The United States Food and Drug Administration (FDA) recently published several notices that the Office of Prescription Drug Promotion (OPDP) was proposing new research related to the direct-to-consumer (DTC) promotion of medicines by pharmaceutical companies.
The mission of OPDP is to protect public health by helping to ensure that prescription drug promotional material is truthful, balanced, and accurately communicated. Toward that end, OPDP consistently conducts research to evaluate various aspects of prescription drug promotion, focusing specifically on three main topic areas: advertising features (including content and format), target populations, and research quality.
Endorser Status and Actual Use in Direct-to-Consumer Television Ads
While OPDP previously conducted one study to determine whether commercials or television advertisements with individual endorsements are effective, this study will focus specifically on television advertisements and the impact of the disclosure of payment in an ad by an endorser. According to OPDP, prior research has shown that endorsements by expert physicians and pharmacists were the most likely to lead to patient purchase intentions, followed by consumers and then celebrities.
This proposed research will extend the prior research by examining the endorser type (patient versus physician), the impact of actual use disclosures (utilizer, actor, none), and whether there is a difference of perception by age and/or education level.
Comments on this proposal are due November 22, 2022.
Perceptions of Prescription Drug Products with Medication Tracking Capabilities
There have been various approaches to support patients’ ability to adhere to taking their medications as prescribed, including pills with ingestible sensors, trained observers watching patients take medication, and a simple smartphone tracking app. Even still, OPDP estimates that only half of all patients with chronic health conditions take their medications as prescribed, which leads to as many as 100,000 preventable deaths and $100 billion in additional medical costs annually.
One avenue that prescription drug sponsors have started to explore to track medication use is to develop software that is distributed by (or on behalf of) the drug sponsor and accompanies the sponsor’s prescription drugs, also known as prescription drug use-related software.
However, OPDP believes that there is not much known about the perception patients and health care providers have about such prescription drug use-related software. To that end, OPDP will study situations in which a promotional communication conveys information about how to track the software use, and whether that may impact the perspective of the audience around risk and benefit.
Comments on this proposal are due November 22, 2022.
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 interpret the term ‘‘targeted’’ in prescription drug promotional materials. In that study, there appeared to be some congruence toward the impression that products with promotional materials using the term “targeted” were safer and more effective than other similar treatments.
OPDP is also currently conducting a nationally representative survey about 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).
Building upon this line of research, this 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 consumers and health care providers. Specifically, the proposed study will explore how varied targeted MoA presentations affect consumer and health care provider understanding of the MoA of a drug, perception of drug benefits and risks, attention to risk information, and interest in the drug.
Comments on this proposal were due by October 24, 2022.
Additional Information
A complete list of current research underway by OPDP can be found here.