[Federal Register Volume 72, Number 94 (Wednesday, May 16, 2007)]
[Notices]
[Pages 27576-27577]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-9347]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007D-0185]


Draft Guidance for Industry and Review Staff on Labeling for 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.

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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availability of a draft guidance for industry and review staff entitled 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DATES: Submit written or electronic comments on the draft guidance by 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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on the draft guidance to the Division of Dockets Management (HFA-305), 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access to the draft guidance document.

[[Page 27577]]


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 Sec.  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.
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    \1\See ``Requirements on Content and Format of Labeling for 
Human Prescription Drug and Biological Products'' (71 FR 3922, 
January 24, 2006; 21 CFR parts 201, 314, and 601).
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    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\
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    \2\See Sec.  201.57(a)(6).
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    ``(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.

    Dated: May 10, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-9347 Filed 5-15-07; 8:45 am]
BILLING CODE 4160-01-S