FDA Issues Guidance for Industry Regarding Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling
January 2012
TOPICS COVERED:
TOPICS COVERED:
PRODUCTS WITH ONE ACTIVE INGREDIENT
• Juxtaposition of Proprietary and Established Names
• Size of Proprietary and Established Names
• Prominence of Proprietary and Established Names
• Frequency of Disclosure of Proprietary and Established Names:
- Traditional Print Promotional Labeling and Advertisements
- Audio-Visual Promotional Labeling and Broadcast Advertisements
- Electronic and Computer-Based Promotional Labeling and Advertisements
PRODUCTS WITH TWO OR MORE ACTIVE INGREDIENTS
• Juxtaposition of Proprietary and Established Names
• Size of Proprietary and Established Names
• Prominence of Proprietary and Established Names
• Frequency of Disclosure of Proprietary and Established Names:
- Traditional Print Promotional Labeling and Advertisements
- Audio-Visual Promotional Labeling and Broadcast Advertisements
- Electronic and Computer-Based Promotional Labeling and Advertisements
PRODUCTS WITH TWO OR MORE ACTIVE INGREDIENTS
This guidance is intended to clarify the requirements for product name placement, size, prominence, and frequency in promotional labeling and advertising for prescription human drugs, including biological drug products, and prescription animal drugs. The disclosure of the product name in promotional labeling and advertising for these products is important for their proper identification to ensure their safe and effective use.
The Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER), the Office of Surveillance and Compliance (OSC) in the Center for Veterinary Medicine (CVM), and the Advertising and Promotional Labeling Branch (APLB) in the Center for Biologics Evaluation and Research (CBER) frequently receive inquiries about the placement, size, prominence, and frequency of the proprietary name and established name in promotional materials. Generally, the inquiries address two topics: (1) the juxtaposition of the proprietary and established names in relation to certain graphic presentations and (2) problems that stem from obscuring the presentation of, or minimizing disclosure of, the established name.
The placement, size, prominence, and frequency of the proprietary and established names for prescription human drugs, including biological drug products, and prescription animal drugs are specified in labeling and advertising regulations. These regulations are applicable to prescription human and animal drug products that contain one or more active ingredient(s).
The recommendations in this guidance pertain to product names in traditional print media promotion (e.g., journal ads, detail aids, brochures), audio-visual promotional labeling (e.g., videos shown in a healthcare provider’s office), broadcast media promotion (e.g., television advertisements, radio advertisements), and electronic and computer-based promotional labeling and advertisements, such as Internet promotion, social media, e-mails, CD-ROMs, and DVDs.
The Office of Prescription Drug Promotion (OPDP) in the Center for Drug Evaluation and Research (CDER), the Office of Surveillance and Compliance (OSC) in the Center for Veterinary Medicine (CVM), and the Advertising and Promotional Labeling Branch (APLB) in the Center for Biologics Evaluation and Research (CBER) frequently receive inquiries about the placement, size, prominence, and frequency of the proprietary name and established name in promotional materials. Generally, the inquiries address two topics: (1) the juxtaposition of the proprietary and established names in relation to certain graphic presentations and (2) problems that stem from obscuring the presentation of, or minimizing disclosure of, the established name.
The placement, size, prominence, and frequency of the proprietary and established names for prescription human drugs, including biological drug products, and prescription animal drugs are specified in labeling and advertising regulations. These regulations are applicable to prescription human and animal drug products that contain one or more active ingredient(s).
The recommendations in this guidance pertain to product names in traditional print media promotion (e.g., journal ads, detail aids, brochures), audio-visual promotional labeling (e.g., videos shown in a healthcare provider’s office), broadcast media promotion (e.g., television advertisements, radio advertisements), and electronic and computer-based promotional labeling and advertisements, such as Internet promotion, social media, e-mails, CD-ROMs, and DVDs.
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