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677 - We have a situation where previously-approved clinical data in our TMA has been removed. This was an editorial request from Health Canada, simply to make room for new content (as Health Canada often requests trade-offs in order to keep TMAs succinct). It does not reflect a change in approval of the data itself. Therefore, can you advise if this previously-approved TMA data can continue to be used in APS? Note, the data does not appear in published studies and is therefore considered Data on File.
• Jennifer Carroll -
674 - Is it acceptable to compare the clinical trial inclusion/exclusion criteria among competitor products? We would like to make the point that patients with certain conditions were included in the trials for 1 product but not in trials for its competitors. I understand non-clinical information can be compared across products, and we wondered if inclusion/exclusion info was considered clinical or non-clinical. Could this be done in a branded context?
• Jennifer Carroll -
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.
• Jennifer Carroll -
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...
• Jennifer Carroll -
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.
• Jennifer Carroll -
638 - Would the use of a publication for a clinical trial evaluating two different head-to-head treatment comparisons be allowed in promotional materials if only one of the head-to-head comparisons is in alignment with the TMA? More specifically: •The comparison of Product A versus Product B is in alignment with the TMA for Product A i.e, a comparison versus another product in the same therapeutic class as Product B is included in the TMA; the primary endpoint in the publication is the same as a secondary endpoint included in the TMA for a pivotal study; same patient population. •The comparison of Product A versus Product C is not in alignment with the TMA indication for Product A. •Would the comparison of Product A versus Product B be allowed in promotional materials for Product A?
• Jennifer Carroll -
626 - We have an ongoing pivotal study and would like to report the latest published data. While the data exceeds the duration of that mentioned in the TMA, it is directionally-consistent with respect to magnitude/significance, and no additional safety concerns were identified. Can we report this data in APS, if there is no emphasis placed on the duration?
• Jennifer Carroll -
623 - Hi; I have a questions regarding usage of the trade mark of the competitor in the promo materials. The owning promo material company wants to include the registered information from the competitor's PM. would it be acceptable to use the competitor's registered trademark in the piece? Thank you
• Jennifer Carroll -
616 - We're developing a branded slide deck for HCPs that will include mention of adverse events as stated in the Product Monograph. It is our intent to provide HCPs with information on how to manage adverse events (e.g. educate patients on dietary measures, consider consulting a dietitian to modify patient diet if required, etc.). Is it correct to assume that the information on how to manage adverse events within this branded APS must be supported by a textbook or recognized third-party website/materials?
• Jennifer Carroll -
614 - Is it acceptable to advertise a statement that says something along the lines of: "Drug X is the only drug containing active ingredient Y that is approved from clinical tests?" assuming that this statement is true? Would that change if the statement is more specific, such as "Drug X is the only epidural drug containing active ingredient Y that is approved from clinical tests?"
• Jennifer Carroll -
611 - Section 3.1.10 of the Code states that "Secondary endpoints should be identified as such and the primary endpoint of the study should be presented in close proximity when warranted." How do you know when presentation of the primary endpoint is warranted? Is it always necessary to present the primary endpoint when presenting data (i.e., a secondary endpoint) that is in the product monograph?
• Jennifer Carroll -
610 - The Guidance document 'Claims Based on Non-Inferiority Trials' states that "In the event the non-inferiority study failed to demonstrate superiority in the primary endpoint, one should not use secondary endpoints to suggest superiority." Does this still apply if the primary/secondary endpoints are unrelated (eg. primary endpoint is an efficacy measure, secondary endpoints are safety measures)?
• Jennifer Carroll