The Major Statement: FDA's Recent Q&A Guidance and Rulemaking on Direct-to-Consumer Prescription Drug Advertisements and the November Deadline

5 min

On December 26, 2023, the Food and Drug Administration (FDA) issued 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 guidance follows the Agency's long-awaited final rule, which was published on November 21, 2023, 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). The rule implements a statutory requirement that direct-to-consumer (DTC) advertisements for prescription drugs in TV or radio format must present the "major statement," a presentation of the drug's most important risks, in a "clear, conspicuous, and neutral" manner.

This rulemaking complements long-standing prescription drug advertising requirements. It brings additional clarity to existing provisions about the major statement in DTC TV/radio ads by providing information on how that major statement must sound and—in the case of TV ads—look. All firms (in general, manufacturers, packers, and distributors of any human prescription drug) must bring all DTC TV/radio ads subject to this requirement into compliance no later than November 20, 2024.

The final rule specifies five standards that, independently and collectively, help ensure that a major statement is presented in a clear, conspicuous, and neutral manner. The Q&A Guidance is intended to help small entities understand and comply with the Final Rule.

Standard 1. The major statement must be presented in consumer-friendly language and terminology that is readily understandable.

Questions to Consider: Is the language used understandable to the ordinary consumer? In the guidance, FDA explains that medical or technical jargon that is usually more familiar to healthcare providers should not be used. In addition, per the guidance, firms must avoid language or terminology that is so vague as to be readily subject to different interpretations. However, FDA recognizes the need for flexibility and that the use of certain complicated or hard-to-read terms might be necessary, such as a reference to a disease like "tuberculosis."

Standard 2. The major statement's audio information, in terms of the volume, articulation, and pacing used, must be at least as understandable as the audio information presented in the rest of the advertisement.

Questions to Consider: Is the audio presentation at least as understandable as the rest of the ad (e.g., the presentation of the benefits of a drug)?

Standard 3. In ads for television, the major statement must be presented concurrently, using both audio and text (dual modality). To achieve dual modality, firms may either display key terms or phrases verbatim (no synonyms) while the corresponding audio plays or display the complete transcript verbatim while the corresponding audio is being played. For example, if the audio states, "The most common side effects of DRUGX are dry mouth, headache, and heartburn," the firm either could display the full transcript of that statement as shown or could display "• dry mouth • headache • heartburn." Duration will be considered sufficient if the ad begins displaying the major statement text at the same time that the corresponding major statement audio information begins and stops displaying the text at approximately the same time that the corresponding audio information ends.

Questions to Consider: Does the display of textual information in the major statement appear for a sufficient duration? Does the pacing of the audio presentation also enable the ad to satisfy Standard 2?

Standard 4. In advertisements for television, 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 must allow the information to be read easily.

Questions to Consider: Do these aspects of the text together result in an easily readable presentation of the major statement? No particular font colors, sizes, placement, or backgrounds are required. Instead, firms must ensure that these aspects of text in combination result in an easily readable presentation. For example, increasing the amount of contrast between the font and the background may improve readability. Furthermore, even at a smaller size, some styles of font are more easily read than others.

Standard 5. During the presentation of the major statement, the advertisement must not include audio or visual elements (music, sounds, text, images, etc.) that, alone or in combination, are likely to interfere with comprehension of the major statement.

Questions to Consider: Are the audio or visual elements, separately or together, likely to be distracting? For example, upbeat music or amusing drawings during the major statement may be fine, but loud music or rapid scene changes during the major statement may be distracting. Firms should examine the facts and circumstances presented by each specific ad to ensure that it complies with this standard.

As FDA notes, failure to follow the new rule will render a drug misbranded. FDA's publication of the rule and its quick follow-up with the Q&A Guidance could indicate that the Agency is committed to enforcing these new requirements. The private bar also may become interested if a major statement is not adequately presented.

If you have any questions or require assistance in ensuring your compliance with the Final Rule, please reach out to our regulatory compliance team for support.