OPDP’s research team is involved in many ongoing research projects. These studies will inform our understanding of important issues related to prescription drug promotion.
Before research is fielded, the public has the opportunity to offer feedback on OPDP research through the public comment process. We appreciate and consider all comments which seek to assist us in improving the quality of our research. If you would like to contribute your comments, check the Federal Register for OPDP research projects by going to www.regulations.gov . The research team can also be reached directly by email at DTCresearch@fda.hhs.gov
Additional information about select research in progress along with links to appropriate Federal Register notices is available below.
The present research involves assessment of how consumers and primary care physicians (PCPs) interpret terms and phrases commonly used in prescription drug promotion as well as those used to describe prescription drug promotion. This includes both what these terms and phrases mean to each population (e.g., definitions) and what these terms and phrases imply (e.g., about efficacy and safety). Some examples of interest include: “natural” or “naturally-occurring,” and “targeted” or “targeted therapy.” The full list for assessment will include approximately 30 terms and phrases for each population. To accommodate such a large number, presented terms and phrases will be accompanied by only limited context (terms within sentences and phrases within paragraphs, as opposed to full promotional materials). Understanding the most prevalent interpretations of these terms and phrases can help OPDP determine the impact of specific language in prescription drug promotion. For example, certain terms and phrases, when used without additional contextual information, might overstate the efficacy or minimize the risk of a product. Additionally, from a health literacy perspective, it is helpful to ascertain general understanding of such terms and phrases as this may aid in the development of best practices around communicating these concepts.
We plan to conduct this research in two phases. First, we will conduct formative semi-structured interviews with 30 members of each population (general population consumers and PCPs). Second, we will conduct nationally representative, probability-based surveys of more than 1,000 members of each population on the same topic.
In the course of promoting their products, pharmaceutical sponsors (sponsors) may present a variety of information including the indication, details about the administration of the product, efficacy information, and clinical trial data. In an effort to present often complicated information concisely, sponsors may not include relevant information in the body of the text or visual display of the claim. Additionally, sponsors may not always present limitations to the claim in the main body of the text or display. In these cases, sponsors typically include disclosures of information somewhere in the promotional piece. This research is designed to examine how effectively healthcare professionals and consumers are able to use these disclosures to appropriately qualify the claims presented in the display or claim.
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?
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.
Examination of Secondary Claim Disclosures and Biosimilar Disclosures in Prescription Drug Promotional Materials
The purpose of this research is to build on prior FDA research on the topic of disclosures by examining the impact of disclosures of two different types of information. Phase 1 of the proposed research will examine the impact of adding a disclosure about a secondary claim in direct-to-consumer (DTC) and healthcare provider (HCP)-directed promotion in the context of a prescription drug website. We will also examine the effect of the presence of a comparative claim about the secondary claim. We will examine four levels of secondary claim disclosure to explore the effects of disclosing that the secondary benefit is not one of the indicated uses of the product (e.g., not a treatment for [the secondary benefit claim], quantitative information about claim, not a treatment for [claim] and quantitative information about claim, or no disclosure), and two levels (presence or absence) of a comparative element regarding the secondary claim, for a total of eight experimental conditions. In Phase 2 we will assess the impact of a disclosure designating the product as a biosimilar as well as varying basic factual statements about biosimilars. In both consumer and HCP audiences, will examine the impact of: (1) Adding a disclosure designating the product as a biosimilar; (2) adding general informational statements about biosimilars; and (3) naming a reference product.
Pursuant to section 506(c) of the FD&C Act and 21 CFR part 314, subpart H (or 21 CFR part 601, subpart E for biological products), FDA may grant accelerated approval to a drug product under section 505(c) of the FD&C Act or a biological product under section 351(a) of the Public Health Service Act. This pathway enables faster approval of prescription drugs intended to treat serious or life-threatening illnesses. Accelerated approval may be based on a determination that a drug product has an effect on a surrogate endpoint (for example, a blood test result) that is reasonably likely to predict clinical benefit, or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit (i.e., an intermediate clinical endpoint). Under FDA’s regulations governing physician labeling for prescription drugs, the INDICATIONS AND USAGE section of the FDA-approved prescribing information (PI) for a drug approved under accelerated approval must include “a succinct description of the limitations of usefulness of the drug and any uncertainty about anticipated clinical benefits, with reference to the ‘Clinical Studies’ section for a discussion of the available evidence.” 21 CFR 201.57(c)(2)(i)(B). This study will examine the presence, wording, and prominence of a disclosure communicating information related to the drug’s accelerated approval in direct-to-consumer (DTC) promotional materials.
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 Disclosures to Health Care Providers Regarding Data That Do Not Support Unapproved Use of an Approved Prescription Drug
Pharmaceutical firms sometimes choose to disseminate publications to health care providers (HCPs) that include data that appear to support an unapproved use of an approved product. At the same time, published data that are not supportive of that unapproved use may also exist. For example, unsupportive published information could describe an increased risk of negative outcomes (e.g., death, relapse) from the unapproved use of the approved product, suggesting that the unapproved use does not have a positive benefit-risk ratio. The purpose of this research is to examine HCPs' perceptions and behavioral intentions about an unapproved new use of an approved prescription drug when made aware of other data that are not supportive of the unapproved use. Five approaches will be examined: (1) The provision of the unsupportive data in the form of a representative publication; (2) a disclosure summarizing the unsupportive data and including a citation to the representative publication; (3) a disclosure that does not include a summary of the unsupportive data but does acknowledge that unsupportive data exist and includes a citation to the representative publication; (4) a general disclosure that unsupportive data may exist, without conceding that such data do exist; or (5) nothing—the absence of any presentation of unsupportive data or any disclosure about such data (control condition).
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).
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.
In 2014, OPDP conducted focus groups designed to provide insights on how consumers and healthcare providers (HCPs), including physicians, nurse practitioners, and physician assistants, interpret the term “targeted” in prescription drug promotional materials. Although diverse views were voiced, there appeared to be some tendency toward the impression that products with promotional materials using this term would be safer and more effective than other similar treatments. OPDP is also now conducting a nationally representative survey regarding the ways in which consumers and primary care physicians interpret terms and phrases commonly used in prescription drug promotional materials, including assessment of impressions of the terms “targeted” and “targeted mechanism of action” (targeted MoA) (86 FR 24867). Building upon this line of research, the proposed study will investigate the influence of targeted MoA claims, graphics, and disclosures that provide context about a drug’s targeted MoA, utilizing an experimental design with both consumer and HCP samples. The experimental approach described here is intended to complement and augment the prior research by facilitating assessment of causality. Specifically, the study will explore how varied targeted MoA presentations affect consumer and HCP understanding of the MoA of a drug, perception of drug benefits and risks, attention to risk information, and interest in the drug.
- Federal Register Notice: 60-day FRN
As part of the prescription drug regulatory review 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 OPDP. OPDP reviews names to assess for alignment with the FD&C Act, which provides, among other things, that labeling can misbrand a product if false or misleading representations are made (see 21 U.S.C. 321(n) and 352(a)). A proprietary name that appears in labeling could result in such misbranding if it is false or misleading. OPDP reviews, among other things, whether names (1) overstate the efficacy or safety of the drug, (2) suggest drug indications that are not accurate, (3) suggest superiority without substantiation, or (4) are of a fanciful nature that misleadingly implies unique effectiveness or composition. It would be helpful in OPDP’s review of promotional implications of proprietary names for data on consumer and prescriber interpretations of proposed proprietary names to be more readily available for consideration. The proposed research will utilize text analysis (e.g., topic modeling and sentiment analysis) to ascertain how consumer and primary care physician populations interpret prescription drug names, which will assist OPDP’s consideration of promotional implications.
- Federal Register Notice: 60-day FRN
The current study focuses on the landscape of healthcare provider (HCP)-directed promotion of prescription drugs at medical conferences in general and, more specifically, at pharmaceutical promotional booths. We will ask attendees who are prescribers within different disciplines (primary care physicians, specialists, nurse practitioners, and physician assistants) general questions about their attendance at medical conferences, including questions about their motivations for attending, activities they participate in (e.g., symposia, poster sessions, social events, exhibit halls), and their opinions about the prescription drug treatments promoted at medical conferences. We will also embed an experimental manipulation into the survey, whereby participants watch a video that mimics a pharmaceutical representative/HCP interaction, and varies in the professional expertise of the pharmaceutical representative (medical vs. business) and whether or not the discussion includes a disclosure of important limitations. Approximately 350 HCPs will be recruited from 12 medical conferences over the course of one year. The entire online survey, including the experiment, will take approximately 20 minutes.
- Federal Register Notices: 60-day, 30-day