FDA to Study Drug Risk Information in DTC Print Ads
The US Food and Drug Administration (FDA) said Monday it plans to conduct an experimental study on consumer impact from the amount and placement of risk information in prescription drug ads.Sponsors tend to include risk information in both the “Important Safety Information” (ISI) section in direct-to-consumer (DTC) print ads and in a consumer brief summary, according to FDA.
“Including risks in both the ISI and the brief summary may have advantages,” FDA said, citing research that showed “repetition of information improves recalls, especially for older adults.” Yet based on a 2002 FDA survey, “it is possible that risks appearing on the main page in the ISI may be more likely to be read than risks appearing in the brief summary.”
Consumers’ perception of risk is reportedly heightened when presented a limited amount of information in DTC ads, according to a study published last year in Nature Human Behavior.
As part of the design of FDA’s new study, the Office of Prescription Drug Promotion (OPDP) will compare short and long ISI sections and examine the presence of a separate brief summary among patients who self-identify as having overactive bladder or rheumatoid arthritis.
The research consists of a 40-participant pilot study and two main studies involving 400 voluntary participants. Using eye-tracking technology to monitor visual reactions to ISIs, brief summaries as well as indication and benefit claims, OPDP intends to conduct the in-person studies across five cities: Chicago, Tampa, Phoenix, Houston and Marlton, NJ.
OPDP has launched a number of similar studies in recent years to bridge gaps in FDA research for regulating prescription drug advertising. These include studies on deceptive drug advertising, market claims in DTC print ads, and quantitative information in DTC TV ads. Last week, the office also released a revised study design for investigating the effectiveness of disclosures.
Further, an OPDP study on DTC drug promotion on mobile devices last year found that drugmakers typically displayed benefits rather than risk information. The study authors concluded that the results have “implications for compliance with FDA fair balance regulations.”
FDA