FDA Draft Guidance Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer Promotional Labeling and Advertisements

What’s New/Significant

Provides recommendations for presenting quantitative efficacy and risk information in Direct-to-Consumer (DTC) promotional labeling and advertisements for prescription human drugs and biological products and prescription animal drugs, and in DTC promotional labeling for Over-the-Counter (OTC) animal drugs (collectively, “Promotional Materials").

Scope

In recent years, the Food and Drug Administration (FDA) has observed an increase in quantitative presentations of efficacy and risk in Promotional Materials submitted to the Agency. The FDA believes that quantitative information can improve consumers’ accuracy in estimating a drug’s benefits and risks. The draft guidance contains recommendations for presenting quantitative efficacy and risk information in Promotional Materials:

• Presentation of probability information in terms of absolute frequencies, percentages, and relative frequencies
• Formatting of quantitative efficacy or risk information
• Use of visual aids to illustrate quantitative efficacy or risk information
• Providing quantitative efficacy or risk information for the treatment group and the control group

Presenting Probability Information

Quantitative efficacy or risk probabilities in Promotional Materials should convey the information in terms of absolute frequencies (e.g., 57 out of 100) or percentages (57%), because research suggests that using these formats to express probabilities when communicating health information can improve consumers’ comprehension and ability to recall the information.

Example: In a clinical trial, 78 out of 100 patients experienced a response after 12 weeks of treatment with Drug X.

Efficacy or risk probabilities that are presented as relative frequencies should contain context to the relative frequency presentation to improve consumers’ ability to accurately understand the efficacy or risk information. Specifically, firms should include the corresponding absolute probability measures in presentations of relative frequency measures to provide the information in a way that does not require further calculation about the effect being communicated.

Example: In a clinical trial, Drug X reduced the risk of stroke by 50% (1% of patients treated with Drug X had a stroke compared to 2% of patients in the control group).

Formatting Quantitative Efficacy or Risk Information

Present the information in the same numerical format throughout a promotional label or advertisement.

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 the probabilities in whole numbers accurately reflect the numerical value being described in the Promotional Material.

Using Visual Aids to Illustrate Quantitative Efficacy or Risk Information

Quantitative information from both the treatment group and the relevant control group should be included in Promotional Materials. Information from the control group plays an important role in evaluating a drug’s benefits and risks.

When including control group information in Promotional Materials, firms should also ensure that they accurately describe the comparator used in the control group.