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.
Animation in DTC Promotion
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.
Character-Space-Limited Online Prescription Drug Communications
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 In 2014, FDA released draft guidance, “Guidance for Industry Internet/Social Media Platforms with Character Space Limitations — Presenting Risk and Benefit Information for Prescription Drugs and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.
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.
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 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
Risk Information Amount and Location in Direct-to-Consumer Print Ads
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).
Utilization of Adequate Provision among Low to Non-Internet Users
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.
Disclosures of Descriptive Presentations in Professional Oncology Prescription Drug Promotion
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.