The Food and Drug Administration (FDA) recently announced that it intends to study whether providing disease awareness information in branded full product advertisements affects consumer perceptions of the product.
Disease awareness communications are communications disseminated to consumers or health care practitioners that discuss a particular disease or health condition, but do not mention any specific drug or device or make any representation or suggestion concerning a particular drug or device. Helpseeking communications are disease awareness communications directed at consumers. FDA believes that disease awareness communications can provide important health information to consumers and health care practitioners, and can encourage consumers to seek, and health care practitioners to provide, appropriate treatment. This is particularly important for under-diagnosed, under-treated health conditions, such as depression, hyperlipidemia, hypertension, osteoporosis, and diabetes. Unlike drug and device promotional labeling and prescription drug and restricted device advertising, disease awareness communications are not subject to the requirements of the Federal Food, Drug, and Cosmetic Act (the act) and FDA regulations.
In a June 20 Federal Register notice, the agency stated that although some research has shown that disease awareness advertising “is viewed by consumers as more informative and containing less persuasive intent than full product advertising,” when that information is included in branded product ads, “a full description of the medical condition may include information about specific health outcomes that are not part of a drug’s approved indication.”
“Although the FDA can investigate these matters, it might be better to study the behavioral response to both disease awareness and product advertising, as well as the value of ads to educate and better inform,” said Coalition for Healthcare Communication Executive Director John Kamp.
Arnie Friede, former Senior Corporate Counsel at Pfizer, Inc., and a former Associate Chief Counsel in the FDA Chief Counsel’s Office, told the Coalition that “there is an important opportunity here to stake out a position on the utility from a public health standpoint of advertising that couples disease awareness information and product promotion and to argue that FDA should revisit its enforcement policy on the matter even as it undertakes and evaluates the consumer survey,” he said. “This is also consistent with Commissioner Hamburg’s position that industry ought to consider doing more disease awareness advertising.”
The agency is concerned that “consumers may mistakenly assume that the drug will address all of the potential consequences of the condition mentioned in the ad by making inferences that go beyond what is explicitly stated in an advertisement.” The FDA notes that if consumers have difficulty distinguishing between disease awareness information and branded drug product claims, consumers “may be misled.”
The study that the FDA is proposing to conduct will explore perceptions that result from including both disease information and promotional information about a specific drug in the same advertising piece.
FDA hopes to more readily generalize their findings by exploring the issues raised in three medical conditions varying in severity and symptomatology: Chronic obstructive pulmonary disease (COPD), lymphoma, and anemia. Two variables will be examined in the study: (1) the type of disease information (possible disease outcomes, versus non-outcome information, versus no information); and (2) the format of the information (integrated with drug information versus separated).
Although a comment sent in response to an Aug. 16, 2011, notice for public comment requested that any survey questions related to behavioral intention be deleted, the FDA states in the notice that its Risk Communication Advisory Committee (RCAC) has recommended that behavioral intention is an important variable to measure in research studies on promotion. [Editor’s note: The RCAC is slated to meet again on June 29 from 8 a.m. to 3 p.m.]
“What is most important now is developing public policies that enable optimal use of life enhancing and life saving medicines,” Kamp said. “It’s time to focus on more effective ads, leading to safe, effective use and better adherence, rather than just focusing on problems with ads.”
Other FDA Promotional Studies, Research
In addition to these studies, FDA’s Office of Prescription Drug Promotion also has several other studies and planned research listed on their website. One study is looking at the Communication of Effectiveness Information in DTC Print Ads, which is expected to be complete sometime this year. This study will investigate the communication of effectiveness information on the main advertising (display) page of print advertisements. FDA will examine whether adding placebo information and whether changing the framing of the information helps consumers understand the risk information. Separately, FDA will examine how physicians use the prescribing information documents, and specifically how they assess efficacy information in this document. For more information about this study: Federal Register Notice: Experimental Study: Presentation of Quantitative Effectiveness Information to Consumers in Direct-to-Consumer Television and Print Advertisements for Prescription Drugs: Part 1 and Part 2.
Another study, expected to be complete in 2013, will look at the Effect of Promotional Offers on Consumer Perceptions of Product Risks and Benefits. This proposed exploratory study will examine what impact, if any, the presence of coupons in DTC advertisements may have on consumers’ recall and perceptions of product risks and benefits, and the overall impression of the product in DTC full-product and reminder advertisements (The FDA does not have the authority to regulate prescription drug pricing and we will not be examining prescription drug prices). For more information about this study: Federal Register Notice: Experimental Study: Effect of Promotional Offers in Direct-to-Consumer (DTC) Prescription Drug Print Advertisements on Consumer Product Perceptions
Another study to be completed by 2013 will look at the Experimental Study of Format Variations in the Brief Summary of Direct-to-Consumer (DTC) Print Advertisements. Research conducted by FDA and others has examined the content and format of the brief summary. Schwartz, Woloshin, and Welch (2009) have compared one format for adding quantitative and qualitative benefit and risk information to the brief summary. Specifically, Schwartz et al. designed a prescription drug facts box similar in format to the Nutrition Facts panel and OTC Drug Facts panel. The box contains a number of elements, including qualitative and quantitative (both absolute frequency and absolute difference) information about benefits and risks. The current study will add to previous research by systematically examining these different elements to determine whether and how to add qualitative and quantitative benefit and risk information to the brief summary. The results of this study will inform FDA of the usefulness and parameters of various format and content options for the brief summary. For more information about this study: Federal Register Notice: Experimental Study: Experimental Study of Format Variations in the Brief Summary of Direct-to-Consumer Print Advertisements
Another study, to be completed by 2014, will Examine Online Direct-to-Consumer Promotion. This project is designed to test different ways of presenting prescription drug risk and benefit information on branded drug websites. This research will complement qualitative research we plan to conduct on issues surrounding social media. The original regulations that presently determine FDA’s position on DTC promotion were written at a time when the available media for DTC promotion were print and broadcast and the primary audience was health care professionals. This dynamic is shifting, and evidence is needed to inform guidance development. For more information about this study: Federal Register Notice: Examination of Online Direct-to-Consumer Prescription Drug Promotion.
Another study to be completed in 2014 will Examine Comparative Claims. Despite extensive research on comparative advertising of consumer products 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. Consequently, it is unclear whether these findings are applicable to comparative drug ads or how such claims influence consumers’ perceived efficacy of advertised drugs.
Currently, most DTC ad comparisons focus on drug attributes, such as differences in dosing or administration method. Because few head-to-head clinical trials have been conducted, very few DTC ads include efficacy-based comparisons; however, this may change given the current national focus on comparative effectiveness research. This study is designed to apply the existing comparative advertising literature to DTC advertising and investigate how consumers interpret and react to DTC comparative drug ads. Specifically, the study will explore two types of drug comparisons in DTC ads: (1) drug efficacy comparisons; and (2) other evidence-based comparisons, such as dosing, mechanism of action, and indication. For more information about this study: Federal Register Notice: Experimental Study of Comparative Direct-to-Consumer Advertising.
Finally, a study to be completed by 2012 on Patient Medication Information. This project is deigned to test different ways of presenting information about prescription drugs to patients who have obtained a prescription. For more information about this study, please see: Federal Register Notice: Experimental Study of Patient Information Prototypes.