May 24, 2021 – The FDA’s Office of Prescription Drug Promotion (OPDP) is preparing to study whether consumers are challenged when multiple indications for the same drug are promoted in a single television ad.

“It is our hypothesis that participants will be more likely to correctly recall and understand the first indication when it is presented alone, compared with when it is presented with a second (similar or dissimilar) indication,” OPDP states in a recent Federal Register notice.

OPDP seeks to learn more about the promotion of drugs approved for multiple indications, either for conditions that are similar in certain respects or that are very different from each other, and states that it wants to explore how promoting multiple indications in one ad affects consumer’s processing of drug information, which “may increase the cognitive load on consumers, thus decreasing their understanding of the drug’s indications.”

Accordingly, OPDP “will explore whether similarity of the indications affects participants’ likelihood to recall and understand the indications. We will also explore the effects of the indication presentation on benefit and risk perceptions, attitudes toward the drug and the indication information, and intentions to look for more information and ask a doctor about the drug.”

OPDP plans to conduct two pretests (one for each main study) and two studies not longer than 20 minutes, administered through an Internet panel of randomly assigned participants, according to the March 4 Federal Register notice. Study participants “will view one study advertisement and then complete a questionnaire that assesses recall and comprehension of the drug’s benefits and risks, benefit and risk perceptions, attitudes and behavioral intentions,” the notice states. OPDP also will “measure covariates such as demographics and health literacy.”

The recent notice follows up on comments filed on the original notice — published July 6, 2020 – regarding the study. For example, three of the four comments received stated that care should be taken to reduce variables in the study stimuli in terms of length, order and presentation of indications, background and actor profiles, ad quality, and audio and visual effects.

“We can confirm that care has been taken to ensure that we do not have any unintentional confounds across the study conditions,” OPDP states in the recent notice, adding that the ads “use the same actors, scenes, audio and visual effects and all other design and content features to ensure that all elements are consistent across experimental conditions. … The only aspect that will change is the manipulated content (i.e., script and superimposed text relaying the indications).”

The multiple indications study joins several other ongoing studies being conducted by OPDP to evaluate aspects of prescription drug promotion. Notably, three OPDP research products were completed in 2020. These studies and their results are as follows:

• Assessing the Inclusion of Foil Items in a Scale to Measure Recognition of Health Messages: The results suggest that creating a recognition scale by summing only the true items in a list of true and false items creates a more discriminant scale than summing both true and false items.
• Patients’ Understanding of Oncology Clinical Endpoints: Formative Research: The results point to the need for more patient-friendly definitions of clinical endpoints developed with general public and cancer patients’ input.
• Risk and Benefit Perception Scale Development: OPDP tested and identified 21 validated measures that represent 11 distinct risk/benefit constructs. Researchers and practitioners can use these items to assess patient perceptions of prescription drug risk, benefit, and efficacy and to ensure greater future comparability between studies.

There are currently 10 OPDP research studies pending peer review and publication and 14 other OPDP research studies in progress, according to the OPDP Research web page.