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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?
Yes, for such statements related to the non-pharmacological management of adverse events, we could consider sources such as medical textbooks and websites of authoritative bodies. Keep in mind that we would still assess consistency with the product monograph and additional information may be required.
Hi, I have a question regarding receiving pre-clearance from PAAB regarding promotional material related to a new product that has been approved under the NOC/c (Notice of Compliance with conditions) policy, as stated in the Qualifying Notice received from HC? Is this mandatory, or optional? Thank you!
If this was a “requirement” stated in the Qualifying Notice, then the request from Health Canada would be mandatory. Otherwise, note that preclearance is generally voluntary. Although preclearance is not required by law, compliance with Food and Drugs Act section 9.1 is mandatory. The essence of this act is that advertising must not be misleading. Little direction is provided in the Act on how not to mislead. This is what the PAAB code is for in HCP advertising. As PAAB adjudicates the PAAB code, PAAB preclearance is the most objective and effective mechanism to attain compliance with the code and, as a result, the Food and Drugs Act. In my mind, this is the most compelling argument in favour of preclearance. In the interest of promoting self-regulation, we report cases of willful non-compliance to Health Canada upon learning about them through our monitoring activities and the complaint system (i.e. the competitor’s monitoring activities). As a secondary point, some trade organizations require preclearance as a condition of membership.
Further guidance for NOC/c advertising requirements can be found on the PAAB website in the document “Guidance on Advertising for Drugs with Notice of Compliance with Conditions (NOCc)“.
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?"
I cannot answer this question as I am not sure what you mean by “approved from clinical tests”. This is not the forum for assessment of particular claims anyways so I suggest submitting your particular question as an opinion (see the fee schedule on our website).
Removed 07/2018
In the context of a Consumer Brochure, is it permissible to provide DINs for a balanced list of medication options?
I’d advise against doing so as DINs tend to be used as the gating mechanism for patient information websites. i.e. promoting the DIN of your products in the consumer realm would likely invalidate the gating mechanism you are using.
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?
It is not always necessary (although it is often necessary). The primary endpoint is required to appear prior to the secondary endpoint when not doing so could mislead the audience in some way. There would be several circumstances in which that could be the case but I’ll present one scenario here to make the point. Let’s say, for example, that non-inferiority versus the active comparator was demonstrated on the primary endpoint in a pivotal trial which is included within the product monograph. It would be misleading to present product monograph superiority data for a secondary endpoint from that same pivotal study without first conveying the fact that the product was non-inferior in the primary outcome. Although, secondary endpoints which are not directionally consistent with the primary endpoint are generally not accepted, the presentation would be acceptable in this case as it is consistent with the product monograph.
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)?
Yes it still applies. Secondary endpoints should not be used from a failed study.
Hello. Can a pharmaceutical company post a tweet on its Twitter platform about its product winning a research/innovation prize? For example, "Congratulations to Product X for winning the 2017 YZ Prize!"
Assuming that this is a prescription product, PAAB would advise against this for a couple of reasons:
If we pay for a beauty expert to talk about one of our OTC products live on a tv show like Breakfast Television (on City TV), should the beauty expert mention live on the show that they are being paid by a pharmaceutical company?
OTC advertising which is broadcasted to the general public does not fall within the scope of the PAAB. Nonetheless, we direct you to the updated Canadian Code of Advertising Standards available at http://adstandards.com/en/Standards/canCodeOfAdStandards.pdf where you’ll find that interpretation guideline #5 (page 13) addresses your precise question.
Does a HCP-directed website for a Schedule D vaccine need to be gated?
The fact that the vaccine (Schedule D) website is intended for HCP’s does not, in and of itself, trigger the requirement for gating (BUT it does trigger the requirement for PAAB preclearance). The piece would require review under the PAAB code for HCP advertising with the consumer as a secondary audience. In addition to being clear that HCP’s are the intended audience, this also means that it would also be reviewed under the Health Canada Therapeutic Comparative Advertising: Directive and Guidance document and the Policy: Principles for Claims Relating to Comparison of Non-therapeutic Aspects of Non-prescription Drug Products. Some changes may be required to the HCP messaging to address the consumer regulations. One example would be that therapeutic claims in the consumer realm require the support of two separate RCTs. This will likely mean the removal of the therapeutic comparisons in the piece (even if they were previously approved in HCP advertising). The alternative, of course, would be to add a gate.
Patrick Massad
Commissaire adjoint
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