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Special FeaturesLast update October 8, 2019

Ask PAAB

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We have enhanced the Ask PAAB section to make it more user-friendly due to the growing number of questions. You can now select a category of interest from the drop down menu above to view existing question and answers or you can also do a search for questions that have been submitted to Ask PAAB since the beginning.

Most Recent Questions and Answers
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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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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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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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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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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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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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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687

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?

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Deputy Commissioner  

Jennifer Carroll
Senior Reviewer Communications

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