Update on Product Name Placement & Prominence

February 19, 2012 Analyst: Dale Cooke

Regulatory Alert

EXECUTIVE SUMMARY
At the annual Drug Information Associations Marketing Pharmaceuticals 2012 conference1, 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 Promotional Labeling2. In his prepared remarks and a later question-and-answer session, Abrams clarified some aspects of the guidance and provided OPDPs views on one crucial element (the definition of a screen size) that was left undefined in the guidance itself3. Most importantly, Abrams clarified that OPDP does not expect the generic name to be used in every instance on a page/screen and that a screen is defined as what would be printed on an 8 x 11 piece of paper. He also discussed how quickly OPDP expects companies to implement the guidance. In light of Abramss 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 the clarified 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 use of the generic name. BACKGROUND 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 or designation 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 not featured but is used in the running text (or body copy) of the advertisement, then the established name must accompany the brand name at least once. (21 CFR 202.1(b)(1), emphasis added) NEW GUIDANCE As discussed in the previous Digitas Health Regulatory Alert on this subject4, the finalized guidance addressed two crucial issues in applying these regulations.5 The first issue is what constitutes a featured use of a brand name, and the second issue is how to understand the requirement to use the generic name on a page in the context of electronic media that display information on screens rather than printed pages. Featured Use The finalized guidance significantly expanded the definition of a featured use of a brand name to include all uses of the brand (proprietary) name that are not in the running text (body copy). 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.6 (emphasis in the original)

2012 Digitas Health. All rights reserved.

As quoted above, the regulations require the established name to accompany the proprietary name each time it is featured. (21 CFR 202.1(b)(1)) FDA is defining featured use in the final guidance as any use other than a running text use, including such uses as footnotes and pictures. To demonstrate the importance of this change, consider the image below for a fictional products website. Image 1

Image 1 shows how the regulation was being implemented before the January guidance was released. The product name is most prominently presented on this page in the logo in the upper left corner. That presentation was viewed as the featured use of the brand name and includes the established name presented in lettering at least half the size of the brand name, as required by 21 CFR 202.1(b)(1). The brand name is also used in other elements on the page, including headlines, navigation elements, and body copy; but the generic name does not accompany the brand name in these other locations. Implementing the guidance recommendations greatly expands the number of locations on this page where the established name is required. As shown in Image 2, all of the uses of the brand name that are not in body copy are highlighted in a red box. Based on the guidance, each of these locations would seem to require the addition of the generic name. Image 2

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Regulatory Alert: Update on Product Name Placement & Prominence

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The first point to note is that this fictional example has a fairly small generic name (Generibrand Sulfate). Some generic names, especially for combination products, are significantly longer. Including a much longer generic name merely exacerbates the issues discussed below. In addition to the obvious design challenge of including the generic name in some of these small locations, many in industry were concerned about the impact of this guidance on health literacy. Would the sudden expanded usage of the generic name have negative effects on the ability of consumers to comprehend the information presented? It seems reasonable to worry that including a long scientific name that is difficult to pronounce would make the information less accessible to consumers, who are not used to reading this information. Screen Size With regard to the second issue of how frequently the established name must accompany the proprietary name in running text, FDAs position on electronic media made use of an undefined concept of screen size. 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.7 The final guidance does not specify how to understand per screen. This matters because screen size varies widely. Smartphones, tablet computers, and desktop computers differ drastically in this respect, and even within a category there is significant variation. In addition, individual users can adjust their display settings to alter the amount of information provided on each screen. On what basis would OPDP determine compliance with this undefined concept? CLARIFYING REMARKS Both in his prepared remarks and during a separate question-and-answer session at the recent DIA conference, Abrams elaborated on both of these issues in addition to the question of how quickly OPDP expects companies to comply with the new guidance. Regarding featured use, Abrams said that the established name is NOT required with every use of the brand name outside of running text. Instead, OPDPs expectation is that the generic name will be used only with the most prominent use. If the most prominent use of the brand name is the logo in the header (as shown in Image 1 above), then the generic does NOT have to be repeated in every other use on the page or screen. In addition, Abrams asked himself rhetorically what a screen is. His answer was that a screen would be understood by OPDP as what would print out on an 8 x 11 piece of paper. This definition provides an objective measure of a screen that removes the ambiguity discussed above. When asked about the timing to implement the guidance, Abrams responded that OPDP does not expect companies to pull existing advertising materials. Instead, OPDP will permit companies to implement the new guidance on materials moving forward.

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RECOMMENDATIONS
These remarks provide important context for understanding OPDPs position as expressed in the guidance and Digitas Health recommends that companies take these comments into account when implementing the guidance. Specifically, companies should take the following actions: 1. Review any internal guidelines developed in response to the guidance and revise to comply with the clarified 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 use of the generic name.

ENDNOTES
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A transcript of the conference proceedings is not yet available. Descriptions of the comments rely on notes taken at the conference and Tweets of the proceedings. The conference program is available at http://meetings.diahome.org/12007/#agenda. This guidance is herein referred to as Product Name Placement and is available from the FDA website at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064956.htm Product Name Placement is a joint guidance representing the views of the Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Veterinary Medicine. Representatives of CBER were present on the panel when Abrams delivered his remarks. Several of the recommendations from that alert are no longer endorsed by Digitas Health. The previous Regulatory Alert is available at http://www.scribd.com/dale_cooke/d/79613523-Product-Name-UsageGuidance. The guidance also addressed other issues outside the scope of this Regulatory Alert, including the presentation of the generic name in the audio of broadcast advertisements and the prominence of the display of the generic name. In implementing the guidance, companies should also take into account these sections of the guidance. Product Name Placement, page 5 Product Name Placement, page 5

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