Federal Food and Drug Administration (FDA) Finalizes Guidance for Direct-to-Consumer (DTC) Prescription Drug Advertisements

CCN Final Rule Guidance: Ensuring Clear, Conspicuous, and Neutral Major Statements

In a substantial move to bolster consumer understanding and accessibility of prescription drug information, the Federal Food and Drug Administration (FDA) issued the CCN Final Rule Guidance in December 2023. This guidance aims to assist small entities in complying with the standards set forth in the final rule, “Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format” (CCN Final Rule).

Key Standards for the Major Statement

The CCN Final Rule establishes five key standards for the “major statement,” which conveys critical information regarding the major side effects and contraindications of prescription drugs directly to consumers. These standards focus on consumer accessibility and understanding rather than the content of the major statement itself.

1. Clear and Conspicuous Presentation: The major statement must be presented in a clear and conspicuous manner, ensuring that consumers can easily locate and comprehend the information.
2. Direct-to-Consumer Format: The major statement must be presented directly to consumers in television or radio format.
3. Prescription Drug Name and Condition(s) of Use: The major statement must state the name of the prescription drug and the condition(s) for which it is intended.
4. Sufficient Detail: The major statement must be sufficiently detailed to avoid multiple or different interpretations, ensuring clarity and consistency in the information conveyed.

FDA Established Standards for Clear, Conspicuous, and Neutral Major Statements

To further assist manufacturers, packers, and distributors of prescription drugs (Firms) in presenting major statements in a clear, conspicuous, and neutral manner, the FDA has established specific standards:

1. Consumer-Friendly Language: Major statements in television format should use consumer-friendly language and terminology that is easily understandable, avoiding medical terms, technical jargon, or industry definitions that consumers may not typically use. However, certain terms may still be necessary depending on the content and context of the advertisement.
2. Understandable Audio Information: Audio information in television advertisements should be at least as understandable as the rest of the advertisement. This includes ensuring consistent properties such as volume, articulation, and pacing throughout the entire advertisement.
3. Dual Modality: Television advertisements should present both audio and text, also known as “dual modality.” Firms must ensure that the text displays the exact key terms or phrases from the corresponding audio or provides a complete transcript of the corresponding audio.
4. Synchronized Text and Audio: The text should be displayed in conjunction with the audio, starting and stopping at about the same time, to enhance comprehension and avoid confusion.
5. Easily Readable Text: Advertisements should present text in a manner that allows consumers to read it easily. This includes introducing high contrast between the major statement text and any background and ensuring that the text is displayed for a “sufficient duration.”
6. Minimized Distractions: Advertisements should not display any other audio or visual elements in combination with the presentation of the major statement to avoid distracting consumers from reading and comprehending the information. Firms should consider whether certain elements may confuse or interfere with the consumer’s understanding of the major statement.

Compliance Deadlines and Voluntary FDA Review

The CCN Final Rule’s effective date is set as May 20, 2024, but Firms have until November 20, 2024, to ensure compliance of all DTC television and radio advertisements subject to the rule. Firms can voluntarily request FDA review and comments on proposed advertisements before publishing and disseminating them. FDA reviewers will evaluate the materials for compliance with the CCN Final Rule and provide feedback to the Firms.

Ongoing Evaluation and Compliance

As Firms evaluate their DTC communications in preparation for the compliance deadline, it is crucial to consider them holistically in light of the FDA’s guidance. Firms should also stay informed about enforcement efforts and any additional compliance guidance issued by the FDA in the coming months.

Conclusion

The CCN Final Rule Guidance serves as a valuable resource for Firms seeking to comply with the standards established in the CCN Final Rule. By adhering to the FDA’s guidance, Firms can ensure that their DTC prescription drug advertisements provide consumers with clear, conspicuous, and neutral information, empowering them to make informed decisions regarding their care and treatment.