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Hello @Maryssa

Great question as I can see where there might be some lack of clarity. The description of the “responsive ads” was intended to address the unique nature of these “small space ads”. Other parts of the Code and submissions guidance (including the Guidance document for Online Activities) continue to apply when there is targeting and/or keywords that cause the ad to surface. We have included the SEM and SEO in the same review efile as the Google responsive ads.

This previous PAAB Q&A also covers some general principles which may be useful.

Sorry @HollyMed this one slipped through the cracks.

Per the RMT guidance document, if the piece is intended to be detailed by a rep to an HCP, it requires going through the standard PAAB review process (i.e. the piece would be subject to all PAAB Code provisions relating to APS). Presentation of the safety data would be subject to the requirements of the PAAB Code. Give the above document a read and this Q&A and let us know if they answer is still unclear.

Hi there,

PAAB can provide approval to APS with links to PAAB acceptable pre-proof articles (see also Code section 3.1.2). However, it is the responsibility of the sponsor to ensure that there are no restrictions to the distribution of the pre-proof article prior to full publication (Code section 3.3).

This post was answered through our office earlier but we will post the answers here as well.

1. No, only opioids are subject to the Health Canada terms and conditions for advertising.
2. It is permissible to create promotional materials to HCPs for a controlled drug. However, note that direct to consumer advertising is not permitted.

This one is tough to answer in a general forum since there are a lot of considerations. First and foremost, the indication is the limitations for the Terms of Market Authorization and therefore sets the context of messaging within advertising. Code section 2.10 applies regardless of perception that terminology has changed. Next, this is a great opportunity for PAAB to remind clients that we do accept endpoints and terminology not listed in the TMA. What we look for is “consistency with the TMA”.

Let’s look at a few examples of where it would not be acceptable.

1. If the “new terminology” appears to expand the scope of the indication into a broader population than what is outlined in the TMA.
2. If the “current medical practices” contradict the TMA, such as “use first line” when the TMA states “after failure on class Y”.
3. The studies based on “newer disease terminology” result in the patient populations or outcomes being broader than those outlined in the Product Monograph.

If a more specific assessment would provide more value, we invite you to submit for an opinion. You may also reach out to admin to set up a short billable consult meeting that would allow discussion of the specific example (more details to come about this service)

Per Health Canada guidance, PSPs are not a type of additional Risk Minimization Measure/Tool, therefore, there should be no mention of the PSP within the RMT. Participation in the PSP should not be seen as a part of conditions for receiving the drug. Given this, the enrollment form question would be moot. Please, let us know if any new questions come up given the response.

Hey @dmauri, we haven't forgot about this question. It promoted an internal discussion to find the best solution moving forward. We'll look to get a full response posted some time next week. Thanks.

Hey @dlew
Coverage claims may be considered in HCP APS. Patient information should not contain promotional claims but formulary information may be considered. Please see our patient information guidance. HCP claims about “cost” should be factual and complete. A claim of “at zero additional cost for most patients” would be a hanging comparison and would need to clearly state versus what and be supportable across all public and private payers. Remember that formulary bodies have requested that messaging around coverage be limited to statements of coverage and not promotional messaging around “savings”. Additionally, messaging around cost should be clear about what costs (e.g. drug acquisition costs, mark-up, dispensing fee, etc.).

Private coverage claims can be supported by independent third party data from an established company who assess’ market access.

It’s Friday @Agency @Manufacturer and PAAB wants to send you into the weekend with some exciting news: The NEW Creative Imagery in Advertising Advisory is NOW live!

After months of insightful and collaborative discussions, we’re excited to finally announce PAAB’s new advisory on the use of creative imagery in pharmaceutical advertising. Industry has asked for clarity, and we hope this document provides that clarity you’ve been waiting for, or at the very least, provides a stronger framework to evaluate creative ideas with your teams.

Note that this is not the finish line. This is a starting point to continue to grow and evolve with the ever-changing landscape, to meet the needs of healthcare professionals and patients.

We’d like to extend our gratitude to all the industry members of the Creative Committee who took time to share challenges, discuss the advertising landscape, listen to the regulatory concerns and work collaboratively with PAAB to refine the creative imagery discussion.

Special thanks to Mike Spelay (bMod), Andy Leeson (Wellworth and Best), and Konstantine Polanski (Point05 Health), for driving the revisions from the first draft document and creating meaningful examples. Thank you to the bMod team for generating creatives to help capture the principles outlined throughout the document.

We look forward to implementing these new approaches with you and continuing the conversations.

Hey @ALee

Please see Q&A 223 & Q&A 713. These were found by searching “ongoing”. If you select “in titles and posts” you may find additional past questions relevant to your question.

Hey @megancouture

In the context of a general question, there are cases where company-generated calculations may or may not be acceptable. For the specific examples presented, a review of the study design/statistical analyses/results would be considered in the assessment. We recommend considering the following Code sections:

• Code section 5.8 - Methodologies, endpoints and independent review. To be considered as evidence, clinical studies must use established research methodologies and validated endpoints. To aid in the assessment of these study parameters, PAAB looks for evidence that the full study results have been subject to independent review, such as that found by achieving the publishing of study results, including statistical analyses, in a peer-reviewed journal

• For the second example, we’d also advise to consider Code section 4.2.3 (principles of relative risk reduction [RRR] and absolute risk reduction [ARR]) and Code section 5.9 (statistical significance required for evidence).

Hey @Maryssa

Any ad which appears in the consumer space (even when limited through targeting based on interests or profession), are subject to the direct-to-consumer advertising regulations. Link to therapeutic use through study design, name, description, fair balance, or any other form, would not be acceptable since it would contravene Section C.01.044 of the Food and Drugs Act and Regulations which does not permit advertising of prescription medications to the general public beyond name, price and quantity.

Hello @adelaidebaker

Per Health Canada’s Terms and Conditions for Class B opioid products, advertising is restricted to messaging verbatim from the Health Canada approved Terms of Market Authorization. While “market research” and “claims” are broad and unclear, it is unlikely that market research can be used in advertising. If you have a specific case in mind, we invite you to submit for an opinion where additional context can be provided.

Good Morning @palanski

There is not a part of the Code that states that it’s “not required”. Per the above response “. Although the PAAB code does not require a reference list to be included in patient information, we do review the list per s4.4.4 when the manufacturer intends to include the list in the piece.” Code section 6 (Patient Information) states “Company controlled or prepared branded patient information is information that contains non-promotional material that is consistent with, and in addition to, the Health Canada approved patient information (e.g. the consumer information section of the product monograph, patient insert, approved product labelling)” and “All health product information must be consistent with the Terms of Market Authorization (TMA), and should not contain promotional claims”. While other sources may support disease understanding, they do not act as sources of evidence for promotional claims which is the case in HCP advertising and therefore requires the source of evidence to be provided to the HCP for transparency. PAAB does not discourage inclusion of reference lists within patient pieces, it is simply not a requirement of the Code.

Please see Q&A 266. See also PAAB Code 1.5.D which states “Use of a healthcare product name may only be used in a context not linked to therapeutic or promotional messages” for exemption considerations. The mentioned claim would not be exempt.

Hi @laraholmes

We can’t speak to specific reviews or the context or understanding of the website you’re referring to. In the absence of context required to provide specific direction, as a general rule of thumb, when you link advertising and non-advertising, everything becomes advertising and should meet the advertising regulations. PAAB can assist during the reviewer process to help create separation between branded and unbranded content as well as links to additional educational materials.

Hey @cscholes

Claims within advertising for biosimilars must meet the same rigors of the Code as other products. Studies from outside of the TMA must be consistent with the TMA. They must also meet PAAB Code requirements for evidence e.g. well-designed, published, peer-reviewed, statistically supported claims based on predefined endpoints, on label, etc.). If you’re not certain if a specific study meets those requirements, we encourage you to submit for an opinion review. Please be specific about how you’d like to use the study in order to receive the most comprehensive opinion.

Hi @Danielle

Section 1.1.4 Endpoints/ Outcomes of the Guidance on Real-World Evidence states “Endpoints/Outcomes must be “consistent with” (though not necessarily “the same as”) those in the TMA. Regardless of whether the evidentiary basis for the presentation is RWE/RWD or an RCT, endpoints are not generally limited to those explicitly included within the TMA. Though the approach for RWE/RWD mirrors that for RCTs in this respect, the following examples are intended to clarify questions received during the consultation process.” You can review the examples in the linked document. Assessment of “consistent with” is made in the context of the combination of the endpoint, TMA and the therapeutic area. The submitter should provide authoritative support within the submission, to support that the endpoint is consistent or similar to those in the TMA and that it is a recognized endpoint within the therapeutic area.

Hey @mef

Thank you for flagging this. We've discussed the matter with the review team to ensure alignment and are updating both internal and external guidance documents for clarity. In most cases, study design footnotes may appear outside the box.

Good Morning @dmauri

This is a specific review question. Please submit the guidelines and proposed product claims. This can be done in a full submission or an opinion if you’d like further clarification prior to building out tools.