The agency announced three proposed studies on how people view direct-to-consumer advertising, as it continues to assess factors that influence assessments of risks and benefits in a bid to ensure its regulations adequately protect public health.
As it announced its first proposed study this month, the FDA said it is interested in studying whether consumers who view the same drug ad several times perceive the safety or efficacy of the advertised drug differently than those who view it only once. The FDA said that perceptual and cognitive effects of increased ad exposure frequency have been studied extensively using nondrug ads, and that it has generally been argued that first exposure to an ad causes attention, while second exposure leads to the learning of the advertised message, and third and subsequent exposures strengthen the learning effects of the second exposure. For example, one study showed that a commercial message repeated twice results in better recall than a message broadcasted only once, while another study found that ads viewed multiple times “improve product attitudes and recall for product attributes.”
For regulators, that information could lead to some concerns since drug ads are meant to portray an accurate assessment of a product’s benefits and risks. The FDA’s standard that companies dedicate equal time, prominence and space to a drug’s benefits and risks stands in contrast to most consumer product ads, which solely focus on a product’s benefits. Because of this, coupled with that fact that research about ad exposure frequency doesn’t include prescription drug ads, the FDA is looking to test its hypothesis that consumers who view the same drug ad multiple times will have a slightly different view of the product each time.
In its notice announcing the study, the FDA appears to imply that if a consumer is bombarded with drug ads, he or she may eventually perceive the product as being safer than it actually is. The agency does note, however, that prominent risk information in drug ads may actually reduce the positive effects of repeated advertising. In the event that the FDA’s study showed that increased exposure to an ad improves consumers’ attitudes toward it, consumer advocates and regulators could consequently push for revised rules to reflect and address that.
The agency is also proposing a study of consumers who view drug ads on TV in a bid to evaluate spousal influence on how consumers understand the risks and benefits of drug products. The FDA said that while consumers are often considered individual targets for prescription drug ads – as though they are always shown DTC ads individually and thus make judgments about advertised products on their own – judgments related to prescription drugs represented in DTC ads are likely made in social contexts much of the time. Because social interactions can lead to unique reactions relative to people who view DTC prescription drug ads alone, the OPDP wants to look at differences between consumers viewing prescription drug ads with a spouse or partner as opposed to alone. The FDA said such outcomes have noteworthy public health implications.
The agency is also planning a study on how patients understand the risks and benefits of drug products. The FDA said research indicates that consumers struggle with the concepts of risk and efficacy, often overestimating drug efficacy. Because of this, the agency is proposing a study in the hope of understanding and accurately gauging how consumers are understanding information and how it affects decisions about prescription drugs.
While the FDA’s OPDP actively examines how direct-to-consumer advertising impacts consumer knowledge, perception measures have a tendency to vary by study. As a result, the FDA wants to create a “pool of reliable and valid measurement items for assessing consumers’ drug risk and benefit perceptions” in a way that’s consistent across studies. The regulator said the aim of the study is to create that pool of reliable measures and increase the rigor and efficiency of its research.