Nearly a decade and a half after a proposed rule was published, the FDA issued a final rule Nov. 20 to amend its prescription drug advertising regulations concerning the major statement in a direct-to-consumer (DTC) TV or radio advertisement that states the name of the drug and its conditions of use.

The rulemaking implements a requirement of the Federal Food, Drug, and Cosmetic Act added by the Food and Drug Administration Amendments Act of 2007 (FDAAA, Pub. L. No. 110-85). The notice of proposed rulemaking (NPRM) for the amended regulation was released in March 2010.

The NPRM proposed four standards and one potential additional standard for determining whether the major statement in DTC ads is presented in the statutorily required manner. The final rule, published in the Federal Register Nov. 21 (88 Fed. Reg. 80958), includes all five standards.

The standards are:

• Information is presented in consumer-friendly language with terminology that is readily understandable.
• Audio information, in terms of the volume, articulation, and pacing used, is at least as understandable as the audio information presented in the rest of the advertisement.
• In TV advertisements, the information is presented concurrently using both audio and text (dual modality). To achieve dual modality, (1) the text displays either the verbatim key terms or phrases from the corresponding audio or the verbatim complete transcript of the corresponding audio, and (2) the text is displayed for a sufficient duration to allow it to be read easily. 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.
• In TV advertisements, for the text portion of the major statement, the size and style of the font, the contrast with the background, and the placement on the screen allow the information to be read easily.
• During the presentation of the major statement, the advertisement does not include audio or visual elements, alone or in combination, that are likely to interfere with comprehension of the major statement.

The final rule is effective May 20, 2024, and the compliance date for the final rule is Nov. 20, 2024.“The FDA believes that this approach will enable firms to bring DTC TV/radio ads subject to the final rule into compliance with the rule, regardless of where those ads may be in their lifecycle,” the agency said.

Submissions to FDA’s Office of Prescription Drug Promotion (OPDP) requesting comments on draft DTC TV/radio ads made on or after the effective date for the final rule (May 20, 2024) will be reviewed for compliance with the final rule. Prior to the rule’s effective date, OPDP comments on submitted ads will not reflect the final rule unless the company specifically requests review of the ad for compliance with the final rule.

Companies should note in their submission cover letter that they are requesting OPDP comments for compliance with the final rule. They also should note whether the draft DTC TV/radio ad in the submission is new promotional material or a revised version that was previously submitted to OPDP on Form FDA 2253 along with the date of the original 2253 submission. OPDP recommended that companies include timestamps for storyboard and video frames.

In addition, if a company chooses to submit a request for comments, OPDP recommends that the company submit proposed DTC TV/radio ads in their entirety.

The FDA noted that more than a decade had passed between the last comment period to the publication of the final rule. “We recognize the passage of time between the closure of the last comment period on the proposed rule and the issuance of this final rule, which resulted in large part from competing demands for limited agency resources,” the agency said. “Despite this passage of time, FDA concludes that this rulemaking is both procedurally and substantively sound,” the notice said.

The FDA also noted that the final comment period, which ended in April 2012 was in response to a request for more time to submit comments to the agency on the Distraction Study as it related to the proposed standards.

The FDA said the Distraction Study examined three factors that might influence viewers' understanding of the risk information presented in the audio portion of a TV ad:

• Presence or absence of superimposed text (SUPERs) that concurrently presented verbatim, key words and phrases from the audio presentation of risk;
• Variations in the positive (affective) tone of visual images; and
• Visual information that was either inconsistent or consistent with the audio risk information.

“The results of the Distraction Study indicate that presenting the same risk information visually (i.e., in SUPERs) and in audio at the same time (dual modality) improves consumers' understanding of the risk information. The Distraction Study did not find support for the hypotheses that understanding of the risk information is adversely influenced by concurrently presenting positively toned visual images or by concurrently presenting information in visuals that is inconsistent with the risk information presented in audio,” the FDA notice said.

“While the Distraction Study and its results were a consideration during the formulation of the standards in this final rule, they were neither the sole justification for, nor the only information considered in, the development of any of the proposed or final standards,” the notice said.

Rather, the FDA based the standards “on scientific research, literature, and existing government standards,” the notice said. “Research findings supporting the proposed rule’s standards – including research findings on dual modality and distraction – were available during the public comment periods and have been subsequently corroborated by additional research, including research supporting that comprehension and recall is increased when information is provided in both audio and text and also when information is presented without distraction.”

The FDA added that the “fundamental concepts” in the final rule “remain the same as those articulated in the proposed rule. 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 since the issuance of the proposed rule,” the notice said.

However, the FDA noted that an informal review of ads that were recently submitted to the agency found that companies “have not developed distinct ads for dissemination on these new devices and platforms and that DTC TV/radio ads remain essentially the same. Moreover, fundamental attributes of communication that impact the likelihood that audiences will notice, attend to, and comprehend information, which the standards in the proposed and final rules concentrate on, do not turn on the delivery technology,” the notice said.

In addition, the final rule implements the Food and Drug Administration Amendments Act of 2007 (FDAAA) requirement that DTC TV and radio ads for human prescription drugs that state the name of the drug and its conditions of use must have a major statement relating to side effects and contraindications presented in a clear, conspicuous, and neutral manner.

In line with other government standards, findings from scientific research and literature, and the proposed rule, “this final rule establishes standards for determining whether the major statement in these ads is presented in a clear, conspicuous, and neutral manner,” the FDA said. However, the final rule does not address “neutral” separately from the overall concept of a “clear, conspicuous, and neutral manner” of presentation, nor does the FDA “associate that attribute exclusively with any single standard. Rather, we conclude that the final standards, independently and collectively, contribute to a clear, conspicuous, and neutral manner of presentation.”