As almost every advertisement on television seems like another direct-to-consumer (DTC) pharmaceutical ad, the US Food and Drug Administration (FDA) is now trying to understand if consumers can handle more information about the drugs in the ads.
The agency is calling for public comment on two studies it's planning to run to see whether consumers, particularly those over 60, can understand more complicated benefit/risk information and images in DTC television ads.
The research comes as a previous FDA study found that simple quantitative information could be conveyed in DTC television ads in ways that increased consumer's knowledge about the drug. However, this research only tested simple information (e.g., one clinical trial, comparison to placebo), whereas other information can be more complicated (e.g., complicated endpoints, multiple study arms).
In one new study, FDA plans to examine the presence and complexity of quantitative benefit and risk information in DTC television ads.
"We hypothesize that, replicating past studies, adding simple quantitative information about benefits and risks will lead to increased understanding among consumers. We will test whether adding complex quantitative information results in the same outcomes as simple quantitative information or whether it is too much quantitative information for consumers to process," FDA said in the Federal Register Friday.
In another study, FDA plans to examine the presence of quantitative benefit information and how the ad visually represents efficacy with various types of images that accurately reflect the improvement in health expected with treatment, or images that overstate the improvement in health that could be expected with treatment.
FDA hypothesizes that overstated images of improvement will lead consumers to overestimate a drug's efficacy, though it wonders if the addition of a quantitative claim may moderate that effect.
In both studies, participants, who will all be 60 years of age or older and not working in the fields of health care or marketing, will be randomly assigned to one experimental condition and view seven ads for a fictitious drug to treat cataracts. The ads will be pretested to ensure that consumers perceive different levels of complexity in the first study, and different levels of image accuracy in the second.
"We selected a sample of participants 60 years and older to increase the likelihood that participants will be interested in the fictitious study drug and therefore motivated to pay attention to the ad during the study. The studies will be conducted with an Internet panel," FDA said.
After viewing the ad twice, participants will complete a questionnaire that assesses their understanding, retention and perception of the drug information.
The studies come as back in 2014, FDA initiated research to understand the potential impact of limiting the number of risks included in a DTC television ad. Currently, companies are required to present the benefits and risks of a drug using a "fair balance" approach that gives equal weight to both.
In addition, FDA is studying whether consumers who view the same drug ad multiple times perceive the safety or efficacy of the advertised drug differently than those who view it only once.