FDA Proposes Study of DTC Advertising

August 23, 2007
Patricia Van Arnum
ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Food and Drug Administration is seeking public comments on a study designed to investigate the impact of visual distraction and the interplay of different sensory modalities (e.g., verbal, visual) used to present risk and benefit information during a television prescription drug advertisement.

Rockville, MD (Aug. 22)-The US Food and Drug Administration is seeking public comments on a study designed to investigate the impact of visual distraction and the interplay of different sensory modalities (e.g., verbal, visual) used to present risk and benefit information during a television prescription drug advertisement.

Data from this study will provide useful information to help improve how broadcast ads present a prescription drug's risks and benefits. Notice of the study was published in Federal Register 72 (162), 47051–47053 (August, 22, 2007) and may be found here.

The purpose of the proposed study is, in part, to determine whether the use of competing, compelling visual information about potential drug benefitsinterferes with viewers’ processing and comprehension of risk information about drugs in direct-to-consumer (DTC) advertising or with their cognitive representations of the drugs, according to the notice. “Positive visual images could influence the processing of risk-related information and the final representation of the advertised drug in multiple ways,” says the notice.

Both healthcare providers and consumers have expressed concerns to FDA about the effectiveness of its regulation of manufacturers’ DTC prescription drug advertising, especially as it relates to assuring balanced communication of risks compared with benefits, specified the notice. One characteristic of DTC television broadcast ads is the use of compelling visuals. Many assert that the visuals present during the product risk presentation are virtually always positive in tone and often depict product benefits. A consistently raised question is whether advertising visuals of benefits interferes with consumers' understanding and processing of the risk information in the ad’s audio or text.

Comments are due by Oct. 22, 2007.