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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
653

Are there any limitations for using Phase II studies as support for therapeutic claims, apart from disclosing the Phase II nature?

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652

I understand that for international conferences held in Canada the following conditions need to be meet for being exempt for PAAB review according to (Health Canada policy document “The Distinction Between Advertising and Other Activities) I. the conference must clearly be an international event, e.g., a significant proportion of the conference delegates are from other jurisdictions, II. the material must emanate from the parent company of the manufacturer, III. the material must only be for use within the confines of the conference, and IV. the material is prominently identified as not being authorized for sale in Canada. The question I have is for the use of material that is non-branded and no product specific that makes reference to a therapy area/class for which several products are approved in Canada for sale by the local subsidiary. Would this non-branded, no-product specific material (banner), that talks about a therapy area/class would it be considered PAAB exempt for use at an international conference?

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651

If I have two clinical trials in slightly different patient populations, is it acceptable to present data from only one of the trials in an APS?  Both populations fall under the same indication.

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650

Hi Patrick, I was wondering, after PAAB approves copy. Is it forbidden to make minor typography changes? I.e. spelling mistakes, punctuation, periods. As long the same message is there is that still considered an unsolicited change?

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649

Our company has an unbranded disease-focused app in the Apple/Google stores. As legally required, the manufacturers name must be disclosed in these stores. Can we make mention of this app in a separate DTCi Help-Seeking campaign (that itself does not mention the sponsor)? The campaign would not focus on the app, but mention it as one of many additional resources.

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648

We have a product indicated for the treatment of 'drug-resistant Condition-X'. Since this disease inherently links to drug therapy, I do not see how we can produce PAAB-exempt disease education materials. Does this seem like a fundamental limitation of the Code (6.6vii)? Could we produce exempt materials describing 'resistant' or 'refractory' Condition-X instead?

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647

In order to discuss switching patients from Product-A to Product-B within an APS, what is required for substantiation: a specific mention in the TMA/indication, Guideline recommendations, a head-to-head study? Also, does this substantiation need to appear in the APS itself?

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646

I recognize that consumer help seeking campaigns cannot disclose the manufacturer's name. In the event of a DTC disease awareness website, that is seeking to allow users to opt in to receive future communications (all unbranded, disease related in nature), we're challenged by CASL regulations which appear to conflict with Health Canada's guidance. CASL regulations indicate the name of the sender must be included. If the sender of the communication is indeed the manufacturer, is the manufacturer's name, allowed for inclusion in the website copy in this circumstance, presumably with minimal prominence in order to solely meet CASL guidance? Or, can you provide examples, guidance, or a recommendation on how a manufacturer may meet CASL and Health Canada guidance in this situation? Thank you.

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645

Hello PAAB! Can sales representatives distribute a tool that was approved by PAAB as DTC to physicians to provide to potential patients? Would this tool need to be re-submitted through PAAB as unbranded patient material? Thank you!

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644

Hi, I wanted some clarity on the rule below. Essentially, we are allowed to use peer reviewed resources, etc. to support claims, as long as the claim made references a clinical endpoint already captured in our monograph? Specifically, if my label mentioned confirmed disability worsening, but I also have long term data that discusses confirmed disability improvement (diff metric), I would not be allowed to use this? -- 3.2.2 Literature used to support claims contained in the APS must be consistent with the indications, dosage regimens, and efficacy and safety information contained in the Health Canada TMA.

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Deputy Commissioner  

Patrick Massad
Deputy Commissioner

To view the PAAB
Code of Advertising Acceptance
click here
Pharmaceutical Advertising
Advisory Board
Upcoming meeting

January 22, 2019

The Future of Cannabis in the Pharmaceutical Industry

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Panel Discussion: 7:00 p.m.

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