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Jennifer CarrollJ

Jennifer Carroll

@Jennifer Carroll
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

  • Presenting AE rates using a higher incidence threshold than what is used in the PM
    Jennifer CarrollJ Jennifer Carroll

    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.

    Claims & Support/References for Claims

  • Fair Balance required for email linking to clincial paper
    Jennifer CarrollJ Jennifer Carroll

    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).

    PAAB Code

  • Clarification on Product Available now! message in the APS
    Jennifer CarrollJ Jennifer Carroll

    Hey @Supriya

    This appears to be a specific question about a specific piece. Copy around “new product availability” is broadly open to interpretation. PAAB would also need to see the third-party program site to assess the combination of all messaging within the piece and the linked content. We suggest submitting for an opinion.

    General Discussion

  • Promotional activities on-line
    Jennifer CarrollJ Jennifer Carroll

    Hey @Pauvian

    Advertising in a consumer space must meet the consumer regulations (i.e. does not exceed name, price, quantity for prescription (Rx) products or treatments for schedule A diseases). We would advise against including the DIN as this is a standard mechanism for gating patient information. Including the DIN would require assessment of all patient sites for the product to ensure this list is not promoting the password to the general public.

    Note that the question is in response to a “list”. The website appears to contain additional elements (such as pictures) which may render the site in non-compliance. We’d recommend submitting for an opinion in order to fully assess the complexities of the proposed activity.

    PAAB Code

  • Clarification on indication inclusion in multi-Product APS
    Jennifer CarrollJ Jennifer Carroll

    Hey @Supriya

    This appears to be a specific question about a specific piece. The piece should be submitted for assessment. The forum is for general questions. As an example, a general question here might be “Is the inclusion of an indication statement required in materials directed exclusively to healthcare professionals, where no therapeutic or pharmacologic claims are presented”. The answer to this question would be, that the indication is not required when there are no marketing benefit or therapeutic claims (see Marketing benefit claims: What are they and what level of support do they require?).

    General Discussion

  • Price Comparisons
    Jennifer CarrollJ Jennifer Carroll

    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.

    Claims & Support/References for Claims

  • Prescription Pads/Tools
    Jennifer CarrollJ Jennifer Carroll

    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".

    PAAB Code

  • Assessment of Risk Management Tools (HCP/Patient)
    Jennifer CarrollJ Jennifer Carroll

    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.

    Comments & Feedback

  • PAAB AI Regulatory Model - Opt-in deadline - Thursday
    Jennifer CarrollJ Jennifer Carroll

    📆AI MODEL - Phase I Testing Opt-In Deadline!

    @Manufacturer the Pharmaceutical Advertising Advisory Board (PAAB) is taking a significant step forward in innovation by launching the first phase of testing of our ground-breaking AI model on live files starting May 1st.

    On April 1st, in preparation for launch, we sent an eblast to industry announcing the deadline for full opt-in was now set for May 1st. Manufacturers who opt-in after the May 1st deadline will likely need to wait until a sufficient number of additional opt-ins are accumulated. This grouping of late opt-ins is intended to support cost-effectiveness.

    This initiative marks a major milestone in enhancing the efficiency, consistency, and effectiveness of advertising review processes for our industry. Ensuring that preclearance keeps pace with the speed and quantity of specialization afforded through AI adoption across the industry.

    If you have not yet reached out to PAAB and want to be among the first to experience the benefits of this exciting new project, please contact info@paab.ca today.

    @Agency we'll be reaching out shortly for your collaboration on the AI driven augmentation of the submission process.

    Cheers
    PAAAB

    Announcements

  • Pooled long-term extension data
    Jennifer CarrollJ Jennifer Carroll

    Good Morning @HollyMed

    Pooled data is not acceptable even if part of a pre-planned long-term extension study.

    Miscellaneous

  • Clarification on indication inclusion in multi-Product APS
    Jennifer CarrollJ Jennifer Carroll

    Good Morning @Supriya

    We assume that you are referring to a patient targeted APS. As a patient would not have a prescription for all the products, this would contravene the direct-to-consumer advertising (DTCA) regulations (Section C.01.044 of the Food and Drugs Act Regulations) to create a link to the therapeutic use (i.e. indication could not be included) for products they are not prescribed. While the three base levels of fair balance apply only to HCP-targeted APS, a weblink to the Terms of Market Authorization (TMA) links the therapeutic use, a violation of the DTCA regulations.

    General Discussion

  • Client Survey Report - 2024
    Jennifer CarrollJ Jennifer Carroll

    🔍 What did we learn from you in 2024?

    In October, PAAB sent out our Client Survey to better understand your experience with us — what’s working, what’s not, and where we can grow together.

    This year’s survey offered deeper insights into awareness of recent Code and guidance updates, and helped us identify how we can better support your PAAB experience moving forward.

    🙌 Thank you to everyone who participated. Your feedback is already driving improvements across training, review practices, and communication.

    📄 Check out the full Customer Insights Report

    Announcements

  • Adverse events rates that are not included in the PM
    Jennifer CarrollJ Jennifer Carroll

    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.

    Claims & Support/References for Claims

  • Adverse events rates that are not included in the PM
    Jennifer CarrollJ Jennifer Carroll

    Hey @dmauri

    Please see PAAB Q&A 427.

    In summary, as per PAAB code section 5.9 and 5.7, when a side-by-side comparative presentation of out-of-TMA safety profile data is desired, a head-to-head RCT with demonstrated statistical analyses between the adverse events that are being compared should be provided as substantiation. In cases where such substantiation is not available, a comparative presentation would not be acceptable. Note that PAAB can consider a neutral comparative side-by-side AE presentation without statistical analysis or conclusion, if it exists in the TMA.

    Claims & Support/References for Claims

  • Clarification on conditions of proportional resize eligible for FYI
    Jennifer CarrollJ Jennifer Carroll

    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

    FYI post-approval change/preclearance exemption/what requires review/PAAB scope fyi

  • question on HCP targeted communication on LinkedIn
    Jennifer CarrollJ Jennifer Carroll

    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.

    Electronic Media

  • Letter of attestation
    Jennifer CarrollJ Jennifer Carroll

    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.

    Claims & Support/References for Claims

  • Samples
    Jennifer CarrollJ Jennifer Carroll

    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.

    Miscellaneous

  • Unbranded Patient and HCP APS
    Jennifer CarrollJ Jennifer Carroll

    Hi @caitlinbyrne

    When an APS has more than one audience, all regulations for each audience apply. The tool would be reviewed to ensure it meets patient and HCP regulations. Generally the patient regulations are more stringent so we recommend strongly considering them when creating the tool.

    PAAB Code

  • Images of real patients' skin condition improvements
    Jennifer CarrollJ Jennifer Carroll

    Hi @hollymed

    Please see this PAAB Forum Q&A

    Claims & Support/References for Claims
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