On June 27, 2023, the Food and Drug Administration (“FDA”) issued its Final Guidance for the presentation of “Quantitative Efficacy and Risk Information” in Direct-to-Consumer (“DTC”) promotional labeling and advertisements for prescription drug and biological products, prescription animal drugs and DTC promotional labeling for over-the-counter animal drugs. The Final Guidance provides recommendations on how to enhance consumer comprehension of promotional materials by making the language and presentation of quantitative information more accessible and consumer-friendly across various media formats.
Under the Federal Food, Drug, and Cosmetic Act and the FDA’s implementing regulations, “drug promotional labeling and prescription drug advertising must be truthful and non-misleading, convey information about the drug’s efficacy and its risks in a balanced manner and reveal material facts about the drug.” While companies have flexibility when presenting efficacy and risk information, provided such presentation is not false or misleading, the FDA emphasizes that companies should “consider how to best convey information about a drug’s efficacy and risks so the audience understands the information.”
Below is a summary of the FDA’s recommendations for presenting quantitative efficacy and risk information in DTC promotional labeling and advertisements:
A. Quantitative Efficacy or Risk Information from the Control Group
When a study includes a control group, companies should provide quantitative information from both the treatment group and the control group. According to the FDA, research suggests consumers can use the information about the control group to form accurate perceptions about a drug’s benefits and risks. Therefore, promotional communications that include information pertaining to the control group should accurately depict the comparator employed in that group.
B. Probability Presentations
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- Absolute Frequencies and Percentages:
Companies should present quantitative probabilities as absolute frequencies (e.g., 57 out of 100) or percentages (57%). Utilizing these formats enhances consumers’ understanding and retention, and facilitates their ability to process and assess the information readily. For example,
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.
In a clinical trial, 45% of patients experienced nausea during 20 weeks of treatment with Drug X, compared to 18% of patients during treatment with Drug Y.
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- Relative Frequencies:
Consumers may have difficulty understanding relative frequencies (e.g., 33% reduction in symptoms; 3 times as likely to experience a side effect), and companies should add context when communicating such relative frequencies to improve comprehension. If presenting probabilities as relative frequencies, companies should include corresponding absolute probability measures to provide information without requiring further calculations. The absolute probability measure should be presented prominently and in conjunction with the relative frequency measure.
For 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).
C. Formatting Quantitative Efficacy or Risk Information
Quantitative information should be formatted to facilitate the consumers’ understanding. Information should be presented consistently in the same numerical format throughout the promotional communication. When possible, companies should use frequencies with the same denominator and consider denominators that are multiples of 10 and express probabilities using whole numbers, without rounding unless necessary. Additionally, promotional communications should avoid downplaying the severity of a risk based on its low probability.
D. Visual Aids
Visual representations improve comprehension by summarizing data and reducing the need for mental calculations; however, the FDA acknowledges that not all visual aid designs are equally effective in conveying certain types of information. Therefore, companies should choose the visual aid that best communicates their information to consumers. To achieve this, companies should clearly explain the purpose of the visual aid, ensure appropriate scaling and proportionality and include representations of both the numerator and denominator of ratios or frequencies.
Conclusion
Promotional materials that follow the FDA’s recommendations for the presentation of quantitative efficacy and risk information help promote informed decision-making, protect public health and reduce the risk of an enforcement action for failure to present information in a manner that is truthful and non-misleading. Given the FDA’s recent enforcement actions, we encourage companies to review the Final Guidance closely before developing their next promotional campaign.
If you have any questions or would like help with the advertising and promotion of drugs, biologics or medical devices, please contact:
- Carolina Wirth at cwirth@hallrender.com or (202) 780-2989;
- Will Wurster at wwurster@hallrender.com or (317) 977-1494; or
- Your primary Hall Render contact.
A special thanks to Johanna Ananth, Summer Associate, for her assistance with the preparation of this client alert.
Hall Render blog posts and articles are intended for informational purposes only. For ethical reasons, Hall Render attorneys cannot—outside of an attorney-client relationship—answer specific questions that would be legal advice.
