Recently, the United States Food and Drug Administration (FDA) released the final rule for Direct-to-Consumer Prescription Drug Advertisements. Under the final rule, in human prescription drug ads that are presented direct-to-consumer (i.e., in television or radio format) that state the name of the drug and conditions of use, the statement relating to major side effects and contraindications (the “major statement”) must be presented in a clear, conspicuous, and neutral manner. The effective date of the final rule is May 20, 2024, and the compliance date is November 20, 2024.
The FDA notes that this “final rule complements the longstanding requirements for including risk information in prescription drug ads, setting standards for the manner of presentation of the major statement of side effects and contraindications in DTC TV/radio ads to help ensure that this risk information is presented effectively – that is, in a way that helps consumers notice, attend to, and understand the drug’s risks.” The FDA also states the importance of “ensuring that DTC ads that provide benefit information about prescription drugs also effectively communicate risk information is particularly important because the effective presentation of risk information is critical to helping to ensure that DTC TV/radio ads convey a truthful and non-misleading net impression about the advertised drug, including its risks, and that consumers are better informed when they participate in healthcare decision making.”
The FDA also indicated in the final rule that more than 70 comments were submitted during the three public comment periods for the proposed rule, and that “the majority of comments express[ed] support for the rule.”
The final rule includes five standards that both independently and collectively help to ensure that the major statement is presented in a clear, conspicuous, and neutral manner: (1) the information must be presented in consumer-friendly language and terminology that is readily understandable; (2) the audio information in the major statement must be at least as understandable as the audio information in the rest of the ad; (3) for TV ads, the information presented in the audio portion of the major statement must also be presented concurrently in text for a sufficient duration to allow it to be easily read; (4) for TV ads, the information in the text must be formatted such that the information can be read easily; and (5) the ad must not include audio or visual elements during the presentation of the major statement that are likely to interfere with the comprehension of the major statement.
The FDA notes that when companies consider consumer understanding, the viewer should be considered to be an “ordinary” consumer, but does not reference a particular grade level of education or reading level. Additionally, the FDA considers the text time on-screen to be of sufficient duration if it begins and ends at the same time as the corresponding audio and regarding the ease of reading the on-screen text, size and style of font must be considered as well as contrast with the background, placement on the screen, and other visual elements.
Importantly, these changes only apply to prescription drugs, not over-the-counter drugs, dietary supplements, or other products.