FDA Policy/General

New DTC Major Statement Standards Become Effective

After a one-year implementation period, new FDA standards became effective 11/20 requiring drug marketers to ensure their direct-to-consumer advertisement’s “major statement” is presented in a clear, conspicuous, and neutral manner. The five standards, outlined in an 11/20/2023 final rule entitled, “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,” are:

Information must be presented in consumer-friendly language and terminology that is readily understandable.
The audio information in the major statement must be at least as understandable as the audio information presented in the rest of the ad.
In ads in TV format, 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 read easily.
In ads in TV format, the information in text must be formatted such that the information can be read easily.
The ad must not include audio or visual elements during the presentation of the major statement that are likely to interfere with comprehension of the major statement.

The agency notes that finalizing the proposed rule, which was issued in 2010, was delayed due to competing resources during the Covid-19 public health emergency.

FDA says it based the standards in both the proposed and final rule on scientific research, literature, and existing government standards. “Research findings supporting the proposed rule’s standards — including research findings on dual modality and distraction — were available during the public comment periods and have been subsequently corroborated by additional research,” it says, “including research supporting that comprehension and recall is increased when information is provided in both audio and text and also when information is presented without distraction.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome