[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Draft Guidance for Industry on Using FDA-Approved Patient 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availability of a draft guidance for industry entitled ``Using FDA-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This draft guidance describes how sponsors can use certain FDA-approved 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DATES: Submit written comments on the draft guidance by July 23, 2001.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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Drug Information Branch (HFD-210), Center for Drug 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 Submit written comments on the draft guidance to the 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INFORMATION section for electronic access to the draft guidance 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