[Federal Register Volume 77, Number 16 (Wednesday, January 25, 2012)]
[Notices]
[Pages 3779-3780]
From the Federal Register Online via the Government Publishing 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 This guidance finalizes the draft guidance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