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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View Answer [+]
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.
686
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)?
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View Answer [+]
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.
685
Does the PAAB have criteria when it comes to determining acceptability of high-quality meta analyses, with respect to clinical claims?
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View Answer [+]
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.
684
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?
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View Answer [+]
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.
683
Hi Patrick I've been told that vaccines fall under different promotional guidelines than other prescription medicines. We are putting together a now available pharmacy fax for our soon to be promoted vaccine and wanted to confirm if we need PAAB approval on this or not. The communication would include the brand name, logo, indication, price, DIN and product number. It would also include corporate trademarks. Thanks
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View Answer [+]
Vaccines are schedule D products and differ from prescription medicines mainly with respect to DTCA. Consumer advertising materials for products in the “prescription” schedule are restricted to name price and quantity. Manufacturers may promote the therapeutic use of vaccines in consumer advertising. The PAAB reviews for Rx and Schedule D consumer materials are based on our interpretation of the Food and Drug Regulations and the Health Canada policy document “The distinction between advertising and other activities”.
For the purpose of drug advertising directed to healthcare professionals, advertising for vaccines are treated the same way as for prescription drugs. The proposed pharmacy fax does fall under the PAAB scope and should be submitted to PAAB for review.
682
If we create a survey asking about the impact of using intravenous vs. subcutaneous drugs on clinic/hospital resources (personnel, time, money) - and we don't mention the therapeutic area, disease state or a specific drug (neither brand nor non-proprietary name will be mentioned), would this survey be exempt from PAAB pre-clearance?
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View Answer [+]
Creation and administration of legitimate market research as described in your question, would be outside of the scope of the PAAB code. However, if the intent is to include the survey results in advertising then the survey methodology and results would fall under the scope of the PAAB code. Use of surveys in advertising should be restricted to non-clinical features of a product. As clinic/hospital resources (personnel, time, money) would be considered pharmacoeconomic claims and therefore fall under clinical claims, a survey would not be considered an acceptable source to support these types of claims. We suggest submitting the survey questions to PAAB for review prior to conducting the survey if the intent is to use the results in advertising.
For more direction on the creation and use of surveys, we suggest reviewing Ask PAAB questions 590 and 551. (As a courtesy, search “survey”)
681
Hi, at an international conference to be held in Canada, there will be a large presence from our parent company (US company), as well as some presence from our local affiliate (i.e. Canadian office). Our product is approved in both US and Canada. Our US counterparts have a booth graphic that has information based on the USPI (i.e indication as well as claims). These are not completely aligned. Is the booth with US information acceptable at this conference? (This booth will be shared by US and Canadian colleagues). Also, can the US promotional materials be handed out or does the information need to only align with the Canadian PM? And finally, can the USPI as well as the Canadian PM for this product be handed out at the conference? Thank you!
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View Answer [+]
Please see Ask PAAB questions 652, 544, 520, and 334 to address your question and provide some additional guidance on international conferences. (As a courtesy, search “conference”)
680
Is the PAAB code applicable to the advertising of veterinary medicines? thanks!
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View Answer [+]
It depends on what you mean by “applicable”. The code is comprised of regulatory standards, ethical standards, clinical standards, and scientific standards that are applicable to advertising for any healthcare product to healthcare professionals. However, the answer is “no” if you are asking whether the PAAB preclearance service is currently applied to advertising veterinary medicines.
679
In the fair balance when we direct customers to a site for the Product Monograph, should we direct them to the Health Canada Drug Database page or to our corporate page with the monograph? We have concerns with directing them to the Health Canada page as they do not always post the most up to date version of the Product Monograph or sometimes the French version is not available.
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View Answer [+]
That’s an important consideration indeed. PAAB code 7.3.2a outlines the acceptable mechanism to link to the product monograph.
678
We understand that a 'Made in Canada' claim can be made for a drug manufactured in Canada. Would the same be true for a drug first discovered in Canada (ie. 'Discovered in Canada')?
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View Answer [+]
The statement could be considered if you can support that it is accurate and not misleading. Keep in mind that a product can be “made” (manufactured) in several countries but it can only be discovered in one.
