Consumer-Facing Promotion Should Use Quantitative Information, FDA Guidance Says

When communicating about the efficacy and risks of prescription and OTC drugs directly to consumers, quantitative information “can improve consumers’ accuracy in estimating the drug’s benefits and risks” and should be “accurate and understandable” says the FDA in a final guidance issued Tuesday.

Quantitative information is better than qualitative, the FDA says in the 15-page document “Presenting Quantitative Efficacy and Risk Information in Direct-to Consumer (DTC) Promotional Labeling and Advertisements.” Research suggests that “consumers can recall and comprehend efficacy and risk information” better than qualitative descriptions because consumers “differ in their interpretations of qualitative descriptors (e.g., rare, common, most),” the guidance says.

The guidance presents examples of recommended approaches, addressing specific concepts described in the guidance — information about the control group, probability of success/side effects, how to format numbers and visual aids such as tables and graphs.

Read the final guidance here.

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