Research in Progress | Office of Prescription Drug Promotion (OPDP) Research
OPDP’s research team is involved in many ongoing research projects. These studies will inform our understanding of important issues related to prescription drug promotion.
Before research is fielded, the public has the opportunity to offer feedback on OPDP research through the public comment process. We appreciate and consider all comments which seek to assist us in improving the quality of our research. If you would like to contribute your comments, check the Federal Register for OPDP research projects by going to www.regulations.gov . The research team can also be reached directly by email at DTCresearch@fda.hhs.gov
Additional information about select research in progress along with links to appropriate Federal Register notices is available below.
Adherence Potential and Patient Preference in Prescription Drug Promotion
This study builds on OPDP’s portfolio of research on market claims and disclosures to explore the influence of statements around patient adherence and preference in prescription drug promotion. It is not known how claims that appeal to the possibility for greater adherence or to social norms around what other patients or healthcare providers prefer influence behavioral intentions or risk, benefit, and adherence perceptions of a drug. A related question is whether including a disclosure stating the uncertainty around such claims (e.g., there is no conclusive research on whether DRUG A results in better adherence) can mitigate any misleading perceptions or influence preferences. Some evidence suggests that disclosures in prescription drug promotion are typically noticed and may help consumers and healthcare providers understand information, but this topic has not been investigated in the context of adherence claims. To complete this research, we will show participants a website for a fictitious prescription drug product for type 2 diabetes. We will vary the website based on whether the fictitious prescription drug promotional communication includes a claim about implied adherence, patient preference, and/or a disclosure that there is no conclusive research on adherence. Recruitment will occur by email through an internet panel, and participant eligibility will be determined with a screener at the beginning of the online survey. Each participant will see one of eight versions of a consumer web page for a fictitious prescription diabetes treatment, as reflected by the 2 (implied adherence claim) x 2 (patient preference claim) x 2 (disclosure) design. They will answer a questionnaire designed to take no more than 20 minutes regarding benefit and risk perceptions, adherence perceptions, behavioral intentions, adherence claim retention, and patient preference claim retention.
- Federal Register Notices: 60-day
Disclosures in Professional and Consumer Prescription Drug Promotion
In the course of promoting their products, pharmaceutical sponsors (sponsors) may present a variety of information including the indication, details about the administration of the product, efficacy information, and clinical trial data. In an effort to present often complicated information concisely, sponsors may not include relevant information in the body of the text or visual display of the claim. Additionally, sponsors may not always present limitations to the claim in the main body of the text or display. In these cases, sponsors typically include disclosures of information somewhere in the promotional piece. This research is designed to examine how effectively healthcare professionals and consumers are able to use these disclosures to appropriately qualify the claims presented in the display or claim.
Dosage Form Presentations in Direct-to-Consumer Prescription Drug Television Advertisements
Prior research has demonstrated that patients tend to prefer certain medication dosage forms over others, such as oral medications over injectable medications. Cognizant of these patient preferences, prescription drug sponsors may choose to minimize the presentation of lesser preferred dosage forms in direct-to-consumer (DTC) prescription drug television advertisements. Whether such minimization occurs and any effects on consumer judgement and decision-making are currently unknown. In addition, it is currently unclear how best to present dosage form information generally in DTC television ads such that this information will be adequately processed and retained by consumers.
The proposed research will provide an assessment of the following:
- Common dosage form presentations in DTC television ads;
- Baseline consumer attitudes about dosage form presentations in DTC television ads; and
- Effects of dual modality and placement of dosage form information in DTC television ads.
More information
Endorser Status and Actual Use in Direct-to-Consumer Television Ads
This research extends prior research (FDA-2019-N-5900, OMB control number 0910-0894, Expiration Date: March 31, 2023) by examining actual-use disclosures and a different medium. The present research specifically examined the influence of two independent variables--endorser type (patient, physician) and an actual-use disclosure (utilizer, actor, none)--in television advertisements. Dependent variables included perceptions of the risks and benefits of the promoted prescription drug, attitudes toward and perceptions of the endorser, attention paid to the ad, and behavioral intentions. Because age and education level may have affected perceptions of the ad, we explored whether age and education level influence these effects.
This research involved two independent studies, one with a sample of consumers who have been diagnosed with diabetes and another sample with rheumatoid arthritis. In both identical studies, each participant watched a DTC television ad for a fictitious drug indicated to treat the corresponding medical conditions. The ads were varied to assess the impact of two categories of commonly used industry spokespeople: a patient and a physician. We tested three actual-use disclosure conditions: (1) an actual-use disclosure that indicated that the endorser either uses or prescribes the prescription drug in real life (i.e., utilizer), (2) an actual-use disclosure that specified the endorser is an actor, and (3) a control with no actual-use disclosure.
Examination of Implied Claims in Direct-to-Consumer Prescription Drug Promotion
Direct-to-consumer (DTC) prescription drug promotion may include truthful and non-misleading claims about the product. A particular claim may be direct (explicit) or indirect (implied or implicit). Some prior research has shown that implied claims are misremembered as explicit claims. Other research has shown that claims can result in a misleading impression of the product through implication, rather than literal interpretation. Understanding how consumers who self-report having been diagnosed with a target condition interpret implied claims in DTC prescription drug promotion—and how their perceptions differ from those of consumers who have not been diagnosed with the target condition—will provide valuable insight into the relevance and impact of various product attributes and promotional claims on treatment decisions. The current project will test the impact of several implied claims in DTC prescription drug advertising on consumer perceptions.
- Federal Register Notices: 60-day
Healthcare Provider Survey of Topics Related to Prescription Drug Promotion
This current project will be a survey with a selection of prescribers examining a variety of topics of interest to OPDP. Topics we plan to assess include, but are not limited to, awareness and use of the Bad Ad program, understanding of quantitative data displays that may appear in prescription drug promotion, perceptions of trust in FDA, perceptions of medical misinformation, and attitudes about prescription drug promotion on social media. These topics were selected to extend previous FDA work on healthcare provider understanding of quantitative data displays, provide an updated snapshot of social media attitudes and Bad Ad program awareness, and help inform FDA’s role in addressing medical misinformation.
- Federal Register Notices: 60 day
A Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising
Direct-to-consumer (DTC) prescription drug advertising may make quantitative claims about the drug's efficacy or risks. 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/117573/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.
Targeted Mechanism of Action Presentations in Prescription Drug Promotion
In 2014, OPDP conducted focus groups designed to provide insights on how consumers and healthcare providers (HCPs), including physicians, nurse practitioners, and physician assistants, interpret the term “targeted” in prescription drug promotional materials. Although diverse views were voiced, there appeared to be some tendency toward the impression that products with promotional materials using this term would be safer and more effective than other similar treatments. OPDP is also now conducting a nationally representative survey regarding the ways in which consumers and primary care physicians interpret terms and phrases commonly used in prescription drug promotional materials, including assessment of impressions of the terms “targeted” and “targeted mechanism of action” (targeted MoA) (86 FR 24867). Building upon this line of research, the proposed study will investigate the influence of targeted MoA claims, graphics, and disclosures that provide context about a drug’s targeted MoA, utilizing an experimental design with both consumer and HCP samples. The experimental approach described here is intended to complement and augment the prior research by facilitating assessment of causality. Specifically, the study will explore how varied targeted MoA presentations affect consumer and HCP understanding of the MoA of a drug, perception of drug benefits and risks, attention to risk information, and interest in the drug.
Tradeoff Analysis of Prescription Drug Product Claims in Direct-to-Consumer and Healthcare Provider Promotion
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. The treatment preferences of diagnosed consumers and treating physicians have been shown to be influenced by certain characteristics, such as the perceived drug’s impact on quality of life, complexity of dosage regimens, mode of administration, cost to family and self, and marketing claims unrelated to medicinal properties. 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. 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. The proposed research will use conjoint analysis techniques to examine 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.