FDA to Study Effects of Complicated Drug Information in DTC TV Ads
The FDA is planning two surveys of 900 adults each to assess the effect of including more complicated information about prescription drugs in direct-to-consumer television advertisements.
In the first survey, participants would be randomly assigned to watch ads for a fictitious drug to treat cataracts that include different levels of complex quantitative risk and benefit information. After viewing the ad twice, participants would complete a questionnaire assessing how well they understood the drug information, whether they retained it and their perceptions of the drug.
The goal is to see if adding complex information has the same positive impact as simple quantitative information on risks and benefits, or whether it is too much for consumers to process, the FDA says.
The second survey would look at how well the ads visually represent efficacy, using different levels of imagery, and whether exaggerated images of patient improvement lead consumers to overestimate the drug’s benefits.
Both surveys would include only people 60 years of age or older—an age group that might care about the fictitious study drug and pay attention to the ad, the agency says.
The proposed surveys bring to seven the number of DTC ad assessments the FDA has announced since early 2014. The others include how hearing and aging affect TV ad comprehension, how spouses influence their partners’ perception of ads and how frequency of exposure affects perception of risks and benefits.
Comments on the proposed study are due by Dec. 11. View the Federal Register notice at www.fdanews.com/10-12-15-DTCQuantitative.pdf. — Kellen Owings