What is this study about?
Federal regulations specify that print advertisements for prescription drugs and biological products must provide a true statement of information “in brief summary” about the advertised product’s “side effects, contraindications, and effectiveness.” This section of the DTC ad is called the “brief summary.” Some of the current approaches to fulfilling the brief summary requirement, while adequate from a regulatory perspective, result in ads that may be difficult to read and understand when used in consumer-directed promotion.
This study was designed to explore the brief summary in traditional formats as well as variations in content and format that may make the brief summary more useful for consumers.
Why did the U.S. Food and Drug Administration (FDA) conduct this study?
To improve its understanding of how consumers use the brief summary and explore ways in which it might be improved, FDA conducted three studies to address the following three questions:
- Does the risk information presented on the first page of the ad where the benefits are discussed (the display page) influence the way that people read through and understand the information in the brief summary, and what topics do people think are important in the brief summary?
- Do additional details and context about side effects make it difficult to read and understand the other risk information in the brief summary?
- How do alternative formats compare with the commonly used format for the brief summary?
What kind of study is it?
FDA conducted three experimental studies, randomly assigning participants to test conditions. The first study examined how the presence or absence of a serious risk might affect the way people understand the brief summary; the second study added different types of context to the brief summary, including the likelihood and duration of side effects; and the third study examined the understanding of and preference for four different brief summary formats: Traditional, Question and Answer, Highlights, and Prescription Drug Facts box.
Who participated in this study?
For Study 1, 800 mall visitors across the United States who reported that a health care provider told them or someone they currently provided care for had asthma, high cholesterol, and/or were overweight (i.e., need to lose more than 15 pounds) participated in the study. For Study 2, 900 mall visitors across the United States who reported that a health care provider told them they were overweight and needed to lose more than 15 pounds participated in the study. For Study 3, 300 mall visitors across the United States who reported that a health care provider told them they were overweight and needed to lose more than 15 pounds participated in the study.
What did you find?
We found that the addition of a serious risk to the display page and the addition of frequency and duration information about side effects in the brief summary did not negatively affect the understanding of the risk information as a whole, including the most serious warnings and precautions. The format of the information had several effects. For instance, participants who viewed the Drug Facts format were better able to recall risks than those who saw the Traditional format. Several other findings are discussed in the Executive Summary.
What does this mean?
Taken together, the results of these studies provide insight into how consumers use information in the brief summary and ways in which the information could be improved. Our studies provide policy makers and researchers with important information regarding the topics and amount of information people want in the brief summary, and the role of context and format in the understanding of the document. The results will inform guidance development designed to improve communication to consumers regarding their use of prescription drugs.