FDA Plans Study of Risk Information in Direct-to-Consumer Print Ads

The FDA submitted a notice to OMB on a proposed plan to collect risk information from direct-to-consumer (DTC) print ads to analyze the effect of placement location on the reader’s ability to recall risk information.

The agency is concerned that risk information that appears on the main page of the important safety information — the main section of the advertisement where risks are listed — may be more likely to be read than risks that are listed in the ad’s separate brief summary page.

“Based on FDA survey research, about 27 percent of consumers surveyed in 2002 reported reading half or more of the brief summary in DTC print ads,” the agency said. “In comparison, when asked how much of the ‘main’ ad they read, about 78 percent reported reading ‘all’ or ‘almost all’ of the main body portion of the ad.”

The in-person study will consist of an hour-long 40-person pilot study, in addition to two hour-long studies with 200 voluntary participants each.