OPDP Considers Potential Misleading Implications of Television Ads

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Recently, the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) research team published a study, “Disease Awareness and Prescription Drug Communications on Television: Evidence for Conflation and Misleading Product Impressions.” In conducting the study, the team considered the conflation of disease state and prescription drug risks and benefits via television and whether it resulted in misleading implications of safety or efficacy when compared to the product’s prescribing information (PI) and information/data consistent with the FDA-approved PI.

Researchers examined how the perceptual similarity and temporal proximity between disease awareness communications and prescription drug promotions on television may impact viewer understanding. The findings showed a tendency for consumers to conflate the information presented, imputing benefits to a drug based on claims made in the separate disease awareness ad.

In conducting the study, the researchers performed two experiments that tested for conflation of fictitious disease awareness and prescription drug promotional communications in a television advertising context and whether similarity, proximity, and number of exposures to the disease awareness communication contributed to the conflation. In both studies, the promoted product was indicated to treat asthma and study participants were adults who experienced asthma or asthma symptoms. The ads were designed with different levels of similarity in terms of visual elements, such as colors, logos, and characters. Study 1 involved a 1 hour television segment while Study 2 used a longitudinal design with1-hourcipants exposed to communications over time. After viewing the ads, participants were asked about their impressions of the drug’s benefits, risks, and approval status.

In Study 1, researchers found that just the mere exposure to disease awareness communication prompted benefit and risk conflation, irrespective of degree of similarity or proximity. In Study 2, similar ads prompted greater conflation of benefits than distinct ads, and greater conflation of risks occurred with greater proximity to disease awareness and promotional communications. Asthma knowledge, health literacy, and perceived ad effectiveness increased conflation of benefits in both studies did not tend to impact similarity or proximity.

The researchers concluded that the findings point to the potential for disease awareness communications to confuse consumers regarding the risks and benefits of using a particular prescription drug.

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