[Federal Register Volume 73, Number 50 (Thursday, March 13, 2008)]
[Notices]
[Pages 13546-13547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-5083]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0150]


Draft Guidance for Industry on Hypertension Indication: Drug 
Labeling for Cardiovascular Outcome Claims; 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availability of a draft guidance for industry entitled ``Hypertension 
Indication: Drug Labeling for Cardiovascular Outcome Claims.'' This 
draft guidance is intended to assist applicants in developing labeling 
for cardiovascular outcome claims for drugs that are indicated to treat 
hypertension. Because blood pressure control is well established as 
beneficial in preventing serious cardiovascular events, FDA believes 
that the appropriate use of these drugs can be encouraged by making the 
connection between lower blood pressure and improved cardiovascular 
outcomes more explicit in labeling. This draft guidance is intended to 
recommend standard labeling for antihypertensive drugs except where 
differences are clearly supported by clinical data.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 
byMay 12, 2008.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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. Send one 
self-addressed adhesive label to assist that office in processing your 
requests. Submit written comments on the draft guidance to the Division 
of Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Devi Kozeli, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, rm. 4183, Silver Spring, MD 20993-0002, 301-
796-1128.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Hypertension Indication: Drug Labeling for Cardiovascular 
Outcome Claims.'' On June 15, 2005, the Cardiovascular and Renal Drugs 
Advisory Committee met in open public session to discuss class labeling 
for cardiovascular outcome claims for drugs that are indicated to treat 
hypertension. With few exceptions, current labeling for 
antihypertensive drug products only includes the information that these 
drugs are indicated to reduce blood pressure; the labeling does not 
include information on the clinical benefits related to cardiovascular 
outcomes expected from such blood pressure reduction. However, blood 
pressure control is well established as beneficial in preventing 
serious cardiovascular events, and inadequate treatment of hypertension 
is acknowledged as a significant public health problem. The committee 
voiced a broad consensus in favor of labeling changes to describe 
briefly the clinical benefits related to cardiovascular outcomes 
expected from lowering blood pressure with any antihypertensive drug. 
The labeling proposed in this draft guidance is consistent with the 
advisory committee's recommendations.
    This draft guidance is being made available to afford the public 
the opportunity to comment on both the intent of the labeling revisions 
and the specific proposed language. This draft guidance is intended to 
recommend standard labeling for antihypertensive drugs except where 
differences are clearly supported by clinical data. After this guidance 
has been finalized, applicants will be encouraged to submit labeling 
supplements containing the new language.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the agency's current thinking on labeling for 
cardiovascular outcome claims for drugs indicated to treat 
hypertension. 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

[[Page 13547]]

requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
mailed comments, except that individuals may submit one paper copy. 
Comments are to be identified 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.
    Please note that on January 15, 2008, the FDA Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will 
be accepted by FDA through FDMS only.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: March 6, 2008.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E8-5083 Filed 3-12-08; 8:45 am]
BILLING CODE 4160-01-S