FDA Issues Final Rule and Guidance on Direct-To-Consumer Prescription Drug Advertisements

In one of the last guidances released in 2023, the Federal Food and Drug Administration (FDA) finalized guidance for direct-to-consumer (DTC) prescription drug advertisements, specifically advertisements in television and radio format (CCN Final Rule Guidance). The CCN Final Rule Guidance was released to advise small entities seeking to understand and comply with the standards established 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).

The CCN Final Rule, published in November 2023, establishes five key standards for the “major statement” which provides information related to the major side effects and contraindications of an prescription drug communicated directly to consumers. The CCN Final Rule does not impact the content of a major statement and instead focuses on consumer accessibility and consumer understanding of the information. With the CCN Final Rule Guidance, FDA aims to provide consumers with more agency in deciding how to approach their care and treatment—at least in relation to prescription drugs directly being advertised to them.

Pursuant to the CCN Final Rule, the major statement in a should be presented in a clear, conspicuous and neutral manner, and should:

1. Be presented directly to consumers;
2. Be in television or radio format;
3. State the name of the prescription drug and its condition(s) of use; and
4. Be sufficiently detailed as to avoid multiple or different interpretations of the major statement.

Furthermore, manufacturers, packers, and distributors of prescription drugs (Firms) can also look to FDA established standards to ensure all major statements are presented in a clear, conspicuous, and neutral manner. The FDA standards advise that major statements in television format should :

1. Contain “consumer-friendly” language and terminology that is easily understandable and avoids medical terms, technical jargon or industry definitions that consumers would not typically use. While Firms should take care to exclude overly technical language, there may still be instances where it might be necessary to include certain terms depending on the content and context, such as when referring to a disease like “tuberculosis”, even though use of the term could result in a higher grade level rating. FDA is seeking to implement a standard of accessibility to the every day consumer while still providing Firms flexibility in the construction of advertisements.
2. Provide audio information at least as understandable as the audio information presented in the rest of the advertisement. This may look like ensuring certain properties of the audio, such as volume, articulation, and pacing, are consistently used throughout the entire advertisement.
3. Present television advertisements with both audio and text, which is also described as “dual modality”, where
   • Firms ensure the text displays the exact key terms or phrases from the corresponding audio, or alternatively, provide a complete transcript of the corresponding audio, and
   • The text is displayed in conjunction with the audio such that both text and audio start and stop at about the same time.
4. Present advertisements with text in a manner that allows the information to be read easily. This might include introducing high contrast between the major statement text and any background and ensuring that any major statement text is presented for a “sufficient duration” so as to be easily read by consumers.
5. Ensure that an advertisement does not display any other audio or visual elements in combination with the presentation of the major statement to avoid consumer confusion in comprehending the major statement. This standard seeks to minimize elements that would distract from a consumer’s reading and comprehension of the DTC advertisement. Though the CCN Final Rule does not prohibit specific categories of audio or visual elements, Firms may consider whether certain elements included in a DTC advertisement may distract or confuse the consumer or otherwise interfere with the consumer’s understanding of the major statement.

Though the effective date of the CCN Final Rule is set as May 20, 2024, Firms have until November 20, 2024 to ensure compliance of all DTC television and radio advertisements subject to the CCN Final Rule. In reviewing DTC advertisements for compliance, Firms may voluntarily request FDA review and comments on proposed advertisements subject to this CCN Final Rule before such advertisements are published and disseminated. FDA reviewers would evaluate the proposed materials for compliance with the CCN Final Rule, among other things, and provide any comments to the Firms.

As Firms start evaluating DTC communications in advance of the compliance deadline, it will be important to consider such communications wholistically in light of the FDA’s guidance and continue to take note of any enforcement efforts and other compliance guidance in the months to come.