Research Pending Peer Review and Publication | Office of Prescription Drug Promotion (OPDP) Research
The following research projects are complete and awaiting peer review and publication in scientific journals. Study results and links to more information will be posted here upon publication.
Disease Awareness and Prescription Drug Promotion on Television
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.
Empirical Study of Promotional Implications of Proprietary Prescription Drug Names
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?
Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion
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, influencer) 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.
Note: “Influencer” is a “regular” person who has gained a following on a blog, a Twitter feed, or other social media medium.
Experimental Study of DTC Advertising Directed at Adolescents
Sponsors for several prescription drug classes market their products directly to adolescents, but research regarding how adolescents use risk and benefit information for health-related decisions is limited. Despite the lack of previous research specific to DTC drug marketing to adolescents, existing theoretical and empirical data make a strong case for treating adolescence as a unique life stage during which vulnerabilities that can affect informed decision-making must be taken into account. We 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.
Physician Interpretation of Information About Prescription Drugs in Scientific Publications vs. Promotional Pieces
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.
Study of Multiple Indications in Direct-to-Consumer Television Advertisements
A number of prescription drugs are approved for multiple indications. These indications can be similar in certain respects (e.g., diabetic peripheral neuropathy and fibromyalgia, which are both conditions that manifest in pain) or very different from one another (e.g., diabetic peripheral neuropathy and generalized anxiety disorder). If a drug is approved for multiple indications, sponsors choose whether to promote only one of those indications in DTC television advertising, or multiple indications in the same television ad. This study will provide preliminary information on whether consumers face challenges when multiple indications are promoted in a single television ad. The study also will explore whether similarity of the indications affects participants’ likelihood to recall and understand the indications, and whether its effect would be positive or negative. We plan to test three types of fictional DTC television ads – one that promotes a single indication, one that promotes an indication plus a similar indication, and one that promotes an indication plus a dissimilar indication – in two different medical conditions (diabetic peripheral neuropathy and rheumatoid arthritis).
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