On November 21, the U.S. Food and Drug Administration (FDA or Agency) issued a final rule establishing the standards for determining whether direct-to-consumer (DTC) advertisements in television or radio format for human prescription drugs and biological products (DTC TV and radio drug ads) present the major statement relating to side effects and contraindications (the major statement) in a "clear, conspicuous, and neutral manner" as required by section 502(n) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 352(n)).1 The final rule has evidently been in the works since FDA published the proposed rule back in March of 2010, albeit subject to delays due to "competing demands for limited Agency resources";2 and the requirement that FDA issue such a regulation dates back to the Food and Drug Administration Amendments Act of 2007 (FDAAA).
In general, the final rule aligns with FDA's longstanding expectations that DTC TV and radio drug ads include important safety information, provide a fair balance between benefit and risk information, be understandable to consumers, and do not downplay or distract consumers from the advertisement's presentation of risks and other important information about the safety and limitations of the drug. FDA has taken the opportunity in the intervening years to conduct social science research in an effort to develop a more informed position on risk information comprehension as it relates to these issues.
Importantly, the final rule establishes a new requirement that DTC TV drug ads must present the major statement of risk information in concurrent audio and text (the dual modality requirement). The final rule also creates some ambiguity as to how the terms "media" and "television format" would apply to content played on the internet or social media platforms. This is important because the format of required information may change depending on the answer.
While the final rule does not deviate from FDA's 2010 proposal in terms of the content which must be included in the major statement, the final rule does establish five standards intended to help ensure that the major statement is presented in a clear, conspicuous, and neutral manner in DTC TV or radio drug ads. Specifically, the final rule provides that the major statement in a DTC TV or radio drug ad meets the requirement to be presented in a clear, conspicuous, and neutral manner if:
- The major statement is presented in consumer-friendly language and in terminology that is readily understandable
- The audio information of the major statement, 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
- 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
- Additionally, for DTC TV drug ads specifically:
- The major statement is presented concurrently using both audio and text (the dual modality requirement)
- 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
To satisfy the "dual modality" requirement (which applies only to DTC TV drug ads) the rule provides the option for the major statement text to either display the verbatim complete transcript of the corresponding audio or to display "the verbatim key terms or phrases" from the corresponding audio. The rule further specifies that the major statement text must be displayed for a sufficient duration to allow it to be read easily, and explains 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. As an example of how to comply with the dual modality requirement, in the preamble, FDA provides an example of a voiceover stating that "the most common side effects of DRUGX are dry mouth, headache, and heartburn" while accompanying text presents bullets stating "dry mouth," "headache," and "heartburn."3
The dual modality requirement is a significant departure from the prior regulation and may be controversial.4 Prior to the publication of the final rule, FDA regulations had specifically provided that DTC TV drug ads could present the major statement in either the audio or in both the audio and visual parts of the advertisement,5 permitting a "voiceover" approach which became an accepted approach in the industry. The new dual modality requirement is also a change in the way the Agency and industry have previously thought about presentation of risk information. The change may require some companies to more concretely establish which side effects and contraindications are "major," as those side effects and contraindications in particular will need to be presented with accompanying text. As FDA has acknowledged, because risks vary from product to product, which side effects and contraindications are "major," and how much information must be included about each of them to satisfy the major statement requirements, will vary from product to product.6
Notably, FDA devotes a significant portion of the rule's preamble to addressing concerns that the Agency may apply the provisions of the rule in an overly restrictive manner or in a manner that suppresses effective marketing techniques. In particular, FDA clarifies that the rule does not require the major statement to be presented in a bland manner such that the audience becomes disengaged during that part of the ad, nor does FDA intend to require a "tombstone" (e.g., black and white) presentation of the major statement. FDA also clarifies that the rule does not categorically prohibit visual depictions of benefits, or positive imagery, during presentation of the major statement.7
It is understandable, however, that companies may be wary of how FDA will apply these standards, particularly considering that FDA had previously sought to implement a separate provision of FDAAA — a provision authorizing pre-dissemination review of TV commercials by FDA — in a manner that much of industry saw as unduly aggressive.8 Perhaps in anticipation of legal and policy challenges down the road, FDA has devoted a significant portion of the preamble to the rule explaining the Agency's rationale as to why it believes it has the authority to regulate DTC TV and radio communications in the manner set forth in the final rule. Further, FDA explains that even if one or more of the rule's standards is stayed or invalidated, the remaining standards would continue to advance the statutory objectives of ensuring the major statement is presented in a clear, conspicuous, and neutral manner.9
While the final rule is set to go into effect May 20, 2024, the compliance date for the rule is November 20, 2024. At such time, the standards established by the rule would apply to all DTC TV and (as applicable) radio drug ads in circulation.
Footnotes
1. 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, 88 Fed. Reg. 80958 (Nov. 21, 2023). The provisions of the final rule will be primarily codified at 21 CFR 202.1(e)(1).
4. While most of the other standards established by the rule arguably clarify certain existing FDA requirements and expectations, the dual modality requirement explicitly changes a regulatory requirement that has been in place for television advertisements for many years. The option to present the major statement in either audio or audio and visual format in TV and radio ads dates back to 1969 (see FDA, "Prescription-Drug Advertisements: Order Acting on Objections," 34 Fed. Reg. 7802 (May 16, 1969)).
5. This provision was in the now-to-be-amended 21 C.F.R. 202.1(e)(1).
6. See, e.g., OPDP Frequently Asked Questions on FDA.gov.
8. See FDA Draft Guidance for Industry, "Direct-to-Consumer Television Advertisements — FDAAA DTC Television Ad PreDissemination Review Program" (March 2012) (implementing FDAAA section 503B). This proposed predissemination review program was never finalized, in the wake of significant pushback from industry and concerns about the proposed program's Constitutional legality.
9. Specifically, FDA states: "Although we believe that the five standards established by this rule, when applied collectively, will best help ensure that the major statement in a DTC TV/radio ad is presented in a clear, conspicuous, and neutral manner, each standard independently enhances the manner of presentation to increase the likelihood that consumers will notice, attend to, and understand the advertised drug's major side effects and contraindications. In the event of a stay or invalidation of any standard(s), those that remain in effect would continue to function sensibly to advance these statutory objectives and provide useful standards for firms to meet their existing statutory obligation.... Therefore, it is FDA's intent to preserve each of the rule's standards to the fullest possible extent, to help advance the important Government interests described [above]." 88 Fed. Reg. at 80967.
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