FDA Product Name Guidance Finalized
On December 12, 2017, the Food and Drug Administration (FDA) released a final version of the Product Name Placement, Size, and Prominence in Promotional Labeling and Advertisements guidance. Though there are many changes in wording and style from earlier iterations of the guidance, this final version does not make any major changes to the recommendations provided by FDA in the most recent version. Instead, this guidance largely reiterates previous recommendations while providing additional examples and clarifications.
In light of this final guidance, pharmaceutical, veterinary medicine, and biologics manufacturers should:
- Confirm all materials (including product logos) meet FDA's regulatory requirements for product name usage
- Review any internal policies or guidelines developed in light of earlier guidance on this topic to ensure consistency with the final guidance
- Ensure marketing and promotional review teams are aware of the updated guidance
According to the Code of Federal Regulations, “the established name [the generic name], if such there be,corresponding to such proprietary name or designation shall accompany such proprietary name or designation each time it is featured in the advertisement for the drug.
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” (emphasis added).
The final guidance released by the FDA provides the Agency's current views about how companies can fulfill these regulatory requirements.
FDA initially provided draft guidance on this topic in 1999, and then in 2012 and 2013 issued two updates to that earlier guidance. Both the 2012 and 2013 guidance made significant changes to the preceding guidance. By contrast, the finalized guidance released on December 12 does not introduce any major new concepts or alter the recommendations in a dramatic fashion from the 2013 version. As the accompanying notice in the Federal Register states, " the guidance has been revised to clarify certain concepts discussed in the revised draft guidance and to provide examples illustrating prominence issues."
This guidance covers principles about the juxtaposition, size, prominence, and frequency of the brand (proprietary) and generic (established) name in traditional print, audiovisual, and electronic or computer-based media.
FDA recommends that the generic name be either directly to the right or directly beneath the the brand name with no intervening matter that might interfere with the communication that the brand is that underlying chemical or biological product. FDA notes that it "does not consider trademark ... or controlled substance symbols ... to be intervening matter."
When presented in body copy, if the generic name is required to accompany the brand name, FDA requires that the generic name be presented in the same typeface as the brand name. When presented in headlines, charts, graphs, and other situations that are larger than the body copy, the generic name must be presented in letters that are " at least half as large as" the letters of the brand name. This size requirement is for the actual size of the letters, not for the font size, as six-point font is not always for every typeface at least
half the size of 12-point font.
The regulations require that the generic name have a "prominence commensurate with" the brand name's presentation. In evaluating whether the presentation meets this requirement, FDA "considers all methods used to achieve prominence" including color selection, contrast, and spacing. FDA provides three new examples (shown below) of what it does NOT consider to be commensurate prominence.
The regulations require that each featured mentioned of a brand name be accompanied by the generic name, and that each page that does not feature the brand name but merely used in body copy include at least one presentation of the generic name "in association with" the brand name. In this final guidance, FDA provides recommendations for meeting this requirement in print, audiovisual, and computer-based media.
For print, FDA accepts that manufacturers have met their requirement to present the generic name with the featured use of the brand name if the generic name is presented "at least once per page or spread" where the brand name "most prominently appears." If the brand name is not featured, then generic name must accompany it at least once per page or spread.
For audiovisual presentations, including videos and television commercials, FDA accepts presenting the generic name on-screen only with the "most prominent" appearance of the brand name. In a footnote, FDA clarifies that "generally the largest display" of the brand name is the most prominent.
Radio spots, and other audio-only presentations, of course do not include on-screen visuals. For those presentations, FDA expresses its intention to accept just a single presentation of the generic name with the most prominent presentation of the brand name.
For computer-based presentations, such as webpages, FDA accepts that a single presentation of the generic name accompanying the most prominent presentation of the brand name is acceptable.
Two- or More-Ingredient Products
In the final section of the guidance, FDA addresses the situation for products with multiple active ingredients without a single established name. The regulations require that such products include all of the active ingredients including the quantitative ingredient information "be placed in direct conjunction with the most prominent" presentation of the brand name. FDA applies the same principles set forth in the previous section about single ingredient products to this class and provides examples of acceptable presentations.
FDA's finalized guidance on product name usage does not introduce any new concepts or significantly change any recommendations from the most recent guidance by the Agency on this topic. This finalized guidance does provide some additional examples and clarification about how product manufacturers can meet their regulatory obligations for advertising and promotional labeling of prescription human and veterinary drugs and biologics.
Title 21--Food and Drugs, Chapter 1—Food and Drug Administration, Department of Health and Human Services, Subchapter C—Drugs: General; Part 201—Labeling, Subpart A—General Labeling Provisions, Sec. 201.10 Drugs; statement of ingredients
Title 21--Food and Drugs, Chapter 1—Food and Drug Administration, Department of Health and Human Services, Subchapter C—Drugs: General; Part 202 – Presecription Drug Advertising, Sec 202.1, Prescription-drug advertisements