Disease Awareness and Prescription Drug Communications on Television: Evidence for Conflation and Misleading Product Impressions.

We conducted two experiments that tested for conflation of fictitious disease awareness and prescription drug promotional communications in a television advertising context and whether similarity, proximity, and number of exposures to the disease awareness communication contributed to this conflation. Study 1 involved a 1-h television segment, and Study 2 used a longitudinal design with participants exposed to communications over time. The promoted product was indicated to treat asthma. Participants (Study 1, n = 2190; Study 2, n = 1621) were adults who had experienced asthma or asthma symptoms. In Study 1, mere exposure to disease awareness communication prompted benefit and risk conflation, but the degree of similarity or proximity did not have an effect. In Study 2, similar ads prompted greater conflation of benefits than distinct ads, and greater conflation of risks occurred with greater proximity to disease awareness and promotional communications. In addition, asthma knowledge, health literacy, and perceived ad effectiveness increased conflation of benefits in both studies but tended not to modify the impact of similarity or proximity. The findings demonstrate the potential for disease awareness communications to confuse consumers regarding the benefits and risks of a drug.

Physician interpretation of information about prescription drugs in scientific publications vs. promotional pieces.

BACKGROUND: Physicians gain knowledge about medical product uses from a variety of information vehicles including FDA-approved labeling, peer-reviewed journal articles, compendia, continuing medical education (CME), and physician-directed promotion. The source of this information, the quality of the information, and environmental pressures such as lack of time may impact perceptions. OBJECTIVE: The authors tested the effect of three types of information sources (journal abstract, sales aid without graphics, sales aid with graphics), the presence or absence of time pressure to read the information, and two levels of methodological rigor (high, low) on perceptions of study quality, perceptions of product effectiveness and riskiness, and prescribing likelihood. METHODS: Primary care physicians (n = 630) were randomly assigned to view one version of a study abstract and then answered questions. RESULTS: Participants who viewed a high-methodological rigor study reported more perceived credibility and importance of the data (ps < .05), and less need for interpreting the study data with caution and less bias than those who viewed a low-rigor study. Those who were not under time pressure to read the stimuli rated the fictitious study description as more credible, rigorous, important, and had more confidence in study data than those who were under time pressure. Participants who had less time to review high-rigor journal abstracts and sales aids with graphics were less likely to agree the study data should be interpreted with caution than doctors who had more time with the stimuli. No effects of source type were observed. CONCLUSIONS: The results suggest that prominently disclosing methodological rigor helps the audience form an accurate perception of the presented information. This also further highlights the importance that any promotional communications should be truthful and non-misleading.

Implied Claims in Drug Advertising: A Review of Recent Literature and Regulatory Actions.

Federal agencies and self-regulatory bodies help to ensure prescription and nonprescription drug promotion contains accurate information; however, false or misleading claims may cause people to have inaccurate perceptions of a drug and inhibit their ability to make informed decisions. We conducted a systematic review assessing evidence from 2012-2021 on how consumers and healthcare providers (HCPs) interpret claims made indirectly or through inference (implied or implicit claims) as well as synthesizing prescription and nonprescription drug advertising claims that have been the subject of regulatory actions from 2017-2021. Our search identified 16 studies from the peer-reviewed literature and 26 letters or case reports issued by the Food and Drug Administration (FDA) or National Advertising Division (NAD). Results from peer-reviewed studies suggest that implied claims can result in inferences that may not be warranted by the material facts about the drug. Perceptions of a drug's efficacy and, to a lesser extent, risk, are influenced by implied and explicitly false claims in prescription drug promotion. Claims related to implied superiority and overstatement of efficacy were the most prevalent claims flagged for review and examined in the literature. These types of claims were also the subject of many of the compliance actions by the FDA and case reports from the NAD. More research is needed to understand how people interpret varying types of implied claims and the impact of such claims on key outcomes. From a policy standpoint, understanding how people interpret implied claims can inform how the FDA approaches these claims in the marketplace.

Healthcare providers' understanding of data displays of clinical trial information: a scoping review of the literature.

BACKGROUND: Healthcare providers often encounter clinical trial results in the form of visual data displays. Although there is a robust literature on patient responses to data displays in medical settings, less is known about how providers comprehend and apply this information. Our study provides a scoping review of the literature on providers' reactions to and perceptions of data displays. METHODS: We searched article databases (PubMed, PsycINFO, Web of Science, Cumulative Index to Nursing and Allied Health Literature, the Cochrane Library) supplemented by handsearching. Eligible articles were published in English from 1990 to 2020. RESULTS: We identified 15 articles meeting our criteria. Studies with physicians were more prevalent (13/15) than those with other healthcare providers (6/15). Commonly assessed outcomes included objective (10/15) and subjective comprehension (4/15), preference for certain data display formats (6/15), and hypothetical decision-making around prescribing (4/15). In studies that assessed comprehension of clinical trial concepts, scores were average or below what would be considered mastery of the information. Data display formats that were preferred did not always correlate with better comprehension of information; lesser preferred formats (e.g. icon array) often resulted in better comprehension. CONCLUSION: Our findings suggest that healthcare providers may not accurately interpret complex types of data displays, and it is unknown if such limitations affect actual decision-making. Interventions are needed to enhance comprehension of complex data displays within the context of prescription drug professional promotion.

Complexity of Data Displays in Prescription Drug Advertisements for Healthcare Providers.

BACKGROUND: Healthcare providers (HCPs) often encounter clinical trial results in the form of data displays in prescription drug promotions. Information conveyed in data displays vary in their presentation and complexity. This study describes characteristics of data displays in prescription drug advertising targeted to HCPs. METHODS: This study characterized the content of 140 data displays in 98 unique print advertisements from 2009 to present and identified in AdPharm, an online database of pharmaceutical advertisements. Two reviewers independently coded the advertisements for characteristics (κ = 0.85) including complexity, format, and quality. RESULTS: About one-third (32%) of the advertisements contained multiple data displays (range 2 to 6) and 44% showed clinical data from oncology trials; other disease domains were mental and behavioral health (14%), rheumatology and autoimmune disorders (8%), endocrinology (7%), cardiology (6%), infectious disease (6%), pulmonology and allergy (4%), and others (< 2% each). About one-half (51%) of displays were classified as "simple" which included "pseudographs" and basic tables or charts. "Complex" displays appeared as survival curves, line graphs, or bar graphs with complex features. Most complex displays included a comparator drug (90%), plain language restatement of the key finding (93%) and disclosure statements (91%) with additional study details, although their placement varied. Complex displays were of high quality, according to our selected indicators; our analysis found no data distortion or errors. CONCLUSION: Data displays in prescription drug advertising are often highly complex. Future research assessing understanding of data displays and the potentially beneficial effect of disclosures and other features is warranted.

Attention to risk information in direct-to-consumer prescription drug print ads: An eye-tracking study.

PURPOSE: FDA regulations state print ads for prescription drugs must provide a true statement of information "in brief summary" describing "side effects, contraindications and effectiveness." To fulfill these requirements, these ads typically display risk information both as important safety information (ISI) on the "main" ad page with the product claims and on a separate "brief summary" page. The ISI can be lengthy and may repeat brief summary content. METHODS: The authors tested two versions of the ISI (short versus long) and the presence or absence of a brief summary in direct-to-consumer prescription drug print ads for two medical conditions: overactive bladder (N = 181) and rheumatoid arthritis (N = 179). Attention was measured with eye-tracking and self-report methods. Risk retention and perceptions were self-reported. RESULTS: Participants spent more time viewing ads with a long ISI or a brief summary and in some instances, recalled more risks. The combination of a long ISI and a brief summary did not increase or decrease attention to or retention of risk information. CONCLUSION: A long ISI and a brief summary may perform similar functions.

Influence of data disclosures on physician decisions about off-label uses: findings from a qualitative study.

BACKGROUND: Prescribing approved products for unapproved uses (off-label use) is not uncommon among physicians in certain medical specialties. Available evidence about an off-label use - both supportive and unsupportive - can influence prescribers' decisions about a drug's appropriateness for a particular case. The objectives of this study were: (1) to examine physician perceptions about off-label uses generally, including their awareness of unsupportive data; and (2) to explore the influence of disclosure information about unsupportive data on off-label prescribing decisions. METHODS: Semi-structured interviews were conducted between December 2019 and January 2020 with oncologists (n = 35) and primary care physicians (n = 35). Interviews explored general prescribing practices, understanding of and information sources for learning about off-label use of prescription drugs, awareness of unsupportive data related to off-label uses, and preferences and reactions to disclosure statements about the existence of unsupportive data related to an off-label use. RESULTS: Most participants reported prescribing drugs for off-label uses (with half reporting regular off-label prescribing). However, among those who prescribe off-label, approximately two-thirds had never seen unsupportive data about off-label uses. Physicians preferred a disclosure statement that provided a summary of the unsupportive data about the off-label use; this statement also led most physicians to say they were unlikely or less likely to prescribe the drug for that use. CONCLUSIONS: This study suggests that physicians' decision-making about prescribing for off-label uses of approved drugs may be influenced by awareness of unsupportive data. Our interviews also suggest that providing more information about unsupportive study findings may result in a reduction in reported prescribing likelihood.

Physician Perceptions of the FDA's Breakthrough Therapy Designation: An Update.

The US Food and Drug Administration developed the Breakthrough Therapy designation to expedite the development and review of drugs that show a clear advantage over available therapy for serious conditions. Prior research has shown that physicians tend to misunderstand that a drug may receive a Breakthrough Therapy designation based on preliminary clinical evidence (eg, effect on a surrogate endpoint or intermediate clinical endpoint that is likely to predict clinical benefit). The objective of this article is to examine whether physicians' familiarity with and interpretation of the Breakthrough Therapy designation have changed since a survey on the topic was published in 2016. We replicated three of the questions in that study and explored beliefs that a Breakthrough Therapy designation automatically qualifies a drug for accelerated approval. We also draw comparisons by specialization (oncologists vs. primary care physicians). In general, physicians remain more likely than not to misunderstand the Breakthrough Therapy designation.

Physicians' use of and preferences for FDA-approved prescribing information.

BACKGROUND: The Prescribing Information (PI) is the US Food and Drug Administration (FDA)'s primary tool for communicating a summary of the essential scientific information needed for the safe and effective use of a prescription drug to healthcare providers.[1] One challenge with this type of communication is balancing the need to be thorough with the need to be concise. OBJECTIVES: This study aimed to explore physicians' preferences for and understanding of specific content and formatting in the PI. This study also explored physicians' use of and perceptions of the PI. METHODS: Seventy semi-structured qualitative interviews were conducted with primary care physicians (n = 35) and physicians from a wide range of specialties (n = 35) using web conferencing technology. Using fictitious PI examples, the guide assessed physicians' interpretation of language and preferences for how certain information is organized and communicated in select sections of the PI. The interview guide also included questions about the resources physicians use to find information about prescription drugs, when and how physicians access the PI, and their perceptions of the PI. RESULTS: The findings suggest that of the content and formatting items surveyed, physicians had the greatest preference for: (1) uniformly specifying the age group for which the drug is indicated in the INDICATIONS AND USAGE section, even for medical conditions that are highly associated with only one particular age group (e.g., adult patients), and (2) uniformly including administration information in relation to food (e.g., "with or without food") in the DOSAGE AND ADMINISTRATION section for drugs with oral dosing. The findings also suggest that including a long list of interacting drug examples in the DRUG INTERACTIONS section may be misinterpreted to be a comprehensive list. CONCLUSION: This qualitative research suggests physicians may prefer more clarity in some sections of the PI.

Utilization of adequate provision in prescription drug broadcast ads among low- and non-Internet users.

To fulfill a key regulation pertaining to prescription drug broadcast advertising, a common practice is to present the major risks along with "adequate provision" referencing several sources where audiences can obtain the full product labeling. In recent years, questions have arisen about the unique value of the various sources of adequate provision and even whether sponsor webpages alone may sufficiently convey product labeling information. Cognizant of the sizable offline population, the present research investigates questions of access, ability, likelihood, willingness, and preference among a nationally representative sample of low- and non-Internet users who may wish to access the product labeling.

Physician Interpretation of Data of Uncertain Clinical Utility in Oncology Prescription Drug Promotion.

BACKGROUND: Little is known about how physicians interpret data displays that depict preliminary or exploratory clinical data in physician-targeted sales aids for oncology drugs. Using three factorial experiments, we examined whether disclosures of data limitations and clinical uncertainty adequately communicate the limitations and practical utility of this type of data. SUBJECTS, MATERIALS, AND METHODS: The studies used a 2 (disclosure of data limitations: technical, nontechnical) × 2 (disclosure of clinical uncertainty: present, absent) + 1 (control: no disclosure) between-subjects experimental design to examine the impact of disclosures as they relate to presentations of preliminary or exploratory data in promotional communications for oncology products. In each experiment, we randomized oncologists and primary care physicians with oncology experience to view one version of a two-page sales aid. Following this exposure, physicians completed a web-based survey. The design was replicated in three concurrently conducted experiments using sales aids for different fictitious oncology drugs, each featuring one of three common data displays: a forest plot (n = 495), a Kaplan-Meier curve (n = 504), or a bar chart (n = 532). RESULTS: Results provide initial evidence that in some contexts disclosures can improve understanding of the clinical utility of certain information about a drug and the limitations of results presented in a data display. Disclosures can also temper perceptions of how much evidence is presented that supports a conclusion that the drug is an appropriate treatment. In terms of the language used in the disclosure of data limitations, physicians in all three experiments strongly preferred the nontechnical disclosures. CONCLUSION: The findings from the three experiments in this study suggest that disclosures have the potential to increase relevant knowledge, but more research is needed to establish best practice recommendations for using disclosures to convey contextual information relevant for interpreting data displays in promotional communications. IMPLICATIONS FOR PRACTICE: This article reports the results from three large, online experimental studies that address a growing concern that drug companies often share favorable clinical trial results with physicians in promotional materials that lack important context for physicians to interpret the data. This series of studies investigates whether strategic use of two types of disclosures (disclosure of data limitations and a disclosure of clinical uncertainty) improves understanding and reduces misinterpretations among physicians. The results from these studies help identify communication factors that impact how physicians critically appraise preliminary or exploratory clinical trial data to inform policy and regulatory efforts.

Consumers' experience with and attitudes toward direct-to-consumer prescription drug promotion: a nationally representative survey.

The way consumers get and seek health information reflects the current information landscape. To gather updated insights on consumer experiences with and attitudes towards direct-to-consumer (DTC) promotion of prescription drugs, we conducted a nationally representative survey of 1,744 US adults using a mail-push-to-web methodology with paper nonresponse follow-up. Results showed high exposure and indifferent attitudes to DTC promotion. Respondents reported DTC promotion has prompted action, particularly searches for more information, increased use of online resources, and some reported that they refused to take or stopped taking a prescription drug because they saw or heard about the drug's side effects.

Opioid Education and Prescribing Practices.

BACKGROUND: Lack of training among health care providers (HCPs) to safely prescribe opioids is a contributing factor to the opioid crisis. Training and other resources have been developed to educate providers about safe and appropriate opioid prescribing practices. METHOD: The national survey was conducted with 2000 HCPs representing primary care physicians (PCPs), including family practice, general practice, and internal medicine; specialists (SPs); physician assistants (PAs); and nurse practitioners (NPs), a mix of primary care and specialists. This survey examined exposure to opioid educational information and opioid prescribing. RESULTS: PCPs reported prescribing opioids for chronic pain to significantly more patients compared with other HCP groups. PCPs (89.8%) and NPs (85.5%) reported significantly greater exposure to opioid educational information compared with both SPs (71.9%) and PAs (78.8%). Overall, HCPs had limited knowledge about abuse-deterrent formulations, but PCPs had greater knowledge than other groups. HCPs had an increased likelihood of prescribing opioids to fewer patients in the last 3 months relative to the prior 12 months if they worked in a state or county clinic vs a solo or group practice type (adjusted odds ratio [AOR] = 1.97; 95% confidence interval [CI], 1.12-3.49) and were exposed to more opioid educational information during the last 12 months (AOR = 1.19; 95% CI, 1.06-1.32). DISCUSSION: HCPs' exposure to opioid educational information was associated with less opioid prescribing for chronic pain. Findings indicated a difference in exposure and knowledge gaps across provider groups. More information is needed on the content of opioid educational information provided to HCPs.

The FDA's Diverse and Dynamic Activities in the Social and Behavioral Sciences: Advancing and Supporting Health Equity.

The U.S. encompasses a heterogenous mix of people and health disparities exist for various subpopulations, such as minorities, women, people with limited English proficiency, those with low socioeconomic status, and other underserved groups. Differences in health outcomes arise in part due to inequalities and injustices rooted in biological, social, and structural factors. Because the origins of health disparities are multifactorial, the approaches to reduce, or even eliminate them, must be multifactorial as well. The social and behavioral sciences are well poised to address the myriad and complex factors that affect health outcomes, including those at the individual level (eg, individuals' behaviors, attitudes, and beliefs), the neighborhood level (eg, housing), the community level (eg, cultural values and norms), and the policy level (eg, public policies that influence healthcare funding and access to healthcare resources and educational materials). In addition, the social and behavioral sciences (1) help equip government agencies with the perspectives and tools needed to promote health equity and (2) contribute to rigorous, evidence-based solutions for public health issues, such as disparities found in childhood vaccination rates, childhood obesity, tobacco use, and access to health information technology. The FDA, in particular, actively conducts social and behavioral sciences research to guide the Agency's efforts to advance and support health equity.

What influences healthcare providers' prescribing decisions? Results from a national survey.

BACKGROUND: Prior U.S. Food and Drug Administration (FDA) surveys with healthcare providers (HCPs) have focused on attitudes toward direct-to-consumer advertising and have not specifically examined professionally-targeted prescription drug promotion. Similarly, there are no recent national surveys of HCPs examining their interactions with the pharmaceutical industry. OBJECTIVES: The goal of this study was to use a national sample of HCPs to examine exposure to professionally-targeted prescription drug promotions and interactions with industry, and knowledge, attitudes and practices related to FDA approval of prescription drugs. METHODS: An online national survey was conducted with 2000 HCPs representing primary care physicians (PCPs), specialists (SPs), physician assistants (PAs), and nurse practitioners (NPs). The sample was randomly drawn from WebMD's Medscape subscriber network, stratified by HCP group, and designed to yield target numbers of completed surveys in each group. Weights were computed to correct for unequal selection probabilities, differential response rates, and differential coverage and used to generalize completed surveys to a national population of PCPs, SPs, NPs, and PAs. RESULTS: Exposure and attention to pharmaceutical promotions and contact with industry were significantly associated with reported increase in pharmaceutical industry influence on decisions about prescription drugs. SPs were significantly more likely to prescribe off-label and serve as opinion leaders for the pharmaceutical industry compared to other provider groups. CONCLUSIONS: Findings indicate pharmaceutical promotions directed at HCPs occur in many forms and are disseminated through multiple channels. By using a nationally representative sample of HCPs, this study provides population-level estimates for exposure and attention to prescription drug promotion and contact with industry and evidence for their influence on prescriber decisions. Findings from this study will help to inform FDA of HCP responses to and impacts of prescription drug promotion.

Development and validation of prescription drug risk, efficacy, and benefit perception measures in the context of direct-to-consumer prescription drug advertising.

PURPOSE: Understanding patient perceptions of prescription drug risks and benefits is an important component of determining risk-benefit tradeoffs and helping patients make informed medication decisions. However, few validated measures exist for capturing such perceptions. The purpose of this study was to develop and validate measures of perception of prescription drug risk, efficacy, and benefit. METHODS: We conducted a mixed-methods study to develop and validate the measures, including three waves of quantitative testing (item nonresponse, criterion-related validity, and convergent validity). We conducted quantitative testing with a probability-based online consumer panel of U.S. adults (n = 7635), eliminating weaker items after each testing wave. RESULTS: Upon completion of all testing, we identified 21 validated measures that represent 11 distinct risk/benefit constructs. The final measures demonstrated face validity, convergent validity, criterion-related validity, and scale reliability in both illness and general population samples, among patients with both symptomatic and asymptomatic health conditions, and in response to both television and print direct-to-consumer prescription drug advertisements. CONCLUSIONS: Our study produced a set of items that researchers and practitioners can use to assess patient perceptions of prescription drug risk, benefit, and efficacy and to ensure greater future comparability between studies.

Direct-to-Consumer Prescription Drug Advertising and Patient-Provider Interactions.

BACKGROUND: Direct-to-consumer prescription drug advertising is prevalent and affects patient care. Previous research that examined its effect on the patient-provider relationship predates many changes in the advertising and medical landscape that have occurred in the last decade, such as the rise in online promotion and the push for value-based medicine. METHODS: We conducted a nationally representative mail-push-to-web survey of 1744 US adults in 2017 to explore how patients view the effects of direct-to-consumer prescription drug advertising on patient-provider interactions. RESULTS: Most respondents (76%) said they were likely to ask a health care provider about advertised drugs; 26% said they had already done so. Among the 26% of respondents who talked to a health care provider about a specific prescription drug they saw advertised, 16% said they received a prescription for the advertised drug. Few respondents (5%) reported that advertising had caused conflict with a health care provider, 16% said it had caused them to question their provider's advice, and 23% said they were likely to look for a different provider if their provider refused to prescribe a requested brand name drug. DISCUSSION: These results suggest that direct-to-consumer advertising is driving some patients to discuss specific products with their health care providers but that most patients do not believe advertising has a negative influence on the patient-provider interaction itself.

Direct-to-Consumer Advertising of Prescription Drugs and the Patient-Prescriber Encounter: A Systematic Review.

We systematically reviewed the research on patients' and prescribers' perceptions of, and self-reported behaviors prompted by, exposure to direct-to-consumer advertising (DTCA) (For ease of reading we use the term "advertising" to encompass advertising and promotional labeling. Broad use of this term does not imply endorsement by FDA) of prescription drugs that occurs in the context of a clinical encounter. This research offers an important perspective on the broader goal of incorporating patient and prescriber voices in decision-making. Outcomes included patient information seeking, medication adherence, patient requests for DTCA-promoted prescription drugs, prescribing behaviors, and perceptions of the patient-prescriber relationship and interactions. We searched PubMed and other databases from 1982-2017 and identified 38 studies meeting our study criteria. Of these, 24 studies used patient-reported outcomes and 18 used prescriber-reported outcomes (four used both). Studies 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. The potential benefits of DTCA on the patient-provider encounter must be balanced with the potential for harms.

Consumer responses to framing statements preceding the major risk statement in prescription drug DTC TV ads.

BACKGROUND: Research on the major risk statement in direct-to-consumer (DTC) prescription drug television ads has shown that risk severity and actionability can affect consumers' risk comprehension and perceptions. A framing statement presented just before the major risk statement may serve as a cue that directs attention to the risk statement that follows, or it may guide consumers' interpretation of the severity of the risks that follow. OBJECTIVE: Examine how the use of different framing statements (severe, life-threatening; serious; or basic) that precede the major risk statement in DTC television ads affect consumers' risk perceptions, risk recognition, benefit perceptions, interest in the drug, and other relevant outcomes. METHODS: An online experiment was conducted using a 1 × 3 between-subjects design to compare three different framing statements, which was replicated across three different DTC television ads that focused on different medical conditions (arthritis, lung cancer, and type 2 diabetes). A sample of US adults (N = 1961) was randomly assigned to view one of nine television ads and asked to respond to a questionnaire. RESULTS: The type of framing statement had significant effects on perceived risk severity, perceived utility of risk and benefit information, fear of risks, and perceived likelihood of explicit and implicit benefits. CONCLUSIONS: Consumers pay attention to and use cues to process and interpret the risk information presented to them in DTC television ads. Using lead-in language that describes risk severity, particularly for products with severe, life-threatening risks, may better allow consumers to make evaluative judgments on risk severity in DTC ads than stating the drug can cause serious reactions or simply that reactions are possible. More work is needed to examine the factors that affect people's understanding of the nature of risk severity, particularly with regard to risk recognition.

Consumer understanding of the scope of FDA's prescription drug regulatory oversight: A nationally representative survey.

PURPOSE: Misperceptions of how the US Food and Drug Administration (FDA) regulates prescription drugs may affect how consumers assess the safety and efficacy of prescription drugs. The study objective was to survey the public on their knowledge of FDA oversight regarding prescription drug approval and advertising. METHODS: In 2017, we conducted a nationally representative mail-push-to-web survey with 1,744 US adults. RESULTS: Although most respondents (86%) knew that FDA approves prescription drugs, we found misperceptions about what that approval means. In addition, 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%). CONCLUSIONS: Enhanced collaboration and communication with the public by key stakeholders in this space could increase public understanding of the roles and responsibilities of FDA.