Yes. Please see Ask PAAB questions 560, 528 and 500 (search: Device)
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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?
Yes. Please see Ask PAAB questions 560, 528 and 500 (search: Device)
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.
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?
Both PAAB and Ad Standards provide review services for direct to consumer advertising of products of products requiring HCP intervention (e.g. vaccines and ethical drugs). You may refer to the Health Canada document “Health Canada and Advertising Preclearance Agencies’ Roles Related to Health Product Advertising”: http://www.hc-sc.gc.ca/dhp-mps/advert-publicit/pol/role_apa-pca-eng.php
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) ?
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.
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?
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.
Regarding teaching tools (slides, desktop tool) used by HCPs to educate patients: Is it possible to include efficacy information in a piece to be used by HCPs with patients, recognizing it would be a clinic-based tool and not something taken away by the patient? Is there a regulation or code that prohibits HCPs from educating patients about efficacy results? Is there any resource that explains why this information is not included in part 3 of the Product Monograph?
As patient teaching tools are used to educate and share disease and product information with patients, the content in these tools must meet the advertising regulations for patient information (see section 6 of the PAAB code). Essentially, patient pieces must contain non-promotional information, consistent with part III of the Product Monograph. As efficacy results are promotional, inclusion of this information in patient teaching tools is prohibited. This standard applies whether it is a teaching tool viewed in the physicians office, or information which can be taken home by the patient.
For further information on the content and review of Part III of the TMA, we suggest directing your questions to Health Canada.
If we want to create an email invite which links to a promotional branded webinar (paab approved), do we have to submit the invite to paab (if the invitation itself has only name of product, time, date & link for registration)?
The invite itself is a branded promotional piece targeting healthcare professionals, and therefore falls under the PAAB scope of review. The question is, does the invite meet the PAAB exemption criteria outlined in section 1.5 of the PAAB code. Based on the description of the invite, there does not appear to be any content which would render it subject to PAAB review. However, we suggest submitting the invite for an opinion, to ensure that the combined content in the piece, including any creative elements, taglines, etc., are considered exempt from PAAB review. An assessment of the link to the branded webinar can be conducted in the opinion file.
Does the PAAB have criteria when it comes to determining acceptability of high-quality meta analyses, with respect to clinical claims?
When assessing the acceptability of any study, “high quality” means that adequate steps have been taken to ensure that the observations are not due to random luck or systematic bias (whether methodological or confounding). This can only be assessed if the study report is comprehensive. For meta-analysis, we look to the PRIMA checklist, this checklists does not tell you whether a study is high-quality, but it does tell you what parameters one needs to know in order to make this assessment.
Please note that a high-quality published and peer-reviewed meta-analysis can be considered as standalone evidence for disease information. Such meta-analysis can also be considered for therapeutic claims that are supported by individual RCT data presented in the APS (i.e. as additional evidence). It should also be noted that meta-analysis data from the TMA can be used in a manner that is consistent with the context and emphasis of the TMA presentation.
When two companies are co-promoting a product and using the same material approved by PAAB, are the promotional materials required to display both company names and/or logos or can the material have one company name and log and still be used by both companies?
The co-marketing of a product and identification of one or both manufacturers in branded advertising is not a PAAB requirement. This is something that can be determined by the two companies involved.
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