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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

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

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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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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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Can baseline patient demographics (not outcomes) captured by Patient Support Program enrollment be used in HCP-directed advertising, in a promotional or claim-neutral manner?

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Hi Patrick, I have the following question: When using the terms "proven efficacy" in a headline in the context of what the product is indicated for, why do we need high level fair balance? For example, "Product X has proven efficacy in the treatment of Arthritis." If the product has received an indication for the treatment of arthritis, it has been shown to be effective - otherwise it would not have received such an indication. So, this headline is simply a factual statement, as opposed to a clinical claim. Thanks in advance for your clarification.

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In an HTML email, does the layout need to include the full product monograph address i.e. , or can it just read click here for Product Monograph. The word 'here' would be bolded and link directly to the unmodified PM. Please let me know.

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A IMC Member is questioning their obligation to submit slides to PAAB under the IMC Code Section 9.6 which states: "9.6 Speaker Training (Faculty Training) and Workshops 9.6.1 General Principle For learning programs, irrespective of the format, on new products, new indications or disease state or significant label changes (i.e. patient safety), a need may arise to train an appropriate number of Health Care Professionals who are recognized experts on this information so as that they may disseminate this information to their colleagues for the benefit of Canadian patients. A product or indication is considered “new” up to one year after its initial marketing. " Assuming we are referring to a new drug or new indication. If the slides for these programs are developed by a scientific committee consisting of HCPs and the slides are then presented by HCPs to other HCPs - do these slides require PAAB approval since they make reference to a specific drug/use?

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As per the PAAB Code section 1.8 Definitions, the New Healthcare Product is defined as follow: "Any prescription or non-prescription product manufactured and/or marketed in Canada by a particular company for a period of less than 2 years". It is our understanding that for any APS we are limited to one year of usage of the word "New" from initial marketing. However, please clarify, what is the less than two years period in the above statement for the “New Healthcare Product" is referring to?

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Are there any circumstances under which data from a reference arm could be included in an APS?

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I'm working on building an app for a pharma client. It's a companion for a drug they market. But I'm concerned that the review section in the App Store will put us at risk of being non-compliant. Do you have any suggestions to help?

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Deputy Commissioner  

Jennifer Carroll
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