FDA issued the final rule Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format (Final Rule) on November 22, which follows a proposed rule on the same topic published in 2010.
Per the preamble to the Final Rule, this new regulation implements 2007 changes to the Federal Food, Drug, and Cosmetic Act (FD&C Act) requiring that human prescription drug direct-to-consumer advertisements that state the name of a drug and its conditions of use also state the major side effects and contraindications of the drug (major statement) in a clear, conspicuous, and neutral manner. (See Section 502(n) of the FD&C Act.)
Although much has changed in how consumer advertisements are delivered since the development of the proposed rule, including with respect to platforms and devices, the preamble to the Final Rule provides that the “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 Final Rule establishes five conditions, which, if met, establish that the major statement in such an advertisement meets the requirement that the information be presented in a clear, conspicuous, and neutral manner.
In the preamble to the Final Rule, FDA emphasizes that the rulemaking does not change the content of the risk information provided in the major statement, but rather addresses how the major statement is presented.
The five conditions established in the Final Rule include the following:
- Condition 1: “It is presented in consumer-friendly language and terminology that is readily understandable.” The preamble to the Final Rule notes on this point that the consumer is considered to be an “ordinary” consumer, without reference to a particular grade level of education or a reading criterion.
- Condition 2: “Its 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.” The preamble to the Final Rule on this criterion is focused on the comparability of the portions of the advertisement containing the major statement and the remainder of the advertisement.
- Condition 3: “In advertisements in television format, it is presented concurrently using both audio and text (dual modality).” The Final Rule further provides that to achieve “dual modality,” the text that is displayed must include (verbatim) (a) the key terms or phrases from the corresponding audio or (b) the complete transcript of the corresponding audio. Further, the Final Rule specifies that the corresponding text must be displayed for a sufficient duration to allow it to be read easily, which will be considered sufficient if it begins at the same time and ends at approximately the same time as the corresponding audio.
- Condition 4: “In advertisements in television format, for the text portion of the major statement, the size and style of font, the contrast with the background, and the placement on the screen allow the information to be read easily.” On this criterion, the preamble to the final rule focuses on appropriate placement of the major statement as well as the combination of contrast, placement, and other visual elements so that the major statement can be easily read.
- Condition 5: “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.” On this criterion, the preamble to the Final Rule refers to avoiding using distracting elements, including statements, text, images, sounds, or combinations of the foregoing.
Providing a longer period for implementation than anticipated in the proposed rule, the Final Rule becomes effective 180 days after its publication on May 20, 2024, with a compliance date of 365 days after its publication on November 20, 2024.
Drug manufacturers engaged in this type of direct-to-consumer advertising will need to carefully consider the ramifications of these new regulations and consider what actions would need to be taken to bring existing and planned advertisements into compliance within the deadlines set by FDA.