Tuesday, January 24, 2012
The FDA has issued a final guidance for industry product name placement, size and prominence in advertising and promotional labeling, including juxtaposition of proprietary and established product names.
But this guidance includes something new since the draft guidance was published 13 years ago. Along with its recommended actions for print and broadcast media, it includes a section on social media.
The FDA said its 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.
Under the section Frequency of Disclosure of Proprietary and Established Names, section three is titled Electronic and Computer-Based Promotional Labeling and Advertisements. It reads as follows:
“Promotional labeling and advertising in electronic and computer-based media also do not contain text pages like print media. However, promotional labeling and advertising in such media often contain running text equivalent to many pages of traditional printed text. If the proprietary name is not part of the running text (e.g., headlines, taglines, logos, footnotes, graphs, or pictures), the established name is required to accompany the proprietary name each time the proprietary name appears. If the proprietary name is part of the running text, the established name is required to accompany the proprietary name at least once in the running text. If the running text spans more than one screen, FDA recommends that the established name accompany the proprietary name at least once per screen.”