Back to: Rx Drug Promotion and the Clear, Conspicuous, and Neutral Final Rule
🔔 Note: Stop playback at 37:30 to complete this lesson.
Presenter
Suzanna Boyle, JD
Regulatory Counsel
Division of Promotion Policy, Research and Operations (DPPRO)
Office of Prescription Drug Promotion (OPDP)
Office of Medical Policy (OMP)
Center for Drug Evaluation and Research (CDER)
US Food and Drug Administration (FDA)
Abstract
This presentation introduces the Clear, Conspicuous, and Neutral (CCN) rule, a new final regulation from the FDA’s Office of Prescription Drug Promotion (OPDP) effective May 20, 2024. This rule mandates that the “major statement”—key side effects and contraindications—in direct-to-consumer (DTC) human prescription drug advertisements on television and radio formats must be presented in a clear, conspicuous, and neutral manner. The CCN rule, driven by the FDA Amendments Act of 2007, focuses on how risks are presented, not what risks are included, aiming to enhance consumer understanding and promote informed decisions. All subject ads, primarily product claim communications mentioning a drug’s name and use, must achieve compliance by November 20, 2024. The rule outlines five standards for television ads (and three for radio), covering aspects like consumer-friendly language, audio clarity, dual audio-visual modality (for TV), text readability, and the absence of interfering elements. The FDA offers resources, including a Small Entity Compliance Guide and voluntary pre-dissemination review, to assist firms in adhering to these new requirements.