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Questions et réponses les plus récentes

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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In a DTC Consumer Brochure discussing treatment options for a given disease, can narcotic treatments be included in a balanced list of treatment options? We are assuming a Consumer Brochure is not defined as advertising under the Narcotic Control Regulations s70.

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We would like to do a table comparing non-clinical aspects (indication, route of admin, dosing, monitoring, etc.) of various products indicated for a specific disease. There are more than 10 drugs with this indication, so it will contain a lot of information, all of which will be based on the respective product monographs. It is our intention to give each brand equal prominence (i.e., it will not be specifically branded to one drug). What are the balance requirements for a piece like this? Normally, we understand that dosing warrants high-level balance. However, we can't possibly fit high-level balance for all of the product that will be mentioned in this piece. What do you suggest? Thank you!

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Dear PAAB, Our Pharmaceutical Company is planning to do a Patient Support Program gated website; we will send this website to PAAB for review. We would like to add links to an independent patient association website that has different resources for patients. If we link to the home page of the patient association, will PAAB need to review the entire website even if we with a disclaimer that they are leaving the company website? Can we link to separate documents (e.g. disease state , treatment options)? In this case does PAAB need to review each document ? Since our website is branded are these going to be reviewed as branded pieces? Thank you.

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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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Patrick Massad
Commissaire adjoint

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