New Prescription Drug Advertisement Rule Effective This Week
(Thursday, May 23, 2024) Direct-to-consumer (DTC) advertisements for prescription drugs and biologics are important for creating product awareness among potential users/patients in the US and critical for their commercial success. Starting this week, a new rule for the tone and content of these advertisements has come into effect that requires these ads to meet five standards to ensure that side effects and contraindications for the drugs are presented in a clear, conspicuous, and neutral manner. Under the new rule, prescription drug advertisements will be evaluated against the following five standards. First, information about side effects and contraindications must be presented in consumer-friendly language and terminology that is readily understandable. Second, audio information included in an advertisement should use a consumer-friendly volume, articulation, and pacing such that it is at least as understandable as the audio information presented in the rest of the ad in similar terms. Third, for ads in TV format, the major statement about side effects and contraindications should be presented concurrently using both audio and text (dual modality). “To achieve dual modality: (1) either the text displays the verbatim key terms or phrases from the corresponding audio, or the text displays a verbatim complete transcript of the corresponding audio; and (2) the text is displayed for a sufficient duration to allow it to be read easily. For the purposes of this standard, 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.” Fourth, textual information about side effects and contraindications should be placed appropriately and presented against a contrasting background for sufficient duration and in a size and style of font that allows the information to be read easily. And fifth, the advertisement should “not include distracting elements (including statements, text, images, or sounds or any combination thereof) that detract from the communication of the major statement.” The Final Rule, is effective starting Monday this week (20 May 2024). AUTHOR
Dr. Mukesh Kumar Founder & CEO, FDAMap Email: [email protected] Linkedin: Mukesh Kumar, PhD, RAC Instagram: mukeshkumarrac Twitter: @FDA_MAP Youtube: MukeshKumarFDAMap |
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