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For advertising a Rx or OTC drug to HCPs, could we add more safety information such as contraindication, warnings...beyond what is in the approved TMA? considering that it is for safety reason e.g. contraindicated in asthma patients (but not stated as such in the TMA). This would be based on a published study or guidelines.
Additional cautionary copy beyond the limitations of the TMA are acceptable and at the discretion of the sponsor. Note that the copy should be purely cautionary, and should not be positioned as a promotional or positive feature of the product and should not be comparative. Any claims would be subject to all requirements of the code for levels of evidence.
Hi Patrick, I often find it easier to apply PAAB code when I understand the rationale behind it. But I have struggled to understand the blanket application of section 3.1. In many instances, the PAAB requirement that claims remain "within the limitations of the TMA" makes sense - specifically when "beyond the limitations" is also off label. However, I am curious to know why efficacy and safety data from longer-term, follow-up of the pivotal trial population is not allowed - especially when we hear from physicians that this is the information they are most interested in. As long as there is no limitation on length of therapy, why not allow longer-term clinical information to be shared with physicians? What is the rationale for blocking it?
The rationale for limiting the duration of data presented to that which is presented in the TMA, is that this is the duration for which Health Canada has reviewed and assessed both the efficacy and safety. In order to present the data beyond this time point, we suggest submitting a revised TMA to Health Canada which demonstrates that they have reviewed the data out to the new time point. This can be as simple as copy such as “Results maintained out to 52 weeks” or something similar. At that point in time, we can review the long-term 52 week data.
Question #497 - Patient video for product use on company website , has Health Canada provided a response?
We have not received a response to date. We will pose the question to them again. Thank you for the follow-up.
We have an HCP piece approved by PAAB to be used as a print Leave-Behind. We would like to use a part of the content (unchanged) for a digital advertisement. Does is require to be submitted to PAAB as a new file?
Yes. PAAB reviews pieces in their entirety. Reproduction of part of a piece would not be representative of the full review and may not meet the full requirements of the code. The digital advertisement should be submitted for review as a new piece.
For further information, we refer you to the “Digitizing Print APS” section of the PAAB Guidance Document for the Submission Process.
We are in the early stages of planning a website for use by healthcare professionals and patients (gated appropriate for each) to access disease and product information for multiple therapeutic areas. For convenience, we wish to create on the ungated home page a link to a portal (also gated) housing accredited CHE for healthcare professional sponsored by the company, The user would be notified that they were leaving the main site and as mentioned they would have to pass through the gate of the CHE portal. Some of the accredited CHE may contain content not consistent with product TMAs. How do we avoid any linkage issues while offering convenience to healthcare professionals of going to one location?
This sounds like a specific project with many facets which should be considered. We suggest setting up a consult meeting or submitting for an opinion. As a starting consideration, please consider that content should be housed in different sections of the site to create a high degree of separation.
Understanding that Help-Seeking messages can not include the sponsor, what if a message was broad enough not to allude to a single product? eg. “Ask your doctor about CV medications from Company-X”.
This would still be considered a help-seeking message and create a link between a condition and the sponsor. It is not acceptable to direct patients to their doctors for treatment for a specific condition from a specific manufacturer.
Can a patient survey be used to support claims of ease of use? Would it make a difference if the prescription product were administered through a Class-II medical device?
A survey can be considered for use to support non-clinical product claims such as taste, smell or attitude regarding easy of administration if it is deemed to be adequately designed, unbiased and statistically validated data. This means that it must be either published and peer-reviewed, or designed, conducted and analyzed by a third party. Although the unpublished survey can be commissioned by the sponsor, the sponsor must have absolutely no influence over it. For example, the sponsor must not have influence over the protocol planning, protocol implementation, data collection, data analysis, or creation of the report. The sponsor must also not have review privileges of the report prior to its finalization. The scope of the PAAB Code currently excludes claims related to Class I, II, III, or IV medical devices as defined in the Medical Device Regulations. However, it is the sponsor’s responsibility to ensure that all device claims are in compliance with all applicable marketing rules and regulations (please see AskPAAB Q&A #183). Device claims should be separate from drug product claims and should not infer significance to the drug product.
What are the rules regarding using similar graphic symbols for branded PAAB approved promotional pieces addressed to HCPs and branded DTC materials for the same OTC product. Is it acceptable that they have the same graphic elements such as icons to illustrate the approved claims/indications?
The link created by using the same visuals (including but not limited to graphics, images, colours and even fonts), is not necessarily problematic, as the content in both cases is branded and as the consumer would not be privy to the HCP pieces. Keep in mind however, that the DTC pieces would be reviewed based on consumer regulations, while the HCP piece would be reviewed based on the PAAB code. This may result in some images which were acceptable for HCP’s, not being acceptable for consumers and vice versa.
With regards to Question #645, the question asked about repurposing a piece approved for DTC use with "potential patients". Is a potential patient not viewed as a consumer? I thought the definition of patient was restricted to those who had already been prescribed a drug. I had previously been advised by a PAAB reviewer that pieces for "potential patients" would be reviewed as DTC. Could you please clarify the differences in these audiences? Thank you.
In differentiating between consumers and potential patients (someone who has not yet been prescribed a drug), the mode of distribution becomes an important factor. In the scenario describe in Question #645, the DTC piece is now distributed through HCPs to potential patients. The interaction has now changed to a counselling tool in which the healthcare professional selects the appropriate patient audience in the context of a condition. As the audience has changed to patients, the content is now subject to the standards of the PAAB code. As a result, the rigors for quality of evidence change.
If a efile was previously exempted and no changes were made, does the file need to go through PAAB assessment again (re-exemption)?
A piece that has been deemed exempt does not require “re-exemption” as the piece does not require review. If something has changed in the marketplace to prompt the re-evaluation of whether something is exempt, than it may require a new look. Assuming that nothing has changed that may challenge the exempt ruling, no approval number is given and therefore no expiry date applies.
Jennifer Carroll
Réviseur principal en communications
Le Conseil Consultatif de
