697
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?
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View Answer [+]
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.
696
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?
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View Answer [+]
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.
695
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.
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View Answer [+]
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).
694
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)?
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View Answer [+]
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.
693
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?
692
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?
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View Answer [+]
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
691
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?
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View Answer [+]
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.
690
On what basis (code?) should a DTC magazine ad be prepared for a nonprescription drug product that is sold to the general public with the intervention of a healthcare professional ("ethical" drugs)? Secondly, should such DTC material be reviewed by PAAB or or by Ad Standard Council of Canada?
689
For clinical endpoints that are a composite of two or more measurements, is it permissible to show the individual measurements if they are not included in the TMA (ie. only the composite endpoint data is stated) ?
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View Answer [+]
If the individual components of the composites meet all relevant code requirements and guidelines (e.g. pre-defined statistical analysis for individual components, directionally consistent with overall, within the limitations of the indication) then individual components of a composite can be presented. Note that they should be presented in the context of the overall composite endpoint. Caution: There are many potential reasons why all relevant code requirements might not be met. For example, last week I saw an example in which the TMA study was not blinded and the endpoints were subjective. We therefore had to limit the APS presentation to the content found in the TMA.
688
Non branded APS I just read the following Ask PAAB questions and I require clarification: Are we required to send material on disease awareness to the PAAB, even if there is no product metnion? Hide Answer [-] PAAB Code section covers editorial pieces generated by a pharmaceutical company. That means the piece would not exist without the pharma company's financial involvement. The PAAB reviews editorial pieces where healthcare products are mentioned. See Code s7.8. Therefore, if you are talking about mechanism of action of how a therapeutic class works, and the piece is sponsored by a healthcare product manufacturer, I would say that would require PAAB review because it would be difficult not to allude to the sponsor's product and it would appear to promote the sale of that product indirectly. See Code s11.1 for a definition of "advertising" applicable to the PAAB code. Section 1 describes the scope of the PAAB Code. Editorial pieces about disease awareness that do not mention healthcare products directly or indirectly through class would be exempt from PAAB review. Keep in mind bundling that type of piece with product advertising would make the whole thing "advertising" subject to the regulations.
My question: I am working on a non-branded piece for a pharma company that will definitely send for PAAB approval. It will talk about the co-morbidity involved with a certain disease, and how this co-morbidity affects quality of life. There will be no product mention. I don't even know if this truly needs to go through PAAB or not. But assuming PAAB approval is required, what type of references would be considered acceptable in terms of talking about typical patient symptoms with various co-morbidities, and medical tests that are done to identify or qualify those co-morbidities. For example, if we want to use medical guidelines that are published in a medical journal to talk about the medical tests required to identify a particular co-morbidity, would that be acceptable? Any tips on what would not be considered acceptable for this type of APS so that I can steer clear from these issues right from the start?
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View Answer [+]
Unbranded disease information should be supported by authoritative sources. This could include published medical textbooks or guidelines. The PAAB review will assess alignment with the authoritative source and it will act as a check that the content does not indirectly allude to the sponsor’s (or a competitor’s) product.
If the piece does not include mention or allude to treatment in any way, and is restricted to disease type information, then it may be exempt from PAAB review. This can be assessed during the review process if you are unsure.
