FDA Issues Final Rule and FAQ Regarding Direct-to-Consumer Drug Advertising

At a Glance

• The final rule 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; rather, it focuses on the accessibility of that information in consumer-friendly language that is readily understandable. 
• Companies may voluntarily request comments from the FDA and receive feedback on their proposed DTC advertisements before their dissemination.
• While the effective date of the final rule is set for May 20, 2024, companies are granted until November 20, 2024, to come into compliance with these new requirements.

In a stride toward transparency and heightened consumer awareness, the Food and Drug Administration (FDA) has issued a final rule, dated November 21, 2023, to amend its regulations regarding direct-to-consumer (DTC) advertisements for prescription drugs in television and radio formats. One month later in December 2023, FDA issued a final guidance document, which is intended to help entities understand and comply with the standards established in the final rule. These standards will be codified at 21 CFR 202.1(e)(1)(ii)(A)–(E).

Executive Summary

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. The audio information in the major statement must be at least as understandable as the audio information presented in the rest of the advertisement. For advertisements in television format, the information presented in the audio portion of the major statement must also be presented concurrently in text for a sufficient duration of time to allow it to be read easily. Additionally, television advertisements must have the information in text formatted such that the information can be read easily. 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.

Overview of Final Rule and FDA Guidance

Companies seeking to comply with these standards may voluntarily request comments from the FDA on their proposed DTC advertisements before their dissemination. Reviewers in the FDA Office of Prescription Drug Promotion within the Center for Drug Evaluation and Research, as well as reviewers within the Advertising and Promotional Labeling Branch of the Center for Biologics Evaluation and Research, will evaluate draft advertisements for compliance and provide feedback to companies, who may submit such requests according to the FDA guidance document Providing Regulatory Submissions in Electronic and Non-Electronic Format — Promotional Labeling and Advertising Materials for Human Prescription Drugs (April 2022).

1. Major statements must be presented in “consumer-friendly” language.

At the heart of the FDA’s new rule is a fundamental change in how information is communicated to consumers. The FDA will now require major statements to be presented in language and terminology that is both “consumer-friendly” and “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. 

2. Audio information must be understandable. 

The final rule clarifies that the audio information in the major statement must be 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. 

3. Text must be presented in a clear, conspicuous and neutral manner.

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. 

4. Text information in advertisements must be readable. 

The readability of text information in television advertisements also received additional focus under the FDA’s final rule. 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.

5. Ads must not include “distractions.”

The final rule addresses potential distractions during the major statement, emphasizing the need for a clear and focused presentation that avoids elements likely to interfere with a consumer’s comprehension of the advertisement. 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. Notably, this fifth standard applies only to the portion of the advertisement during which the major statement is provided.

Compliance Date

While the effective date of the final rule is set for May 20, 2024, companies are granted until November 20, 2024, to come into compliance with these new requirements. This extended timeline reflects that the FDA is aware of the evolving landscape of DTC advertising and provides companies with a transition period to align with the revised standards.

Looking Ahead: Potential Industry Impact

As the pharmaceutical and advertising industries navigate these new regulations, questions remain regarding the potential impact on telehealth services. The convergence of regulatory changes in both prescription drug advertising and telehealth prescribing adds a layer of complexity to drug advertising. The new standards for DTC advertising of prescription drugs signal a shift towards empowering consumers with clearer, more accessible information. Pharmaceutical and advertising stakeholders will need to pay close attention to compliance and enforcement in this area.