FDA wants to know how much of the information presented in television advertisements consumers understandGem, and how much more information they could handle. In an effort to answer these questions, FDA has announced plans to conduct research testing consumers’ understanding of the quantitative information in direct-to-consumer (DTC) television ads about prescription drugs.
A previous study conducted by FDA found that “simple quantitative information could be conveyed in DTC television ads in ways that increased consumer's knowledge about the drug.” However the study only tested simple information and drug information can be extremely complicated. The Agency has designed two studies (described below) to answer the question of “whether consumers can use more complicated information when assessing prescription drug information in television DTC ads.”
Both studies will be conducted in an attempt to build on the Agency’s previous research by:
- “Examining more complicated quantitative information,
- Examining quantitative information for both benefits and risks, and
- Examining how visuals designed to represent efficacy interact with quantitative information.”
Study 1:
FDA will conduct an experiment to examine “the presence and complexity of quantitative benefit and risk information in DTC television ads.” The Agency hypothesizes that by replicating previously conducted studies and adding information about the benefits and risks, consumers understanding of the information and product(s) could increase.
The study 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.”
Study 2:
FDA will also study “the presence of quantitative benefit information and how the ad visually represents efficacy.” The Agency’s hypothesis is that “overstated images of improvement will lead consumers to overestimate the drug's efficacy; however, adding a quantitative claim may moderate this effect.”
FDA will complete the study through the conduct of “inferential statistical tests such as analysis of variance (ANOVA). With the sample sizes described below, we will have sufficient power to detect small- to medium-sized effects in each study”
The study participants will consist of individuals 60 years of age and older not working in healthcare or marketing. They will be randomly assigned to one of the two studies described above, and will be shown seven ads for a theoretical drug to treat cataracts. “The ads will be created and pretested to ensure that consumers perceive different levels of complexity across the ads in study one, and different levels of image accuracy in study two. After viewing the ad twice, participants will complete a questionnaire that assesses consumers' understanding of the drug information, their retention of the information, and their perceptions of the drug.” FDA says covariates such as demographics and numeracy will also be measured.
FDA is asking for public comment on the two proposed studies. The comment period is open for 60 days following the Agency’s announcement in the Federal Register (October 13, 2015). The comment period will close on December 12, 2015; so if you have any input to provide, make sure you get it to FDA soon. (View the Agency's full announcement here.)
ProPharma has significant expertise in working through advertising compliance issues. To discuss this or any other FDA-related matter, contact us today.
