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?
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View Answer [+]
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.
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View Answer [+]
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.
718
If a efile was previously exempted and no changes were made, does the file need to go through PAAB assessment again (re-exemption)?
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View Answer [+]
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.
717
How can I access archival copies of the PAAB Code? I am looking for the version relevant to 1996. Many thanks.
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View Answer [+]
The PAAB website only contains the most recent version of the code so as to clearly promote current best practices.
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.
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View Answer [+]
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.
715
Hi, I'm from the Arthritis Society. I have a company that is currently developing a product; in phase 2. They want to support/sponsor one of our tool in a field that is relevant to their upcoming indication. Content and material will be elaborate by the Society without any interference by the pharma company. Would that interfere with any regulation in Canada. If so, which one? Thanks Ken Gagnon kgagnon@arthritis.ca
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View Answer [+]
The content and message of the piece that they are planning to sponsor/support would dictate the acceptability of the activity. If the content speaks to therapy, it should be reviewed to ensure that there is no competitive bias or off-label content. For example, if the piece were to discuss modulating a pathway for which there are no approved drugs with that specific mechanism of action, this would be deemed pre-NOC advertising and would not be acceptable. As such, we suggest that this type of content be reviewed as an opinion, to ensure that the content meets the regulations.
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?
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View Answer [+]
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.
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View Answer [+]
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.
712
We have an online newsletter where we post healthcare-related information, as well as society news pertaining to our association. Our member and supporter base primarily consists of hospital pharmacists as well as a small number of architects, students, and pharmaceutical companies. We can set-up advertising on the site to require a login to limit access by the general public. My concern is with the students who are not yet healthcare professionals, the pharmaceutical organizations, and the small number of architect members. Would their exposure to pharmaceutical advertising go against PAAB standards, even if we include a disclaimer that the advertisements are meant for healthcare professionals only? When we used to have a print journal that contained advertising for pharmaceutical products, the same individuals would have received copies of it. To my knowledge, this was not an issue in the past. However, we would appreciate some guidance to ensure we are being PAAB compliant, as online advertising is new to our association. Thank you kindly.
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View Answer [+]
The regulations that are applicable to your question emanate from Health Canada rather than the PAAB. In other words, the question in this case should be are you Health Canada compliant rather than are you PAAB compliant. Nonetheless, we can provide an advisory opinion on the matter.
It sounds as though the publication does not target Healthcare Professionals specifically. As such, the consumer advertising regulations set the boundaries for which ads are permissible in the publication. These regulations differ based on the Federal Drug Schedule of the product being promoted. As an example, direct-to-consumer advertising for prescription drugs is limited to name, price, quantity and direct-to-consumer advertising of narcotics is prohibited. These regulations apply to both digital and print pieces.
711
Can patient survey data from CADTH be used for an unbranded tool on current patient experience and behaviour?
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View Answer [+]
CADTH is an important tool for explaining recommendations for funding decisions, but it is not designed or intended to support product claims in drug advertising. See AskPAAB question 541 for more information on this topic.
For claims related to patient experience and behaviour which do not relate to pharmacotherapy (i.e. disease attitude and opinions), then we may consider surveys as a source depending on the design, and execution of the survey. However, the primary source to support these claims should be the survey itself, not the CADTH document.
