Analysis of the risk and benefit information presented in broadcast direct-to-consumer advertising

Abstract

The Food and Drug Administration (FDA) mandates that prescription drug advertisements cannot be false or misleading in any particular, must reveal material facts about the product being promoted, including facts about the consequences that can result from use of the product as suggested in the promotional piece and should present information about effectiveness and information about risk in a balanced manner.4,11 This study evaluates the a sampling of the current broadcast Direct-to-Consumer Advertising with the newly released FDA guidance document titled Presenting Risk Information in Prescription Drug and Medical Device Promotion. DRAFT GUIDANCE May 2009. The fair balance presentation of risk and benefit information within a cross section of drug advertisements was examined during two national nightly network television news broadcasts from May 25, 2009 to June 25, 2009.