16 Years in the Making: FDA Publishes Final Rule Related to Presentation of Risk Information in Direct-to-Consumer Prescription Drug Ads in TV and Radio Format

On November 21, 2023, the U.S. Food and Drug Administration (“FDA”) published a long-awaited final rule on the “Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format.”¹ This final rule, which amends FDA’s prescription drug advertising regulations, implements a statutory requirement established by the Food and Drug Administration Amendments Act of 2007 (“FDAAA”) that direct-to-consumer (“DTC”) advertisements for prescription drugs in TV and radio format present the so-called “major statement” related to side effects and contraindications “in a clear, conspicuous, and neutral manner.”

FDA originally published a proposed rule to implement this requirement more than 13 years ago in March 2010. Despite the significant passage of time and the way that evolving technologies have affected how companies disseminate prescription drug advertisements, FDA asserts that the rulemaking remains procedurally and substantively sound and that no additional opportunity for public comment was warranted. Although much of the final rule aligns with the 2010 proposed rule, the final rule now includes a requirement for advertisements in TV format that the major statement be presented simultaneously in both the audio and visual portions of the ad. Besides establishing standards for what “in a clear, conspicuous, and neutral manner” means, the final rule does not otherwise alter the required content of the major statement in broadcast advertisements, nor does it clarify how FDA currently interprets the term “television and radio format” even though the way society watches “TV” and listens to “radio” has evolved substantially since 2007.

This Alert summarizes the key aspects of the final rule and the important takeaways for marketers of prescription drugs. While the effective date of the final rule is technically May 20, 2024, the “compliance date” for companies to adhere to the new requirements is November 20, 2024.

Overview of the Final Rule

The final rule establishes five standards for conveying the major statement in a DTC prescription drug ad in a “clear, conspicuous, and neutral manner.”

1. The major statement is presented in consumer-friendly language and terminology that is readily understandable. Language and terminology used in the major statement should be appropriate for a consumer audience and should avoid medical or technical jargon or terms usually more familiar to health care professionals. FDA declined to adopt the “least sophisticated consumer” standard used by the FTC in the context of debt collection practices, as suggested by one comment, and instead will follow its long-standing position that the consumer audience is an ordinary consumer acting reasonably.
2. The audio presentation of the major statement is at least as understandable as the audio in the rest of the ad. Audio information in the major statement should be as understandable as audio information in the rest of the ad in terms of volume, articulation, and pacing. FDA states that because pharmaceutical companies have an incentive to present the benefits of a drug using volume, articulation, and pacing that ensure understandability, requiring that the audio presentation of the major statement be at least as understandable as the rest of the advertisement will help ensure that risk information is appropriately understood.
3. For ads in TV format, the major statement is presented concurrently in both audio and text and for long enough for the text to be read easily. This standard is also known as dual modality. Dual modality can be achieved either by displaying the verbatim key words or phrases from the corresponding audio or by displaying the verbatim complete transcript of the corresponding audio. Regarding duration, FDA states that duration of the information would be considered sufficient if the text display begins at the same time and ends at approximately the same time as the corresponding audio. In the Federal Register preamble, FDA responded to concerns that the dual modality requirement might run afoul of the First Amendment by noting that the Supreme Court has upheld required disclosures of factual and uncontroversial information about a product or service in commercial speech,² which FDA posits is the case for information conveyed in the major statement.
4. For ads in TV format, text information is presented in easy-to-read format. This standard requires that text information be easily readable for consumers in terms of size and style of font, contrast with the background, and placement on the screen. However, FDA declined to dictate a specific font size or other similar criterion, despite comments requesting that the Agency do so. FDA found this level of detail unnecessary given the number of ways to present textual information in an easy-to-read manner.
5. During the major statement, the ad does not include audio or visual elements, alone or in combination, that are likely to interfere with comprehension. This standard addresses the statutory requirement to ensure the major statement is clear and conspicuous by limiting distracting audio or visual elements during the major statement. This standard does not categorically prohibit any specific types of elements during the major statement, such as music, sound effects, or drawings. Additionally, the standard does not categorically prohibit visual depictions of benefits or positive imagery during presentation of the major statement. Rather, FDA will take a holistic approach to determine whether the major statement has elements that distract or otherwise interfere with a consumer’s ability to adequately understand the content being presented.

Key Takeaways

• The five standards included in the final rule for ensuring that the major statement is presented “in a clear, conspicuous, and neutral manner” address a long-standing concern by FDA and Congress regarding DTC advertisements that may not adequately convey risk information to consumers. FDA has issued numerous untitled letters to pharmaceutical companies on this topic in the past. For example, FDA has cited pharmaceutical companies for TV ads that contain attention-grabbing, distracting visual and audio elements (e.g., a person dancing to an upbeat song) and superimposed text slogans during the presentation of risk information that competed for the viewer’s attention and allegedly made it difficult to adequately process risk information.
• Some of the standards in the final rule include broad and potentially subjective language where it remains to be seen how FDA will apply the standard in practice. For example, it is not clear how strictly FDA will enforce the requirement that the major statement use “consumer-friendly” and “readily understandable” language, especially for ads involving products where the relevant indications or risk considerations are inherently complex and where some “jargon” may potentially be necessary to avoid oversimplifying. Additionally, the final rule does not elaborate on how FDA interprets the term “at least as understandable” with regard to volume, articulation, and pacing or exactly what sorts of presentations would be likely to interfere with comprehension of the major statement.
• Consistent with the statutory language of FDAAA, the final rule specifically applies to prescription drug advertisements in “television and radio format” but does not provide further clarity regarding the meaning of this phrase. This omission represents a missed opportunity for FDA to clarify whether ads that resemble traditional TV or radio ads in terms of content but that are only disseminated via social media, podcasts, or other digital platforms are considered to be in TV or radio “format.” In the preamble to the final rule, FDA acknowledges that “evolving technologies have allowed for DTC TV/radio ads to be presented on a broader range of devices and disseminated via a broader range of platforms,” citing several articles about viewing and listening habits for TV (including streaming TV services) and radio. FDA then asserts that “firms have not developed distinct ads for dissemination on these new devices and platforms and that DTC TV/radio ads remain essentially the same.” The final rule does not otherwise address the streaming TV landscape, and the final rule nowhere mentions podcasts or “social media,” “online,” or “digital” communications. FDA has previously distinguished between “TV” ads for prescription drugs and video ads on the internet in the separate context of submissions of promotional materials via Form 2253.³ This distinction suggests that video ads presented only via online and social media platforms—and not broadcast, cable, or streaming TV—are not in “TV format” for purposes of the final rule. Whether FDA will confirm this view—and also confirm that ads presented on podcasts are not in “radio format”—remains to be seen.
• In connection with the issuance of the final rule, FDA responded to a citizen petition submitted in 2020 that had asked FDA to amend the prescription drug advertising regulations to ban music outright during the presentation of risk information in DTC prescription drug ads.⁴ In its response, FDA acknowledged that music can be distracting but declined to impose a regulatory ban on all music in DTC ads. FDA said it would instead apply existing regulations, including the new final rule, to the specific facts of each ad – which includes an assessment of background music, if any, along with other creative elements.

We will continue to monitor developments related to prescription drug advertising. If you have any questions regarding this Alert, please contact any member of Ropes & Gray’s FDA regulatory practice or your usual Ropes & Gray advisor.