Instead, these guidelines respond to requests that the FDA clarify the specific regulations for placement, size and prominence of brand names vs. generic names appearing in promotional advertisements (print, audio/video and online). Below is a high level overview of the FDA guidance. You can find a more detailed explanation of each section further down in this article. For the full PDF of the FDA guidance, click here.
Please note: The FDA makes the distinction between “running text,” (the main body of text) and other items on a web page including “headlines, taglines, logos, footnotes, graphs or pictures.”
Frequency of Disclosure
While the FDA guidance takes steps to clarify the required relationship between brand and generic names in promotional materials, it merely notes specifics regarding the physical placement/presentation of the terms.
The agency does not take into account certain inherent aspects of technology. For instance, the agency references “screens” in the section regarding “frequency of disclosure of names…,” however, it does not take into account the many different types of screens and various ways a website or advertisement can be displayed. Is the FDA referring to what you see upon landing on the page? or scrolling from top to bottom? What about browser specifications, screen resolutions and viewing content on tablets or various mobile devices? These are all questions that have yet to be addressed by the FDA.
Furthermore, the classification of “online media” does not distinguish between advertisements, websites or social media channels. As with most of the recent FDA guidance, these issues are left to interpretation.
Our CCC teams are here to help clients navigate the FDA guidance and ensure adherence to all rules and regulations. If you have any questions or concerns, don’t hesitate to reach out.
Note: The FDA defines “proprietary” as the “brand” name and “established” as the “generic” name of the drug.
Juxtaposition of Proprietary and Established Name
Previous FDA guidance directed that “the established name shall be placed in direct conjunction with the proprietary name or designation.” The January 2012 guidance further clarifies this to state that the established name be placed either directly to the right of, or directly below, the proprietary name. FDA also recommends that “the proprietary name and the established name not be separated by intervening matter, such as a logo, tagline, or other graphics.”
Note: FDA does not intend to prohibit companies from using trademark symbols, such as registered trademark (®) and unregistered trademark (™), or controlled substance symbols (e.g., CII).
Size of Proprietary and Established Names
When the established (generic) name accompanies the proprietary name (brand), the regulations also state that:
Prominence of Proprietary and Established Names
This section clarifies that FDA will consider all methods used in promotional communications to provide emphasis (type size, spacing and contrast), when evaluating whether the established name is presented within the above guidelines. For example, if the proprietary name is printed in bold black text, the FDA recommends that the established name be presented in the same way.
Frequency of Disclosure of Proprietary and Established Names
Note: This section only covers “Electronic and Computer-Based Promotional Labeling and Advertisements” and “Audio-Visual Promotional Labeling and Broadcast Advertisement” as defined by the FDA.