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Can we present two different brands, (which are two different therapeutic areas) in one APS (i.e. in a LB) as long as the indication and balancing info is presented for both brands?
The co-promotion of different products within a single APS is possible, even for different therapeutic areas. The key is that there is a clear separation of the content. For example, a two-sided card could promote drug A on the front, and drug B on the back. We can provide further direction on how to accomplish this during the review process.
A pharma company wishes to produce an Unbranded video that will be used by reps for a call with HCPs. The video will feature a patient campaign that has already been approved by PAAB. There are no claims being made in the video, and it just provides an emotional story behind the campaign. Would this be considered PAAB exempt?
As this sounds like a specific example, we suggest submitting for an opinion. As a generally guiding principle, if the unbranded promotional piece is for a branded patient campaign, it should be reviewed in the context of the brand, regardless of whether or not the brand is mentioned within the rep directed piece or not. The thought process behind this is that if you link branded and unbranded content, all content becomes branded and therefore requires review in the context of the brand.
If the program or unbranded campaign speak to “treatment” in any way (even without direct mention of a product), it would fall under the purview of the PAAB code and be subject to review.
If the program is unbranded, the piece is unbranded, and there is no mention or implication of “treatment” in either, it is possible that the piece is exempt from PAAB review.
Could you clarify a few points for us: 1 - Is a product indication (verbatim from the product monograph) seen as a claim by PAAB? 2 - If a detail piece, journal ad etc., contains only branding colours, brand name and product indication, does PAAB need to review this or is it exempt? 3 - Per question 2 above, if the piece also contains imagery related to the indication, does that change the PAAB review requirement? Thanks for the clarification.
Let’s assume that we’re talking about claims in HCP advertising. Pieces which include direct or implied claims (including the product indication) are subject to PAAB review. In fact including the indication would prompt the requirement for the lowest level of fair balance. This applies regardless of the imagery included in the piece (although imagery may result in middle or highest level fair balance being required if it alludes to other claims).
I have read the HC Policy 'Distinction between advertising...' for Press Release (PR). However I see many PR online that go beyond simply stating name and therapeutic area. Many PR mention efficacy and safety data. Am I misinterpreting the HC policy or can we in fact speak to the degree of efficacy and safety in a PR?
The Health Canada policy document “Distinction between advertising and other activities” provides criteria which may help determine if a particular message, such as a press release, is considered to be non-promotional and thus exempt from PAAB review. One of the conditions for press releases is that no statement is made regarding the expected safety or efficacy. Informative presentations of non-comparative findings from a recently completed clinical trial would be consistent with the distinction document. If the press release does not abide by all the criteria listed in the document, then it may be deemed promotional and subject to direct-to-consumer advertising regulations.
We have a study we would like to use to support a claim in a new tool. In this study “DRUG B” is used as an add-on to our product, whereas in our product monograph our indication is stated as an add-on to “DRUG B”. Would this be an issue?
The first step in assessing the acceptability of the study is to determine if it is consistent with the TMA. We would consider consistency with the indication/patient population studied, dosing, etc. As the indication specifies that the product is an add-on to drug B and it is not used in that fashion in the study, the study design does not appear to be consistent with the TMA. As this appears to be a specific question about a specific product and study, we suggest submitting the published study in an opinion file where we can assess the study design and consistency with TMA.
Would a DTC website directing consumers to speak to a healthcare professional about a medical condition be considered a help-seeking announcement or a consumer brochure? The content would not direct consumers to discuss treatment, only the medical condition in general.
The Health Canada policy document “The Distinction Between Advertising and Other Activities" defines a help-seeking message as a message asking patients among the general public with a particular medical disorder or who experience a given set of symptoms, to consult a physician for discussion of treatment or to call a 1-800 number for further information. In order to be considered a non-promotional activity, the specific drug cannot be identified, it may not imply that a drug is the sole treatment available for the disease/condition and no drug manufacturer’s name may be included.
If the website does not contain information related to treatment, but is related to a medical condition, and it directs the patient to speak to a physician, it seems to meet the requirements for a help-seeking message assuming no company name is mentioned. From your description of the piece, it appears that the help-seeking provisions would apply even though the public is directed to speak to an HCP about the condition (as opposed to speaking to an HCP about treatment options for a condition).
Question #242 discusses a Help-Seeking Announcement linking through to a Consumer Brochure with regard to disclosing the sponsor. Would the opposite be equally acceptable (Consumer Brochure linking to a Help-Seeking Announcement)?
Yes, the opposite would also be true. A tool meeting all the requirements of a Consumer Brochure from the Health Canada policy document “The Distinction Between Advertising and Other Activities" may direct patients to a help-seeking announcement if it also meets all the requirements of the Health Canada distinction documents (particularly referring to the provision to remove company logo’s), even though the Consumer Brochure may mention the company name.
Is a non-medical device associated with a drug be recognized as a therapeutic product regardless of whether the ad in question contains information about the drug itself in a direct to consumer standpoint?
In DTC would non-medical devices (i.e. Breezhaler/Respimat/Ellipta) be associated with their drugs immediately? As such be limited to the name, price and quantity in terms of messaging or would there be leeway to talk about device features in a comparative standpoint or would that be against the code?
Please see Ask PAAB Question #500 (search: Device). As it is our understanding that Breezhaler/Respimat/Ellipta are not Class I, II, III or IV medical devices, and promotion of these devices would be promotion of the products and therefore unacceptable
With regards to the PAAB-exempt regulations, and the requirement to not link to product information - can you confirm if the definition of linkage is in the language used in the piece? For example, if you had a webinar invitation that had only the product name (no indication, disease information, etc) however that invitation was inviting someone (via website link) to a webinar/registration page etc that was all PAAB reviewed/approved, is the invitation still PAAB exempt or by virtue of having a weblink (or intention to direct to PAAB-approved material if it were paper copies etc), is the invitation now in scope of PAAB review?
Linkages can be created in many ways, such as, by proximity, appearance (i.e. using similar imagery or branding colours), and by including language in the piece which directs the reader to a specific site/content. This content does fall under the PAAB scope of review. We suggest submitting the invite (quoting the efile number for the PAAB approved registration page) to PAAB as an exemption request, as an assessment of the combined content is required to ensure that the linkage does not affect the exemption status of the invite.
Jennifer Carroll
Senior Reviewer Communications
Pharmaceutical Advertising
