Disclosure requirements: PI & Safety Information, Federal schedule, study parameters, reference lists
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758 - In the PAAB Fair Balance guidance, for lowest level FB, it states "messages which do not relate to the healthcare product (e.g. disease information)". Question is: If the message does not relate to the product and only disease info, why would we require any FB at all? it is not advertising. Or could you provide an example for this scenario?
• Jennifer Carroll -
753: In the PAAB Fair Balance guidance, for lowest level FB, it states "messages which do not relate to the healthcare product (e.g. disease information)". Question is: If the message does not relate to the product and only disease info, why would we require any FB at all? it is not advertising. Or could you provide an example for this scenario?
• Jennifer Carroll -
736 - We're developing a pull-up banner and the amount of Fair Balance is not allowing for space for the message. Could we apply the principles allowed for journal ads? Specifically, have medium fair balance on the pull-up banner and direct the reader to a handout adjacent to the panel with the full fair balance?
• Jennifer Carroll -
679 - In the fair balance when we direct customers to a site for the Product Monograph, should we direct them to the Health Canada Drug Database page or to our corporate page with the monograph? We have concerns with directing them to the Health Canada page as they do not always post the most up to date version of the Product Monograph or sometimes the French version is not available.
• Jennifer Carroll -
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...
• Jennifer Carroll -
662 - 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.
• Jennifer Carroll -
661 - In an HTML email, does the layout need to include the full product monograph address i.e. www.Bestpharma.greatdrug.ca/productmonograph.English , 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.
• Jennifer Carroll -
655 - 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!
• Jennifer Carroll -
586 - If a leading pharmaceutical company provides funds for an article on adult immunization but without having any control on the content of the article, can the disclaimer at the end of the article read "brought to you by a leading pharmaceutical company" or does it have to specifically mention the name of the company that provided the necessary funding.
• Jennifer Carroll -
580 - Hi, My question pertains to the construction of the required "Relevant warnings and precautions" section include in a fair balance section. Specifically, can the incidence of the events, for example "serious adverse events of neoplasm' or "QTc prolongation", have incidence or other clarifying information included in the fair balance section for clarification purposes so a HCP more clearly understands the context of the warnings and precautions?
• Jennifer Carroll -
484 - What happens when a piece which contains information on multiple drugs is already approved by PAAB but then a product monograph update comes out for one or more of the drugs. Does this require revision and re-submission or is the piece still valid for the duration of the approval period?
• Jennifer Carroll