Key Takeaways:
- The Food and Drug Administration ("FDA") finalized its guidance on how manufacturers of certain drug products should present quantitative efficacy and risk information in promotion directed to consumers.
- The Final Guidance does not depart materially from the draft guidance, but it provides additional examples for greater clarity.
On June 27, 2023, the Food and Drug Administration’s ("FDA") Office of Prescription Drug Promotion ("OPDP") published a final guidance (the "Final Guidance") on Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements. The guidance makes recommendations on how to best present quantitative efficacy and risk information in direct-to-consumer promotional labeling and advertisements for prescription human drugs, prescription animal drugs, and over-the-counter ("OTC") animal drugs. (Advertising for OTC human drugs is regulated by the Federal Trade Commission ("FTC").)
The term "quantitative efficacy and risk information" in the guidance refers to information that provides numerical details about the probability or extent of a drug's effectiveness or potential risks. FDA’s recommendations primarily revolve around improving the language in promotional communications and presenting the efficacy and risk information in a more consumer-friendly manner to foster an easier and more accurate consumer understanding. The Final Guidance explains that firms can make the promotional language and presentation more consumer-friendly if they follow these general recommendations.
1) Include quantitative information from control groups. When mentioning a study with a control group in a promotional communication, firms should provide quantitative information from both the treatment group and the control group. Specifically, firms should fully describe the comparator used in the control group.
2) Use of probability presentations. Firms should largely present quantitative information in terms of absolute frequencies (e.g., 57 out of 100) or percentages (57%) because consumers have an easier time processing information in such a format. Firms should generally avoid using relative frequencies (e.g. “3 times as likely”). If firms choose to use relative frequencies, they should include the corresponding absolute probability measures to add context in a prominent way.
3) Format for consistency and higher accuracy. Firms should format their presentations in a manner that enhances consumer understanding of quantitative risk and efficacy information. For example, the Final Guidance recommends that firms:
- Use the same numerical format throughout the promotional communication.
- Use frequencies with the same denominators, preferably in multiples of 10.
- Use whole numbers to express probabilities, unless it would be inappropriate or inaccurate to do so.
- Present probability about a risk without minimizing or detracting from the severity or significance of the risk.
4) Use of visual aids. Lastly, the Final Guidance recommends that firms present quantitative information through visual aids (e.g., graphs, tables, and icon arrays) that best convey the promotional communication’s purpose and objectives. Some guidelines suggested by FDA are to:
- Clearly and accurately explain the purpose of the visual aid and define the elements.
- Ensure the visual aids proportionately represent the quantity displayed and identify the scales and axes used.
- Include visual representations of both the numerator and denominator when using ratios or frequencies.
In the Final Guidance, FDA provides more specific examples illustrating ways firms could improve their promotional communications.
Overall, the Final Guidance contains few changes from the draft guidance that was issued in October 2018. The Final Guidance provides additional examples and makes more pointed recommendations on how a graph should be presented (e.g., scaling the y-axis to ensure the difference in height between the bars is proportional to the value difference). Another difference from the draft guidance is that the Final Guidance changed the term collectively referring to promotional labeling and advertisement for prescription drugs from “promotional materials” to “promotional communications”—perhaps signaling the guidance’s application to promotion accomplished through oral statements (e.g., detailing speech). Nevertheless, the changes are minor, and the overarching message of the guidance has not changed from the October 2018 draft guidance.
