Draft Guidance for Industry and Review Staff on Labeling for Human Prescription Drugs-Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and review staff entitled “Labeling for Human Prescription Drugs—Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information.” This guidance is intended to help applicants and the review staff in the Center for Drug Evaluation and Research (CDER) at FDA determine when a drug belongs to an established pharmacologic class as well as how to select the appropriate word or phrase (term) that describes the pharmacologic class for inclusion in the Indications and Usage section of Highlights of Prescribing Information (Highlights) of approved labeling.

DATES:

Submit written or electronic comments on the draft guidance by August 14, 2007. General comments on agency guidance documents are welcome at any time.

ADDRESSES:

Submit written requests for single copies of the draft guidance to the Division of Drug Information (HFD-240), Center for Drug Evaluation and Research, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857. 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 Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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.fda.gov/dockets/ecomments . See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:

William Pierce, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6474, Silver Spring, MD 20993-0002, 301-796-0700.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry and review staff entitled “Labeling for Human Prescription Drugs—Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information.” This guidance is intended to help applicants and CDER's review staff determine when a drug belongs to an established pharmacologic class as well as how to select the appropriate word or phrase (term) that describes the pharmacologic class for inclusion in the Indications and Usage section of Highlights of Prescribing Information (Highlights) of approved labeling, as required by § 201.57(a)(6) (21 CFR 201.57(a)(6)).

In January 2006, FDA published a final rule that amended the requirements for the content and format of labeling for human prescription drug and biological products.¹ The new labeling format is intended to make it easier for health care professionals to access, read, and use the information in prescription drug labeling, thereby facilitating professionals' use of labeling to make prescribing decisions.

The rule requires that the following statement appear under the Indications and Usage section of Highlights if a drug is a member of an established pharmacologic class:²

“(Drug) is a (name of class) indicated for (indication(s)).”

If the drug is not a member of an established pharmacologic class, the statement must be omitted.

Knowing the established pharmacologic class can provide health care professionals with important information about what to expect from a drug and how it relates to other therapeutic options. Such information can also help reduce the risk of duplicative therapy and drug interactions. This draft guidance provides recommendations for identifying the established pharmacologic class and its appropriate term for inclusion in the Indications and Usage section of Highlights.

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 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) 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.

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 .