- The Food and Drug Administration plans to launch a new study that will study consumers’ perceptions of risk information in direct-to-consumer (DTC) ads.
- The agency filed a request for comment in the federal register for the study, which aims to enroll 120 subjects in a pilot experiment and 400 participants across 5 different U.S. cities in two main experiments.
- The FDA's Office of Prescription Drug Promotion wants to investigate whether the lengthy lists of side effects, risks and warnings that come standard on drug ads could potentially overwhelm consumers and actually lessen attention to safety warnings.
DTC advertising, a staple of pharmaceutical marketing in the U.S., has always been controversial. As industry gets more sophisticated, however, the FDA is taking a closer look at whether the regulations governing how drugs' safety and efficacy is presented are actually working.
In March of last year, for example, the FDA launched a study to assess whether animation in DTC ads influences consumer behavior. A number of high-profile ad campaigns in recent years have featured cartoon characters to advertise for conditions that are more difficult to talk about, such as Valeant Pharmaceutical's "gut guy" for its irritable bowel syndrome drug Xifaxan (rifaximin).
The new FDA study will delve into the effects of repeating the same warnings in the Important Safety Information (ISI) and the brief summary page of DTC drug ads. While some research has found that repetition of information can improve consumer recall, researchers have also cautioned that "overwarning" may cause consumers to discount all risks or gloss over the most important risk information. When consumers see the same warning about risks repeatedly, they may just stop paying attention to the information.
The FDA study will use eye tracking technology to monitor the perceptions of consumers about risks presented in the ISI and summary page of two DTC print ads — one an ad for a fictitious drug that treats rheumatoid arthritis and the other an ad for a fictitious drug treatment of overactive bladder.
The participants in the study will all self-identify as having the condition mentioned in the ads. The eye tracking technology will allow researchers to detect and measure where a participant looks while viewing a print ad, and for how long. The pattern of the subjects’ eye movements may also indicate attention to and processing of information in the ads, according to the FDA.
The consumers will be given 60 minutes to read the ads in the two main experiments. Participants in the experiments will also complete a questionnaire that assesses risk perception, risk recall, efficacy perceptions, efficacy recall and demographic and health literacy information. In the pilot study, the subjects will answer questions as part of a debriefing interview to assess the FDA study design and study questionnaire.