In 1972, Johnny Nash sang the catchy song, “I Can See Clearly Now.” A little more than 50 years later, the Food and Drug Administration’s Office of Prescription Drug Promotion issued a Final Rule relating to direct-to-consumer (“DTC”) advertisements for human prescription drugs presented in television or radio format.¹ The Final Rule implements the Food and Drug Administration Amendments Act of 2007 (“FDAAA”) provision, which requires DTC TV/radio ads to include a “major statement” of side effects and contraindications that are presented in a clear, conspicuous, and neutral manner (“CCN”). The CCN presentation requirement relates to the major statement and not to the content of the ad as a whole. In the Final Rule, FDA provides five standards (to be discussed) that, independently and collectively, should help ensure that an ad’s major statement is presented in a CCN manner.

The rule, which amends 21 C.F.R. 202.1(e), becomes effective on May 20, 2024. The compliance date is November 20, 2024.

Highlights

• Standard #1: The Final Rule requires a company to provide the major statement in consumer-friendly language and terminology that people can understand.
• 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.
• Standard #3: In a TV ad, the major statement must be presented concurrently using both audio and text (“dual modality”). Either the text displays the verbatim key terms or phrases from the corresponding audio, or the text displays the verbatim complete transcript of the corresponding audio, and the text is shown for a sufficient duration to allow it to be read easily.
• Standard #4: In a TV ad, the major statement must be presented 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 read easily.
• 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).
• FDA has said, in its revised OPDP FAQ (on its website), a company may submit draft DTC TV/radio ads for OPDP evaluation to ensure CCN compliance before the effective date. OPDP will respond to the firm’s request for comments “as soon as possible.”

AGG Observations

• FDA’s new rule is not significantly different from what it has stated in guidance documents and enforcement letters over the years. However, it reiterates that the major statement must be “easily readable” and “readily understandable” by consumers. Of course, what constitutes “easily” and “readily” is subject to interpretation and will depend on the facts of a particular ad. Similarly, FDA does not define “neutral,” but believes that the guidance it provides will lead to a “neutral” presentation.
• Unlike guidance, the rule is legally binding. Failure to comply can lead to “misbranding” the drug product, which is a prohibited act.
• While the Final Rule is specific to a major statement in TV/radio ads for prescription drugs, companies may want to review the Final Rule as they consider social media promotional campaigns and risk information presentation. Social media promotion is also DTC advertising. The basic themes of consumer comprehension and readability apply.
• The rule does not become effective until May 2024, and the compliance date is not until November 2024. A year’s notice should give companies time to ensure future DTC TV/radio ads are compliant. Hopefully, industry will see no obstacles in its way (a lyric from the aforementioned song).

[1] https://www.federalregister.gov/documents/2023/11/21/2023-25428/direct-to-consumer-prescription-drug-advertisements-presentation-of-the-major-statement-in-a-clear. Shortly thereafter, FDA revised its OPDP FAQ website to address these changes. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/opdp-frequently-asked-questions-faqs.