© 2012 Digitas Health. All rights reserved.
Update on Product Name Placement & Prominence
February 19, 2012
Analyst: Dale Cooke
At the annual Drug Information Association’s Marketing Pharmaceuticals 2012 conference
, Thomas Abrams,the director of the Office of Prescription Drug Promotion (OPDP), spoke about the recently finalized
Guidance to Industry: Product Name Placement, Size, and Prominence in Advertising and PromotionalLabeling
. In his prepared remarks and a later question-and-answer session, Abrams clarified some aspects of the guidance and provided OPDP’s views on one crucial element (the definition of a screen size) that was leftundefined in the guidance itself
. Most importantly, Abrams clarified that OPDP does not expect the genericname to be used in every instance on a page/screen and that a “screen” is defined as what would be printedon an 8½” x 11” piece of paper. He also discussed how quickly OPDP expects companies to implement theguidance.In light of Abrams’s comments, Digitas Health recommends that companies take the following actions:1.
Review any internal guidelines developed in response to the guidance and revise to comply with theclarified position espoused at the DIA conference.2.
Incorporate the definition of a “screen” into company guidelines.3.
Review materials currently under development to ensure compliance.4.
Revise materials as they undergo expiry review to incorporate the newly clarified standards for useof the generic name.
According to the Code of Federal Regulations, “the established name [the generic name], if such there be,corresponding to such proprietary [brand] name or designation shall accompany such proprietary name ordesignation each time it is featured in the advertisement for the drug.” (21 CFR 202.1(b)(1))In addition, regulations require that “[o]n any page of an advertisement” if the brand name “is
featuredbut is used in the running text” (or body copy) of the advertisement, then the established name mustaccompany the brand name “at least once.” (21 CFR 202.1(b)(1), emphasis added)
As discussed in the previous Digitas Health Regulatory Alert on this subject
, the finalized guidance addressedtwo crucial issues in applying these regulations.
The first issue is what constitutes a featured use of a brandname, and the second issue is how to understand the requirement to use the generic name on a page in thecontext of electronic media that display information on screens rather than printed pages.
The finalized guidance significantly expanded the definition of a “featured” use of a brand name to includeall uses of the brand (proprietary) name that are not in the running text (body copy).“If the proprietary name is
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 timethe proprietary name appears.”
(emphasis in the original)