A new final rule promulgated by the United States Food and Drug Administration (FDA) is now in effect, amending regulations concerning direct-to-consumer advertisements for human prescription drugs that are presented in a television or radio format and states the name of the drug and its conditions of use.
The final rule now implements a requirement of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by the Food and Drug Administration Amendments Act of 2007 (FDAAA), that in such DTC TV/radio ads, the major statement relating to side effects and contraindications must be presented in a clear, conspicuous, and neutral manner. As directed by FDAAA, the final rule outlines those standards to determine whether the major statement in DTC TV/radio ads is presented in a clear, conspicuous, and neutral manner.
The rule provides five standards for DTC ads to convey the major statement in a clear, conspicuous, and neutral manner: (1) the major statement is presented in consumer-friendly language that is easily understandable; (2) the audio presentation of the major statement is at least as understandable as the audio in the rest of the advertisement; (3) for television ads, the major statement is presented concurrently in both audio and text and for long enough for the text to be read easily; (4) for television ads, text information is presented in an easy-to-read format; and (5) during the major statement, the advertisement does not include audio or visual elements – either alone or in combination – that are likely to interfere with comprehension.
Easily Understandable
The language and terminology used in the major statement should be appropriate for a general consumer audience and should not be bogged down with medical or technical jargon, or with terms that are more familiar to health care professionals. The FDA will follow its typical position, which is the consumer audience is an ordinary consumer who acts reasonably.
Audio Presentation
The rule also requires that audio information in the major statement be as understandable as audio information in the rest of the advertisement. This includes in terms of volume, articulation, and pacing.
Concurrent Presentation in Audio and Text
This standard is known as dual modality and can be met by either displaying the verbatim key words or phrases from the corresponding audio or by displaying the verbatim transcript of the corresponding audio. The duration of the information is sufficient if the text display starts and ends at roughly the same time as the corresponding audio.
Easy-to-Read Format
For television ads, the text must be easy to read, including with respect to the size and style of the font, contrast with the background, and the placement on the screen. The FDA did not specify font sizes or other criteria as part of this standard.
No Interference with Comprehension
This standard aims to limit distracting audio or visual elements during the major statement but stops short of prohibiting any specific types of audio or visual elements, such as music or drawings. The standard also does not specifically prohibit visual depictions of benefits or other positive images while the major statement is being presented. Instead, the FDA will take a holistic approach to determine if an advertisement is compliant with this standard.
Compliance Date is November 20, 2024
While the rule became effective on May 20, 2024, the compliance date of the rule is November 20, 2024. Additionally, some may say that while this final rule is helpful, the agency still has a ways to go in protecting the consumer. For example, it does not cover over-the-counter drugs, dietary supplements, or other products not under the purview of the FDA. Additionally, it is not clear how the FDA plans to interpret the “television and radio format,” and whether it will include streaming services and/or social media platform advertisements.