725
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.
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Questions mises à jour jusqu’au: 4 octobre 2021
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731
Is the PAAB logo required to appear on HCP advertising or patient information approved by PAAB.
Yes. This also applies to editorials and corporate ads. Inclusion in RMTs is not permitted at all as these tools have not been reviewed for compliance with the Code. Health Canada has simply requested that PAAB review these tools to ensure they are non-promotional.
730
Hi Patrick, I have a question related to providing PAAB training. I remember few years ago you came to our company and you provided training. There have been many changes since then and I was wondering if you are still providing similar training. What is the cost associated with this type of activity?
Yes, we do still provide training as part of our ongoing commitment to help industry better understand the regulations. There are a few options. We provide in-house training, at a location of your choice. This is a 2 hour training session and the cost is $1000 plus travel expenses. We also offer national workshops once a year in Toronto and Montreal, which are full day sessions. This information can be found on the PAAB website under “About – Fee Schedule”.
721
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 Although the unpublished survey can be commissioned by the sponsor, the sponsor must have absolutely no influence over it.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.
720
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.
719
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.
717
How can I access archival copies of the PAAB Code? I am looking for the version relevant to 1996. Many thanks.
The PAAB website only contains the most recent version of the code so as to clearly promote current best practices.
714
If a representative during a social meal mentions to an HCP a reference to a slide that was viewed at another meeting to HCP's with regards to utilization rates of a genericized molecule, is this considered a violation?
The PAAB code applies to all advertising pieces (i.e. detail aid, website, email, etc.) distributed via all media (i.e. print, audio, visual, electronic, etc). A verbal communication between the representative and the healthcare professional does not fall under the scope of the PAAB code. However, verbal communication between a rep and an HCP is covered by the Food & Drugs Act and Regulations. If you are unsure about a specific topic or claim, a good rule of thumb is that if the content would not be approved in a print piece, the rep should likely not be discussing it verbally with a physician.
713
Can ongoing studies for a group of products (same therapeutic category) be discussed in a Corporate APS, or must this be done in individual branded APS? For example, a company has a portfolio of diabetes drugs that with ongoing research into weight loss indications, and would like to produce a single piece discussing all trials.
The main message conveyed in a corporate APS must be related to the company and its programs or services. If the messaging in the piece is strictly related to broad program-level messaging (e.g. a total of 1000 patients across studies in our cardiovascular research program), then the piece may meet the requirements of a corporate APS. That said, discussion of ongoing studies for an existing portfolio of products would likely be reviewed as a branded APS, as it relates to individual brands. This information could potentially be presented in a single APS as a co-promotional tool, with the information relating to each individual brand being separate and distinct. Reference to the ongoing studies must be made in a non-promotional context, with no prominence on information that has not been authorized by Health Canada. Be mindful that as branded tools, these pieces will require the indication and fair balance copy. Refer to AskPAAB Question #223 for more information on how we review ongoing studies, including studies involving off-label use, in branded APS.
716
Hello, I'm looking for where to find guidance regarding regulations for executing a 'help seeking' DTC campaign for vaccines at the same time as a branded DTC vaccine campaign. Given the DTC nature, pre-clearance would likely be through ASC. I've reviewed the guidance from Health Canada at length and am well aware of the criteria for help seeking. My understanding is that the help seeking and branded campaigns must be different (ie: in colour, tag lines etc) and not linked in any way, but I'm unable to find specific direction. I'd like to be more clear on how the campaigns must be different, assuming they are not linked in anyway (visually or otherwise), and if/how they may be executed concurrently. ie: can a vaccine help seeking TV ad be on during the same time a vaccines DTC branded banner ad or social media campaign is running (again, assuming not linked in any way). Thank you in advance for your assistance.
Your assessment is correct in that help-seeking messages, which are reviewed as DTC information, cannot be linked to DTC branded advertising as this would render all content subject to advertising regulations. The key here is understanding how linkages are created. To assess this we consider a number of factors, including:
- appearance (e.g. using branding colours or images)
- proximity (e.g. side by side presentation)
- sequence (e.g. a rep presenting unbranded disease information followed by branded product information)
- context (e.g. positioning a branded consumer banner ad on an unbranded disease information website)
If any of these factors would create a link between the two campaigns, such as concurrent airing/viewing of the messages, it would violate the regulations.