In June 2023, the U.S. Food and Drug Administration (FDA) published final guidance (Guidance) on presenting risk and efficacy information for direct-to-consumer (DTC) promotional labeling and advertisements for prescription drug and biologic products for humans and drug products for animals.

The publication of this Guidance is significant for those entities engaged in promotional DTC communications.   While this Guidance does not establish legally enforceable responsibilities, FDA intends it to be viewed as its recommendations for practice for entities (including, manufacturers, packers, and distributors of prescription drugs and over-the-counter (OTC) animal drugs) that utilize quantitative efficacy.

The Guidance directs that entities presenting quantitative efficacy and risk information adhere to the following recommendations: (1) include quantitative information from control groups; (2) use probability presentations; (3) implement formatting for consistency and higher accuracy; and (4) effectively use visual aids to illustrate quantitative efficacy or risk information.

What is Quantitative Efficacy and Risk Information?

Quantitative efficacy and risk information refers to information “that numerically addresses the likelihood or magnitude of a drug’s efficacy or risks.” Guidance at 1. Research shows that consumers are more likely to retain and understand promotional content regarding a drug’s performance if that information is presented quantitatively, rather than qualitatively. The FDA has observed an increase in quantitative presentations of efficacy and risk information in DTC promotional communications submitted to the FDA. Consequently, the FDA has an interest in ensuring that firms present quantitative information to consumers simply and accurately.

FDA Recommendations

As mentioned above, the FDA Guidance provides the following recommendations for entities to implement into their DTC promotional advertisements.

1. Quantitative Efficacy or Risk Information from the Control Group. Firms should provide quantitative information from both a treatment group and a control group. Consumers are better able to form accurate perceptions regarding a drug’s benefits and risks when analyzing results of a control group. Promotional communications that include group information should accurately describe the comparator used in the control group. (E.g., “In a clinical trial of 173 participants, 68% of patients who were treated with Drug X plus a sulfonylurea experienced a reduction in blood glucose levels, while 33% of patients treated with a sulfonylurea alone experienced a reduction in blood glucose levels.” Guidance at 4.)
2. Probability Presentations. Firms should use absolute frequencies when communicating health information. Research suggests that consumers can more easily process information about a drug’s efficacy and risk rates when that information is presented in terms of absolute frequencies (e.g. 57 out of 100) or percentages (57%). (E.g., “In a clinical trial, 78 out of 100 patients experienced a response after 12 weeks of treatment with Drug X, compared to 20 out of 100 patients on placebo.” Guidance at 5.)
3. Formatting Quantitative Efficacy or Risk Information. Entities should incorporate the following formatting recommendations:
   • Present information in the same numerical format throughout a promotional communication;
   • 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 when appropriate to accurately reflect the numerical value being described; and
   • Promotional communications should present quantitative probability information about a particular risk in a manner that does not minimize or detract from information about the severity of the risk.
4. Visual Aids. Visual aids such as graphs, tables, and icon arrays are often used to illustrate the information and put the numerical values in context. When utilizing visual aids, entities should (1) Explain the purpose of the visual aid clearly and accurately, and define the elements displayed; (2) Make visual displays of numeric information proportionate to the quantity being described and ensure the scaling of axes is appropriate to accurately represent effect sizes; and (3) Include visual representations of both the numerator and denominator of ratios or frequencies.

This Guidance reflects FDA’s continued interest and monitoring of DTC advertising and that such advertising be “consumer friendly” and understandable by consumers. This should not replace an evaluation to ensure information also meets the standard that it be truthful and not misleading. Foley attorneys regularly work with its clients to review and advise on advertising and promotional materials to ensure compliance with FDA requirements.