FDA weighs brief summary format redesignThe FDA is looking at shifting to a brief summary format more like that of the “Drug Facts” design used for OTC products, based on a study showing that it led to higher risk comprehension.
The agency's Division of Drug Marketing, Advertising and Communications tested ads for a bogus weight-loss drug, Oncazil, carrying risk info in four different brief summary formats on 300 mall-goers 18 and over who said doctors had told them they were overweight and needed to lose 15 pounds. The drug facts format was the clear winner, both in terms of comprehension and “self-efficacy,” of sense of mastery of the information. The runners-up, in order, were: a Q&A format, with headings framed as questions; a “Highlights” format based on the summary section of the professional labeling; and finally, a “Traditional” format, basically the risk info from the PI rendered into plainer language.
Unchanged from format to format were behavioral intention, risk/benefit tradeoff, log time on the display page and log time on the brief summary.
The agency introduced the drug facts format for OTC products in 1999. More recently, in 2006, DDMAC green-lighted the highlights format for professional labeling.
“Because physicians responded favorably to it, we chose to test a similar version in our examination of non-physicians,” said the study's authors. “It appears that this format, rated favorably by physicians, may not work well when applied to the brief summary setting.” The drug facts format, by contrast, was designed based on consumer research, and may have been more intuitive to viewers given their familiarity with it, the authors wrote.
On the downside, the drug facts format had the smallest word count of the four. It was not clear, they noted, whether improved comprehension was due to fewer words or to other features, such as the box.
“Although there is some support for the drug facts format specifically, the results do not lead unequivocally to this format,” they concluded. “The results do demonstrate that improvement over the traditional brief summary format is possible and suggest that future research explore these other formats, particularly the drug facts format.”
The study appears in the online edition of Medical Decision Making. All three studies were led by FDA researchers Kathryn Aikin, Amie O'Donoghue and Helen Sullivan, along with American University's Jack Swasy (all are PhDs).
The agency has conducted two more studies, the first adding a serious risk to the first and second page of the ad, and the second including additional information about side effects on the second page.