FDA STUDYING PRESENTATION OF RISK INFORMATION IN DTC ADVERTISING

The FDA will conduct two studies to investigate how the context and format of risk information in direct-to-consumer (DTC) print advertisements influence consumers' understanding of drug risks.

To comply with FDA regulations, sponsors often simply reprint the risk-related sections of their drugs' labeling in DTC advertisements. However, this labeling is written for health professionals, and consumers may have difficulty understanding the terminology, the agency said. In addition, the information is often printed in very small type.

Some research suggests describing a smaller number of minor side effects may improve consumer understanding of a drug's risk-benefit trade-off more than a long list from the labeling, the FDA said. The agency's proposed studies will investigate the best format to make risk information clear to consumers.

One study will examine the best supporting context to present with risk information, the FDA said. The context study will test whether different types of information about minor side effects influence consumers' understanding of major side effects and risks.

The other study will examine whether alternative formats influence consumers' understanding of major risks, behavioral intentions and self-efficacy. It will also determine which format consumers prefer. The study will compare a patient package insert, a highlights format and a format based on labeling used for OTC drugs, the agency said.

The FDA added that it wants 900 respondents for the content study and 300 for the format study.

The agency will also look at different ways to communicate risk information to consumers who have difficulty reading, such as providing a toll-free telephone number they can call for information.

The agency's notice about the two studies can be viewed at www.fda.gov/OHRMS/DOCKETS/98fr/06n-0133-n000002.pdf ( http://www.fda.gov/OHRMS/DOCKETS/98fr/06n-0133-n000002.pdf ).

( http://www.fdanews.com/did/6_52/ )