May 1 -- The Office of Prescription Drug Promotion (OPDP), Food and Drug Administration (FDA) solicits comments to OMB by June 5, 2023 on research entitled “Tradeoff Analysis of Prescription Drug Product Claims in Direct-to-Consumer and Healthcare Provider Promotion.” [Comments due 30 days after submission to OMB on May 5.]
The OPDP's mission is to protect the public health by helping to ensure that prescription drug promotion is truthful, balanced, and accurately communicated. 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. Our research focuses in particular on three main topic areas: (1) advertising features, including content and format; (2) target populations; and (3) research quality. Through the evaluation of advertising features, we assess how elements such as graphics, format, and disease and product characteristics 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, and our focus on research quality aims at maximizing the quality of research data through analytical methodology development and investigation of sampling and response issues. This study will inform the first and second topic areas, advertising features and target populations.
Because we recognize that the strength of data and the confidence in the robust nature of the findings are improved by using 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.
The proposed research examines the relative importance of prescription drug product information such as prescription drug efficacy, risk, adherence, and patient preference claims in two medical conditions (type 2 diabetes and psoriasis) in consumer and physician samples. When confronted with an important decision, people tend to make choices that reflect a series of tradeoffs between certain desirable and undesirable attributes of a product, service, or experience. Pharmaceutical manufacturers provide information about prescription drug products, including side effects, contraindications, and effectiveness, through product labeling and promotional materials (21 CFR 202.1(e)). The treatment choices of diagnosed consumers and treating physicians have been shown to be influenced by certain characteristics, such as the drug's perceived impact on quality of life, complexity of dosage regimens, mode of administration, cost to family and self, and marketing claims unrelated to medicinal properties (Refs. 1 to 5). Although diagnosed consumers may weigh the risks, benefits, or other salient characteristics of prescription drug products differently than physicians, little research directly compares the treatment preferences of these two groups (Ref. 6). Understanding the tradeoffs among drug product characteristics diagnosed consumers make—and how the tradeoffs could potentially differ from the tradeoffs made by physicians—will provide valuable insight into the relevance and impact of various product attributes and promotional claims on informed choices and treatment decisions.
We intend to examine these tradeoffs using a choice-based conjoint analysis, also known as a discrete choice experiment. Conjoint analysis is a broad class of survey-based techniques used to estimate how attractive or influential different features of choice options or product attributes are in determining purchase behavior or treatment choices (Ref. 7). Conjoint analysis can be used to examine the joint effects and tradeoffs of multiple variables or product attributes on decisions. A choice-based conjoint analysis is based on the principle that products are composed of a set of attributes, and each attribute can be described using a finite number of levels. In the proposed research, participants will be shown a carefully designed sequence of choice tasks containing up to five hypothetical product attributes—in this case, profiles describing fictitious prescription drug products for either type 2 diabetes or psoriasis. Using data from the choices that participants make across these tasks, we can use statistical techniques to draw inferences about the relative value they place on different product attributes, estimate the relative importance of different attributes, explore the tradeoffs that consumers and physicians are willing to make to avoid or accept specific attribute levels, and compare the preferences of these two groups (Ref. 8).
We estimate that participation in the study will take approximately 20 minutes. Adult participants aged 18 years or older will be recruited by email through an internet panel, and participant eligibility will be determined with a screener at the beginning of the online survey. The consumer sample will consist of adults who self-report as having been diagnosed by a healthcare provider with either psoriasis or type 2 diabetes. For the consumer sample, we will exclude individuals who work in healthcare settings because their knowledge and experiences may not reflect those of the average consumer. The physician sample will consist of primary care physicians and specialists who report treating patients with psoriasis or type 2 diabetes. For the physician sample, we will exclude individuals who spend less than 50 percent of their time on direct patient care. Department of Health and Human Services employees and individuals who work in the marketing, advertising, or pharmaceutical industries will be excluded from both respondent groups. Respondents will receive a survey invitation with a unique password-protected link. All panel members are recruited following a double opt-in process. Sample sizes were estimated by combining approaches for conjoint analysis suggested by Orme (Ref. 9) and Johnson et al. (Ref. 10).
The target sample size for the main study is 800 physicians and 800 consumers, with half of each cohort focusing on treatments for psoriasis and the other half focusing on treatments for type 2 diabetes. Prior to conducting the main study, we will conduct at least one pretest. If the first pretest reveals that changes to the measurement instruments, stimuli, or procedures are required, a second pretest will be conducted with revised materials. The target sample size for each wave of pretests is 60 physicians and 60 consumers.
Office of Prescription Drug Promotion (OPDP) Research: https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/office-prescription-drug-promotion-opdp-research
FDA submission to OMB: https://www.reginfo.gov/public/do/PRAViewICR?ref_nbr=202303-0910-023
Click on IC List for questionnaire, View Supporting Statement for technical documentation. Submit comments through this site.
FR notice inviting public comment: https://www.federalregister.gov/d/2023-09183
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