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.
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.
As mentioned above, the FDA Guidance provides the following recommendations for entities to implement into their DTC promotional advertisements.
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.
Foley is here to help you address the short and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Foley relationship partner, or to our Health Care Practice Group with any questions.