[Federal Register Volume 66, Number 78 (Monday, April 23, 2001)]
[Notices]
[Pages 20468-20469]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-9948]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 01D-0162]
Draft Guidance for Industry on Using FDA-Approved Patient
Labeling in Consumer-Directed Print Advertisements; 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availability of a draft guidance for industry entitled ``Using FDA-
Approved Patient Labeling in Consumer-Directed Print Advertisements.''
This draft guidance describes how sponsors can use certain FDA-approved
patient labeling to fulfill the requirement that prescription drug and
biological product advertisements directed toward consumers (DTC) in
print media contain adequate risk disclosure. FDA does not intend to
object to the use of certain FDA-approved patient labeling, reprinted
exactly as approved, to fulfill the requirement that DTC print
advertisements contain a brief summary of the product's risks.
DATES: Submit written comments on the draft guidance by July 23, 2001.
General comments on agency guidance documents are welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Drug Information Branch (HFD-210), Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857; or to the Office of Communication, Training,
and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation
and Research, Food and Drug Administration, 1401 Rockville Pike,
Rockville, MD 20852-1448. Send one self-addressed adhesive label to
assist that office in processing your requests. Submit phone requests
to 800-835-4709. Submit written comments on the draft guidance to the
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT:
Regarding prescription human drugs: Nancy M. Ostrove, Center for
Drug Evaluation and Research (HFD-42), Food and Drug Administration,
5600 Fishers Lane, Rockville, MD 20857, 301-827-2828.
Regarding prescription human biological products: Toni M. Stifano,
Center for Biologics Evaluation and Research (HFM-600), Food and Drug
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6190.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Using FDA-Approved Patient Labeling in Consumer-Directed
Print Advertisements.'' The draft guidance describes how sponsors can
use certain FDA-approved patient labeling to fulfill the requirement
that prescription drug and biological product advertisements DTC in
print media contain adequate risk disclosure.
The requirement that all prescription drug and biological product
advertisements disclose product risks comes from section 502(n) of the
Federal Food, Drug, and Cosmetic Act
[[Page 20469]]
(the act) (21 U.S.C. 352(n)). This section of the act requires that
advertisements for prescription drugs and biological products include a
true statement of information ``in brief summary'' about the benefits
and risks of using the advertised product. This is often called the
``brief summary'' requirement. The prescription drug advertising
regulations (21 CFR 202.1(e)(3)(iii)) specify that the information
about risks include every risk in the advertised drug's approved
product labeling.
Some prescription drug and biological products have FDA-approved
patient labeling that contains information that is most important for
the safe and effective use of these products in language consumers are
likely to understand. The draft guidance specifies that FDA does not
intend to object to the use of certain FDA-approved patient labeling,
reprinted exactly as approved, to fulfill the brief summary requirement
for DTC print advertisements. The draft guidance describes the
characteristics that such patient labeling should have to be used to
fulfill the brief summary requirement.
This draft guidance is being issued as a level 1 guidance,
consistent with FDA's good guidance practices regulations (21 CFR
10.115; 65 FR 56468, September 19, 2000). The draft guidance represents
the agency's current thinking on using FDA-approved patient labeling in
DTC print advertisements. 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 Dockets Management Branch
(address above) written comments on the draft guidance. Two copies of
any comments are to be submitted, except that individuals may submit
one copy. Comments are to be identified with the docket number found in
brackets in the heading of this document. The draft guidance and
received comments are available for public examination in the Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
III. Electronic Access
Persons with access to the Internet may obtain the document at
http://www.fda.gov/cder/guidance/index.htm and at http://www.fda.gov/cber/guidelines.
Dated: April 17, 2001.
Ann M. Witt,
Acting Associate Commissioner for Policy.
[FR Doc. 01-9948 Filed 4-20-01; 8:45 am]
BILLING CODE 4160-01-S