
[Federal Register Volume 77, Number 16 (Wednesday, January 25, 2012)]
[Notices]
[Pages 3779-3780]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1431]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1999-D-4079 (Formerly Docket No. 1999D-0254)]


Guidance for Industry on Product Name Placement, Size, and 
Prominence in Advertising and Promotional Labeling; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance document entitled ``Product Name Placement, 
Size, and Prominence in Advertising and Promotional Labeling.'' The 
guidance is intended to clarify for applicants the requirements for 
product name placement, size, prominence, and frequency in promotional 
labeling and advertising for prescription human and animal drugs and 
biological products. This guidance finalizes the draft guidance 
published in January 1999.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 2201, Silver Spring, MD 20993-0002; or Office of Communication, 
Outreach and Development (HFM-40), Center for Biologics Evaluation and 
Research, Food and Drug Administration, 1401 Rockville Pike, Suite 
200N, Rockville, MD 20852-1448. Send one self-addressed adhesive label 
to assist that office in processing your requests. See the 
SUPPLEMENTARY INFORMATION section for electronic access to the guidance 
document.
    Submit electronic comments on the guidance to  http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: 

[[Page 3780]]

Regarding Human Prescription Drugs

    Ernest S. Voyard, Jr., Center for Drug Evaluation and Research, 
Food and Drug Administration, 10903 Hampshire Ave., Bldg. 51, Rm. 3276, 
Silver Spring, MD 20993, (301) 796-1200.

Regarding Prescription Human Biological Products

    Stephen Ripley, Center for Biologics Evaluation and Research (HFM-
17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, 
Rockville, MD 20852-1448, (301) 827-6210.

Regarding Animal Prescription Drugs

    Julie Garnier, Center for Veterinary Medicine, Food and Drug 
Administration, 7519 Standish Pl., Rockville, MD 20855, (240) 276-9300.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance document entitled 
``Product Name Placement, Size, and Prominence in Advertising and 
Promotional Labeling.'' This guidance discusses the requirements for 
product name placement, size, prominence, and frequency in promotional 
labeling and advertising for prescription human and animal drugs and 
biological products. The disclosure of the product name in promotional 
labeling and advertising for all prescription human and animal drug and 
biological products is important for the proper identification of such 
products to ensure their safe and effective use.
    The placement, size, prominence, and frequency of the proprietary 
and established names for human and animal prescription drug products 
are specified in labeling and advertising regulations (21 CFR 201.10(g) 
and (h); 202.1(b), (c), and (d)). These regulations are also applicable 
to biological product labeling and advertising materials.
    The recommendations in this guidance pertain to product names in 
traditional print media promotion (e.g., journal ads, detail aids, 
brochures), audiovisual promotional labeling (e.g., videos shown in a 
health care provider's office), broadcast media promotion (e.g., 
television advertisements, radio advertisements), and electronic and 
computer-based promotional labeling and advertisements, such as 
Internet promotion, social media, emails, CD-ROMs, and DVDs.
    In the Federal Register of March 12, 1999 (64 FR 12341), FDA 
announced the availability of the draft guidance of the same title, 
dated January 1999. FDA received six comments on the draft guidance, 
five were from the pharmaceutical industry and one was from a consumer. 
The majority of the comments related to requests to provide additional 
clarifications and examples related to the individual recommendations 
in the draft guidance. These comments were considered carefully during 
the finalization of the guidance document. The guidance has been 
revised in the following ways: (1) It clarifies certain concepts 
previously discussed in the draft guidance and adds definitions for 
certain terms; (2) it provides examples to illustrate the appropriate 
juxtaposition and prominence of proprietary and established names for 
products with one active ingredient and examples to illustrate the 
juxtaposition of products with two or more active ingredients; (3) it 
reorganizes and renames the draft guidance's sections pertaining to the 
frequency of the disclosure of proprietary and established names in 
various media into one section with three subsections--traditional 
print promotional labeling and advertisements, audiovisual promotional 
labeling and broadcast advertisements, and electronic and computer-
based promotional labeling and advertisements; and (4) it discusses the 
use of proprietary and established names in columns in traditional 
print promotional labeling and advertisements.
    The guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents FDA's 
current thinking on this topic. It does not create or confer any rights 
for or on any person and does not operate to bind FDA or the public. An 
alternative approach may be used if such approach satisfies the 
requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the guidance at 
either  http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm, or http://www.regulations.gov.

    Dated: January 19, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-1431 Filed 1-24-12; 8:45 am]
BILLING CODE 4160-01-P


