect link to a general Formulary/Provincial homepage would maintain this exemption? The Sponsor has done their diligence in not directly linking to the therapeutic use, and the onus would be on the HCP to seek out the product information (if desired) through the Formulary.
  • Consensus Guidelines

    PAAB Code
    3
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    3 Posts
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    M
    Hi @Jennifer-Carroll , thank you so much for confirming!
  • Guidance on Patient Reported Outcomes

    Guidance on Code Application
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    3 Posts
    958 Views
    Jennifer CarrollJ
    Hi tk2022 Please see our more recent “Guidance on Real World Evidence/Data” for criteria and direction on the presentation of RWE in advertising to health care professionals. Please also see our "Guidance on the use of the Attention Icon" regarding unblinded data.
  • Clinical Guidelines

    PAAB Code
    2
    0 Votes
    2 Posts
    172 Views
    Jennifer CarrollJ
    A sale representative may leave a physician a full, unedited copy of a published, authoritative consensus guideline for a given condition. Please see the linked document on “What constitutes current medical opinion and practice?”. Depending on the nature of the visit, please also be reminded that distribution of material by a sales representative may constitute an act of advertising and should adhere to the advertising regulations, e.g. product specific guidelines on off label use would be a violation of the regulations.
  • 0 Votes
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    Jennifer CarrollJ
    Hello @dmauri PAAB will generally consider alternate cut offs from the TMA if it does not appear to be minimizing the risks of the product. The alternate cut-offs should not remove pertinent ADRs/safety information that would otherwise be important to the product and within the therapeutic landscape. The TMA should also not have other safety considerations that would preclude the higher percentage cutoff.
  • Fair Balance required for email linking to clincial paper

    PAAB Code
    2
    0 Votes
    2 Posts
    237 Views
    Jennifer CarrollJ
    Good Morning @Jennifer_CM Linking out to an unedited acceptable reprint would not render the email subject to highest level fair balance. The level of fair balance would be assessed based on the content of the email body in combination with the linked content. Therefore, it’s likely that the level of fair balance could be lowest level if the body copy does not prompt middle or highest itself as per the PAAB Guidance on Base Fair Balance Level Selection and Placement (HCP Advertising).
  • 0 Votes
    3 Posts
    336 Views
    S
    Thank you @Jennifer-Carroll!
  • Promotional activities on-line

    PAAB Code
    3
    0 Votes
    3 Posts
    314 Views
    P
    Jennifer, thank you very much for your prompt answer. We will do that.
  • 0 Votes
    5 Posts
    575 Views
    S
    Thank you @Jennifer-Carroll. This is very helpful!
  • Price Comparisons

    Claims & Support/References for Claims
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    0 Votes
    2 Posts
    240 Views
    Jennifer CarrollJ
    Good Morning @Constance PAAB would need additional information to make the assessment of the claim proposed above. There are many considerations outside of just the source such as, does it suggest equivalence between products on a per unit basis and what is the intent of the per unit comparison. Given these unknowns, it is difficult to provide a definitive answer in a general space. We suggest submitting the copy for review.
  • Prescription Pads/Tools

    PAAB Code
    4
    1
    0 Votes
    4 Posts
    624 Views
    Jennifer CarrollJ
    Hey @GMC This copy would be reviewed in the context of the entirety of the piece. The context of the message “dispensed as written” will matter. See also the PAAB advisory on Advertising messages referring to "no sub".
  • 0 Votes
    2 Posts
    257 Views
    Jennifer CarrollJ
    Hey @mhouzer The difference between the Standard 4-day initial review of RMTs and submitting as an ARO-4 is that the subsequent revision turnaround time will be an expedited 2-days rather than the standard 3-days. If you anticipate needing a few rounds of back and forth, this can be a good option to get to your final letter more quickly.
  • PAAB AI Regulatory Model - Opt-in deadline - Thursday

    Announcements
    1
    0 Votes
    1 Posts
    252 Views
    No one has replied
  • Pooled long-term extension data

    Miscellaneous
    2
    0 Votes
    2 Posts
    258 Views
    Jennifer CarrollJ
    Good Morning @HollyMed Pooled data is not acceptable even if part of a pre-planned long-term extension study.
  • Client Survey Report - 2024

    Announcements
    1
    1 Votes
    1 Posts
    130 Views
    No one has replied
  • 0 Votes
    4 Posts
    482 Views
    Jennifer CarrollJ
    Hi @dmauri This would not apply to comparative data. As per the first sentence “statistical analysis to support inclusion of comparative therapeutic data” is required. The comment also states that the AEs have to be aligned. Your original question appears to suggest that you are looking to speak to AEs which are not presented in the TMA and therefore would be difficult to demonstrate alignment.
  • 0 Votes
    2 Posts
    245 Views
    Jennifer CarrollJ
    Apologies for the delay @SMurcar. We were in the process of upgrading the forum over the last two days. As the piece would be moving from two sided to one sided this would change the flow. The content in the top section may set context for the bottom section depending on the formatting and flow. We would suggest submitting for a minor update (if the resizing is intended to replace the small postcard altogether) so that we can assess the revised visual flow to ensure all aspects of the Code remain met. The addition of the QR code as described above could be considered as a minor update. Please see the Submission Guidelines for more information
  • question on HCP targeted communication on LinkedIn

    Electronic Media
    2
    0 Votes
    2 Posts
    285 Views
    Jennifer CarrollJ
    Hey @cscholes We understand that LinkedIn is an ungated platform and open to consumers. As such, the site is subject to consumer regulations similar to PF question 458 and is highly restricted for prescription advertising. Targeting to HCPs within the open platform may not guarantee that consumers won’t see the ad as well. Please also see this linked PF question and our Guidance on Gating Mechanisms for Healthcare Professional Targeted Digital Assets and subsequent clarification document Gating Mechanisms for HCP Digital Assets (designed in collaboration with Health Canada) regarding HCP validation. How HCPs are identified and verified, the nature of the targeting and how well it can limit the audience to only validated HCPs would be information that is required as part of the review process. PAAB will provide advice and direction based on the Health Canada DTC regulations, the PAAB code principles and the information that the sponsor can provide for the restriction of the intended HCP audience within this consumer space.
  • Letter of attestation

    Claims & Support/References for Claims
    2
    0 Votes
    2 Posts
    228 Views
    Jennifer CarrollJ
    Hey @mimi77 This sounds like a file specific question which should be addressed with the review through the eFiles ticket system. If the question is with respect to “attestation letters” in general term, there are many different reasons an attestation letter might be required in a file. The person signing the attestation letter can vary depending on the copy. Most commonly attestation letters are signed by a representative of the manufacturer’s medical or regulatory team. It may be possible for it to be a representative from the global team. There are a number of Q&As which address attestations which may also support your understanding.
  • Samples

    Miscellaneous
    2
    0 Votes
    2 Posts
    249 Views
    Jennifer CarrollJ
    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.