As 2023 came to a close, the U.S. Food and Drug Administration issued a new rule on direct-to-consumer prescription drug advertising along with business guidance to assist companies with compliance.  

When a DTC television or radio commercial promotes the name of a drug and the conditions of use, the law requires that the advertising also include – in a clear, conspicuous, and neutral manner – the “major statement,” which provides information relating to the major side effects and contraindications of the drug.  The new rule establishes five specific standards for advertisers to comply with that will help ensure that the major statement is presented in a clear, conspicuous, and neutral manner.  They are:

• Standard 1 - The major statement must be presented in consumer-friendly language, using terminology that is readily understandable.  In its business guidance, the FDA explained that this means that advertisers “must use consumer-friendly language and terminology that is readily understandable, rather than medical or technical jargon or terms usually more familiar to health care providers.”  The FDA also explained that advertisers must also “avoid language or terminology in the presentation of the major statement that is so vague as to be readily subject to different interpretations.” 
• 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 commercial.  
• Standard 3 - In television commercials, the major statement must be presented concurrently using both audio and text – which the FDA refers to as “dual modality.”  In order to achieve dual modality, first, either the text must display key terms or phrases from the corresponding audio or the text must display the verbatim complete transcript of the audio.  Second, the text must be displayed for sufficient duration to allow it to be read easily.  For purposes of this standard, the duration is considered sufficient if the text display begins at the same time and ends at approximately the same time as the corresponding audio. 
• Standard 4 - For television commercials, for the text portion of the major statement, the size and style of font, the contrast with the background, and the placement on screen must allow for the information to be read easily. 
• Standard 5 - During the presentation of the major statement, the advertising should not include any audio or visual elements that are likely to interfere with the comprehension of the major statement.  The FDA's business guidance explained that advertisers “must ensure that television and radio commercials ”do not include audio or visual elements (music, sounds, text, images, etc.) during the presentation of the major statement that, alone or in combination, are likely to interfere with the comprehension of the major statement."  The FDA reassured advertisers, though, that this standard “does not categorically prohibit use of other creative elements during the major statement.”

These new standards, which go into effect on November 20, 2024, will require some substantial changes in DTC broadcast advertising moving forward.  The FDA reiterated that is available to review commercials before they are published, if advertisers have concerns about whether their new commercials are compliant.