The Office of Prescription Drug Promotion (OPDP) has an active research program designed to investigate applied and theoretical issues of relevance to direct-to-consumer (DTC) and professional promotional prescription drug materials. This research program utilizes a number of different research methodologies, including survey and experimental research as well as qualitative research for development purposes. OPDP’s research supports the Food and Drug Administration’s (FDA) goal of science-based policy while maintaining its commitment to protect the public health.
The OPDP research team also provides technical assistance to outside organizations on the design and implementation of studies concerning prescription drug promotion. Some of these organizations include academic researchers, pharmaceutical companies, and non-profit groups.
The OPDP research team consists of Kathryn Aikin, Ph.D. (Team Lead), Kevin Betts, Ph.D., Amie O’Donoghue, Ph.D., and Helen Sullivan, Ph.D., M.P.H.
CONTACT US: DTCresearch@fda.hhs.gov
This webpage is divided into three sections. Please click the links below to access more information about completed research projects, research pending peer review and publication and research in progress.
Do Prescription Drug Ads Tell Consumers Enough About Benefits and Side Effects? Results From the Health Information National Trends Survey, Fourth Administration. (Completed in 2015)
The U.S. Food and Drug Administration (FDA) analyzed data collected by the National Cancer Institute to determine whether average American consumers believe direct-to-consumer advertisements (DTCA) include enough information about the risks and benefits of prescription drugs.
In this survey, 52% of respondents reported that DTCA does not have enough information about risks and 46% of respondents reported that DTCA does not have enough information about benefits. When we looked at these two questions together, we found that a large group of respondents, 41%, reported that DTCA does not have enough information about both risks and benefits.
- Do Prescription Drug Ads Tell Consumers Enough About Benefits and Side Effects? Results From the Health Information National Trends Survey, Fourth Administration
Experimental Study of Format Variations in the Brief Summary of DTC Print Advertisements (Completed in 2015)
There have been recent calls to create a “drug facts box” for prescription drug ads similar to the one currently used for OTC drug labels. However, it is unclear which data—whether numeric, qualitative, or a combination of the two—best aids consumer understanding. The statement “50 out of 100 people reported less pain” is an example of numeric data whereas “more people had pain relief” is an example of qualitative data. For this study, we tested combinations of numeric and qualitative data to find out what information may be most useful in a drug facts box. Our study demonstrates that the majority of participants who viewed numeric data were able to accurately report it. When people were provided with absolute frequencies and percentages, they were able to use this numeric data to report benefit and risk information regardless of whether they also saw absolute differences or qualitative information. These findings suggest that a simpler drug facts box may be useful for people trying to make decisions about prescription drugs.
- Communicating Benefit and Risk Information in Direct-to-Consumer Print Advertisements: A Randomized Study
Examination of Corrective DTC Television Advertising (Completed in 2015)
FDA regulations require prescription drug ads to contain accurate information about the benefits and risks of the drug advertised. When this is not the case, corrective advertising can be used to dissipate or correct erroneous beliefs resulting from a false claim. In 2009, for example, Bayer HealthCare Pharmaceuticals produced and aired corrective advertising for Yaz, a birth control pill, following a warning from FDA regarding misleading claims. Despite these developments, there is little experimental evidence about the influences of DTC corrective ads on prescription drug consumers. The current project examined the influence of corrective messages in the realm of consumer-directed prescription drug advertising. Specifically, the project examined the following variables of interest: (1) exposure to corrective advertising, (2) visual similarity between the original and corrective ads, and (3) time delay between the original and corrective ads. Regarding exposure to corrective advertising, we found that a corrective ad counteracted beliefs of an overstatement of efficacy claim, but was less successful in counteracting omission of risk. Corrective ad exposure also affected perceptions of, and intended behaviors toward, the drug. Broadly, these results offer evidence in support of the contention that television advertising explicitly designed to correct viewer beliefs about the risks and benefits of a prescription drug can be successful, and while further research is needed, these findings suggest that corrective advertising appears to be a viable remedy to combat some forms of misinformation through advertising. Analysis of the second study (visual similarity and time delay) is in progress.
Stimuli Development and Pretests for an Attentional Effects Study (Completed in 2014)
FDA’s proposed rule, "Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner" (75 FR 15376), proposes including the risk information in prescription drug television ads in both superimposed text and in the audio. In addition, FDAAA required a study to determine if the statement “You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088” (the MedWatch statement) is appropriate for inclusion in DTC television advertisements for prescription drug products. These communications have been tested separately by FDA; however, they have not been examined together. In addition, questions continue to arise about the use of potentially distracting images during the major statement of risks in the television ads. This project was designed to create and pretest stimuli that will include these additional elements (superimposed risk information and the MedWatch statement) and vary the degree of distraction during the major statement. The stimuli created for this project is being used in an experimental study—described under “Eye Tracking Study of Direct-to-Consumer Prescription Drug Advertisement Viewing”—that will use eye-tracking methodology.
Focus Groups to Investigate Specific Terminology in Prescription Drug Promotion (Completed in 2014)
Focus groups allow FDA to investigate areas of interest to OPDP and sharpen the focus of the research questions for later quantitative studies. For this particular set of focus groups, we examined consumer and healthcare provider associations with the terms “natural” and “targeted,” and obtained reactions to prescription drug ads that use these terms. Both consumers and healthcare professionals were generally skeptical about claims using the term “natural,” in particular when the term was associated with prescription drug ads. They did not expect that prescription drugs, which must be approved by the FDA and are developed by pharmaceutical companies, would be pure and free of all additives. In the context of the particular ads and examples given, most consumers and healthcare providers thought that the use of the term “targeted” was appropriate for certain prescription drugs. Select differences between healthcare providers and consumers were also observed. For example, providers seemed more willing than consumers to accept the use of the term “natural” for products with less than 100% natural ingredients. While these results do not provide conclusions regarding the acceptability of these terms in advertising or promotional labeling for individual prescription drugs, they do provide valuable information about consumer and healthcare provider perceptions that will be useful for consideration in future research.
Examination of Comparative Claims (Completed in 2014)
Despite extensive research on comparative advertising of consumer products in general and a limited number of studies on how DTC ads could help consumers compare drugs, very little research has been conducted on comparative prescription drug advertisements. Currently, most DTC ad comparisons focus on drug attributes, such as differences in dosing or administration method. Because few head-to-head clinical trials have been conducted, very few DTC ads include efficacy-based comparisons. This study explored two types of drug comparisons in DTC print and television ads: (1) drug efficacy comparisons; and (2) other evidence-based comparisons: dosing, mechanism of action, and indication.
The first experiment showed that participants who viewed print (but not video) ads with named competitors had greater efficacy and lower risk perceptions than participants who viewed unnamed competitor and noncomparative ads. In the second experiment, named competitors in print ads resulted in higher risk perceptions than unnamed competitors. In video ads, participants who saw an indication comparison had greater benefit recall than participants who saw dosing or mechanism of action comparisons. In addition, visual depictions of the comparison decreased risk recall for video ads. Overall, the results suggest that comparative claims in DTC ads could mislead consumers about a drug’s efficacy and risk; therefore, caution should be used when presenting comparative claims in DTC ads.
- Effects of Comparative Claims in Prescription Drug Direct-to-Consumer Advertising on Consumer Perceptions and Recall
Communication of Effectiveness Information in DTC Print Ads (Completed in 2014)
This project contained two studies. The first study involved the main advertising (display) page of DTC print ads. We examined whether adding placebo rate information and whether changing the framing of the information to include only the number who benefit (positive frame) versus the number who benefit and the number who do not benefit from the drug (mixed frame) helps consumers understand the risk information. Results showed that adding placebo rates to DTC ads may be useful for consumers, whereas the evidence does not support the use of mixed frames.
The second study explored how physicians use the approved label (prescribing information or PI), and specifically how they assess efficacy information in this document. We found that physicians review the sections in order, looking most frequently at “Warnings and Precautions” and “Dosage and Administration.” Viewing certain PI sections was associated with greater perceived risk, lower perceived benefits, and lower intention to prescribe. The results suggest that the content and format changes to the PI in 2006 are effective and that information in the PI is relevant to physician decision-making.
- Randomized Study of Placebo and Framing Information in Direct-to-Consumer Print Advertisements for Prescription Drugs
- Primary Care Physicians’ Use of FDA-Approved Prescription Drug Labels
- Important Safety Information or Important Risk Information? A Question of Framing in Prescription Drug Advertisements
- Presenting Quantitative Information About Placebo Rates to Patients
Patient Medication Information (Completed in 2013)
To make informed decisions about healthcare and to use their medications correctly, consumers need easy access to up-to-date and accurate information about the risks, benefits, and safe use of their prescription drugs. Consumers currently receive multiple pieces of paper with their prescription drugs from the pharmacy, containing information that is developed and distributed through various sources. Written prescription drug information is provided through a voluntary effort (Consumer Medication Information) as well as through FDA-mandated use of Medication Guides and Patient Package Inserts (PPI). We found that patients describe a wide range of experiences and varying degrees of satisfaction with information currently provided at the time medicines are received at the pharmacy. In some cases, the written documents are difficult to read and understand, duplicative and overlapping, and incomplete or contradictory. This project is designed to test different ways of presenting information about prescription drugs to patients who have obtained a prescription.
- Preferences for Patient Medication Information: What Do Patients Want?
- Influence of Patient Medication Information Format on Comprehension and Application of Medication Information: A Randomized, Controlled Experiment
Presentation of Quantitative Benefit Information in DTC Television and Print Advertisements for Prescription Drugs (Completed in 2012)
We assessed whether quantitative information could be successfully added to television and print advertisements to maximize audience understanding of benefit information in the piece. We investigated the level of product efficacy (high or low), the statistical format of that information (frequency, percent, frequency plus percent, relative frequency, or frequency plus relative frequency), and ways in which that information can be expressed visually (pie chart, bar chart, table, or pictograph). In general, we found that providing quantitative benefit information in DTC ads increased participants’ ability to accurately report the benefits of the drug in quantitative terms. Further, adding visual aids, in particular bar charts and tables, increased participants’ ability to accurately report the drug’s benefits.
Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review (Completed in 2011)
A literature review was conducted in response to Section 3507 of the Patient Protection and Affordable Care Act of 2010. The literature review focused on two questions:
- What is the value of quantitative information or summaries about the risks and benefits of medical interventions for consumers, patients, and clinicians?
- How does presentation of quantitative information influence consumers’, patients’, and clinicians’ processing and understanding of the risks and benefits of medical interventions?
The review suggests that quantitative information about risks and benefits of medical interventions may have a positive effect on outcomes such as accurate knowledge. However, the review did not identify a specific presentation (for example, format or graph) that consistently led to better outcomes than other presentations. The review also addressed related issues, such as numeracy and health literacy.
- Communicating Quantitative Risks and Benefits in Promotional Prescription Drug Labeling or Print Advertising
- Risk Communication Advisory Committee Meeting Materials: November 17, 2011
Effect of Distraction on Information Processing in DTC Television Ads (Completed in 2011)
DTC television ads tend to attract much attention because they are so widely disseminated. Critics of DTC ads speculate that visual images of emotionally pleasant scenes during the presentation of risk information detract from the comprehension of that risk information. The current study investigated the role of visual and tonal distraction as well as the potential mitigating role superimposed text may play. Results demonstrated strong evidence that including risk-reinforcing superimposed text during the major statement increases comprehension of that risk information. Findings regarding visual and tonal distraction were less clear, partially due to manipulations that were not as strong as intended.
- Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements: Executive Summary
- Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Television Advertisements: Questions and Answers
As part of this study, the OPDP research team conducted a supplementary examination of the same issues using an alternate method. For more information about the supplementary study, please see:
- A Supplementary Test of Distraction in DTC Advertising Using an Implicit Measure, The Affect Misattribution Procedure: Executive Summary
- A Supplementary Test of Distraction in Direct-to-Consumer (DTC) Advertising Using an Implicit Measure, The Affect Misattribution Procedure (AMP): Questions and Answers
Evaluation of Format and Content in the Brief Summary in Print Ads (Completed in 2011)
To improve understanding of how consumers use the brief summary and explore ways in which it might be improved, we conducted studies to address the following three questions:
- Does the risk information presented on the first page of the ad (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 negatively affect the reading and understanding of other risk information in the brief summary?
- How do alternative formats compare with the commonly used format for the brief summary?
The results of these studies provide important insights into how consumers use information in the brief summary and ways in which the information could be improved. For instance, 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. Thus, the addition of other types of context to the brief summary, such as numerical (quantitative) summaries, can be explored with less concern about overloading readers.
- Evaluation of Consumer-Friendly Formats for Brief Summary in Direct-to-Consumer (DTC) Print Advertisements for Prescription Drugs
- Randomized Trial of Risk Information Formats in Direct-to-Consumer Prescription Drug Advertisements
Toll-Free Statement for Reporting Side Effects in Drug Labeling (Completed in 2008)
In 2006, the Best Pharmaceuticals for Children Act mandated that a statement be included on packaging for prescription and over-the-counter (OTC) products that gave consumers a contact number for FDA to report serious side effects. OPDP, in coordination with FDA’s Office of Regulatory Policy, conducted a study to determine the best wording for this statement. A series of focus groups with consumers was held which led to the selection of nine possible statements for quantitative testing. Experimental research was then conducted to evaluate these statements. Analyses showed that all statements were generally clear and understandable with the exception of one statement. Participants were able to distinguish between serious and minor side effects and reported that they would call their healthcare provider for medical emergencies rather than FDA. Overall, few individuals reported that they would call the FDA to report side effects.
- Toll-Free Number for Reporting Adverse Events on Labeling for Human Drug Products: Label Comprehension
Patient and Physician Attitudes and Behaviors Associated with DTC Promotion of Prescription Drugs (Completed in 2004)
To evaluate attitudes toward DTC broadcast ads and the impact these ads have on doctor-patient interactions, two surveys of consumers were undertaken in 1999 and 2002. A survey of physicians was also conducted in 2002. Findings indicate that DTC advertising has both positive and negative effects, as reported from both the physician and patient perspective. DTC advertising has potential to increase awareness of conditions and treatments, motivate questions for the healthcare provider, and help patients ask better questions. However, DTC advertising may also lead physicians to feel pressured to prescribe particular drugs. These findings are important because any influence that DTC advertising has on the doctor-patient relationship may have broad implications for healthcare.
- Patient and Physician Attitudes and Behaviors Associated With DTC Promotion of Prescription Drugs - Summary of FDA Survey Research Results
The following research projects are complete and awaiting peer review and publication in scientific journals. Findings and links to more information will be posted here upon publication.
Communicating Composite Scores in DTC Advertising
To market their products, manufacturers of prescription drugs must demonstrate efficacy and safety to FDA, typically in two adequate and well-controlled clinical trials. In some cases, product efficacy can be measured by a single endpoint, such as high blood pressure. More often,In other cases, however, efficacy is measured by multiple endpointssymptoms or outcomes that are sometimes combined into an overall score called a composite score. For example, nasal congestion is measured by examining individual symptoms such as runny nose, itchiness, and sneezing. Each symptom is measured on its own. An overall score is computed from the individual symptom measurements and if the drug has a significantly better overall score than the comparison group (e.g., placebo), the drug may gain approval and be marketed for nasal congestion. The drug may be significantly better overall but not be significantly better on a particular aspect (e.g., runny nose), however. Scientists and medical professionals have had training to understand the difference between composite score endpoints and individual endpoints but the general public has not. Given the frequency of DTC advertising, it is important to determine whether consumers grasp composite scores as they are currently communicated and how best to communicate such scores to lay audiences in general. The current project is designed to address these issues.
Disease Information in Branded Promotional Material
When broad disease information accompanies or is included in an ad for a specific product, consumers may mistakenly assume that the drug may solve all of the potential consequences of the condition mentioned in the ad. The prevention of these consequences may be far beyond what the drug has been clinically proven to do. For example, untreated diabetes can lead to blindness, loss of limbs, coma, and early death. However, the advertised product may have been approved only for the maintenance of blood sugar level. If consumers are able to distinguish between disease outcome information and product claims in an ad, then they may not be misled by the inclusion of disease information in a branded ad. If consumers are unable to distinguish these two, however, then consumers may be misled into believing that a particular drug product is effective against long-term consequences.
This study explored the implications of including both disease outcome and promotional information about a specific product in the same advertising piece. The format of the information (integrating the disease information with the product information versus separating it) was also examined.
Effect of Promotional Offers on Consumer Perceptions of Product Risks and Benefits
Research shows that consumers rate a product more favorably when they own it or are simply given a gift certificate or a coupon for that product or service. The inclusion of a coupon or other price incentive in the body of a DTC ad may affect consumers' perceptions of the risks and benefits of the prescription drug. For instance, consumers may assign more weight to benefit claims in cases where a coupon or other price incentive is embedded in the advertisement. For "simple" consumer products, coupons and free trial offers may enable the customer to test new products while minimizing his or her financial risk of testing the product. For products that consumers can readily test and ones where performance can be adequately verified, coupons and free trial offers provide both the consumer and manufacturer an efficient mechanism for matching consumers and products. For more complex products such as prescription drugs where supervision of a physician is required to evaluate both appropriateness and performance, coupons and free trial offers may send different signals.
This study examined what impact, if any, the presence of coupons in DTC advertisements have on consumers' recall and perceptions of product risks and benefits, and the overall impression of the product in DTC full-product and reminder advertisements.
Examination of Online DTC Drug Promotion
This project was designed to test different ways of presenting prescription drug risk and benefit information on branded drug websites. This research will complement qualitative research we plan to conduct on issues surrounding social media. The original regulations that presently determine FDA’s position on DTC promotion were written at a time when the available media for DTC promotion were print and broadcast and the primary audience was healthcare professionals.
We conducted focus groups as part of this project; one issue explored in these focus groups was the role of online health communities in patient-provider discussions. Our analysis showed that individuals use online health communities to obtain more information about their health in addition to their communication with, and reliance on, their healthcare providers.
Healthcare Professional Survey of Prescription Drug Promotion
FDA surveyed physicians about their attitudes toward DTC advertising and its role in their relationships with their patients in 2002. Almost 10 years later, FDA questioned physicians again, both to get an updated sense of physician attitudes and to extend the 2002 survey. Specifically, FDA (1) recruited a wider range of prescribers, including nurse practitioners and physician assistants; (2) weighted the data to obtain a representative sample of healthcare professionals; and (3) asked a wider range of questions, both about DTC and professional promotion of prescription drugs. The study also examined awareness of FDA’s Bad Ad program and healthcare professionals’ use of social media.
Toll-Free Statement for Reporting Side Effects in DTC Television Ads
As part of the requirements of the Food and Drug Administration Amendments Act of 2007 (FDAAA), we examined the addition of a statement in DTC television ads directing individuals to a phone number and website to which they can report side effects. We investigated the role of placement, duration, and prominence in the understanding of the product risk and benefit information in the ad, and the comprehension of the toll-free statement itself.
- Who Said it Better? A Test of Wording Differences in the MedWatch “Toll-Free Statement” for Consumer Reporting of Side Effects in Direct-to-Consumer Television Advertisements.
OPDP’s research team is involved in many ongoing research projects. These studies will inform our understanding of important issues related to prescription drug advertising.
Before research is fielded, the public has the opportunity to offer feedback on OPDP research through the public comment process. We appreciate and respond to 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.
Animation in DTC Advertising
Animation has been used in direct-to-consumer (DTC) prescription drug advertising to adults (for example, Digger the Dermatophyte in Lamisil ads, and Dot in Zoloft ads). A content analysis of DTC animation usage showed that animation was used in a variety of ways and resulted in higher recall for aspects of the ad. No studies to our knowledge have examined the effects of animation on other outcome variables such as the comprehension and perceptions of product benefit and risk information in DTC ads. The current research involves the creation of professional quality DTC prescription drug television ads and the conduct of a two-part experimental study to examine issues of animation and personification in DTC advertising. We will examine the effects of different types of animation (live action, full animation, and rotoscoping, a process of animating live action scenes) as well as the particular character that is the focus of the animation (sufferer, disease, or benefit). This research will provide information on whether animation influences the recall and perceptions of risk and benefit information in DTC ads.
- Federal Register Notice: Not yet available
Clinical Trial Data in Professional Prescription Drug Promotion
Several studies show that physicians are influenced by the way clinical trial results are reported. This may be a function of physicians’ knowledge about clinical trial design, or their experience with and skill in interpreting statistics. Surveys find that physicians believe knowledge of biostatistics is important but have less knowledge than is needed to understand all clinical trial results. However, little is known about physicians’ reactions to and understanding of clinical trial data presented in professional prescription drug promotion. The objective of this task orderproject is to conduct remote one-on-one interviews that will provide FDA with information about physicians’ training in biostatistics and clinical trial design, their understanding of clinical trial design in general, and their understanding of clinical trial data as presented in prescription drug promotional materials.
- Federal Register Notice: Not yet available
Comparative Price Information in DTC and Professional Prescription Drug Advertisements
By their very nature, medical and health decisions are comparative (e.g., treatment versus no treatment). For consumers, these decisions may include whether to use prescription drug products, over-the-counter products, or herbal supplements. Similarly, advertising is often comparative. In prescription drug advertising, sponsors are permitted to include truthful, non-misleading information about the price of their products in promotion. This may extend to price comparison information, wherein sponsors may include information about the price of a competing product in order to make advantageous claims. Currently, when price comparisons are made, the ad should also include context that the two drugs may not be comparable in terms of efficacy and safety and that the acquisition costs presented do not necessarily reflect the actual prices paid by consumers, pharmacies, or third-party payers. Despite the inclusion of this additional information, there is concern that adding contextual information about efficacy or safety is not sufficient to correct the impression that the products are interchangeable and that price is the main factor to consider. We plan to investigate, through empirical research, the impact of price comparison information and additional contextual information on prescription drug product perceptions. This will be investigated in DTC and healthcare-directed professional advertising for prescription drugs.
- Federal Register Notices: 60-day
Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Advertising
Prescription drug advertising sometimes includes false or misleading (i.e., deceptive) claims, images, or other presentations; for instance, representations that a drug is more effective or less risky than is demonstrated by evidence. A number of empirical studies have examined the occurrence and influence of deceptive advertising, both in regard to prescription drugs and other products. No research to our knowledge, however, has investigated the ability of consumers and healthcare professionals (HCPs) to independently identify and discount deceptive prescription drug advertising. The ability to identify and discount such advertising has important public health implications. If unable to identify and discount deceptive advertising, consumers may ask their HCPs to prescribe specific drugs that they would not otherwise request. Likewise, HCPs unable to identify and discount deceptive advertising may prescribe specific drugs that they would not otherwise prescribe. In the case that consumers and HCPs are able to identify and discount deceptive advertising, then they may instead be equipped to incorporate such information into their medication decisions, and perhaps even report deceptive advertising to appropriate government regulators who can take corrective action. The FDA Bad Ad program, for example, encourages HCPs to report deceptive prescription drug advertising, a goal which requires that HCPs successfully identify such advertising when it appears in the course of their duties.
This project will examine the ability of consumers and HCPs to identify deceptive prescription drug advertising, and the influence of such advertising on their attitudes and intentions toward the advertised drug. Additionally, analyses will draw comparisons between consumers and HCPs on these outcomes to generate insight about differential effects.
- Federal Register Notices: Not yet available
Disclosure Regarding Additional Risks in DTC Prescription Drug TV Ads
Prescription drug advertising regulations require that broadcast (TV or radio) advertisements present the product’s major risks in either audio or audio and visual parts of the advertisement; this is often called the “major statement.” There is concern that, as currently implemented in DTC ads, the major statement is often too long, which may result in reduced consumer comprehension, minimization of important risk information and, potentially, therapeutic non-compliance due to fear of side effects. At the same time, there is concern that DTC TV ads do not include adequate risk information or leave out important information. These are conflicting viewpoints. A possible resolution is to limit the risks in the major statement to those that are serious and actionable, and include a disclosure to alert consumers that there are other product risks not included in the ad. FDA plans to investigate the effectiveness of this “limited risks plus disclosure” strategy through empirical research.
Experimental Study of DTC Advertising Directed at Adolescents
Sponsors for several prescription drug classes market their products directly to adolescents, but research regarding how adolescents use risk and benefit information for health-related decisions is limited. Despite the lack of previous research specific to DTC drug marketing to adolescents, existing theoretical and empirical data make a strong case for treating adolescence as a unique life stage during which vulnerabilities that can affect informed decision-making must be taken into account. We plan to conduct a randomized, controlled study in two different medical conditions that assesses adolescents’ perceptions following exposure to DTC prescription drug advertising that varies in benefit and risk onset and risk severity. We plan to compare adolescents’ perceptions with the perceptions of their young adult counterparts. Each participant will view a web-based promotional campaign for either a fictitious Attention Deficit Hyperactivity Disorder medication or a fictitious acne medication. Because adolescents typically depend on their parents for prescription drug purchases, we also will include a sample of parents matched to their adolescent children to explore similarities and differences in perceptions for these matched pairs. The study will enroll three specific age groups (13–15, 16–17, and 25–30). We propose to explore differences in effects of the ad manipulations across these three age groups on a variety of outcomes, including benefit and risk recall, benefit and risk perceptions, and behavioral intentions. The study findings will provide information related to DTC promotion directed at adolescent populations.
Eye Tracking Study of Direct-to-Consumer Prescription Drug Advertisement Viewing
Current FDA regulations require that a major statement of the risks of prescription drugs be included in at least the audio of DTC television ads. FDA has proposed including the risk information in DTC television ads in superimposed text as well as in the audio (75 FR 15376, “Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner”). In addition, FDAAA required a study to determine if the statement “You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088” (the MedWatch statement) is appropriate for inclusion in DTC television ads. These communications have been tested separately by FDA; however, they have not been examined together. In addition, questions continue to arise about the use of potentially distracting images and sounds during the major statement of risks in DTC television ads. Previous research has shown that factors such as multiple scene changes and music in advertising can be distracting. However, the effects of this kind of distraction during the major statement of risks on consumers' perceptions and risk recall has not been tested in the presence of risk-reinforcing superimposed text. This project is designed to use eye tracking technology to determine how these communications in DTC ads are perceived, as well as to measure the impact of distraction. Eye tracking technology is an effective method to determine the extent to which consumers attend to risk information presented in DTC television ads. This technology allows researchers to unobtrusively detect and measure where, and for how long, a participant looks while viewing a television ad.
General Population Survey on Prescription Drug Promotion
FDA last surveyed patients about their attitudes toward DTC advertising in 2002 (Aikin, Swasy & Braman, 2004). Results from the 1999 and 2002 patient surveys on this topic indicate a number of areas for follow-up including 1) the percentage of patients who are likely to receive a prescription when they ask for a specific brand, 2) the influence of DTC ads in prompting further information search about the product or the medical condition, 3) patients’ perceptions about the amount of information about the products’ risks versus benefits, and 4) patients’ perceptions that the ads sometimes make the products seem better than they really are.
The purpose of this project is to conduct a follow-up survey to the FDA’s 1999 and 2002 patient surveys on attitudes toward direct-to-consumer promotion of prescription drugs and the impact of such promotion on the doctor-patient relationship. Specifically, we plan to: 1) recruit a wider range of respondents, 2) weight the data to obtain a nationally representative sample, and 3) ask a wider range of questions about DTC promotion, including questions about online DTC promotion.
- Federal Register Notice: Not yet available
Hearing, Aging, and DTC Television Ads
Because older adults use a disproportionate number of prescription drugs and watch more television than other age groups, their understanding of DTC television advertising is important to investigate. Age-related changes in hearing are nearly universal and may influence the understanding of speech and therefore the understanding of DTC television ads. A large part of hearing and understanding speech involves both the physical structure of the ears as well as sufficient cognitive processes, meaning that cognitive factors specific to hearing and understanding speech are important to examine. This study will explore how hearing and cognitive declines in older adults affect comprehension of DTC television ads in general and of the major statement of risks in particular.
- Federal Register Notices: 60-day
Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in DTC Prescription Drug Ads
In a typical promotional campaign, consumers may be exposed to a DTC prescription drug ad any number of times. Perceptual and cognitive effects of increased ad exposure frequency have been studied extensively using non-drug ads. For instance, one study demonstrated that a commercial message repeated twice generates better recall than a message broadcast only once. Another study demonstrated that increased ad exposures improve both consumer attitudes toward the product and recall for product attributes, particularly when the substance of the repeated messages is varied. Generally, it has been argued that first exposure to an ad results in attention, second exposure affects learning of the advertised message, and third and subsequent exposures reinforce the learning effects of the second exposure. To our knowledge, the literature concerning ad exposure frequency has not been extended to include specific attention to prescription drug ads. Prescription drug ads are unique in that they are required to provide both benefit and risk information whereas other ad types tend to include only benefit information. We plan to examine the effects of variation in ad exposure frequency on perception and mental processing of risk and benefit information in DTC prescription drug ads through empirical research.
Major Statement Content Analysis
This is a descriptive content analysis of major statements of risk information in DTC television ads. We plan to capture characteristics of these risk presentations, including speed of presentation, complexity of the language, and the voice frequency of the statement.
- Federal Register Notices: Not applicable to content analyses
Market Claims in DTC Prescription Drug Print Ads
The marketing literature divides product attributes (“cues”) into intrinsic and extrinsic. Intrinsic cues are physical characteristics of the product (e.g., size, shape) whereas extrinsic cues are product-related but not part of the product (e.g., price and brand name). Research has found that both intrinsic and extrinsic cues can influence perceptions of product quality. Consumers may rely on product cues in the absence of explicit quality information. The objective quality of prescription drugs is not easily obtained from promotional claims in DTC ads; thus consumers may rely upon extrinsic cues to inform their decisions. Market claims such as “#1 prescribed” and “new” may act as extrinsic cues about the product’s quality, independent of the product’s intrinsic characteristics. Prior research has found that market leadership claims can affect consumer beliefs about product efficacy, as well as their beliefs about doctors’ judgments about product efficacy. One limitation of these prior studies is the lack of quantitative information about product efficacy in the information provided to respondents. Efficacy information may moderate the effect of the extrinsic cue by providing insight into characteristics that would otherwise be unknown. Other research has shown that consumers are able to use information about efficacy to inform judgments about the product. This project will examine market claims in the context of a DTC print ad with and without product efficacy information.
- Federal Register Notice: 60-day
Quantitative Information in Direct-to-Consumer Television Advertisements
A previous FDA study found that simple quantitative information could be conveyed in DTC television ads in ways that increased consumer’s knowledge about the drug (see “Presentation of Quantitative Benefit Information in DTC Television and Print Advertisements for Prescription Drugs” above). However, this research only tested simple information (e.g., one clinical trial, comparison to placebo). Drug information can be much more complicated (e.g., complicated endpoints, multiple study arms). The studies in this projectare designed to address the question of whether consumers can take more complicated information into account when assessing prescription drug information in television DTC ads. These studies will build on previous research by (1) examining more complicated quantitative information, (2) examining quantitative information for both benefits and risks, and (3) examining how visuals designed to represent efficacy interact with quantitative information.
- Federal Register Notice: 60-day
Risk and Benefit Perception Scale Development
To gauge how product risks and benefits are communicated in promotional materials, OPDP research uses measures designed to assess both recall/comprehension and perceptions of product risks and benefits. As OPDP’s research program has matured, the way in which we measure risk and benefit perception has evolved over time. This has resulted in perception measures that, while internally valid, tend to vary by study. The goal of this study is to develop and validate risk and benefit perception scales and to explore various methods for measuring recall and comprehension that can be used for OPDP research moving forward.
This is a multi-stage project. Stage 1 will involve identifying existing relevant measures and concepts related to the proposed measures. It will also involve identifying measures and concepts from which the proposed measures can be distinguished. Stage 2 will involve focus groups to explore the concepts of risk and benefit perception, as related to prescription drugs and advertising, in order to generate and augment the pool of questions for testing. Stage 3 will involve cognitive testing of draft measures to refine question wording. Stage 4 will involve iterative testing and analysis of draft measures to narrow the pool of questions and establish internal validity.
Spousal Influence on Consumer Understanding of, and Response to, DTC Prescription Drug Advertisements
Consumers are often thought of as individual targets for prescription drug advertisements, as if they are always exposed to DTC ads individually and subsequently make judgments about advertised products on their own. However, judgments about prescription drugs portrayed in DTC ads are likely made in social contexts much of the time. For example, a potential consumer and his or her spouse (e.g., marital or domestic partner) may view an ad together and discuss drug benefits, side effects, and risks. These social interactions may result in unique reactions relative to consumers who view DTC prescription drug ads alone. For example, spouses may influence their partner by expressing concern about risks and side effects that might occur, or pressuring their partner to consider the drug despite its risks and side effects. These outcomes have important public health implications. Through empirical research, we plan to examine differences between consumers viewing prescription drug ads with a spouse versus alone.
Superimposed Text in DTC Promotion
Research in the late 1980s and 1990s examined the size of superimposed text (supers) in general print and television advertising. They found that larger text size generally resulted in greater comprehension of the information featured in the super. These studies also examined other factors such as the type of super, the complexity of the super, and the number of supers per ad. All of these studies occurred before the advent of common direct-to-consumer (DTC) television advertising and other promotion based on new technologies. A more recent study examined the role of supers in DTC television ads in terms of dual modality, looking at the content of the supers but not format issues. The current study will attempt to apply and extend the earlier findings to DTC promotion. Moreover, because new technologies have emerged since the publication of these studies, we will examine whether findings from television screens are generalizeable when viewed on a tablet, where many people now view their media. Finally, we will examine the contrast between the super text and the background on which it is located to determine whether that has a measurable effect on recall of the information in the super and the overall message of the ad.
- Federal Register Notices: Not yet available
Web and Mobile Technology DTC Content Analyses
This project includes descriptive content analyses of two forms of online DTC prescription drug advertising. The first content analysis focuses on whether and how branded prescription drug ads delivered on mobile technology (phones, pads) present drug benefit and risk information. The second content analysis focuses on whether and how cancer-related branded prescription drug websites present quantitative information about drug benefits and risks.
- Federal Register Notices: Not applicable to content analyses