Trust Through Transparency

FDA Research Suggests Disclaimers and Detailed Information in Promotional Materials Can Increase Intent to Prescribe

The FDA’s Office of Prescription Drug Promotion (OPDP) funds research to understand how promotional material can be both safe and effective. This research then informs their recommendations for how to tackle various regulatory challenges faced by industry. While the regulatory landscape is often perceived as rigid, the ultimate goal is to create promotional materials that ensure the audience has the information that they need to make informed decisions.

In pharmaceutical marketing, one of the main ways to establish trust in your messaging is through rigor. Rigor is a measure of the competency of supporting research for a particular message or claim. Some might mistake rigor for adding unnecessary rigidity and complexity; however, it is essential in ensuring reliability and trustworthiness.

A 2024 publication from OPDP sought to investigate and advise on how the perceived rigor of an advertisement changes its perception in the minds of healthcare professionals (HCPs).1 This work was built upon a previous study of HCPs who found that providing disclaimers that qualified a hypothetical drug for off-label use increased the likelihood of prescribing. In this foundational study, the likelihood of prescribing for off-label and on-label use was similar when disclaimers were included, but the likelihood dropped by 80% when the disclaimers were removed.

Building on the 2019 work, the OPDP research team identified that increasing the perceived rigor of a study by prominently disclosing the double-blind and active-comparator design of the trial increased HCPs’ perceptions of credibility and importance. Additionally, HCPs were more likely to prescribe and had a more favorable view of the risk/benefit profile of the drug.

The high-rigor information provided also decreased HCPs’ perception of bias within the piece and made participants feel they did not need to approach the material with the same caution they would use with purely promotional content.1

Perception of Bias Remains an Obstacle for Pharmaceutical Promotion

Promotional material without graphics, similar to a study reprint or summary, are often approached with less skepticism and caution than more traditional promotional pieces such as sales aids.1 The recent publication revealed that HCPs were twice as likely to report they thought the messaging was biased when presented with promotional pieces compared to non-promotional abstract-style documents. Messaging provided in forms similar to what would be seen in a research or clinical setting may have the benefit of not triggering this unconscious bias towards promotional material. Additionally, this format naturally lends itself to having room for all the disclaimers and qualifying statements an HCP would look for in order to feel comfortable trusting the information.

Time Flies When You’re Being Marketed To: Decisional Caution in Real-Word Settings

Considerations for the format and substance of promotional materials should also be assessed within the context they are conveyed. How much time a doctor has to read and comprehend the information presented to them can alter their perception of the information. When HCPs were allowed as much time as they wanted to sit with and read the product information provided, they reported being more confident in the data and were more likely to prescribe the drug. However, time pressure in all things is an inherent aspect of a busy medical practice and HCPs rarely have abundant time to read promotional pieces.

In the study by Aikin et al, mimicking this time pressure in the experimental setting resulted in “decisional caution” as HCPs were not given enough time to develop confidence in their evaluation of the information they read.1 This decisional caution then translated into a reduced likelihood to prescribe. While it would be ideal to find some way of communicating with HCPs that eliminates these time constraints, research into magically creating a few extra hours each day for people with busy schedules has yet to bear fruit. Therefore, overcoming this decisional caution by instilling trust in the information being provided remains the most important goal.

Rigor Not Rigid: The Klick Science + Regulatory Team’s Perspective on Building Trust Between Marketers and Medical Professionals

Through this recent research, OPDP has uncovered that there is a clear appetite for rigorous information in the HCP pharmaceutical marketing space. To build trust through transparency, Klick’s Science + Regulatory team recommends that high-rigor information is clearly and prominently disclosed. Let’s look at a few examples of how marketers and regulatory can collaborate to achieve both rigor and innovation.

Promotional materials often seek to reduce the content of a message to focus on a main concept or claim. This is especially true when working in space-limited settings such as banner ads and social media. One of the best ways to highlight a claim is to ensure it has enough space away from other information so a reader can fully focus on it. Although footnotes and disclaimers may add visual clutter, they remain essential to showing HCPs that they can trust what is being said.

Even when space is not necessarily a limiting factor for promotional material, several considerations remain important to building trust with our HCP audiences. When presenting data that is consistent with the FDA label (CFL) in-market, including high-rigor information such as baseline characteristics, study design details, and controls for statistical errors can give HCPs confidence that even though the information is not present in the FDA-approved labeling, it is still grounded in the same scientific excellence and is appropriate for the same patient population.

The Klick Science + Regulatory team is here to help navigate this trust-building process by understanding when and where to incorporate the appropriate rigor in our promotional pieces. Working with our Creative and Strategy teams, we combine impactful science with transformative creative that results in rigor without any of the rigidity. Reach out to our Science + Regulatory team for help with rigorous innovation!

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