[Federal Register Volume 69, Number 210 (Monday, November 1, 2004)]
[Notices]
[Pages 63402-63403]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-24308]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0459]


Draft Guidance for Industry on Pharmacokinetics in Pregnancy--
Study Design, Data Analysis, and Impact on Dosing and Labeling

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availability of a draft guidance for industry entitled ``Draft Guidance 
for Industry on Pharmacokinetics in Pregnancy--Study Design, Data 
Analysis, and Impact on Dosing and Labeling.'' This guidance discusses 
agency recommendations on issues to consider when designing and

[[Page 63403]]

conducting pharmacokinetic (PK) studies in pregnant women and, 
specifically, on how to assess the influence of pregnancy on the PKs, 
and where appropriate, the pharmacodynamics (PD) of drugs or biologic 
products. The goals of this guidance are to recommend a framework for 
designing and conducting PK studies in pregnant women and stimulate 
further study and research to assist in rational therapeutics for 
pregnant patients.

DATES: Submit written or electronic comments on the draft guidance by 
January 3, 2005. 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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, or the Office of Communications, Training, 
and Manufacturers Assistance (HFM-40), Center for Biologics Evaluation 
and Research (CBER), 1401 Rockville Pike, Rockville, MD 20852-1448. 
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 Submit written comments on the draft guidance 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draft guidance document.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: Kathleen Uhl, Center for Drug 
Evaluation and Research (HFD-020), Food and Drug Administration, 5515 
Security Lane, Rockville, MD 20852, 301-443-5157.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Draft Guidance for Industry on Pharmacokinetics in 
Pregnancy--Study Design, Data Analysis, and Impact on Dosing and 
Labeling.'' This guidance is intended to provide recommendations to 
sponsors and investigators on how to design, conduct, and assess 
studies investigating the influence of pregnancy on the 
pharmacokinetics, and where appropriate, the pharmacodynamics of drugs 
or biologic products. During the clinical development of most products, 
pregnant women are actively excluded from trials, and, if pregnancy 
does occur during a trial, the usual procedure is to discontinue 
treatment and drop the patient from the study. Consequently, at the 
time of a drug's initial marketing, except for products developed to 
treat conditions specific to pregnancy, there are seldom meaningful 
human data on the appropriate dosage and frequency of administration 
during pregnancy. Even after years of marketing, data in product labels 
regarding PK and dose adjustments during pregnancy rarely provide more 
information for appropriate prescribing in pregnancy than what was 
available at the time of initial marketing.
    The information in this guidance is intended to promote an increase 
in the amount of useful data concerning how drug kinetics are affected 
by pregnancy and to further encourage the development of appropriate 
therapeutic treatments for pregnant women. Topics covered include 
ethical considerations associated with conducting PK studies in 
pregnant women, study design, data analysis, labeling, and 
considerations for future research. The agency recommends using this 
guidance in conjunction with other pharmacological and clinical 
literature on the design, conduct, and interpretation of PK studies. 
Because the conduct of studies in pregnant women requires specialized 
knowledge in a variety of areas, investigators designing such studies 
are encouraged to obtain advice from experts in fields such as 
obstetrics, pediatrics, pharmacology, clinical pharmacology, 
pharmacometrics, statistics, and other applicable disciplines.
    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 on the draft guidance. 
Two copies of mailed 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 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: October 21, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-24308 Filed 10-29-04; 8:45 am]
BILLING CODE 4160-01-S