FDA Issues Two Federal Register Notices on Prescription Drug Promotion

On December 11, 2017, the United States Food and Drug Administration (FDA) published two Federal Register notices regarding prescription drug promotion from the FDA’s Center for Drug Evaluation and Research (CDER) Office of Prescription Drug Promotion (OPDP).
Final Guidance on Promotional Labeling
The first notice announces the FDA’s Final Guidance on product name placement, size, prominence, and frequency in promotional labeling and advertisement for prescription drugs (human and animal), including prescription biological products. The FDA believes that the disclosure of the product name in promotional materials is important for the proper identification of the products to help ensure they are used safely and effectively.
The recommendations in this guidance relate to product names in traditional print media promotional labeling and advertisements such as journal ads, detail aids, brochures; audiovisual promotional labeling, such as videos shown in a health care provider’s office; broadcast advertisements (e.g., television advertisements, radio advertisements); and electronic and computer-based promotions such as internet, social media, emails, CD-ROMs, DVDs). In this guidance, FDA further clarifies issues relating to the direct conjunction of the proprietary and established names, as well as the frequency of use of the established name on printed pages or spreads, in running text or columns, in the audio portion of audiovisual promotions, and in electronic media.
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Source: Policy and Medicine - December 18, 2017 Category: American Health Authors: Thomas Sullivan - Policy & Medicine Writing Staff Source Type: blogs