FDA issues new standards for DTC prescription drug ads

The US Food and Drug Administration (FDA) published its final rule changing how companies must present the “major statement” in direct-to-consumer (DTC) TV and radio advertising.

The rule, published on 21 November, implements a Food and Drug Administration Amendments Act requirement in effect since March 2008 and establishes five standards for conveying a DTC ad major statement in “a clear, conspicuous, and neutral manner” (RELATED: Labeling, DTC advertising and compounding rules make FDA’s semiannual regulatory agenda, Regulatory Focus 27 July 2023).

These standards require that:

The major statement is presented in language and terminology that is consumer friendly and readily understandable
Audio information in the major statement is as understandable as audio information in the rest of the ad in terms of volume, articulation and pacing
During presentation of the major statement, the ad does not contain audio or visual elements that might interfere with a consumer’s understanding of the content
During TV ads, the text information is presented in way that is easy to read
During TV ads, the major statement is be presented simultaneously in audio and text, and is shown for long enough to be read easily

“The clear, conspicuous, and neutral presentation of risk information in DTC TV/radio ads, in addition to benefit information, helps ensure that these ads convey a truthful and non-misleading net impression about the advertised drug and that consumers are better informed when they participate in healthcare decision making,” FDA wrote in the Federal Register notice.

The rule goes into effect on 20 May 2024 and the compliance date is 20 November 2024.

Changes from proposed rule

The proposed rule, issued in March 2010, initially contained four similar standards concerning major statements made in TV and radio ads for prescription drug ads. The four proposed standards included that information be presented to consumers with language that was readily understandable; audio information be understandable in terms of volume, articulation, and pacing used; ad text have an appropriate and readable placement; and that the ad should not contain any distractions during the presentation of the major statement.

In the proposed rule, FDA also asked for comment on a fifth standard to require that the major statement be conveyed simultaneously in an audio and visual format in the ad.
The proposed rule went through three public comment periods, with the last ending in 2012. FDA acknowledged in the Federal Register notice that more than a decade had passed between the last comment period to the publication of the final rule.

“We recognize the passage of time between the closure of the last comment period on the proposed rule and the issuance of this final rule, which resulted in large part from competing demands for limited Agency resources,” the agency said, citing “repeated redirection of personnel into emergency operations for natural disasters, the opioid epidemic, and infectious disease outbreaks including Ebola, Zika, and the COVID-19 pandemic” as reasons for the gap.

“Despite this passage of time, FDA concludes that this rulemaking is both procedurally and substantively sound,” FDA wrote.

Distraction study, comments on proposed rule

FDA also discussed the results of the Distraction Study, which evaluated how consumers reacted to visual distractions when risk information was conveyed through audio in a DTC TV ad for a prescription drug. The agency analyzed how consumers reacted to the absence and presence of superimposed text that contained a verbatim statement of the concurrent audio statement of risk, key words associated with the audio statement and phrases from the audio. They also examined how visual images did, or did not, impact consumers’ perceptions, including visuals that were consistent or inconsistent with the message.

Overall, consumers understood the risk information better when they saw the same risk information in audio format with a verbatim text accompaniment. However, they did not find that contrasting visuals negatively affected the consumers’ understanding of the risk information.

“While the Distraction Study and its results were a consideration during the formulation of the standards in this final rule, they were neither the sole justification for, nor the only information considered in, the development of any of the proposed or final standards,” FDA wrote.

The agency dedicated much of the remaining space in the 87-page Federal Register responding to comments on the proposed rule, which generally asked for clarification or more detail, or suggested the agency conduct more research before issuing the final rule.

Responding to comments criticizing the scope of the Distraction Study and asking FDA to do more research, the agency said, “there is a strong basis for the final rule without the Distraction Study or the additional research that some comments suggest be conducted.”

Federal Register Notice

FDA issues new standards for DTC prescription drug ads

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