To increase transparency and consumer awareness, the Food and Drug Administration (FDA) issued a final rule to amend its regulations regarding direct-to-consumer (DTC) advertisements for prescription drugs in television and radio formats. Additionally, one month later in December 2023, FDA issued a final guidance document complementing the rule, which is intended to help entities understand and comply with the standards established in the final rule.
More on Rule and Guidance
The final rule, implemented as part of the Food and Drug Administration Amendments Act of 2007, establishes five key standards aimed at presenting the “major statement” in a DTC advertisement in a clear, conspicuous and neutral manner. The final rule does not affect the content of a major statement. For example, information regarding the major side effects and counterindications. Rather, it focuses on the consumer accessibility of that information.
The final rule establishes that the information in the advertisement must be presented in consumer-friendly language that is readily understandable. Firms must not use medical or technical jargon or other industry terminology not commonly used by consumers. This standard seeks to position consumers as informed decision-makers in their health care. By enhancing the accessibility of information, the FDA aims to bridge the gap between complex medical terminology and the understanding of prescription drugs by the average consumer. Notwithstanding, while risk information must be understandable to the ordinary consumer, the FDA also indicates that — by virtue of the content — certain terms, such as “tuberculosis,” may still be necessary to include within the major statement, even though such terms are associated with a higher grade level of reading and comprehension.
Continuing, the audio information in the major statement must be at least as understandable as the audio information presented in the rest of the advertisement. This focus on the audio experience seeks to ensure that risk information is presented consistently with the overall auditory elements of the advertisement. Characteristics such as “volume, articulation, and pacing” will now receive attention as integral components of conveying critical information regarding prescription drugs so that consumers may better understand a drug’s risks and benefits.
A significant requirement in the FDA’s final rule is that the major statement must be presented simultaneously using both audio and text, which the FDA describes as “dual modality.” This dual modality requirement has specific requirements for the display of text, including the display of verbatim key terms or phrases from the corresponding audio and the displaying of text for a sufficient duration of time to allow for it to be read easily. Alternatively, a firm may display a complete transcript of the corresponding audio throughout the entire duration of the advertisement. FDA considers the duration to be sufficient if the text begins at the same time and ends at approximately the same time as the corresponding audio message.
Additionally, television advertisements must have the information in text formatted such that the information can be read easily. The final rule introduces a requirement that the text portion of the major statement in television advertisements must be placed appropriately and presented against a “contrasting background” for a “sufficient duration.” The FDA further underscores the significance of font size, style and contrast with the background, though it declined to dictate a specific font size or other similar criterion.
Furthermore, the advertisement cannot include audio or visual elements during the presentation of the major statement that would interfere with a consumer’s comprehension of the major statement. In particular, the FDA establishes that a major statement may not include distracting representations that detract from the communication of the major statement. The rule makes clear that it does not categorically prohibit any specific audio or visual elements — such as music, sounds, statements, texts, and images — so long as such elements do not detract from the communication, considering the facts and circumstances presented by the specific advertisement. The FDA’s final guidance document makes it further clear that this standard is very fact-specific — it notes that, in certain circumstances, even things like upbeat music or amusing drawings may be permissible, though it does not elucidate under what circumstances these creative elements may “interfere” with audience comprehension.
Finally, the related guidance helps address the rule. The questions and answers guidance addresses issues that manufacturers should consider when making a major statement about their product that the agency considers to be clear, conspicuous and neutral. FDA restates the standards in the guidance and details how it expects manufacturers to comply with each standard.