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Jennifer Carroll

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.

H.l

Hi,
Are controlled drugs listed under Schedule I of the Controlled Drugs and Substances Act subject to the same marketing and advertising regulations as opioids?
Is it permissible to create and provide promotional materials for controlled drugs to healthcare professionals or medical staff?
If not, can product fact sheets still be distributed?

Jennifer Carroll

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.

Jennifer Carroll

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).

Jennifer Carroll

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.

Jennifer Carroll

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.

Jennifer Carroll

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.

Jennifer Carroll

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.

Jennifer Carroll

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.

Jennifer Carroll

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.

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