Ask PAAB

257

Would a natural OTC Supplement (no DIN number) require PAAB approval for promotional materials targeted to HCPs? Would consumer advertising require PAAB and/or ASC?

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  Per PAAB code section 11.3(a), APS promoting supplements purely for the maintenance of normal health do not require PAAB review. Note that APS directed to healthcare professionals (or patients through healthcare professionals) relating to DIN, NPN, and DIN-HM products for more specific uses require PAAB review. For example, APS which promote the use of a Vitamin supplement for maintenance of strong bones would require PAAB review.

256

Is there a ratio needed between the graphic display (image) and the monograph font size?

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  Please see answer #92.

255

Removed 07/2018

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254

I'm curious as to why the STI Innovicares program is allowed to advertise specific brand name drugs on a website without PAAB review; especially given two main pharmaceutical companies are behind a large promotion of their brands (AZ/Sanofi)? Isn't this considered DTC advertising linked to brand name drugs? The website is at www.innovicares.ca and also has DTC ads and posters in addition to the website.

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  I have not reviewed the site as this is a forum for Q&A on the general meaning and application of the PAAB Code of Advertising Acceptance and not for advertising monitoring, reviews, or complaints. You may call me if you have questions about whether specific content on publicly accessible portions of the site exceed this restriction. As a general point, promotion of Rx drugs to consumers is permitted, but it is restricted to name, price, and quantity. You may call me if you have questions about whether specific content on publicly accessible portions of the site exceed this restriction. Note that Health Canada adjudicates complaints about DTC advertising of healthcare products.

253

Are there restrictions on the use of the Australian flag in advertising?

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  Assuming you are referring to Canadian drug advertising directed to HCPs, as in many situations, context would be important in determining the acceptability of the proposed image. Feel free to call the PAAB office to discuss your scenario. We are here to help.

252

Do they have a PAAB expiration of 1 year (i..e, do we need to renew annually)?

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  Yes. Here is an excerpt from the October 2010 PAAB Newsletter (at that time called the "PAAB Review"): "We encourage you to show the PAAB logo on all material reviewed to acceptance (HP) or to no objection (DTC). The new DTC codes are CA for advertising and CI for information. The clearance period is for 12 months and please submit a renewal request if you wish to use the advertising for longer than 2 months. Two month extensions for exceptional circumstances can be granted by the commissioner".

251

The Code (in part) states:

1. that patient information is exempt from PAAB review if the information is direct from and consistent with the product monograph.
2. patient materials must be non-promotional.

The questions,

• if by PAAB's interpretation, would the content of PART III of a product monograph be exempt if produced in a multipage brochure layout, accompanied by product branding elements (colors, graphic design, brand logo, etc).
• if a brochure layout is acceptable, then may the formatting be comparable, or are there restrictions or requirements related to formatting treatments for section titles, italics, bolded fonts, underlined text, etc.

• View Answer [+]

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  Distribution of part III of the PM would not require PAAB preclearance.

  Modification (e.g. removal of content, insertion of text/visuals) made to the document for distribution to patients through HCPs would require PAAB even if the resulting document meets the PAAB code 6.4.3 requirements for consistency with part III & non-promotional content/tone. Indeed, PAAB pre-clearance is intended to ensure that these requirements are met. Call me at the PAAB office if you'd like to discuss your specific case.

250

In addition to the automatic renewal email I just submitted, it would be AMAZING if the final PAAB approval letter (or final communication letter -- for both languages if applicable) was included in the eFile library along with the historical files. There is so much turnover in agencies, it would be incredibly helpful to have a complete document history in one location to help alleviate anything slipping through the cracks.

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  I've forwarded your suggestion to Glenn Golaz. Thanks.

249

This isn't really a question, but it would be great if PAAB were able to send an automatic email out 2 months before expiry on electronic media/websites. I am sure this is an easy thing to tag to the submission database and would be of great value to agencies and clients. Perhaps it is something that users can opt in to if there are any concerns. I hope you will consider this.

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  Thanks for the suggestion. We did once consider this, but there are currently companies which provide this service. As an aside, we will soon be embarking on the process of revamping our electronic filing system.

  Suggestions are always welcome, but now they'd also be particularly timely. Don't hesitate to send your eFile system suggestions to Glenn Golaz at glenng@paab.ca.

248

Is it acceptable to have a multiple choice practitioner-poll if the statements are not in any way therapeutic claims? The data collected is presented but will not be utilized in claims.

• View Answer [+]

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  Your non-therapeutic polling questions can be considered provided they are non-comparative. The polling questions would obviously need to be reviewed against all provisions of the PAAB code (e.g. consistency with TMA, validity of evidence, etc.).