FDA Releases Final Guidance on Placement of Product Proprietary and Established Names in Advertising and Promotional Labeling

The Office of Prescription Drug Promotion (OPDP) in the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research issued a final guidance document in January 2012 to clarify the regulations that specify requirements for the placement of a product’s name, size, prominence and frequency in promotional labeling. The regulations at issue, which appear at 21 C.F.R. §§ 201.10(g), (h) and 202.1(b), (c) and (d), apply to prescription drug products that contain one or more active ingredients. OPDP developed the guidance jointly with the Center for Biologics Evaluation and Research (CBER) and the Center for Veterinary Medicine (CVM). As such, the guidance applies to all prescription drugs, biologics and veterinary medicines. Notably, the guidance also addresses requirements pertaining to internet promotion and social media, an area in which FDA guidance has traditionally been less vocal. The guidance does not speak to requirements for over-the-counter drugs, medical devices, dietary supplements, or cosmetics. While the guidance is not legally binding, it represents the FDA’s current thinking on this topic.

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