The FDA’s final rule for Direct-to-Consumer Prescription Drug Advertisements (released on November 21, 2023) will certainly impact the creative decisions agencies will make about how to structure the agency refers to as the “major statement” or the dual modality of presenting in a balanced or “neutral” manner the drug’s benefits and risks in visually clear, easily read and verbally paced, consumer-friendly language. The new requirements only apply to prescription drugs and not over-the-counter drugs, dietary supplements, and other products.

Drug companies and marketing agencies will now have to clearly state side effects and contraindications in direct-to-consumer (DTC) advertisements. The 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 Final Rule provides the establishes several specific 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. The FDA’s justification for each of the following five conditions can be found in the final rule’s preamble.

1)  The information must be presented in “consumer-friendly language and terminology that is readily understandable.” The FDA notes on this point that the viewer is considered to be an “ordinary” consumer, without reference to a particular grade level of education or a reading criterion.

2)  Audio information (in terms of the volume, articulation, and pacing used) must be “at least as understandable as the audio information presented in the rest of the advertisement.” The FDA stipulates that there must be comparability between the portions of the advertisement containing the major statement and the remainder of the advertisement.

3) For television advertisements, the information must be presented “concurrently using both audio and text” (or often referred to as dual modality). The final rule further provides that to achieve “dual modality,” the text that is displayed must include:

• the key terms or phrases from the corresponding audio, or
• the complete transcript of the corresponding audio.

Please note that the FDA 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.

4)  In addition for televisions ads, the format of the major statement text must “allow the information to be read easily.” This includes its the size and style of font, the contrast with the background, placement on the screen, and other visual elements so that the major statement can be easily read.

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.” The FDA urges avoiding using distracting elements, including statements, text, images, or sounds during the major statement.

Although much has changed in how consumer advertisements are delivered since the development of the 2007 Federal Food, Drug, and Cosmetic Act and more than 10 years after closing the third and final comment period, the FDA states 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.”

As you may recall, the FDA proposed in 2010 changing its regulations on DTC ads that run on TV and radio to address the Food and Drug Administration Amendments Act requirement for the “major statement relating to side effects and contraindications [to] be presented in a clear, conspicuous and neutral manner.” The FDA ran one comment period in 2010, and two after the release of a study of viewers’ understanding in 2012 receiving over 70 comments.

This may be a contributing factor with the FDA providing a longer period for implementation than anticipated in the original 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.

Agencies should begin educating their employees and pharmaceutical clients about the rule change before the implementation date. Marketing agencies and pharmaceutical manufacturers engaged in 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 both existing and planned advertisements into compliance within the FDA’s deadlines.

For questions about the FDA’s final rule on direct-to-consumer (DTC) prescription drug advertisements, please contact Jim Potter, CHC Executive Director at jpotter@cohealthcom.org.