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DH Reg Alert Update Product Name Usage Guidance

DH Reg Alert Update Product Name Usage Guidance

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Published by Dale Cooke
This Regulatory Alert provides an update based on comments at the Drug Information Association conference about the FDA's latest guidance on product name usage.
This Regulatory Alert provides an update based on comments at the Drug Information Association conference about the FDA's latest guidance on product name usage.

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Published by: Dale Cooke on Feb 20, 2012
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02/20/2012

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© 2012 Digitas Health. All rights reserved.
Regulatory Alert
 Update on Product Name Placement & Prominence
February 19, 2012
Analyst: Dale Cooke
 
EXECUTIVE SUMMARY
At the annual Drug Information Association’s Marketing Pharmaceuticals 2012 conference
1
, 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
2
. 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 
3
. 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.
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 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
not
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)
NEW GUIDANCE
As discussed in the previous Digitas Health Regulatory Alert on this subject
4
, the finalized guidance addressedtwo crucial issues in applying these regulations.
5
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.
Featured Use
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
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 timethe proprietary name appears.”
6
(emphasis in the original)
 
 
February 19, 2012 Regulatory Alert: Update on Product Name Placement & Prominence Page2 of 4 
As quoted above, the regulations require the established name to accompany the proprietary name “eachtime it is featured.” (21 CFR 202.1(b)(1)) FDA is defining featured use in the final guidance as any use otherthan 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 product’s website.
Image 1
Image 1 shows how the regulation was being implemented before the January guidance was released. Theproduct name is most prominently presented on this page in the logo in the upper left corner. Thatpresentation was viewed as the “featured” use of the brand name and includes the established namepresented in lettering at least half the size of the brand name, as required by 21 CFR 202.1(b)(1). The brandname 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 wherethe established name is required. As shown in Image 2, all of the uses of the brand name that are not in bodycopy are highlighted in a red box. Based on the guidance, each of these locations would seem to require theaddition of the generic name.
Image 2
 
 
February 19, 2012 Regulatory Alert: Update on Product Name Placement & Prominence Page3 of 4 
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 longergeneric 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 suddenexpanded usage of the generic name have negative effects on the ability of consumers to comprehend theinformation presented? It seems reasonable to worry that including a long scientific name that is difficult topronounce would make the information less accessible to consumers, who are not used to reading thisinformation.
Screen Size
With regard to the second issue of how frequently the established name must accompany the proprietaryname in running text, FDA’s 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 accompanythe proprietary name at least once in the running text. If the running text spans more than onescreen, FDA recommends that the established name accompany the proprietary name at least onceper screen.”
7
 The final guidance does not specify how to understand “per screen.” This matters because screen size varieswidely. Smartphones, tablet computers, and desktop computers differ drastically in this respect, and evenwithin a category there is significant variation. In addition, individual users can adjust their display settingsto alter the amount of information provided on each screen. On what basis would OPDP determinecompliance with this undefined concept?
CLARIFYING REMARKS
 Both in his prepared remarks and during a separate question-and-answer session at the recent DIAconference, Abrams elaborated on both of these issues in addition to the question of how quickly OPDPexpects companies to comply with the new guidance.Regarding featured use, Abrams said that the established name is NOT required with every use of the brandname outside of running text. Instead, OPDP’s expectation is that the generic name will be used only withthe most prominent use. If the most prominent use of the brand name is the logo in the header (as shown inImage 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 beunderstood by OPDP as what would print out on an 8½” x 11” piece of paper. This definition provides anobjective 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 expectcompanies to pull existing advertising materials. Instead, OPDP will permit companies to implement the newguidance on materials moving forward.

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