FDA Issues Draft Guidance with Recommendations on Presenting Quantitative Efficacy and Risk Information in DirecttoConsumer Promotion
On October 17, 2018, the Food and Drug Administration published a draft guidance for industry on “Presenting Quantitative Efficacy and Risk Information in DirecttoConsumer Promotional Labeling and Advertisements.” The draft guidance provides FDA’s recommendations for how firms that include quantitative efficacy or risk information in directtoconsumer (DTC) promotional materials (e.g., print, electronic, audiovisual, broadcast) for their prescription drugs or biological products can make the language and presentation more consumerfriendly. Quantitative efficacy and risk information refers to information that numerically addresses the likelihood or magnitude of a drug’s effectiveness or risks. Industry should make a concerted effort to incorporate FDA’s recommendations into DTC promotional materials.
Background
When firms develop DTC promotional materials, they should consider how to best convey information about a drug’s efficacy and risks so consumers understand it. In recent years, FDA has observed an increase in quantitative presentations of efficacy and risk information in DTC promotional materials submitted to the agency. Recent research suggests that consumers can recall and comprehend efficacy and risk information when it is provided quantitatively. In fact, when compared to qualitative descriptions of efficacy and risk information, quantitative information can improve consumers’ accuracy in estimating the drug’s benefits and risks.
FDA’s Recommendations in the Draft Guidance

 Probability Presentations

 Firms presenting quantitative efficacy or risk probabilities should convey the information in terms of absolute frequencies (e.g., 57 out of 100) or percentages (57%).
 If firms choose to present efficacy or risk probabilities as relative frequencies, they should add context to the relative frequency presentation (i.e., the corresponding absolute probability measures).

 Probability Presentations

 Formatting Quantitative Efficacy or Risk Information

 Present the information in the same numerical format throughout a promotional piece, and consistently characterize efficacy or risk information quantitatively throughout a piece, rather than alternating between qualitative descriptors and quantitative information.

 Use frequencies with the same denominator when providing more than one absolute frequency, and consider using denominators that are multiples of 10.
 Express probabilities using whole numbers to the extent that whole numbers accurately reflect the numerical value being described. Where a whole number would not be appropriate, express the value as is (e.g., as a decimal) instead of rounding the value up or down to the nearest whole number. Ensure that quantitative probability information about a particular risk does not minimize or deter from information about the severity of the risk (e.g., do not disproportionately emphasize the low probability of a serious risk as a way to detract from the seriousness of that risk).

 Formatting Quantitative Efficacy or Risk Information

 Visual Aids

 Visual aids (e.g., graphs, tables, icon arrays) can improve consumer comprehension of quantitative efficacy or risk information. Firms should select the visual aid design that best communicates the quantitative information being presented (e.g., a bar graph is appropriate for depicting comparisons between probabilities; a line graph is more useful for illustrating trends or changes over time).

 Explain the purpose of the visual aid clearly and accurately, and define the elements displayed (e.g., include a title, header, or caption, and identify the visual aid’s variables scales, and axes).

 Make visual displays of numeric information proportionate to the quantity being described (e.g., the height of a bar on a bar graph should be proportionate to the quantity it represents).
 Include visual representations of both the numerator and denominator of ratios or frequencies.

 Visual Aids
 Quantitative Efficacy or Risk Information from the Control Group
 Firms that provide quantitative efficacy or risk information about a drug should provide quantitative information from both the treatment group and the relevant control group. Firms should also ensure that they accurately describe the comparator used in the control group.
AGG Observations

 The draft guidance contains a number of helpful examples to illustrate FDA’s recommendations.

 Because all promotion has an element of subjectivity, firms can choose to present quantitative data in a number of ways. In its standard guidance disclaimer, FDA acknowledges that alternative approaches are acceptable if they satisfy the requirements of the FDC Act and FDA regulations. However, if firms are considering an alternative approach, they are advised to contact FDA first.

 In issuing this draft guidance, FDA’s operating assumption (backed by research) is that, by following these recommendations, DTC promotion will be more consumerfriendly. If this is true, firms should consider whether DTC promotion that is more consumerfriendly is also more effective (i.e., sells more product).
 Although the draft guidance is not mandatory or binding, firms are advised to follow FDA’s recommendations. In a footnote, the draft guidance makes clear that it is not intended to describe whether or when a presentation of quantitative efficacy or risk information would be truthful or nonmisleading. Thus, failure to follow the recommendations in the guidance by itself will likely not result in an enforcement letter from FDA. However, our experience tells us that FDA would like to see these recommendations implemented, so firms should make a concerted effort to do so.
Interested stakeholders may submit comments to FDA on the draft guidance until December 17, 2018.