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Ask PAAB is a question-and-answer system that allows you to ask questions anonymously to PAAB. They then post their answers in this archive on a periodic basis. If your question requires more immediate attention, we encourage you to contact PAAB directly. Please ensure that you ask your question in English. To view the PAAB Code of Advertising Acceptance, please click here.
Questions updated to: October 4, 2021
Is it acceptable to put a Sales Representative image as part of a VAE signature? So at the bottom of the PAAB approved email.
The PAAB logo is presented on pieces that are approved by PAAB. Any alteration to that piece, renders the display of the PAAB logo invalid. It should be submitted for re-review with a placeholder for the reps image. Please reach out to PAAB with the specifics of the eFile in order to determine next steps.
This question relates to PAAB code 3.2.3 (information on ongoing trials)
Q1: Can you please confirm the elements that can be included in an APS - Study design, objectives, endpoints?
Q2: We are assuming that when the code states 'ongoing' it means prior to an NOC which includes a trial that is no longer recruiting but collecting data.
Q1: Yes, study design, objectives and endpoints, can be presented in a non-promotional manner per code section 3.2.3. Remember that the study must still be in the data gathering stage, with no interim analyses having been performed (including safety analysis), and it must be disclaimed accordingly.
Q2: Please see Q&A 537 and Q&A 223.
A primary endpoint is stratified by multiple parameters, as stated in the TMA. Would it therefore be acceptable to include the subgroup analysis results for these parameters in advertising (Forest plot) from the published study, assuming they are statistically and directionally consistent with the overall primary endpoint result?
There are many considerations in the assessment of subgroup analysis for claims in advertising. See PAAB Guidance on Subgroup Analysis for more comprehensive guidance.
Hi, I wanted to confirm whether an unbranded disease awareness website that does not speak about treatment would need to be a gated site? The website would be targeted to HCPs and we would have campaign emails and digital banners linking to the website. Would this website also be considered PAAB exempt because it doesn't mention treatment?
If the website is disease state only and there is no direct/indirect mention of treatment, it may qualify as exempt. The promotion of the website would also need to have no mention of treatment. Mentioning treatment in a linked tool would be linking advertising to non-advertising (the exempt piece) and render it all advertising and subject to review. Note that there should be no branding elements such as colours or images that would link it to advertising. If the site is targeted to HCPs but there is no gate, DTC regulations would apply as well as HCP regulations. We would suggest this piece be reviewed for use in both audiences.
One additional caution. A disease state piece or campaign which focuses on a pathway or therapeutic area for which no products currently exists or the sponsor has a product coming for, may be perceived as pre-NOC advertising. See Pre-NOC Corporate/Editorial Communications.
Product name on sales business cards
If the unaltered PDF is being delivered via fax, this does not require re-review but should be submitted as an FYI for assessment. See also Q&A 650.
Hello, I've had a launch announcement PDF file approved for e-mail distribution by PAAB. If I want to send this exact same file via fax, do I need to get it approved again by PAAB? Thanks.
If the unaltered PDF is being delivered via fax, this does not require re-review but should be submitted as an FYI for assessment. See also Q&A 650.
Is the following service exempt from PAAB review, as we think it does not meet the the criteria for a promotional activity. A pharma company would use a vendor to include a link to a peer-reviewed, on-label, full publication for their approved product, on a website other than the journal in which that publication was published. The vendor has agreements with other health websites which are frequented by physicians and other HCPs. Some of these sites are also other medical journals. The link to a recommended article would be disseminated via a targeted approach - it would only be displayed to potentially interested physicians (eg/a certain specialty, only Canadian HCPs). the link is also clearly market as being driven by the vendor, and is labeled as being "recommended reading/other articles you may be interested in". The physician makes the decisions to click the link to be redirected to the other peer-reviewed article. The link could be time-limited, rather than an everlasting link. It could be limited to a certain number of clicks on the link or to a defined time period (ex/ 3 or 6 months). (see example https://ascopubs.org/doi/abs/10.1200/JCO.20.01366. Look at the grey vertical bar to the right "We Recommend")
Duration of the link, number of click, etc. would not be what renders this activity advertising or not. The nature of the link and the association that it creates could render it advertising. For example, paying to have a link to a study which favours the sponsors product in the context of a competitors study, could be considered advertising and may not be acceptable. Likewise, placing a recommended link to a study about the sponsors product in the context of a disease state or epidemiological study may also be considered advertising and would require the assessment of the appropriateness of the link. While this link could happen organically, when the sponsor influences this association, it may be considered advertising.
Hello, I work at an agency and one of our clients is considering a website for patients enrolled in their PSP. This website would be DIN gated at which point the patient can create an account using their email address. The patient would then receive a confirm profile email with a link to create a password. Once the account is confirmed, the patient accesses this site with the email address and password. All information within the site falls into the following categories: - navigational content - unbranded therapeutic area information previously approved by PAAB or ASC - branded patient-facing information previously approved by PAAB Our client is deciding if this is something worth pursuing and part of this decision depends on the regulatory requirements. Could you tell me if a website of this nature would require PAAB preclearance and, if so, which parts of the site would be subject to review. Thank you for your input.
When we link branded and unbranded content, all content is considered branded. Linkages include, but are not limited to, temporal, visual, direct or implied. By virtue of the fact that they are registering to the PSP as a patient on a product, all content provided through the patient support program is subject to the PAAB code and review.
Further to response to question 726, the FDA in the US has issued Guidance on Medical Communications That Are Consistent With the FDA-Required Labeling - Questions and Answers. This approach outlines that information about long-term safety/efficacy of products approved/cleared for chronic use may be considered "consistent with" the FDA-required labelling, if features of the use of the product (indication, population, dosage and administration etc) in the long term study are consistent with the authorized details in labelling. Given this science-based approach, it is not clear to me why PAAB's interpretation would be that this information is not consistent with the TMA in the context of a chronically used product. Can you elaborate on the rationale?
The current approach taken by PAAB is based on consultation with Health Canada based on the duration of time which they have assessed the product for safety within the Canadian population. It is not uncommon for the approach to advertising to be different within other jurisdictions such as the US. Having said that, you are likely aware that we’ve been actively engaging in global benchmarking activities in order to narrow the gap, were possible between Canada and other jurisdictions. We came across the FDA’s CFL guidance through those global benchmarking activities. We are currently looking into ways that this approach (or parts of it initially) can be incorporated into the Canadian regulatory landscape. We’ll soon be preparing a proposal for key stakeholders, which will include Health Canada. Keep in mind that PAAB review practices are not determined unilaterally by PAAB in a bubble.
Our corporate logo has recently changed. We would like to swap out our old logo with new one on digital assets that are PAAB approved. Do we need to notify PAAB as an FYI? Does this invalidate the approval somehow? Thank you.
It does not invalidate the pieces. The transition of the corporate logo can be performed without the need for an FYI. Note that this refers to the logo alone. Should taglines be added as part of the logo, this may invalidate some pieces and would require a new review.