On April 25, 2023, the United States Food and Drug Administration (FDA) published a request for comments on a planned survey on quantitative claims in direct-to-consumer (DTC) prescription drug advertising, with a due date for comments of June 26, 2023. FDA and the Office of Prescription Drug Promotion (OPDP) has “consistently conducted research to evaluate the aspects of prescription drug promotion that are most central to [the agency’s mission of protecting public health], focusing on three main topic areas: advertising features, including content and format; target populations; and research quality.
OPDP notes that when it comes to advertising features, the agency looks to see how elements such as graphics, format, and the characteristics of the disease and product impact the communication and understanding of prescription drug risks and benefits. The focus on target populations includes understanding how prescription drug risks and benefits are interpreted as a function of audience. Finally, the focus on research quality aims to maximize the quality of research data through analytical methodology development and investigation of sampling and response issues. This particular study is focused on area number one: advertising features.
DTC advertising for prescription drugs can make quantitative claims about the drugs effectiveness and risks. While there is some current research and FDA guidance about how to generally present quantitative information, it is not fully understood by the agency how consumers interpret specific quantitative claims. Based on a literature review, many questions remain on how companies should best communicate certain quantitative information about prescription drugs. One example provided in the Federal Register notice is a lack of sufficient information on how consumers interpret different claims describing medians alone or in combination with a definition. Therefore, the agency wants to survey United States adults about their interpretation of specific quantitative claims.
To conduct the research, FDA plans to “use an address-based, mixed-mode methodology that will direct one randomly chosen member of sampled households to complete a 20-minute online survey, with nonrespondents receiving a paper questionnaire.” The contacts will receive up to four mailings via United States mail and will include the URL for the online survey as well as a unique survey login, which will be used to track completed surveys without using personally identifying information. FDA expects a 40% response rate based on recent experience, for a total of 1,100 respondents completing the main study.
FDA also plans to include a small prepaid incentive in the second mailing to the selected addresses to encourage responses and maintain data quality. The efficacy of a promised post-paid incentive will also be studied, as 75 % of the sample will receive the promised incentive upon completion of the survey while 25% will not be notified of or receive any promised incentive.
The survey will include questions about respondents’ perceptions and understanding of quantitative claims pulled from active DTC ads, as well as other variables, such as demographics and numeracy. FDA will examine the descriptive statistics for the survey items (e.g., frequencies and percentages) and explore the relationship between the survey items and demographic and health characteristics as well as weight the data to account for different probability of selection and nonresponse.
If you would like to submit comments, instructions to do so are included in the Federal Register notice. All comments must be received by June 26, 2023.