YOUR QUESTIONS? ALL ANSWERED
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
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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.