The Science Of Advertising Regulation: DDMAC Studies In Progress

The Science Of Advertising Regulation: DDMAC Studies In Progress

FDA's Division of Drug Marketing, Advertising and Communications has several ongoing studies looking at how advertisements should be formatted. Below is a list of projects highlighted by DDMAC officials during a recent presentation.

Brief Summary in Print Ads

FDA has completed one study - investigating the current brief summary format - and expects to release the results of two more - testing different ways of presenting side effect information and different formats in general - by the end of the summer.

Distraction in TV Ads

The distraction study will begin after review by the White House Office of Management and Budget has been completed. Major goals of the study are to examine:

• How does the use of competing or compelling visual information affect viewers' understanding of risk information?

• What is the role of textual elements in the processing of risk information?

• How can the presentation of the major statement be "clear, conspicuous, and neutral"? FDAAA requires that term to be defined in regulation ('The Pink Sheet,' May 5, 2008, p. 27).

Toll-Free Number Statement in TV Ads

This study is required by FDAAA, which also mandated that print DTC carry a toll-free number that consumers can use to report adverse events to FDA. Congress was concerned that including the number in TV ads might be counterproductive because of the limited amount of time available to communicate information, and asked FDA to study whether it should be required. Although the agency discussed the topic with the Risk Communications Advisory Committee last year ('The Pink Sheet,' May 26, 2008, p. 19), the study has been a little slow to get under way; FDA received public comments and is preparing to submit it for OMB review.