Product Name Placement & Prominence

January 27, 2012 Analyst: Dale Cooke

Regulatory Alert

EXECUTIVE SUMMARY
On January 24, 2012, the Food and Drug Administration (FDA) released a final Guidance to Industry: Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling1. This guidance was originally released as a draft in January 1999. Finalization of the guidance this week included some significant changes from the original draft version, including a new definition of what constitutes featured use of a brand name and a change in how frequently to include the established name in body copy as applied to electronic media. In light of this guidance, Digitas Health recommends that companies take the following actions2: 1. Ensure that new materials being developed comply with the recommendations in this new guidance. 2. Review existing materials as they undergo expiry review for compliance with this guidance. 3. Incorporate the generic, established product name in all graphic treatments of the brand name. 4. Take into account the different screen sizes available on mobile devices when preparing materials to be accessible from such devices.

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
Two distinct issues from these regulatory requirements are addressed in this newly finalized guidance. 1. The first issue is what constitutes featuring a name, because the regulations as written clearly require that each time the proprietary name is featured that it be accompanied by the established name. 2. The second issue is when an advertisement omits a featured use of the product name, what is the meaning of a page of an advertisement. This is particularly important for digital media, which present information not on printed pages but on electronic displays, because the regulations require that the established name, in the absence of a featured use, be presented on every page. The draft guidance from 1999 was silent on the issue of what constitutes a featured mention and the general industry practice has been to treat the most prominent usage of the product name as a featured mention. In most cases, this meant ensuring that the logo, which included the generic name, was the most prominent use of the product name. In the final guidance, FDA has expanded the definition of featured use to include all uses of the brand (proprietary) name that are not in the running text (body copy).

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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. (emphasis in the original)3 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. With regard to the second issue of how frequently the established name must accompany the proprietary name in the running text, FDA has changed its position from the draft guidance, particularly with respect to electronic media. In the draft version, FDA provided multiple means for complying with the regulation and also noted that there were other approaches available. Sponsors can fulfill the requirements of 21 CFR 201.10(g)(1) and 202.1(b)(1) by using one of the following approaches. Sponsors are not limited to the approaches listed below. The approaches for including the established name were: Each time the proprietary name was used Once per paragraph At regular intervals [A]t the beginning, middle, and end of the running text.4

That multifaceted approach to compliance has been replaced in the final guidance with the following recommendation: 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.5 Although the final guidance does not follow the draft guidance in explicitly mentioning that alternative approaches are available when this recommendation is provided, this is always true for FDA guidances. That provision is included in the boilerplate introduction to this and all guidances from FDA.6 The final guidance does not specify how to understand per screen. This should be taken into account when applying this guidance. 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. The lack of a standard definition of screen size complicates application of the guidance. The requirement to include the established name with the proprietary name in running copy applies only if the brand name is not featured on the page. (21 CFR 202.1(b)(1)) That caveat should be taken into account when applying this guidance. Digitas Health understands the FDA to be interpreting the requirement of providing the established name [o]n any page to mean per screen in electronic media. As such, it seems reasonable to assume that if the brand name is featured on the screen (and includes the established name when so featured, as required by the regulations), then the requirement to include the established name in the body copy would not hold.7

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Regulatory Alert: Product Name Placement & Prominence

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RECOMMENDATIONS
In light of this new, finalized guidance, companies should take the following actions: 1. Ensure that new materials being developed comply with the recommendations in this new guidance. 2. Review existing materials as they undergo expiry review for compliance with this guidance. 3. Incorporate the generic, established product name in all graphic treatments of the brand name. 4. Take into account the different screen sizes available on mobile devices when preparing materials to be accessible from such devices.

ENDNOTES
1

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 In this Regulatory Alert, I make no distinction between biologic products and drugs. The essential regulatory requirements for both are the same, and the descriptions and recommendations of this alert should be applied to both categories with only minor modifications. Product Name Placement, page 5 Draft Guidance for Industry: Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling, FDA, January 1999, page 4. Product Name Placement, page 5. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. Product Name Placement, page 1. There is an additional requirement to include the established name if the proprietary name is included in larger type within the body copy. [I]f the proprietary name or designation is used in the running text in larger size type, the established name shall be used at least once in association with, and in type at least half as large as the type used for, the most prominent presentation of the proprietary name or designation in such running text. (21 CFR 202.1(b)(1)) Nothing said in the body of this Regulatory Alert should be read as implying that this additional requirement is moot.

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Regulatory Alert: Product Name Placement & Prominence

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