On December 26, 2023, the Food and Drug Administration’s Office of Prescription Drug Promotion (“OPDP”) issued a Questions and Answers Guidance for industry titled “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 Guidance for Industry.”¹ The Questions and Answers Guidance is intended to help small entities comply with OPDP’s Final Rule that was issued on November 21, 2023, titled “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.”² The November Final Rule is summarized in a previous Bulletin.³

Highlights

• The Questions and Answers Guidance answers 10 questions on how FDA intends to interpret the Final Rule.
• The Final Rule is applicable to advertisements for human prescription drugs that:
  1. are presented directly to consumers;
  2. are in television or radio format; and
  3. state the name of a drug and its condition of use.
• The compliance date for the Final Rule is November 20, 2024.
• The Final Rule provides five standards to ensure that an advertisement’s major statement is presented in a clear, conspicuous, and neutral (“CCN”) manner.
  • Standard #1: The Final Rule requires a company to provide an advertisement’s major statement in consumer-friendly language and terminology.
    • The Questions and Answers Guidance states that companies should use terminology that is readily understandable, and not medical or technical jargon that is utilized more by healthcare providers. There is no requirement to use language associated with a particular grade level of reading. Rather, the risk information must be understandable to an ordinary consumer. Use of certain medical terms (e.g., a reference to a disease, such as tuberculosis) may be necessary.
  • Standard #2: The audio information in the major statement must be at least as understandable as the audio information presented in the rest of the ad in terms of volume, articulation, and pacing.
    • The Questions and Answers Guidance mirrors what the Final Rule says about Standard #2.
  • Standard #3: In a TV ad, the major statement must be presented concurrently using both audio and text (“dual modality”). The text must either display the key terms or phrases verbatim from the corresponding audio or display the complete transcript of the corresponding audio. The text must be shown for a sufficient duration to allow it to be read easily.
    • The Questions and Answers Guidance provides an example:
      “If the audio states, ‘The most common side effects of DRUGX are dry mouth, headache, and heartburn,’ the firm could provide the same wording in the text. The firm could also display ‘• dry mouth • headache • heartburn.’”
    • The Guidance also states that the pacing of the audio presentation of the major statement must enable the ad to satisfy Standard #2.
  • Standard #4: A company must present a TV ad’s major statement so that a consumer can easily read it. Placement on the screen and contrast with the background, as well as size and style of font, must enable the text portion of the major statement to be viewed easily.
    • The Guidance provides that companies are not required to use specific font colors, sizes, places, or background. Instead, the major statement must be presented in an easy-to-read manner. The Guidance explains that increasing the amount of contrast between the font and the background may improve readability. The Guidance also points out that some font styles are easier to read in a smaller size.
  • Standard #5: The ad must not include audio or visual elements that, alone or in combination, could interfere with, or distract, comprehension of the major statement (e.g., music, sounds).
    • The Guidance explains that not all audio and visual elements may impede comprehension of the major statement. The Guidance notes that dual modality, discussed in Standard #3, requires concurrent use of audio and visual elements and actually increases understanding. Standard #5 does not categorically prohibit creative elements during the major statement, such as music, sound effects, or drawings, or any subtypes of creative elements.
• The content of the major statement is not changed by the Final Rule.
• Firms may voluntarily request comments from OPDP within the Center for Drug Evaluation and Research (“CDER”) or the Advertising and Promotional Labeling Branch within the Center for Biologics Evaluation and Research (“CBER”) on proposed advertisements before they are disseminated to ensure that they comply with the Final Rule.

AGG Observations

• OPDP has issued several Untitled Letters and Warning Letters to companies in the past about promotional communications relating to misleading advertisements. For example, in 2022, a company received an Untitled Letter in part because the risk information was only presented in text format in a small font that appeared for four seconds at the end of the ad.⁴ This Questions and Answers Guidance should educate industry more on FDA’s expectations.
• The Questions and Answers Guidance is not legally binding, but it does offer the agency’s current thinking on providing the major statement in a CCN manner.
• While the Guidance does not require companies to use focus groups to review ads in advance to ensure CCN compliance, it is something to consider to minimize the potential risk of FDA scrutiny and potential enforcement.
• FDA expects the Guidance to help industry see more clearly now that it has issued a Final Rule and Guidance. We will wait and, yes, see.

[1] https://www.fda.gov/media/175074/download.

[2] https://www.federalregister.gov/documents/2023/11/21/2023-25428/direct-to-consumer-prescription-drug-advertisements-presentation-of-the-major-statement-in-a-clear.

[3] https://www.agg.com/news-insights/publications/i-can-see-clearly-now-fda-issues-final-rule-on-dtc-rx-ads-relating-to-presentation-of-the-major-statement-in-tv-and-radio-format/.

[4] See, e.g., https://www.fda.gov/media/146528/download?attachment.