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.
- Patients’ Understanding of Oncology Clinical Endpoints: A Literature Review
- Quantitative Information in Direct-to-Consumer Television Advertisements
- General Population Survey on Prescription Drug Promotion
- Market Claims in DTC Prescription Drug Print Ads
- Impact of Ad Exposure Frequency on Perception and Mental Processing of Risk and Benefit Information in DTC Prescription Drug Ads
- Hearing, Aging, and DTC Television Ads
- Content Analysis of Accelerated Approval Prescription Drug Direct-to-Consumer Websites
- Clinical Trial Data in Professional Prescription Drug Promotion
- Major Statement Content Analysis
- Disclosure Regarding Additional Risks in DTC Prescription Drug TV Ads
- Comparative Price Information in DTC and Professional Prescription Drug Advertisements
- Prescribers’ Knowledge and Skills for Interpreting Research Results: A Systematic Review
- Web and Mobile Technology DTC Content Analyses
- Eye Tracking Study of Direct-to-Consumer Prescription Drug Advertisement Viewing
- Examination of Online DTC Drug Promotion
- Effect of Promotional Offers on Consumer Perceptions of Product Risks and Benefits
- Prescription Drug Promotion from 2001-2014
- Disease Information in Branded Promotional Material
- Communicating Composite Scores in DTC Advertising
- 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
- Examination of Corrective DTC Television Advertising
- Healthcare Professional Survey of Prescription Drug Promotion
- Toll-Free Statement for Reporting Side Effects in DTC Television Ads
- Spousal Influence on Consumer Understanding of, and Response to, DTC Prescription Drug Advertisements
- Stimuli Development and Pretests for an Attentional Effects Study
- Focus Groups to Investigate Specific Terminology in Prescription Drug Promotion
- Examination of Comparative Claims
- Communication of Effectiveness Information in DTC Print Ads
- Patient Medication Information
- Presentation of Quantitative Benefit Information in DTC Television and Print Advertisements for Prescription Drugs
- Quantitative Summary of the Benefits and Risks of Prescription Drugs: A Literature Review
- Effect of Distraction on Information Processing in DTC Television Ads
- Evaluation of Format and Content in the Brief Summary in Print Ads
- Toll-Free Statement for Reporting Side Effects in Drug Labeling
- Patient and Physician Attitudes and Behaviors Associated with DTC Promotion of Prescription Drugs
Oncology clinical trials use a variety of clinical endpoints, such as overall survival and progression-free survival. Patients’ understanding of the differences between clinical endpoints is important because misperceptions of treatment efficacy may affect treatment decisions. The objective of this literature review was to find and synthesize available empirical publications assessing patients’ understanding of common oncology clinical endpoints. We searched the literature for empirical research studies focused on (1) clinical endpoints, (2) oncology, and (3) patient understanding. Thirteen publications met the inclusion criteria. These few publications suggest that healthcare professionals and cancer patients generally do not discuss clinical endpoint concepts and that patients can be confused about the purpose of a treatment based on misperceptions about endpoints. Research is needed on how to discuss oncology clinical endpoints with patients.
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” below). 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 project were 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 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.
The first published article from this project suggests that there are tradeoffs to adding multiple quantitative benefit outcomes in DTC ads. However, presenting multiple quantitative risk categories helps consumers better understand a drug’s risks. Specifically, compared with an ad containing no quantitative information, presenting two benefit outcomes and multiple risk categories increased gist and verbatim recall and affected drug perceptions. Compared with presenting a single benefit outcome, presenting two benefit outcomes increased verbatim recall for the second outcome but decreased verbatim recall for the first outcome. Likewise, compared with presenting a single risk category, presenting multiple risk categories increased gist and verbatim recall for the multiple risk categories but decreased gist recall for a concept more closely associated with the single risk category. Adding multiple risk categories decreased risk perceptions even more than did the single risk category.
Additional results from this project on the effect of visuals are pending publication.
- The Effect of Including Quantitative Information on Multiple Endpoints in Direct-to-Consumer Prescription Drug Television Advertisements
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: 1) recruited a wider range of respondents, 2) weighted the data to obtain a nationally representative sample, and 3) asked a wider range of questions about DTC promotion, including questions about online DTC promotion.
The first published article from this survey evaluated US adults’ knowledge of FDA regulation of prescription drug approval and advertising. The results highlight gaps in consumer knowledge of FDA’s roles and responsibilities. For instance, few respondents understood FDA oversight of prescription drug advertising, with approximately half of respondents reporting that they did not know whether FDA approved these ads or components of the ads, and several mis-reporting that FDA approves these ads (31%) or components of the ads (22-41%).
The second published article from this survey explored how patients view the effects of DTC prescription drug advertising on patient-provider interactions. The results suggest that DTC advertising is driving some patients to discuss specific products with their healthcare providers, but that most patients do not believe advertising has a negative influence on the patient-provider interaction itself.
- Consumer Understanding of the Scope of FDA’s Prescription Drug Regulatory Oversight: A Nationally Representative Survey
- Direct-to-Consumer Prescription Drug Advertising and Patient-Provider Interactions
Direct-to-Consumer Advertising and the Patient-Prescriber Encounter: A Systematic Review (Completed in 2019)
We systematically reviewed the research on patients’ and prescribers’ perceptions of, and self-reported behaviors prompted by, exposure to direct-to-consumer advertising (DTCA) of prescription drugs that occurs in the context of a clinical encounter. We identified 38 studies that met our criteria, 24 of which used patient-reported outcomes and 18 used prescriber-reported outcomes (four used both). Results suggested some potential benefits of exposure to DTCA, including patients’ enhanced information-seeking, increased patient requests for appropriate prescriptions (when addressing potential underuse) and patients’ perceptions of higher-quality interactions with prescribers. Most prescribers perceived a neutral influence on the quality of their clinical interactions with patients regarding DTCA. Harms included patients receiving prescriptions for drugs that were not appropriate for them or that the patients did not need, and the potential for DTCA to interfere with medication adherence in some populations, such as those with mental illness.
- Direct-to-Consumer Advertising of Prescription Drugs and the Patient–Prescriber Encounter: A Systematic Review
Product attributes (“cues”) can be thought of as 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 examined 1) the effect of two market claims (New, #1 Prescribed) in the context of a DTC print ad with and without product efficacy information, and 2) the tradeoff between a market claim of #1 Prescribed and quantitative efficacy information.
Results of the first part of the project (experimental study) suggest the market claim affects personal perceptions and perceptions of the ad’s message about drug benefits and perceptions about doctors’ opinions of the drug. Inclusion of quantitative information about product efficacy did not show a large influence on perceptions.
In the second part of the project (tradeoff analysis), results showed an advantage of “#1 Prescribed.” A drug without this claim needed at least 1.23% greater efficacy to be chosen over a drug with this claim.
- Market Claims and Efficacy Information in Direct-to-Consumer Prescription Drug Print Advertisements.
- Consumer Tradeoff of Advertising Claim Versus Efficacy Information in Direct-to-cConsumer Prescription Drug aAds.
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.
- Taking Repeated Exposure into Account: An Experimental Study of Direct-to-Consumer Prescription Drug Television Ad Effects
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. This study explored how hearing and cognitive declines across the lifespan affect comprehension of DTC television ads in general and of the major statement of risks in particular. Results showed that cognitive changes and age were driving factors in the recall of risks in DTC television ads. The study also showed that the speed of the spoken major statement and the complexity of the spoken major statement, but not the audio frequency of the voiceover, had negative effects on recall.
- Assessing Hearing and Cognition Challenges in Consumer Processing of Televised Risk Information: Validation of Self-reported Measures using Performance Indicators
- Aging and Direct-to-Consumer Prescription Drug Television Ads: The Effects of Individual Differences and Risk Presentation
We examined direct-to-consumer (DTC) websites for brand-name accelerated approval prescription drugs to determine whether and how accelerated approval is communicated to consumers. From the 34 brand-name prescription drugs under the Food and Drug Administration’s accelerated approval pathway presubmission requirement for promotional materials in December 2016, we identified a sample of 26 that had active DTC websites. Two raters independently coded the websites for the presence, placement, content, and readability of an accelerated approval disclosure. Most (73%) of the websites contained an accelerated approval disclosure. Most of the disclosures (84%) included the basis for accelerated approval, whereas 68% stated that the clinical benefit of the product was unknown and 47% conveyed the need for additional research to confirm study findings. On average, the disclosures required at least a high school reading level and most conveyed the information in medical terms.
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. We conducted 60-minute interviews with practicing physicians across the United States (50 primary care physicians and 22 endocrinologists). Physicians viewed prescription drug promotional materials that contained clinical trial data and answered follow-up questions. Physicians demonstrated low to moderate knowledge about clinical trial-related terms found in promotional prescription drug materials. Results from this qualitative analysis underscore a need to determine how clinical trial data in prescription drug promotional materials affect physicians' attitudes and decision making.
This is a descriptive content analysis of major statements of risk information in DTC television ads. We examined characteristics of these risk presentations, including speed of presentation, complexity of the language, and the voice frequency of the statement. Major statements often presented numerous risks, usually in order of severity, with no quantitative information about the risks’ severity or prevalence. The major statements required a high school reading level, and many included long and complex sentences. The major statements were often accompanied by competing non-risk information in the visual images, presented with moderately fast-paced music, and read at a faster pace than benefit information. Overall, we discovered several ways in which the communication of risk information could be improved.
- Communicating Risk Information in Direct-to-Consumer Prescription Drug Television Ads: A Content Analysis
Broadcast direct-to-consumer (DTC) prescription drug ads that present product claims are required to also present the product’s major risks. Debate exists regarding how much information should be included in these major risk statements. Some argue that such statements expose people to unnecessary amounts of information, which may result in reduced consumer comprehension, minimization of important risk information and, potentially, therapeutic non-compliance due to fear of side effects. Others argue that they leave out important information. We examined the impact of the type of risk statement (unedited versus serious and actionable risks only) and a disclosure indicating that not all risks are presented on consumers’ ability to remember the important risks and benefits of a drug following exposure to a DTC television ad. Risk and benefit perceptions, ad-prompted actions, recognition of the disclosure statement, and evaluations of both the disclosure and risk statement were also examined. A web-based experiment was conducted in which US adults who self-reported as having depression (N = 500), insomnia (N = 500), or high cholesterol (N = 500) were randomly assigned to view one of four versions of the television ad, and then complete a questionnaire. The type of risk statement had a significant effect on risk recall and recognition, benefit recognition, perceived risk severity (depression condition only), and perceived benefit magnitude (high cholesterol condition only). Disclosure recognition (using bias-corrected scores) ranged from 63% to 70% across the three illness samples. The revised risk statement improved overall processing of the television ad, as evidenced by improved risk recall and recognition and improved benefit recognition. Further, the presence of the disclosure did not adversely affect consumers’ processing of drug risk and benefit information. Therefore, limiting the risks presented in DTC television ads and including a disclosure alerting consumers that not all risks are presented may be an effective strategy for communicating product risks.
- Serious and Actionable Risks, Plus Disclosure: Investigating an Alternative Approach for Presenting Risk Information in Prescription Drug Television Advertisements
- Individual- and Ad-Level Predictors of Perceptions of Serious and Actionable Risks in Direct-to-Consumer Prescription Drug TV Advertising
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. Sponsors of prescription drug advertisements may decide 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, provided certain conditions are met. These advertisements may not, either directly or by implication, represent that the drug is safer or more effective than another drug unless substantiated by appropriate evidence. We investigated, through empirical research, the impact of price comparison information about the reference and comparator product and additional contextual information about the comparative safety and efficacy of the productson prescription drug product perceptions. This was investigated in DTC and healthcare-directed professional advertising for prescription drugs.
For the HCP-directed component of the study, we found that the majority of physicians accurately recognized the price claim (76%) but far fewer accurately recognized the associated context statement (44.9%). The context statement did not affect evaluations of the price-comparison claim importance or accuracy and did not have the intended effects on perceptions of uncertainty about drug interchangeability. Physicians may be affected by price-comparison claims in thinking that the drug has risks that are relatively less severe. Price-comparison claims also affected intentions to look for information about the drug.
Results for the DTC ad portion of the study indicated that when people remembered seeing the disclosure, they demonstrated uncertainty regarding risks, efficacy, and savings; however, most did not notice the disclosure, despite its prominent placement in the ad.
- Physician Response to Contextualized Price-Comparison Claims in Prescription Drug Advertising
- Consumer Reactions to Price Comparison and Disclosure Information in Prescription Drug Print Advertising
The objective of this review was to synthesize the research related to prescribers' critical appraisal knowledge and skills about understanding of statistical methods, biases in studies, and relevance and validity of evidence. We screened 1204 abstracts, 72 full-text articles, and included 29 studies. Results indicated that physicians' extant knowledge and skills were in the low to middle of the possible score ranges and demonstrated modest increases in response to interventions. Physicians with formal education in epidemiology, biostatistics, and research design demonstrated higher levels of knowledge and skills. In hypothetical scenarios presenting equivalent effect sizes, the use of relative effect measures was associated with greater perceptions of medication effectiveness and intent to prescribe, compared with the use of absolute effect measures, but this evidence was limited by use of convenience samples and study designs that limit internal validity. Critical appraisal knowledge and skills are limited among physicians. The effect measure used can influence perceptions of treatment effectiveness and intent to prescribe.
This project included descriptive content analyses of two forms of online DTC prescription drug promotion. The first content analysis focused on whether and how branded prescription drug promotion delivered on mobile technology (phones, tablets) present drug benefit and risk information. We analyzed a sample of 51 mobile promotional communications and their associated linked landing pages. We assessed the content and format of the mobile communications and landing pages with regard to presentation of drug benefits and risks. These results indicate that, while risks and benefits are both represented in mobile communications and their associated landing pages, they are not equally prominent and accessible.
The second content analysis focused on whether and how cancer-related branded prescription drug websites present quantitative information about drug benefits and risks. We analyzed a sample of 65 active cancer-related prescription drug websites. We assessed the inclusion and presentation of quantitative information for two audiences (consumers and healthcare professionals) and two types of information (drug benefits and risks). We found that consumers and healthcare professionals have access to quantitative information about oncology drugs and, in particular, about the benefits of these drugs.
- Direct-to-Consumer Promotion of Prescription Drugs on Mobile Devices: A Content Analysis
- Quantitative Information on Oncology Prescription Drug Websites
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 introduced the idea of 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, the Food and Drug Administration Amendments Act of 2007 (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, potentially distracting images and sounds during the major statement of risks in DTC television ads continue to be a topic of interest. 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 used eye tracking technology to determine how these communications in DTC ads were 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. We found that distracting elements during the major statement decreased attention to the superimposed risk text, which led to lower retention of the drug risk information. This suggests that even if the risk information is presented in audio and in superimposed text, distracting visuals should still be avoided.
- Attention to and Distraction from Risk Information in Prescription Drug Advertising: An Eye Tracking Study
This project was designed to test different ways of presenting prescription drug risk and benefit information on branded drug websites. One study explored the role of risk information placement and format. We found that the location of risk information on prescription drug websites affected consumers’ risk knowledge, suggesting that risk information is more effective when located on the homepage. We found no significant effects for including a signal to the risk information or for different formatting of the risk information (e.g., paragraphs versus bulleted lists).
In another study, we explored consumers’ understanding of drug information when a branded prescription drug website included a link to disease information. We found that consumers who saw a prescription drug website with a link to a disease information website confused drug benefits and disease information, even when disclosures explained that the disease information website was external. In an analysis of data across studies, we found that some consumers interpreted precautions on prescription drug websites as potential side effects.
We also 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.
Research on multimedia website presentations is pending peer review and publication.
- Testimonials and Informational Videos on Branded Prescription Drug Websites
- Actors in Whitespace: Communicating Risk Information on Pharmaceutical Websites
- Placement and Format of Risk Information on Direct-to-Consumer Prescription Drug Websites
- Are Disease Awareness Links on Prescription Drug Websites Misleading? A Randomized Study
- Consumer Confusion Between Prescription Drug Precautions and Side Effects
- Peer-generated Health Information: The Role of Online Communities in Patient and Caregiver Health Decisions
- Perceived Healthcare Provider Reactions to Patient and Caregiver Use of Online Health Communities
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. We found little effect of promotional offers. Adding benefit (risk) information to the ad increased consumers’ knowledge of the benefit (risk) information and their efficacy (risk) perceptions. In most cases, adding risk information to an ad with benefit information increased risk knowledge and perceptions without decreasing benefit knowledge or perceptions.
- Consumer Perceptions of Prescription and Over-the-Counter Drug Advertisements with Promotional Offers
The volume of prescription drug promotion over time is often measured by assessing changes in promotional spending. However, this method obscures the fact that some types of promotion are more expensive than others. Another way to measure the changes in prescription drug promotion over time is to assess the number of promotional pieces submitted to the U.S. Food and Drug Administration (FDA). Form FDA 2253 collects information such as the date submitted and the type of material submitted. We analyzed data from Forms FDA 2253 received from 2001–2014. We examined the frequency of submissions by audience (consumer and healthcare professional) and type of promotional material. There was a noted increase in prescription drug promotion submissions across all media in the early 2000s. Although non-Internet promotion submissions have since plateaued, Internet promotion continued to increase. These results can help public health advocates and regulators focus attention and resources.
DTC prescription drug advertisements sometimes include information about the disease condition in addition to information about the advertised product. Although the intent of such information is to educate about the disease condition, in some cases consumers may mistakenly assume that the drug will address all of the potential consequences of the condition mentioned in the ad. We investigated the effects of adding disease information to DTC prescription drug print ads on consumer product perceptions and understanding.
We found that exposure to disease information as part of DTC prescription drug ads can promote the impression that the drug addresses consequences of the condition that are not part of the drug's indication.
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. In other cases, however, efficacy is measured by multiple endpoints 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. This study found that participants were not familiar with the concept of composite scores but that informing them about composite scores increased their understanding of them and influenced perceptions of the advertised products.
- Consumers’ Understanding of FDA Approval Requirements and Composite Scores in Direct-to-Consumer Prescription Drug Print Ads
- Communicating Efficacy Information Based on Composite Scores in Direct-to-Consumer Prescription Drug Advertising
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
There have been 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
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. Examining the effect of similarity and time delay suggests corrective ad exposure can influence consumer perceptions of drug efficacy, risks, and benefits previously established by violative ads. Corrective ads also can weaken consumer intentions to consider and seek more information about a drug. However, ad similarity does not appear to affect consumer perceptions and preferences. The length of the delay between violative and corrective ad exposure has limited influence. 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.
- Correction of Overstatement and Omission in Direct-to-Consumer Prescription Drug Advertising
- Correction of Misleading Information in Prescription Drug Television Advertising: The Roles of Advertisement Similarity and Time Delay
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.
- Awareness of the Food and Drug Administration’s Bad Ad Program and Education Regarding Pharmaceutical Advertising
- Professional Online Community Membership and Participation among Healthcare Providers: An Extension to Nurse Practitioners and Physician Assistants
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. We found that presenting the statement in both text and audio resulted in better processing of the statement than text-only presentations. When the statement was shown in text alone, presenting it during the entire advertisement or after the statement of risks resulted in better processing than a placement before the risk information. The placement, duration, and prominence of the statement did not affect risk or benefit comprehension. Further, the FDAAA statement was more noticeable, clear, and more participants were able to recall and recognize its correct purpose. Comprehension of product risk and benefit information did not differ based on statement wording.
- An Empirical Examination of the FDAAA-Mandated “Toll-Free Statement” for Consumer Reporting of Side Effects in Direct-to-Consumer Television Advertisements
- 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
In 2013, OPDP developed research to provide fuller understanding about the social context in which DTC ads are often viewed. Some components of this research were completed, whereas others were withdrawn due to concerns about their practical utility. Completed portions of the research examined experiences related to chronic illness management and medication decision-making among asthma patients and partners of asthma patients. That research showed that partners were involved in a variety of roles in asthma management and medication decision-making. Discussion triggers included worsening of symptoms, doctor visits, and medication cost and insurance coverage. Most partners are moderately or actively involved in the patient experiences of managing asthma, and this involvement is generally beneficial to the patient.
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 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 promotion 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 promotion. 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.
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
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
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 was 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
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.
- Presenting Efficacy Information in Direct-to-Consumer Prescription Drug Advertisements
- Visual presentations of Efficacy Data in Direct-to-Consumer Prescription Drug Print and Television Advertisements: A Randomized Study
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
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
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.
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
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
- Animation in DTC Promotion
- Character-Space-Limited Online Prescription Drug Communications
- Consumer and Healthcare Professional Identification of and Responses to Deceptive Prescription Drug Advertising
- Experimental Study of DTC Advertising Directed at Adolescents
- Risk and Benefit Perception Scale Development
- Superimposed Text in DTC Promotion
- Utilization of Adequate Provision among Low to Non-Internet Users
Animation has been used in DTC prescription drug promotion 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. 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.
Prescription drug regulations require a fair balance of the content and prominence of risk and benefit information in prescription drug product claim promotion. The rise of Internet communications that have character space limitations, such as sponsored link promotion and microblog messaging, has led to questions about how to use these communications for prescription drug promotion while complying with the fair balance requirements. In 2014, FDA released draft guidance, “Guidance for Industry Internet/Social Media Platforms with Character Space Limitations — Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices” which states:
Regardless of character space constraints that may be present on certain Internet/social media platforms, if a firm chooses to make a product benefit claim, the firm should also incorporate risk information within the same character-space-limited communication. The firm should also provide a mechanism to allow direct access to a more complete discussion of the risks associated with its product.
This project is designed to address the question of whether substantive risk information in the character-space-limited communications is effective in communicating risks when benefit claims are made, or whether a link to the risk information is sufficient. Within each study, we will manipulate whether or not substantive risk information appears in the character-space-limited communication.
Prescription drug promotion sometimes includes false or misleading (collectively, 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 promotion, 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 promotion. The ability of consumers and HCPs to identify deceptive prescription drug promotion has important public health implications. If unable to identify deceptive promotion, consumers may ask their HCPs to prescribe specific drugs that they would not otherwise request. Likewise, HCPs who are unable to identify deceptive promotion may prescribe specific drugs that they would not otherwise prescribe. On the other hand, if consumers and HCPs are able to identify deceptive promotion, they may appropriately discount or disregard such information in their medication decisions, and perhaps even report deceptive advertising to appropriate government regulators who can take corrective action.
This project will examine the ability of consumers and HCPs to identify deceptive prescription drug promotion, and the influence of such promotion on their attitudes and intentions toward the promoted drug. Additionally, analyses will draw comparisons between consumers and HCPs on these outcomes to generate insight about differential effects.
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 conducted a randomized, controlled study in two different medical conditions that assessed adolescents’ perceptions following exposure to DTC prescription drug advertising that varies in benefit and risk onset and risk severity. We compared adolescents’ perceptions with the perceptions of their young adult counterparts. Each participant viewed 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 included a sample of parents matched to their adolescent children to explore similarities and differences in perceptions for these matched pairs. We explored 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. Results showed that adolescents were able to understand the risk and benefit information depicted in the Web sites that they viewed. Results also showed that adolescents tend to both overestimate and underestimate risks, viewing them at the more extreme ends of the continuum, when compared to young adults. Perceptions of short term benefits seemed to have appeal, suggesting a desire for a “quick fix” among the adolescents in this study.
To gauge how product risks and benefits are communicated in promotional materials, OPDP’s research team 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.
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 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.
DTC prescription drug broadcast ads containing product claims are required to present the product’s major side effects and contraindications in either the audio or audio and visual parts of the presentation. Broadcast advertisements must also contain a brief summary of all necessary information related to the side effects and contraindications or provide adequate provision, or information about how consumers can gain full access to approved package labeling. Adequate provision is typically fulfilled through the option of obtaining the FDA-required labeling via a sponsor’s website, a toll-free telephone number, or a print ad, as well as a recommendation to consult with a healthcare provider. The purpose of including all four elements is to ensure that most of a potentially diverse audience can access the information. Internet accessibility is increasing, but many members of sensitive demographic groups (e.g., older adults, low socioeconomic status (SES) individuals) nonetheless report that the Internet is inaccessible to them either as a resource or due to limited knowledge, and so a website alone may not adequately serve all potential audiences. Similarly, some consumers may prefer to consult sources other than a healthcare provider to conduct initial research, for privacy reasons or otherwise. In light of these considerations, the toll-free number and print ad may provide special value to consumers, though not necessarily unique value relative to one another. This project will examine the value of including both the toll-free number and print ad as part of adequate provision in DTC broadcast ads. Secondarily, we will also investigate the ability and willingness of low to non-internet users to make use of internet resources if other options were unavailable.
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.
- Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion
- Empirical Study of Promotional Implications of Proprietary Prescription Drug Names
- Assessment of Terms and Phrases Commonly Used in Prescription Drug Promotion
- Disclosures in Professional and Consumer Prescription Drug Promotion
- Disclosures of Descriptive Presentations in Professional Oncology Prescription Drug Promotion
- Disease Awareness and Prescription Drug Promotion on Television
- Experimental Study of an Accelerated Approval Disclosure
- Healthcare Professional Interviews: Risk Processing for Newly Promoted Prescription Drugs
- Healthcare Professional Survey of Professional Prescription Drug Promotion
- Physician Interpretation of Information About Prescription Drugs in Scientific Publications vs. Promotional Pieces
- Risk Information Amount and Location in Direct-to-Consumer Print Ads
- Study of Oncology Indications in Direct-to-Consumer Television Advertising
Advertisers have used celebrity endorsers for years, and DTC pharmaceutical promotion is no different. As researchers studied the influence of celebrity endorsers, they theorized that a correspondence bias occurs in which people believe that the endorser truly believes what they are saying. Previous research has examined whether medical experts, celebrities, or consumers would be most persuasive in advertisements (see Federal Register link for more details and citations). We propose to extend previous research by examining four types of endorsers in two separate studies (celebrity, physician, patient, influencer1 ) and examining whether the presence of a disclosure of their payment status influences participant reactions. We propose to also test two different types of disclosure language—one direct and more consumer-friendly, and one less direct.
- Federal Register Notices: 60-day
During the prescription drug approval process, sponsors propose proprietary names for their products. These names undergo a proprietary name review (PNR) that involves the Office of Drug Safety, the relevant medical office, and the OPDP. OPDP reviews names to assess for alignment with the spirit of the Federal Food Drug & Cosmetic Act (FD&C Act), which provides that labeling or advertising can misbrand a product if misleading representations are made (See 21 U.S.C. 321(n)). A proprietary name, which appears in labeling, could result in such misbranding if it is false or misleading. OPDP focuses its misbranding review on identifying names that overstate the efficacy or safety of the drug, expand drug indications, suggest superiority without substantiation, or are of a fanciful nature that misleadingly implies unique effectiveness or composition. While there are several ways proprietary names can be misleading, this research will primarily focus on overstatement of the efficacy of the drug product.
The proposed study is designed to provide systematic, empirical evidence to answer two research questions: 1) Primary research question: How, if at all, do names that suggest the drug’s indication affect consumers’ and/or healthcare providers’ perceptions of the prescription drug?, and 2) Secondary research question: How, if at all, do names that overstate the efficacy of the drug affect consumers’ and/or healthcare providers’ perceptions of prescription drugs?
- Federal Register Notices: 60-day
The present research involves assessment of how consumers and primary care physicians (PCPs) interpret terms and phrases commonly used in prescription drug promotion as well as those used to describe prescription drug promotion. This includes both what these terms and phrases mean to each population (e.g., definitions) and what these terms and phrases imply (e.g., about efficacy and safety). Some examples of interest include: “natural” or “naturally-occurring,” and “targeted” or “targeted therapy.” The full list for assessment will include approximately 30 terms and phrases for each population. To accommodate such a large number, presented terms and phrases will be accompanied by only limited context (terms within sentences and phrases within paragraphs, as opposed to full promotional materials). Understanding the most prevalent interpretations of these terms and phrases can help OPDP determine the impact of specific language in prescription drug promotion. For example, certain terms and phrases, when used without additional contextual information, might overstate the efficacy or minimize the risk of a product. Additionally, from a health literacy perspective, it is helpful to ascertain general understanding of such terms and phrases as this may aid in the development of best practices around communicating these concepts.
We plan to conduct this research in two phases. First, we will conduct formative semi-structured interviews with 30 members of each population (general population consumers and PCPs). Second, we will conduct nationally representative, probability-based surveys of more than 1,000 members of each population on the same topic.
- Federal Register Notices: 60-day
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.
Under the Food, Drug, & Cosmetic Act and implementing regulations, promotional labeling and advertising about prescription drugs are required to be truthful, non-misleading, and to reveal facts material to the presentations made about the product being promoted . As a part of the ongoing evaluation of FDA’s regulations in this area, FDA plans to study the impact of disclosures as they relate to presentations of preliminary or descriptive scientific and clinical data in promotional labeling and advertising. The use of disclosures is one method of communicating information to healthcare professionals about scientific and clinical data, the limitations of that data, and practical utility of that information for use in treatment. These disclosures may influence prescriber comprehension and how and what treatment they prescribe for their patients. These impacts may vary based on the technical nature and content of the language used in the disclosure and the level of clinical training the healthcare professional possesses. The current research will address the question of whether the presence and language of disclosures and the presence or absence of a general statement about clinical utility influences prescriber comprehension, perceptions, and intention to prescribe the advertised product.
When pharmaceutical companies market a new drug, they often also release disease awareness communications about the medical condition the new drug is intended to treat. FDA is interested in the extent to which this practice may result in consumers confusing or otherwise misinterpreting the different information and claims presented in disease awareness communications and prescription drug promotion. Prior research has documented that in both print and online contexts, consumers tend to conflate the information presented in prescription drug promotional materials with information presented in disease awareness communications. Specifically, the results of these studies suggest consumers incorrectly ascribe benefits to a prescription drug as a result of being exposed to information in a disease awareness communication that broadly describes the symptoms and negative consequences of the disease. There are ways in which this effect can be attenuated. For example, prior research has indicated that greater visual distinctiveness between the two ad types can ameliorate such confusion. The present research seeks to extend previous findings to the context of television promotion, and broadly examine how perceptual similarity between the two communication types as well as their temporal proximity and exposure frequency can impact the nature and extent of viewer confusion.
Pursuant to section 506(c) of the FD&C Act and 21 CFR part 314, subpart H (or 21 CFR part 601, subpart E for biological products), FDA may grant accelerated approval to a drug product under section 505(c) of the FD&C Act or a biological product under section 351(a) of the Public Health Service Act. This pathway enables faster approval of prescription drugs intended to treat serious or life-threatening illnesses. Accelerated approval may be based on a determination that a drug product has an effect on a surrogate endpoint (for example, a blood test result) that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit (i.e., an intermediate clinical endpoint). Under FDA’s regulations governing physician labeling for prescription drugs, the INDICATIONS AND USAGE section of the FDA-approved prescribing information (PI) for a drug approved under accelerated approval must include “a succinct description of the limitations of usefulness of the drug and any uncertainty about anticipated clinical benefits, with reference to the ‘Clinical Studies’ section for a discussion of the available evidence.” 21 CFR 201.57(c)(2)(i)(B). This study will examine the presence, wording, and prominence of a disclosure communicating information related to the drug’s accelerated approval in direct-to-consumer (DTC) promotional materials.
Healthcare professionals (HCPs) are often incredibly busy. This hectic schedule may restrict the ability or willingness of HCPs to process new information, including risk information included in promotional materials for new prescription drug products. HCPs may instead rely on schematic processing, informed by what they already know, to reach conclusions about drug risks. For example, products designed to treat high blood sugar associated with type 2 diabetes are known to have similar risk profiles, and thus HCPs may rely on previous knowledge about risks for similar products rather than read through specific risk information for a newly promoted product. This poses a problem if a newly promoted product includes unique risks. HCPs may rely on other strategies as well, such as restricting attention to risk information presented earlier in a presentation, or risk information that is presented prominently. Or—recognizing the importance of product risks—HCPs may tend to read risk information for newly promoted products in full.
This research will provide evidence regarding how HCPs process risk information for newly promoted prescription drug products, including consideration for the impact of typical time constraints. The research methodology will involve in-person, semi-structured interviews with practicing HCPs—including primary care physicians, specialists, physician assistants, and nurse practitioners. These interviews will include an assessment of attention to risk information in a mock promotional piece using eye-tracking technology.
In 2002 and 2013, FDA surveyed healthcare professionals (HCPs) about their attitudes toward DTC advertising and its role in their relationships with their patients. The 2013 survey included multiple types of HCPs: primary care physicians and specialists, as well as nurse practitioners and physician assistants. Whereas the focus of both previous FDA surveys was on DTC advertising and promotion, the current study is designed to address issues related to professional prescription drug promotion. The goal is to query a representative sample of HCPs about their opinions of promotional materials and procedures targeted at HCPs, clinical trial design and knowledge, and FDA approval status. We will also take this opportunity to ask HCPs briefly about their knowledge of abuse-deterrent formulations for opioid products. We proposed to conduct a nationally representative survey of approximately 1,240 physicians (primary care and specialists), nurse practitioners, and physician assistants, drawn from WebMD’s subscriber network. The survey, assessed via Internet, is expected to take 15-20 minutes. Analyses will include frequencies, Chi-square, and correlational and factor analysis. The proposed survey is designed to provide further insights about how professionally targeted prescription drug promotion might influence health care professionals’ decision-making processes and practices and how information may be communicated more accurately.
This study will investigate how physician perception of professional prescription drug communications is influenced by variations in information context, methodologic rigor of the underlying clinical study, and time pressure. We propose to test three different contextual presentations of drug information (medical journal abstract, sales aid without graphic design elements, sales aid with graphic design elements), and two types of study methodological rigor used by Kesselheim et al., 2012 (classified as high or low). We have chosen to test a mock sales aid presentation and a medical journal abstract in order to examine the potential differences in perception that may arise by presenting the same information in different vehicles. Mirroring the time constraints of practicing physicians, we will examine the role of time pressure by randomly assigning half of the study participants to a limited amount of available time to read the materials.
Physician Interviews on FDA-Approved Labeling
FDA-approved labeling, or prescribing information, is an FDA-approved summary of the information needed to use a prescription drug safely and effectively. The labeling is written for healthcare practitioners. There are two types: Physician Labeling Rule (PLR) format (newer labeling format) and “non-PLR” format labeling (older labeling format). FDA’s Drug Labeling Coordinating Committee identified several topics related to the newer labeling format that would benefit from input from physicians. These topics include the resources physicians use to find information about prescription drugs; physicians’ interpretation of specific language in labeling; and presenting information on risks, drug interactions, and overdosage in labeling. The purpose of these interviews is to conduct qualitative research focusing on physicians’ use of, preferences for, and understanding of FDA-approved labeling.
- OMB generic information collection control number: 0910-0695
To fulfill the regulatory requirements for fair balance and the brief summary, sponsors have typically included risk information about the product in DTC print ads both in the main part of the ad where the product claims appear, and in a separate brief summary page. The section of the main ad where the risks appear is often referred to as the "Important Safety Information" (ISI). Including risks in both the ISI and the brief summary may have advantages. However, a potential downside to including the same warnings in both the ISI and again in the brief summary is reduced attention by recipients over time. OPDP plans to investigate, through empirical research, combinations of the ISI and the brief summary. We will test two levels of the ISI (short versus long) and the presence of the Brief Summary (absent versus present) in two different medical conditions (overactive bladder and rheumatoid arthritis).
Oncology products are increasingly being promoted to consumers via DTC television advertising. Oncology indications are often complicated and supported by different clinical endpoints such as overall survival, overall response rate, and progression-free survival that are referenced in the DTC TV ads. The first objective of this project is to determine whether disclosing information about the nature of the endpoints that support the indications for oncology products helps consumers understand the drug's efficacy.
Because of the length of some indications, sponsors sometimes convey some of the indication in superimposed text rather than in the audio in the TV ads. The second objective is to test whether consumers adequately comprehend indication statements when portions of the indication are presented only in the superimposed text of television ads while other information is conveyed in the audio.
1 “Influencer” is a “regular” person who has gained a following on a blog, a Twitter feed, or other social media medium.