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Why Schering-Plough's Nasonex Bee Is to Blame for FDA's New Drug Ad Rules

The FDA's new proposed guidelines on drug advertising read like a full-employment act for medical copywriters and graphic designers: they control font size, white space, context, contrast, placement, background and the use of sections in ads.

Overall, they require companies to produce materials that are more comprehensible to the "reasonable consumer;" that are more overt about risks; and warn that the FDA will judge them by their "net impression" "as a whole," not simply whether they are technically accurate.

One person who will smile when reading the new guidelines is Ruth Day of Duke University. Back in 2005, she presented to the FDA a study showing that when drug ads listed benefits, the images on the screen matched the voiceover and moved slowly. But when side effects were listed, the images often became mis-matched to the voiceover and moved much faster or were more distracting. Day's infamous example was of Schering-Plough's Nasonex ads, featuring a talking bee voiced by Antonio Banderas. Day counted the wing-flaps of the bee and found they fluttered faster during side effect information that during benefit information. The result was that viewers found it more difficult to remember the side effects than the benefits. You can see Day's original presentation here.

Day's ideas seem to have been written wholesale into the new guidelines. The FDA gives an example:

... [an] audio presentation is accompanied by quick scene changes showing comforting visual images of patients benefiting from the drug. It is also accompanied by loud, upbeat music. In this case, the audio disclosure may not adequately communicate risks because of the accompanying discordant visuals and distracting music.
Those of you who pay attention to pharma blogs may remember that in 2007 I suggested that Day's study should be No. 1 on a list of FDA reforms for drug advertising. Others ridiculed this idea, including Pharma Marketing Blog's John Mack, who produced this graphic of the bee and Ruth Day. Lo and behold, four years later, the Day thesis is No. 1 in FDA's examples of misleading advertising, right there on page 5 of the "Policy Overview" section.

Mighty regs from little Powerpoints grow ...

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