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Hey @kshulist As per the principles noted in Q&A 508, if the published paper conveys a statistically significant improvement in the absolute risk reduction for the response rates (with multiplicity adjustments performed when required to manage risk of type I error), the NNT may be calculated.

Hey @tk2022 Q&A #763 refers to just one scenario which could render a piece exempt. The tool outlines other factors/scenarios that may or may not render a piece exempt from PAAB pre-clearance. Can you please provide us with the flow you followed through the tool and the nature of the piece you’re thinking of (unbranded/branded, treatment/no treatment, company generated/independently generated, distribution, etc.)? This will help us better assess the question. (Note 6.6. in the document will be updated to 1.5D per the current code.)

Hey @kellyyefet We were unable to locate the quote “if it’s mean to be gated” in the above copy and therefore cannot comment on what is meant by it. The possible forms of gating are outlined in the gating guidance document which can be found on the PAAB website under resources. To clarify “Note that if the branded site URL is intended to be the gating mechanism…” in our previous response, we were referring to the context where de-indexing is the form of gating. If this de-indexed URL is acting as the gate for your brand it would not likely meet the requirements. Note that “soft gate” is not a term that PAAB or Health Canada use. A website which contains information which goes beyond what is allowable in the consumer space requires a gate which ensures access is limited to the intended audience.

Hello @gmc As per our response above, there are many aspects that would impact acceptability. It is highly probable that the proposed link above would present an issue because the patient would know certain things about the medication that was prescribed to them (i.e. the indication). By linking to a pre-gate page that has a second medication which the patient has likely not been prescribed, it may be considered direct to consumer advertising. This is because the patient could start drawing inferences/conclusions about that second medication, even if they only see the name of it on a pre-gate landing page. This would be assessed and discussed during the review process.

Hi @gmc It is acceptable to acknowledge the contribution from HCPs in the development of an APS. Note that the content within the piece would still be required to meet the standards for evidence (i.e. individual opinion that is not supported by evidence would not qualify as an authoritative source). The overall principle of not associating branded and unbranded should also be adhered to. Wording would be discussed during the review to ensure that it does not contravene advertising regulations. We’d encourage the sponsor to also check with HCP governing bodies and other trade associations to ensure there are no concerns with the activity.

Hey @ap An unbranded piece that speaks to products which the patient is not on, would be considered consumer advertising. The activity above appears to fall under “Medical condition and treatment awareness material” (formerly consumer brochure) and as such would have to meet the requirements outlined in the Distinction Between Advertising and Other Activities document under section “Medical condition and treatment awareness materials”. This outlines that all options must be included (pharmacological and non-pharmacological). The Product Monograph can be used as a reference for treatment formulation but would not support direct or implied comparative claims. The reference should not be listed in the piece as this would create a link between the brand and therapeutic use which is in violation of the Food and Drug Regulations.

Hello @lags This is a complex question that would be better suited as an opinion submission where details on the therapeutic area, class of products, proposed inclusion and exclusion criteria etc. could be provided. It is not possible to create an exhaustive list that would be clear enough to apply across all therapeutic areas. As a general response, any selection criteria that have eliminated other products from the presentation, should be clearly conveyed along with disclosure to the audience that this is a selective presentation.

Hello @ap Schedule 2 in this case appears to be referring to NAPRA. For drug advertising, one should refer to Health Canada schedules. Since the question was posted under the category “DTCI” we will assume you’re asking about the consumer regulations. The Food and Drug Regulations, Food and Drug Act, relation to conditions listed on Schedule A and the Health Canada document Therapeutic Comparative Advertising: Directive and Guidance Document should be applied. For content directed to healthcare professionals, the PAAB Code applies and all aspects of the Code should be met.

Hi @alee The full TMA of both Drugs A and B along with original study would be required to assess the extension study. As an example, PAAB would need to assess the TMA of drug B to determine the parameters for the 1 year restriction—Does the 1 year restriction also relate to safety or is it only that the clinical trials were one year in length? Etc. The consideration for acceptability of the extension is dependent on the pertinent information. Given the nature of the required assessment, it would be advisable to consider the PAAB’s written opinion service (refer to the fee schedule on the PAAB website).

Hi @vt, This appears to be about a specific product and class. We would assess on a case-by-case basis considering the totality of the market. In these instances, we suggest going through the review process.

@jennifer-carroll Thank you for clarifying these points. Highly appreciated.

@jennifer-carroll Thanks very much, this is helpful!

Hey @gmc Food and Drug Regulations – C.01.007

Hi @costeap, We are nearing completion of the messenger programming, however due to issues we uncovered during previous testing we are not in a position to provide a firm launch date just yet. Assuming testing of the most recent updates go smoothly, we are aiming for launch the third week of May. We will be following up soon with a firm launch date as well as more information on how to use Messenger.

@jennifer-carroll Thank you!

Hi @cynthia-tab1, The following is provided with the understanding that the rep can only select one fragment per email in the example. In general, if the fragments are different messages, then they may not be reviewed under one submission as there will be discrete emails with distinct messages sent. Assuming the common content of the emails exceed 60% pickup, the emails should be submitted as a series for each separate fragment with an initial parent file and all subsequent fragments submitted as a child file. If the fragments are the same message but written in varying language, then an iterative submission may be possible under the same efile number. Please see our submissions guidance document under 2.2.1 (b) iterative submissions and (c) Other series for additional information.