Spitz Weighs in: FDA Guidance on Product Name, Size & Prominence

Written by Michael Spitz, VP of Engagement Planning, Ignite Health

The FDA’s recent guidance regarding “Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling” features a section of particular interest to digital marketers called “Electronic and Computer-Based Promotional Labeling and Advertisements.”

Here the dual presentation of the established and proprietary names of a drug is stipulated for when the proprietary name is part of the running text (headlines, taglines, etc.), and if the running text spans more than one screen. By calling attention and providing name placement guidance for electronic text going to multiple pages, the FDA is beginning to think about the qualities of digital content, as qualitatively distinct from print and broadcast media—might this new approach usher in an era of FDA guidance specifically focused on the unique and increasingly pressing needs of the digital space?

Only time will tell, but all the signs point to this fresh and very welcome perspective.

FDA Issues Guidance for Industry Regarding Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling

January 2012

[Click here to download full PDF of Guidance]

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

[Click here to download full PDF of Guidance].

[Click here to read Ignite's quick take on the Guidance].

INTRODUCTION

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.

[Click here to download for PDF of Guidance].