Dec 18 -- The Food and Drug Administration (FDA) invites comments to OMB by January 22, 2024 regarding a proposed Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising. [Comments due 30 days after submission to OMB on December 21.]
The mission of the Office of Prescription Drug Promotion (OPDP) is to protect the public health by helping to ensure that prescription drug promotion is truthful, balanced, and accurately communicated so that patients and healthcare providers can make informed decisions about treatment options. OPDP's research program provides scientific evidence to help ensure that our policies related to prescription drug promotion will have the greatest benefit to public health. Toward that end, we have consistently conducted research to evaluate the aspects of prescription drug promotion that are most central to our mission, focusing in particular on three main topic areas: advertising features, including content and format; target populations; and research quality. Through the evaluation of advertising features, we assess 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. Focusing on target populations allows us to evaluate how understanding of prescription drug risks and benefits may vary as a function of audience. Our focus on research quality aims at maximizing the quality of our research data through analytical methodology development and investigation of sampling and response issues. This study will inform the first topic area, advertising features.
Because we recognize that the strength of data and the confidence in the robust nature of the findings are improved through the results of multiple converging studies, we continue to develop evidence to inform our thinking. We evaluate the results from our studies within the broader context of research and findings from other sources, and this larger body of knowledge collectively informs our policies as well as our research program. Our research is documented on our homepage at
https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research, which includes links to the latest Federal Register notices and peer-reviewed publications produced by our office.
Direct-to-consumer (DTC) prescription drug advertising may make quantitative claims about the drug's efficacy or risks (Ref. 1). Although there is research and FDA guidance (“Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements,” available at
https://www.fda.gov/media/169803/download) that provides general guidelines for how to present quantitative information, it is not fully understood how consumers will interpret specific quantitative claims. We conducted a literature review and found that while some types of quantitative information are well-studied (e.g., relative frequencies), many questions remain on how best to communicate certain quantitative information about prescription drugs. For example, we do not have sufficient information about how consumers interpret different claims describing medians (e.g., “People treated with Drug X lived for a median of 8 months” alone or in combination with a definition such as “In people receiving Drug X, this means that about half lived more than 8 months and about half lived less than 8 months” or “A median is the middle number in a group of numbers ordered from smallest to largest”). This study aims to survey U.S. adults about their interpretation of specific quantitative claims.
We plan 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 sample will be representative of the U.S. population. A sample of U.S. households will be drawn from the U.S. Postal Service Computerized Delivery Sequence File. Adults aged 18 or over will be eligible for participation. Up to four contacts (mailings) will be sent to respondents by U.S. mail. The contacts will include the URL for the online survey and a unique survey login. This unique survey login will be used to track completed surveys without the use of personally identifying information. The contact method, based on recent recommendations (Ref. 2), includes a prenotification letter (week 1), a web survey invitation letter (soft launch in week 2, full launch in week 3), a reminder postcard sent to nonresponders (week 5), and a final mailing with the paper version of the survey sent to nonresponders (Week 7). We estimate a 40-percent response rate, based on recent experience with similar surveys. We estimate 1,100 respondents will complete the main study (see table 1).
Based on previous research, we plan to include a small prepaid incentive in the second mailing sent to the sampled addresses as a gesture to encourage response and maintain data quality. We expect that approximately 5 percent of the sampled addresses will be postal non-deliverable returned letters from the first mailing (prenotification letter), so the second mailing is estimated to go out to the remaining addresses. We also will conduct an experiment to assess the efficacy of using a promised post-paid incentive. Seventy-five percent of the sample will be sent the promised incentive upon completion of the survey, and the remaining 25 percent of the sample will not be notified of or provided with any promised incentive. We opted to split the sample 75–25 rather than 50–50 because the initial evidence shows the benefits of including a promised incentive, and we aimed to maximize response rates.
The survey contains questions about respondents' perceptions and understanding of several quantitative claims drawn from DTC ads in the marketplace. We will also measure other potentially important variables, such as demographics and numeracy. The survey questions will be informed by consumer feedback elicited in one-on-one interviews (approved under OMB Control No. 0910–0847). The survey is available upon request from DTCResearch@fda.hhs.gov.
We will test whether any variables differed between modes (online versus mail survey) and will account for any mode effects in our analyses. We 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. We will weigh the data to account for different probability of selection and nonresponse.
FDA submission to OMB:
https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202311-0910-009 Click IC List for information collection instrument, View Supporting Statement for technical documentation. Submit comments through this webpage.
FRN:
https://www.federalregister.gov/d/2023-27652
For AEA members wishing to submit comments, "A Primer on How to Respond to Calls for Comment on Federal Data Collections" is available at
https://www.aeaweb.org/content/file?id=5806