Research in Progress | Office of Prescription Drug Promotion (OPDP) Research
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.
Adherence Potential and Patient Preference in Prescription Drug Promotion
This study builds on OPDP’s portfolio of research on market claims and disclosures to explore the influence of statements around patient adherence and preference in prescription drug promotion. It is not known how claims that appeal to the possibility for greater adherence or to social norms around what other patients or healthcare providers prefer influence behavioral intentions or risk, benefit, and adherence perceptions of a drug. A related question is whether including a disclosure stating the uncertainty around such claims (e.g., there is no conclusive research on whether DRUG A results in better adherence) can mitigate any misleading perceptions or influence preferences. Some evidence suggests that disclosures in prescription drug promotion are typically noticed and may help consumers and healthcare providers understand information, but this topic has not been investigated in the context of adherence claims. To complete this research, we will show participants a website for a fictitious prescription drug product for type 2 diabetes. We will vary the website based on whether the fictitious prescription drug promotional communication includes a claim about implied adherence, patient preference, and/or a disclosure that there is no conclusive research on adherence. Recruitment will occur by email through an internet panel, and participant eligibility will be determined with a screener at the beginning of the online survey. Each participant will see one of eight versions of a consumer web page for a fictitious prescription diabetes treatment, as reflected by the 2 (implied adherence claim) x 2 (patient preference claim) x 2 (disclosure) design. They will answer a questionnaire designed to take no more than 20 minutes regarding benefit and risk perceptions, adherence perceptions, behavioral intentions, adherence claim retention, and patient preference claim retention.
Disclosures in Professional and Consumer Prescription Drug Promotion
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.
Dosage Form Presentations in Direct-to-Consumer Prescription Drug Television Advertisements
Prior research has demonstrated that patients tend to prefer certain medication dosage forms over others, such as oral medications over injectable medications. Cognizant of these patient preferences, prescription drug sponsors may choose to minimize the presentation of lesser preferred dosage forms in direct-to-consumer (DTC) prescription drug television advertisements. Whether such minimization occurs and any effects on consumer judgement and decision-making are currently unknown. In addition, it is currently unclear how best to present dosage form information generally in DTC television ads such that this information will be adequately processed and retained by consumers.
The proposed research will provide an assessment of the following:
- Common dosage form presentations in DTC television ads;
- Baseline consumer attitudes about dosage form presentations in DTC television ads; and
- Effects of dual modality and placement of dosage form information in DTC television ads.
More information
Endorser Status and Actual Use in Direct-to-Consumer Television Ads
The objective of the present research is to conduct experimental studies to examine issues related to endorsers in direct-to-consumer (DTC) prescription drug promotion. This study complements one that has recently been completed (FDA-2019-N-5900, OMB control number 0910-0894, Expiration Date: March 31, 2023). As that study examined a number of different endorser types in print or internet settings and focused on examining how various disclosures of the payment status of the endorser influenced audience reactions, this proposed research extends the prior research by examining actual-use disclosures and a different medium. The present research will specifically examine the influence of two independent variables--endorser type (patient, physician) and an actual-use disclosure (utilizer, actor, none)--in television advertisements. Dependent variables will include perceptions of the risks and benefits of the promoted prescription drug, attitudes toward and perceptions of the endorser, attention paid to the ad, and behavioral intentions. Because age and education level may affect perceptions of the ad, we plan to explore whether age and education level influence these effects.
This research will involve two studies. Studies 1 and 2 will use a 2 × 3 factorial design run concurrently and independently with a sample of consumers who have been diagnosed with diabetes (Study 1) or rheumatoid arthritis (Study 2), each watching a DTC television ad for a fictitious drug indicated to treat the corresponding medical conditions. The ad will be manipulated to assess the impact of two categories of commonly used industry spokespeople: a patient and a physician. We will test three actual-use disclosure conditions: (1) an actual-use disclosure that indicates that the endorser either uses or prescribes the prescription drug in real life (i.e., utilizer), (2) an actual-use disclosure that specifies the endorser is an actor, and (3) a control with no actual-use disclosure. Each participant will see one of six versions of a television ad for a fictitious prescription diabetes or rheumatoid arthritis treatment, and they will answer a questionnaire designed to take no more than 20 minutes.
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.
Experimental Study of an Accelerated Approval Disclosure
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.
Medical Conference Attendees’ Observations about Prescription Drug Promotion
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.
Perceptions of Prescription Drug Products with Medication Tracking Capabilities
Patient non-adherence to medication regimens is a challenge in health care. As attention to the public health issue of medication adherence has grown, OPDP has noted an increase in the number of claims and presentations in prescription drug promotion that focus on a product’s potential to improve adherence to treatment regimens. Many of these presentations include information about options available to help patients track their medication usage. The focus of the present study is to explore patient and health care provider perceptions of a fictitious prescription drug product that is accompanied by software that is intended to track medication use. Research questions include perceptions about the product’s risks and/or benefits (including its effect on medication adherence) when the promotion claims this tracking ability; and whether a disclosure that describes what is known about the effect of medication tracking on medication adherence has an influence on perceptions of the product’s risks and/or benefits (including its effect on medication adherence). Primary care physicians and consumers will be recruited to view one of a number of websites for a fictitious diabetes drug and asked to answer questions about it. We will use statistical methods such as analysis of variance to analyze the data.
Prescription Drug Promotion: State of the Literature and Consumer/HCP Perspectives on Emerging Topics
A significant amount of research pertinent to prescription drug promotion has now been conducted. As examples, the U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) has focused efforts on three main topic areas: advertising features, including content and format; target populations; and research quality. This research is presented on OPDP’s webpage, available at https://www.fda.gov/about-fda/center-drug-evaluation-andresearch-cder/office-prescription-drug-promotion-opdp-research. Outside of FDA, researchers at academic institutions and other organizations have pursued lines of inquiry relevant to prescription drug promotion as well. Given this now substantial research literature, it is an ideal time to consider and evaluate what is known about key topics concerning prescription drug promotion as well as to identify emerging topics and research gaps.
The objective of this research is to conduct a scoping review of the research literature on prescription drug promotion, with an emphasis on research completed within the last decade (2011-2021); and additionally conduct remote, semi-structured interviews with consumers and healthcare providers to probe on emerging topics identified in the scoping literature review.
More information
- A Scoping Review of Empirical Research on Prescription Drug Promotion
- OMB generic information collection control number: 0910-0695
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 Survey on Quantitative Claims in Direct-to-Consumer Prescription Drug Advertising
Direct-to-consumer (DTC) prescription drug advertising may make quantitative claims about the drug's efficacy or risks. Although there is research and FDA guidance (“Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements,” available at https://www.fda.gov/media/117573/download) that provides general guidelines for how to present quantitative information, it is not fully understood how consumers will interpret specific quantitative claims. We conducted a literature review and found that while some types of quantitative information are well-studied (e.g., relative frequencies), many questions remain on how best to communicate certain quantitative information about prescription drugs. For example, we do not have sufficient information about how consumers interpret different claims describing medians (e.g., “People treated with Drug X lived for a median of 8 months” alone or in combination with a definition such as “In people receiving Drug X, this means that about half lived more than 8 months and about half lived less than 8 months” or “A median is the middle number in a group of numbers ordered from smallest to largest”). This study aims to survey U.S. adults about their interpretation of specific quantitative claims.
- Federal Register Notice: 60-day
Targeted Mechanism of Action Presentations in Prescription Drug Promotion
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.
Text Analysis of Proprietary Drug Name Interpretations
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 present 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.
Tradeoff Analysis of Prescription Drug Product Claims in Direct-to-Consumer and Healthcare Provider Promotion
When confronted with an important decision, people tend to make choices that reflect a series of tradeoffs between certain desirable and undesirable attributes of a product, service, or experience. The treatment preferences of diagnosed consumers and treating physicians have been shown to be influenced by certain characteristics, such as the perceived drug’s impact on quality of life, complexity of dosage regimens, mode of administration, cost to family and self, and marketing claims unrelated to medicinal properties. Although diagnosed consumers may weigh the risks, benefits, or other salient characteristics of prescription drug products differently than physicians, little research directly compares the treatment preferences of these two groups. Understanding the tradeoffs among drug product characteristics diagnosed consumers make--and how the tradeoffs could potentially differ from the tradeoffs made by physicians--will provide valuable insight into the relevance and impact of various product attributes and promotional claims on informed choices and treatment decisions. The proposed research will use conjoint analysis techniques to examine the relative importance of prescription drug product information such as prescription drug efficacy, risk, adherence, and patient preference claims in two medical conditions (type 2 diabetes and psoriasis) in consumer and physician samples.