Office of Prescription Drug Promotion (OPDP) Research
The Office of Prescription Drug Promotion (OPDP) has an active research program designed to investigate applied and theoretical issues in the communication of risk and benefit information in 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 FDA’s goal of science-based policy while maintaining its commitment to protect the public health.
The OPDP research team also provides technical assistance to outside groups on the design and implementation of studies concerning prescription drug promotion. Some of these groups include academic researchers, pharmaceutical companies, and non-profit organizations.
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.
COMPLETED RESEARCH PROJECTS
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 direct-to-consumer 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.
- Presentation of Quantitative Benefit Information in Direct-to-Consumer (DTC) Television and Print Advertisements for Prescription Drugs: A Randomized Study (PDF)
Toll-Free Statement for Reporting Side Effects in DTC Television Ads – Completed in 2012
As part of the requirements of the Food and Drug Administration Amendments Act of 2007 (FDAAA), we examined the addition of a statement in direct-to-consumer 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. A summary of the study results can be found here when they are available.
- Federal Register Notice: 30-day
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 (PDF)
- Risk Communication Advisory Committee Meeting Materials
Effect of Distraction on Information Processing in DTC Television Ads – Completed in 2011
Direct-to-Consumer (DTC) television ads tend to attract much attention because they are so widely disseminated. Critics of DTC 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 Broadcast Advertisements: Executive Summary
- Experimental Evaluation of the Impact of Distraction on Consumer Understanding of Risk and Benefit Information in Direct-to-Consumer Prescription Drug Broadcast 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 DTC Advertising Using an Implicit Measure, The Affect Misattribution Procedure: 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
- Aikin KJ, O’Donoghue AC, Swasy JS, Sullivan HW. Randomized trial of risk information formats in direct-to-consumer prescription drug advertisements. Med Dec Making. 2011;31:E23-E33. DOI: 10.1177/0272989X11413289.
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 products that gave consumers a contact number for FDA to report serious side effects. OPDP, in coordination with the 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 direct-to-consumer (DTC) broadcast ads and the impact these ads have on doctor-patient interactions, two surveys of consumers were undertaken in 1999 and 2002 and a physician survey took place 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 Direct-to-Consumer (DTC) Promotion of Prescription Drugs - Summary of FDA Survey Research Results
The Office of Prescription Drug Promotion’s (OPDP) research team is involved in many ongoing research projects. These studies will inform our understanding of important issues such as the impact of corrective advertising, promotional offers, disease awareness information, and more.
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.
Communication of Effectiveness Information in DTC Print Ads
This study will investigate the communication of effectiveness information on the main advertising (display) page of print advertisements. We will examine whether adding placebo information and whether changing the framing of the information helps consumers understand the risk information. Separately, we will examine how physicians use the prescribing information documents, and specifically how they assess efficacy information in this document.
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, however, efficacy is measured by multiple endpoints 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 can 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 direct-to-consumer 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.
- Federal Register Notice: 60-day
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 will 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. In this case, the question becomes what additional context or type of presentation may minimize this misperception.
The current study will explore 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) will also be 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 direct-to-consumer (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 their 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. The proposed exploratory study will examine what impact, if any, the presence of coupons in DTC advertisements may 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 Comparative Claims
Despite extensive research on comparative advertising of consumer products in general and a limited number of studies on how direct-to-consumer (DTC) ads could help consumers compare drugs, very little research has been conducted on comparative prescription drug advertisements. Consequently, it is unclear whether these findings are applicable to comparative drug ads or how such claims influence consumers’ perceived efficacy of advertised drugs.
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; however, this may change given the current national focus on comparative effectiveness research. This study is designed to apply the existing comparative advertising literature to DTC advertising and investigate how consumers interpret and react to DTC comparative drug ads. Specifically, the study will explore two types of drug comparisons in DTC ads: (1) drug efficacy comparisons; and (2) other evidence-based comparisons, such as dosing, mechanism of action, and indication.
Examination of Corrective DTC Television Advertising
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, researchers and policymakers currently lack empirical literature regarding the various influences of DTC corrective ads on prescription drug consumers. The current project will examine the influence of corrective messages in the realm of consumer directed prescription drug advertising. Specifically, the study will focus on the following variables of interest: (1) exposure to corrective, (2) visual similarity between the original and corrective ads, and (3) time delay between the original and corrective ads.
Examination of Online DTC Drug Promotion
This project is 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 direct-to-consumer (DTC) promotion were written at a time when the available media for DTC promotion were print and broadcast and the primary audience was health care professionals. This dynamic is shifting, and evidence is needed to inform guidance development.
Experimental Study of Format Variations in the Brief Summary of DTC Print Advertisements
Previous research has examined the content and format of the brief summary of risk information in DTC print ads. One series of studies tested a prescription drug facts box similar in format to the Nutrition Facts panel and OTC Drug Facts panel. The box contains a number of elements, including qualitative and quantitative (both absolute frequency and absolute difference) information about benefits and risks. The current study will add to previous research by systematically examining these different elements to determine whether and how to add qualitative and quantitative benefit and risk information to the brief summary. The results of this study will inform FDA of the usefulness and parameters of various format and content options for the brief summary.
Healthcare Professional Survey of Prescription Drug Promotion
FDA last surveyed physicians about their attitudes toward direct-to-consumer (DTC) advertising and its role in their relationships with their patients in 2002. Five hundred general practitioners and specialists who represented areas in which DTC advertising was currently prominent (e.g., psychiatrists, dermatologists, endocrinologists) reported that a majority of their patients asked about prescription drugs frequently. Physicians reported that DTC advertising led to benefits such as better discussions and greater awareness of treatments and problems such as extra time spent correcting misconceptions and requests for unnecessary drugs. Overall, about a third of physicians reported that DTC had a positive effect on their practice, a third said it had a negative effect, and another third said that it had no effect on their practice.
Almost ten years later, FDA will question physicians again, both to get an updated sense of physician attitudes and to extend the 2002 survey. Specifically, FDA will: 1) recruit a wider range of prescribers, including nurse practitioners and physician assistants, 2) weight the data to obtain a representative sample of healthcare professionals, and 3) ask a wider range of questions, both about DTC and professional promotion of prescription drugs.
Patient Medication Information
To make informed decisions about health care 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). 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, incomplete or contradictory. This project is designed to test different ways of presenting information about prescription drugs to patients who have obtained a prescription.
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.
- Federal Register Notices: Not yet available.