United States: FDA's Major Statement: The Agency's Recent Direct-To-Consumer CCN Final Rule, Q&A Guidance And Enforcement Trends

Key Takeaways

• FDA issued a new Q&A Guidance, which provides helpful context and examples for compliance with its November Direct-to-Consumer Clear, Conspicuous, and Neutral (CCN) Final Rule.
• The Final Rule provides standards for ensuring that a television or radio commercial for a prescription drug presents its "major statement" on side effects and contraindications in a clear, conspicuous, and neutral manner. Notably, when ads are presented in television format, the information presented in the audio portion of the major statement must also be presented concurrently in text for a sufficient duration, but the ad must not include any elements that are likely to distract from the major statement.
• The Q&A Guidance clears up some industry questions regarding dual modality requirements and the permissibility of certain audio and visual elements that are broadcasted during the major statement.

Executive Summary

On December 26, 2023, the Food and Drug Administration (FDA) released a Small Entity Compliance Guide Final Guidance Document: 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 Final Rule Questions and Answers (Q&A Guidance). This Q&A Guidance follows the Agency's November 21, 2023 Direct-to-Consumer Prescription Drug Advertisements; Presentation of the Major Statement in Television and Radio Advertisements in a Clear, Conspicuous, and Neutral Manner final rule (the Final Rule).¹ Both pertain to the "major statement," which describes a prescription drug's most important risks and is required for broadcast advertisements for prescription drugs.

The Final Rule sets forth five standards for compliant major statements:

1. The major statement must be presented in consumer-friendly language and language that is readily understandable.
2. Audio information presented for the major statement must be at least as understandable as other audio information in the advertisement.
3. For television advertisements, the major statement must be presented in audio and text (known as "dual modality"), either with verbatim phrases from the audio or a transcript, with the text visible for long enough for viewers to understand it.
4. The major statement text must be placed "appropriately," with contrast, sizing, and font choices that allow it to be read easily.
5. There cannot be "distracting" audio or visual elements during the presentation of the major statement that are likely to interfere with comprehension.

The Q&A Guidance describes scenarios that illustrate each standard and outlines existing practices that FDA interprets as being compliant with these standards. Notably, the regulations formally only apply to television and radio advertisements, but the standards are also helpful for manufacturers preparing advertisements for other audio and visual formats. Firms will have until November 20, 2024, to bring all direct-to-consumer (DTC) television and radio ads into compliance with the Final Rule, according to the guidance document.

Background

The Food and Drug Administration Amendments Act (FDAAA) of 2007 amended the Federal Food, Drug and Cosmetic Act (FDCA) to require FDA to establish standards for assessing "clear, conspicuous, and neutral" (CCN) language for major statements within 30 months of the bill's passage, and the Agency published its proposed rule on the topic on March 29, 2010, within that deadline.² The Agency has now finalized this proposed rule following multiple comment periods. The original proposed rule set forth four standards detailing the Agency's interpretation of the statutory "clear, conspicuous, and neutral" requirement for presentation of the major statement. Specifically, the proposed rule outlined the following standards for ensuring that the major statement is CCN:

• Information is presented in language that is readily understandable by consumers.
• Audio information is understandable in terms of the volume, articulation, and pacing used.
• Textual information is placed appropriately and presented against a contrasting background for sufficient duration and in a size and style of font that allows the information to be read easily.
• The advertisement does not include distracting representations (including statements, text, images, or sounds or any combination thereof) that detract from the communication of the major statement.

The 2023 Final Rule (briefly described above and further expounded on below) by and large maintains these original four standards and adds the dual modality standard.

After FDAAA, but prior to announcing the proposed rule, FDA provided guidance on the presentation of risk information within prescription drug promotion in a 2009 draft guidance. The 2009 draft guidance covered promotion of both prescription drugs and medical devices, and provided much more general standards for all kinds of "risk communication," but it did not provide specific details on the Agency's interpretation of the major statement or CCN requirement.

FDA, in the meantime, conducted multiple major studies related to risk communication in prescription drug advertising. For example, FDA conducted a Distraction Study analysis, which was completed in 2011. FDA reopened the comment period in 2012 for the proposed rule to receive feedback on the study and again reopened the comment period later that year in response to requests to accept more comments.³ FDA points out in the preamble to the Final Rule two especially prominent findings of the Distraction Study: (1) that presenting information through both superimposed text and audio improves consumer understanding, and (2) that presenting risk information alongside positive imagery does not impede understanding of the information presented. FDA completed more studies in 2023 that were incorporated into the preamble to the Final Rule—the completion of which may have prompted the Agency to finalize the rule after all this time.

CCN Final Rule Standards and Related Implementation Guidance

The Q&A Guidance consists of 10 topics related to implementation of the Final Rule. Five of these topics address each standard from the Final Rule individually, as discussed below.

• The Final Rule's first standard mandates that the major statement be presented in consumer-friendly language and language that is readily understandable. The Q&A Guidance clarifies that firms should favor consumer-friendly language rather than medical or technical jargon or terms that are usually more familiar to health care providers. The Agency acknowledges, however, that certain terms naming a disease might still be necessary in a major statement even if they are complex or difficult-to-read. The Agency uses "tuberculosis" as an example of a high grade level reading term that still might be included in a major statement. Firms should avoid vague language or terminology that would be open to different interpretations.
• The second standard requires that the audio presentation of the major statement be at least as understandable as the audio presentation of other information in the advertisement in terms of volume, articulation, and pacing. (FDA apparently believes that this standard is rather self-explanatory since the Q&A Guidance commentary on the standard is merely a rearrangement of the regulation's language).
• The third standard presents what is likely the largest shift for firms currently engaged in DTC television prescription drug advertising – the dual modality requirement. The Agency will now require that for advertisements in television format, the major statement must be presented concurrently using both audio and text (dual modality). As mentioned in the Final Rule preamble and the Q&A Guidance, firms may include the major statement risk language verbatim on the television screen while the corresponding audio is transmitted. A firm may alternatively opt to present bullets of major points such as side effects on the screen as the major statement audio plays. The Q&A Guidance offers the following example:

• The Final Rule's fourth standard also relates to television" advertisements and requires that for the text portion of the major statement, the size and style of font, the contrast with the background, and the placement on the screen allow the information to be read easily. Firms are not required to use particular font colors, sizes, placement, or backgrounds but instead are required to ensure that these aspects of text, in combination, result in an easily readable presentation of the major statement. The Q&A Guidance mentions that adjusting font and contrast to improve readability would help firms comply with this standard.
• Finally, the fifth standard requires that during the presentation of the major statement, the advertisement does not include audio or visual elements, alone or in combination, that are likely to interfere with comprehension of the major statement. Any music, sound, text, or visual elements that can interfere with the audience's ability to comprehend the major statement should be avoided. The Agency's commentary in the Q&A Guidance suggests that the scope of this standard may be rather narrow:

Prescription Drug Promotion Enforcement Remains a Priority for FDA

Direct-to-consumer prescription drug advertisements are subject to FDA enforcement somewhat regularly, reflecting the Agency's commitment to ensuring that manufacturers do not mislead consumers about the relative health benefits and risks of FDA-approved prescription drug products.

As the Agency notes in the Final Rule, failure to comply with the direct-to-consumer advertising regulations can result in the drug being deemed misbranded under Section 502 of the FDCA (21 U.S.C. 352). FDA has issued several warning and untitled letters in recent years for DTC television and radio content, including one untitled letter as recently as this past October. For example:

• In 2021, FDA issued an Untitled Letter to a manufacturer of a migraine treatment for failing to adequately present risk information (which was presented only visually and in a small font, while benefits were conveyed via audio), as well as false or misleading presentation of efficacy.
• In 2020, FDA issued a Warning Letter to a manufacturer for the omission of all contraindications and some risks from a radio advertisement regarding a drug for sexual desire disorders.
• In 2019, FDA issued a Warning Letter to a manufacturer for a video presentation, broadcast on television, which omitted discussion of risks and contraindications for a birth-control product.

In total, since 2017, FDA has issued at least 12 warning or untitled Letters regarding DTC television or radio ads, including at least 10 letters that cited issues specifically with the major statement or lack thereof.

Conclusion

The Q&A Guidance is the first of potentially many Agency activities related to publication of the DTC Final Rule. FDA describes the DTC Final Rule as "an incremental addition to a longstanding body of prescription drug advertising regulations," and the Final Rule's publication indicates that the Agency will commit to enforcing these regulations while also providing industry guidance and opportunity for pre-distribution Agency review through the voluntary advisory comment process. With publication of the Q&A Guidance about a month after the Final Rule's publication, the Agency likely anticipates substantial back-and-forth with industry – either through comments, more questions, or through pre-distribution advertisement review. The Agency's regular issuance of warning or untitled Letters regarding DTC advertisements also underscores its continued interest in enforcing these regulations, reflecting the Agency's commitment to promoting consumer understanding of prescription drugs' benefits and risks as a public health priority. Foley Hoag is available to address any question you might have about the DTC CCN Final Rule and its upcoming implementation.

Footnotes

1. 88 Fed. Reg. 80958 (Nov. 21, 2023)

2. 75 Fed. Reg. 15376 (Mar. 29, 2010).

3. Docket No. FDA–2009–N–0582.

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