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.
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.
Examination of Secondary Claim Disclosures and Biosimilar Disclosures in Prescription Drug Promotional Materials
The purpose of this research was 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 examined 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 also examined the effect of the presence of a comparative claim about the secondary claim. We examined 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 assessed the influence of a disclosure designating the product as a biosimilar as well as varying basic factual statements about biosimilars. In both consumer and HCP audiences, we examined 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.
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.
Medical Conference Attendees’ Observations about Prescription Drug Promotion
The current study focused 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 asked 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 also embedded an experimental manipulation into the survey, whereby participants watched a video that mimicked a pharmaceutical representative/HCP interaction, and varied 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 were recruited from 12 medical conferences over the course of one year.
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 was 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 were recruited to view one of a number of websites for a fictitious diabetes drug and asked to answer questions about it.
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).
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.