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.
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 In 2014, FDA released draft guidance, “Guidance for Industry Internet/Social Media Platforms with Character Space Limitations — Presenting Risk and Benefit Information for Prescription Drugs and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.
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.
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 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.