On October 17, 2018, FDA issued draft guidance on Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements. The guidance outlines recommended approaches for how to make Direct-to-Consumer (DTC) language and presentation more consumer-friendly, providing examples to illustrate the recommendations and citing to recent research that supports the suggestions. Overall, the research shows that consumers can recall and comprehend efficacy and risk information when it is provided quantitatively.

The guidance recommends that quantitative efficacy or risk probabilities in DTC promotional materials should convey the information in terms of absolute frequencies (e.g., 57 out of 100) or percentages (57%), rather than relative frequencies (e.g., 33% reduction in symptoms), as this can improve consumers’ comprehension and ability to recall the information. Information should be presented in the same numerical format throughout the label or advertisement. If efficacy or risk probabilities are presented as relative frequencies, the corresponding absolute probability measures should be included as well. Promotional materials should consistently describe efficacy or risk information quantitatively throughout the piece, such as using absolute frequencies or percentages but not both. The guidance recommends using consistent frequencies with the same denominator when providing more than one absolute frequency. It also recommends that probabilities are expressed using whole numbers where appropriate. Where it is not appropriate, such as comparing probabilities that are very close in value, the guidance suggests using a decimal instead of rounding the value up to the nearest whole number.

Visual aids such as graphs, tables, and icon arrays help consumers comprehend quantitative efficacy by illustrating the information and putting the numerical values in context. However, the visual aid should be appropriate for the information presented, and the text should explain the purpose of the visual aid clearly and accurately and define the elements. Lastly, the guidance suggests that quantitative information should be presented from both the treatment group and the relevant control group and accurately describe the comparator used in the control group. Research suggests that consumers can use the information about the control group to form accurate perceptions about a drug’s efficacy and risk. Readers are encouraged to read the draft guidance, also available on FDA’s website.