2011-5945. Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims.” This guidance is intended to assist applicants in developing labeling for outcome claims for drugs that are indicated to treat hypertension. With few exceptions, current labeling for antihypertensive drugs includes only 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 Agency 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.

DATES:

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

ADDRESSES:

Submit written requests for single copies of this 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. 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:

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 guidance for industry entitled “Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims.” The intent of the guidance is to provide common labeling for antihypertensive drugs except where differences are clearly supported by clinical data. With publication of this guidance, applicants are encouraged to submit labeling supplements containing the new language.

A draft guidance of the same title was announced in the Federal Register on March 13, 2008 (73 FR 13546), and Docket No. FDA-2008-D-0150 was open for comments until May 12, 2008. Comments received from industry, professional societies, and consumer groups on the draft guidance were taken into consideration by FDA in finalizing this guidance. Throughout the guidance, the language has been condensed and simplified to be more concise and clear. A section has been added to clarify procedures for obtaining approval of new labeling and its applicability to advertising. The guidance describes how applicants can provide clinical evidence for any drugs they perceive to be missing from Table 1, Approved Drugs for Chronic Treatment of Hypertension, by submitting the information to the docket number listed in brackets in the heading of this document. The division will review the information and revise the guidance to include any new labeling changes supported by clinical data submitted to the docket.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on labeling for cardiovascular outcome claims for drugs 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 requirements of the applicable statutes and regulations.

II. The Paperwork Reduction Act of 1995

This guidance contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collection of information in this guidance was approved under OMB control number 0910-0670.

III. 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. It is no longer necessary to send two copies of mailed 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.

IV. Electronic Access

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

Dated: March 9, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.