Insights on PAAB Review and Evaluation of Creative Imagery

Creative imagery/concepts are among the core messages of an APS.

The PAAB endeavours to ensure the credibility of evidence-based drug advertising and it is important that benefits that have not been demonstrated by a drug product are not implicitly imputed to it. In our effort to expand the range of creative imagery in branded advertising, we are aiming for an approach that balances utility and credibility.

This document is not intended to provide a set of prescriptive rules for creative imagery. We recognize that there must be room for nuance and creativity and remain open to conversation and collaboration around creative ideas within the review process.

The clarification and guidance provided in this document are intended to help illuminate the ways the PAAB intakes and reviews creative imagery to help inform the Sponsor and Agency’s creative process.

Key changes from current PAAB review practice in this document include an updated approach toward depictions of patients in general life settings and the potential use of disclosures as an option to help move previously unacceptable visuals towards acceptance. These new approaches create greater flexibility with regards to acceptance of creative concepts.

Review Scenarios

When assessing creative imagery/concepts, the PAAB considers the overall message and its components (e.g. copy, image) in addition to the therapeutic area and supporting data that meets PAAB evidentiary requirements. Each of these elements contribute to the context of the message and how it can be interpreted.

During the initial layout review, the PAAB will determine which scenario the creative concept depicts. This process informs how the creative will be evaluated, as well as possible solutions that can be provided to help move the concept to approval. During the initial review process, multiple PAAB Reviewers will assess the new creative to help ensure that multiple perspectives are considered. Please note that this document presents 3 common and challenging scenarios seen at the PAAB. The scenarios described in the pages that follow do not provide an exhaustive list of all possible scenarios and there may be creative imagery concepts that continue to remain unacceptable in spite of the changes listed within this document.

NOTE: The examples provided herein are included strictly for illustrative purposes. They do not cover all PAAB requirements for an acceptable APS.

Scenario 1: Depiction of patients in a GENERAL LIFE SETTING

This scenario shows patients existing in their daily lives. Specific clinical outcomes are typically not connected to these visuals through evidence or data. However, images and copy may still imply potential outcomes for the brand.

When a creative visual could convey multiple meanings, one of which extends beyond the terms of marketing authorization (TMA) (e.g., suggesting an unapproved indication), and/or implies a clinical outcome, a disclosure statement may be used to clarify the intended message. A disclosure statement may serve as an option when other solutions, such as modifying the imagery or the accompanying copy, are not preferred and an impasse arises regarding the visual’s interpretation. However, disclosure statements cannot be used to justify overtly misleading or off-label messages. To ensure clarity and accessibility, the disclosure must be placed in direct proximity to the visual and presented with equal or greater prominence than the balance copy.

In most cases, depicting a patient in a general life setting is acceptable.

NEW If the creative imagery is unclear with respect to the intended patient population or patient selection limitations, the PAAB can consider a disclosure to assist the reader with interpretation. Note: The disclosure should be placed in direct proximity to the visual, in a size and prominence equal to or greater than balance copy.

In some cases, the therapeutic category may have inherent implications for clinical outcomes or quality of life, even in a general life setting (particularly mental health). In these cases, the PAAB will collaborate with the Sponsor to ensure the image is interpreted in accordance with the TMA and supporting data. In the above example, the Sponsor could elect to modify the creative imagery to lessen the implied claim for improved social interactions (e.g., remove some people from scene, crop closer to the patient). Should any implied claims remain, the creative imagery would then fall under Scenario 2 below.

Scenario 2: Creative imagery with IMPLIED outcomes

 

The evaluation of creative imagery is inherently subjective. Often, the audience can derive multiple interpretations from a concept. When a concept does not explicitly visualize an outcome, it can still be perceived to carry an implicit claim. These implied claims are often the result of category or context, and not just the image itself.

Below are three examples of solutions when dealing with implied claims.

Note: The examples are for illustrative purposes only. They are not the only solutions.

NEW In cases where an outcome is implied through the nature of the therapeutic category or the surrounding headline/message, the PAAB may consider including a disclosure to help mitigate that implication. The PAAB will work with the Sponsor to ensure that any perceived implication is not interpreted as an indirect claim of therapeutic benefit or claim of merit. Note: The disclosure should be in direct proximity to the visual, in a size equal to or greater than balance copy.

NEW In cases where the product has qualifying data to support an implied claim for quality of life (QOL) but the Sponsor elects not to include this in direct proximity to the creative imagery, the PAAB can consider a prominent disclosure directing the reader to the data within the APS. This is applicable for quality of life endpoints only.                    Note: The claim neutral disclosure must appear in body copy for adequate prominence to the reader. Should the Sponsor elect to include data on the same page, the disclosure is not required.

In cases where the product has qualifying data, and there are important considerations with respect to its limitations or interpretation, the PAAB will continue to require this be presented in direct proximity to the creative imagery.                                                              Note: In this case, the qualifying data must be disclosed with the creative. The PAAB may also ask for disclosures or disclaimers that are relevant to the therapeutic landscape. Note: Products with NOC/c or other label limitations are required to provide supporting data in direct proximity to all creative imagery with implied outcomes.  Advertisers should be mindful of creatives in banner/small space ads.

Scenario 3: Creative imagery with EXPLICIT outcomes

 

A creative that explicitly depicts an outcome requires substantiation and inclusion of the supporting data that meets the PAAB requirements.  

Clearly presenting the extent of benefits demonstrated in studies allows health professionals to make informed risk–benefit assessments, essential for rational prescribing or recommending of treatments. All messages in HCP advertising, whether conveyed through text or imagery, must be evidence-based. The PAAB will not approve imagery that is misleading or which misrepresents the evidence.

In cases where the creative imagery and/or accompanying claims convey an explicit claim of merit, the PAAB will continue to require supportive data be presented in direct proximity for qualification and/or quantification.            As a helpful reminder, the PAAB accepts general study parameters to appear on other pages of the APS, such as the References listing. Important study limitations must still be presented with qualifying data on the same page.

NEW In some instances, exaggeration or metaphor is used in creative imagery to emphasize an explicit claim. In cases where the depicted effect exceeds the qualifying data, the PAAB may consider a strongly worded disclosure to help mitigate the effect. Note: The disclosure must appear in body copy for adequate prominence to the reader. Use of such disclosures will be highly dependent on the therapeutic category and product label. The PAAB will work with Sponsors to ensure APS remain truthful and balanced.

In cases where an exaggerated visual clearly misleads the reader such as by extending the measured outcome or overstating the magnitude of effect of a treatment, the PAAB will continue to question such creative imagery, even in the presence of qualifying evidence. As a helpful reminder, the PAAB opinion process can help gauge the preliminary acceptability of new creative, including pre-NOC.