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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
673

A company has a product approved in the US. They have a booth at a Canadian convention. Can the company distribute product specific materials in the 'international' section of the booth as long they are in line with FDA approved label? If so, do these materials need to be reviewed/approved by PAAB too?

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672

Would materials used to train Healthcare professionals prior to using a product be items to be reviewed by PAAB, or do they reflect more Continuing education materials? The trainings would be done on site by medical science liaisons.

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671

It seems that materials that cite a product is available through the Special Access Program would be considered promotional. Are these types of materials reviewed and approved by PAAB, or are they strictly prohibited as alluded to in the Health Canada Guidance regarding special access programs? Without some notice, I don’t know how healthcare professionals know whether a product is available through SAP.

670

I have seen mixed messages as to whether PAAB review of prescription pharmaceutical advertising must be reviewed by PAAB. Can you confirm or refute that PAAB review is required?

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669

If you are creating a corporate APS in a print format that lists a pharmaceutical company's products, do you also need to include some level of fair balance for those products?

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668

We will be offering OTC product samples through a third party sampling program. In the order brochure there will be a pack shot of the sample pack, brand name and dosing. Does this need to be PAAB approved?

667

We have a non-prescription drug and we plan to leave coupons for patients in the doctors' offices. Do the coupons need to be PAAB approved?

666

Is it possible to make a “#1 reccommended” brand claim? If so, what support would be required?

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665

We would like to produce a non-branded APS that highlights the current medical practice on using a specific class of medication. The most recent Canadian consensus guidelines (updated in 2017) support the message that this class of medication should now be offered as an option to patients undergoing continued maintenance treatment (this is a big change vs the last consensus guidelines publication from 2003). 2 Questions: 1) We assume it would be acceptable to make a claim in an APS that outlines this recommendation, given that this is from an approved, authoritative source, correct? 2) This guideline document also provides context around why their position has changed. They provide details about how this class of medication was used historically, and also outline some of the evidence that supports their new recommendation, which included reviewing 3 RCTs among other sources (note: they communicate that there is data that supports the classes superiority, but also data that challenges it). Would it be permissible to also include a balanced presentation of these additional details in our APS? If not, why? Wouldn't a consensus guidelines document be an acceptable reprint that a company sales rep could distribute to HCPs? And if so, then why would be ok for them to distribute the document that includes this information, but it wouldn't be permitted to use the content on its own in an unbranded APS if referenced accordingly and presented in a balanced and objective manner?

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664

In the "other relevant warnings and precautions" section of the highest-level fair balance, is there a requirement to include warning/precautions about effects that were not systematically studied/evaluated and that are not class warnings. Here is an examples of what I suspect needs to be included: bullet point " seizures" if PM has "seizures" bolded followed by "xxx has not been systematically evaluated in patients with a seizure disorder. Patients with a history of seizures were excluded from clinical studies. Seizures are a potential risk with antidepressant drugs. xxx should be prescribed with caution in patients with a seizure disorder." Here is an example of what I suspect does not need to included: bullet point "cognitive and motor disturbances" if PM has "cognitive and motor disturbances" bolded followed by "The effects of xxx on the ability to drive or to operate machinery were not systematically evaluated in the xxx development program." Please advice if my assumption is correct. Thank you.

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Deputy Commissioner  

Patrick Massad
Deputy Commissioner

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Code of Advertising Acceptance
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Pharmaceutical Advertising
Advisory Board
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January 22, 2019

The Future of Cannabis in the Pharmaceutical Industry

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