DTC Print Ads Need Consumer-Friendly Fair Balance Information

The FDA recently published revised draft guidance on "Brief Summary: Disclosing Risk Information in Consumer-Directed Print Advertisements." (see "Disclosing Risk in DTC Print Ads: Introducing the 'Consumer Brief Summary'").

The brief summary is the part of direct-to-consumer (DTC) ads that conveys detailed risk information. Typically, this information appears on the back side of the print ad and is sometimes written in small type.

In the original guidance published in 2004, FDA suggested a "less is more" approach (see “FDA Draft Guidance for Print DTCA: Less than Feared”). At that time, FDA said it "believes that exhaustive lists of minor risks detract from and make it difficult to comprehend and retain information on the more important risks." In the revised guidance, FDA suggests specific, more readable formats for the brief summary. As shown in the example below, some DTC print ads have already used these formats in the brief summary section of the ad.

What no one is talking about, however, is the "fair balance" section of the ad. Let's look at a typical Rx drug print ad.

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