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It is not uncommon for employees in a sales or marketing function to have the name of the product they support in their email signatures. If such an employee sends an email to a HCP and attaches materials that are not specific to a product (i.e. unbranded disease related) does that attachment now become an APS and therefore subject to PAAB review due to its association to the product name in the email signature?
You are correct in your assumption that this would brand the email and its content. When we link branded and unbranded, everything becomes branded. As the sign-off is content within the entirety of the message, the disease content becomes branded and needs to be reviewed in this context. Note that this would also trigger code section 2.10.1 and 2.4, requiring the inclusion of the indication and fair balance.
Can you confirm if a CSR (Clinical Summary Report) is an acceptable document to support a data presentation from a published clinical trial. For example, the published clinical report presents pooled data results but the CSR captures this same endpoint by individual pivotal studies which garnered NOC for the drug. Additionally, can client share a portion of the document rather than the entire document given these reports are typically 2000+ pages. If it is possible to submit a partial version of the report, please confirm what parameters should be considered. Thank you.
Pooled data generally does not meet PAAB Code evidence requirements. Code section 3.1.1 states “Clinical/therapeutic claims must be based on published, well-controlled and/or well-designed studies with clinical and statistical significance clearly indicated. Publication in peer-reviewed journals is usually a good criterion for establishing scientific rigor. Review articles, pooled data, meta-analysis and post-hoc analysis are generally regarded as not being high level evidence to support claims in drug advertising. Non-clinical claims must be well supported by evidence". Additionally, as per code section 3.1.2, data on file (e.g. CSR) can only be used to clarify existing data, not to present new data. Section 3.3 states that “References cited in the APS must be available to health professionals on request…A copy of the summary of the Data on File must be provided to health professionals upon request” however, this is upon request. Summaries of data on file should not be distributed in an unsolicited manner.
I believe there is a condition in the code that we can have APS reviewed/approved by PAAB even before NOC ? Where can I find this in the code for proper guidance. Thanks.
PAAB will provide review of up to a maximum of two core pieces prior to NOC only when the Product Monograph has reached the final-draft stage. As per the guidance documents mentioned below, advertisers should be aware that under PAAB's mandate, we can only provide acceptances for advertising for use post-NOC. PAAB does not issue acceptances for any branded promotional activities carried on pre-NOC. Guidance can be found on the PAAB website under resources: Administrative Guideline for the Review of Pre-NOC Advertising Submissions and Chapter 5 of Guidance on Submission Process.
Dear PAAB, Can we have an e mail (APS sent to HCPs) linking to a patient support program provider's (3rd party) website or patient association website? Thank you!
In theory, it is possible to have an email which contains links to patient support provider’s and patient associations websites. The nature of the remaining content within the email will impact if the action is acceptable in the context of the overall message of the APS. This linkage would be reviewed upon submission. As an additional piece of information, we always suggest linking to the home page of patient association websites to help minimize the risk of linking unacceptable content and it should be clearly presented as “patient” resources.
When and why was the following removed from the PAAB code? Disease information materials which make no mention of treatment by name, class, or category AND are not linked to healthcare product advertising in any way, are exempt from PAAB preclearance. Does it not still apply?
The code has been revised through stakeholder consultations, to be a succinct outline of pharmaceutical advertising standards. As the above copy was redundant copy (see The Distinction Between Advertising and Other Activities document) it was removed. The concept still applies.
I am interested in the safety data for one of the products. Can i use data from a pooled analysis of 10 clinical trials (same indication and product) in our marketing materials. It contains data from pivot clinical trials as well. Can it be considered as a meta-analysis?
The short answer to both questions in your described case is, “Almost certainly no”.
In general terms, there are two instances in which PAAB will accept pooled analysis as stand-alone evidence for a therapeutic claim relating to a healthcare product:
Failing these two scenarios, pooled analysis are only used to corroborate (and immediately follow) acceptable data from the TMA or an individual RCT (which meets all the standards of the PAAB Code and guidances). In this case, the pooled analysis is not the evidentiary support for the claim. It is simply re-affirmation of the same claim which is already supported by an acceptable individual trial (i.e., same endpoint, same comparator, same or shorter duration, similar magnitude of effect/safety, same study population). It is possible, although not required, that one or more of the individual studies included in the pooled analysis satisfies this requirement (particularly for efficacy endpoints which are more likely to have statistically significant findings in an individual study).
You see that, in general, the ability to use pooled analysis in APS is quite narrow. The possibilities get even narrower when dealing with safety data. Adverse events tend not to undergo statistical analysis in individual studies. The potential option to corroborate the findings in an existing individual study is therefore typically non-existent.
In response, to your question about whether this could be considered a meta-analysis, the answer is, “No, but it wouldn’t really matter from an APS perspective”. Meta and pooled analysis are entirely different types of analysis. For example, the studies that are included in a meta-analysis are dictated by a documented and reproducible systematic analysis. This is not the case for a pooled analysis. This is only one of many differences between meta and pooled analysis but it likely marks the simplest way to differentiate between these two forms of analysis. Nonetheless, the instances in which meta-analysis are acceptable for therapeutic claims are pretty much aligned with the approach for pooled analyses. The only difference being that item ii (preplanned) would not occur in a meta-analysis context. The PAAB accepts meta-analysis data excerpted from the TMA. The PAAB also accepts high-quality meta-analysis data to corroborate (and immediately follow) acceptable data from the TMA or an individual RCT (which meets all the standards of the PAAB Code and guidances). Again by “corroborate” we mean that the presented data simply re-affirms the same claim which is already supported by an acceptable individual trial (i.e., same endpoint, same comparator, same or shorter duration, similar magnitude of effect/safety, same study population). The matter of “high quality” in the context of meta-analyses is discussed in response to question #685.
Can a company website that contains Health Canada approved product monographs also contain brand logos and product photos? The website is not gated and publicly available.
Our understanding of the term “product photos” refers to pack shots. It is acceptable to have pack shots in a consumer space, as long as no content on that pack shot goes beyond the consumer regulations (name, price, quantity). If there are claims or additional information on the pack shot, they should be blurred out.
What type of gating is required for a HCP website for a schedule 1 product (narcotic)? is de-indexing considered a form of gating? What type of information can be available pre-gate? can information around a patient support program be made available pre-gate for a schedule 1 (narcotic) product?
Yes, de-indexing is considered a form of gating. Note that the de-indexed URL should also be something that is not easily guessable (controlled distribution). For example, “BrandX.ca” would not be acceptable. Neither would “BrandXHCP.ca” or “BrandXresources.ca”. There should be some aspect of the URL which is not easily guessed. We suggest a set of random characters/numbers.
Note that advertising of narcotics falls under the Narcotic Control Regulations and the Controlled Drugs and Substances Act. Advertising of narcotics is prohibited to the general public (this includes reminder ads that would be limited to only the product name, price and/or quantity). As such, it would not be acceptable to have a landing page which makes mention of the narcotic. In addition, the inclusion of promotions for a patient support program in a public space, would not be acceptable.
Please also be advised that Health Canada has provided additional guidance on the promotions of opioids. Please see: https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/submission-targeted-rm-plans-commitments-prescription-opioid-containing-products-guidance-industry/document.html#a3.2.3.3 and https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/additional-restrictions-advertising-opioids.html
We want to develop an unbranded, ungated website that we plan to send to ASC. The content is about adherence and as such is appropriate for all audiences. Can we develop unbranded promotional tools, like banner ads on NEJM, that direct HCPs to this site?
The content and execution of this tool will impact the answer. In general, if the primary objective is to direct HCP to the tool to learn and implement, then the tool should be reviewed and approved by PAAB as it requires assessment for an HCP audience. If the objective is to inform HCP’s that a tool exists which they can direct consumers towards, then an assessment of the link would be required. PAAB would assess if the linked content was acceptable in the context of the message copy as the primary audience is HCPs.
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?
You’ll note that the “Scope” of the document states “This document applies only to healthcare professional advertising/promotions systems (APS) that require fair balance per PAAB code 2.1, 2.4, 3.5 and 7.3”.
Mention of the brand or branding elements, and discussion of disease content would suggest the therapeutic use without properly limiting to the specifics of the products indication. The brands indication and lowest level fair balance should be presented so as to accurately convey the limitations of use.
Jennifer Carroll
Réviseur principal en communications
Le Conseil Consultatif de
