FDA Clarifies Use of Product Names in Advertising and Promotional Labeling


The U.S. Food and Drug Administration recently published final guidance to clarify the requirements for the use of product names in promotional labeling and advertising for prescription drugs (including biological drug products).  This newsletter provides a brief summary of the guidance and its implications.

On January 24, 2012, the U.S. Food and Drug Administration (FDA) posted final guidance entitled Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling.  The final guidance, which modifies a draft guidance issued in January 1999, is intended to clarify the agency’s interpretation of the requirements for product name placement, size, prominence and frequency in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 recommendations provided in the final guidance apply to the use of product names in traditional print media, audio-visual (AV) promotional labeling (e.g., videos shown in a doctor’s office), broadcast media advertisements and electronic media (e.g., internet, social media, e-mail).  The guidance discusses requirements relating to single active ingredient products and products with two or more active ingredients.

The following topics are addressed in the sections of the final guidance that pertain to products with one active ingredient...

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