[Federal Register Volume 65, Number 193 (Wednesday, October 4, 2000)]
[Notices]
[Pages 59192-59193]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-25386]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1519]


Clinical Pharmacology During Pregnancy; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing an FDA/
National Institute for Child Health and Human Development co-sponsored 
meeting on ``Clinical Pharmacology During Pregnancy: Addressing 
Clinical Needs Through Science.'' Experts from industry, academia, and 
the public have been invited to provide their perspectives on drug 
therapeutics during the second and third trimester of pregnancy. The 
goals of the meeting are: To summarize the state of knowledge regarding 
clinical pharmacology in pregnancy; to raise awareness among clinician 
researchers and leaders about the need for clinical research and 
collaboration in this area; and to garner support for such research 
from health advocacy groups and others.

DATES: The meeting will be held on Monday and Tuesday, December 4 and 
5, 2000, from 8 a.m. to 5 p.m. The deadline for registration is 
November 13, 2000.

ADDRESSES: The location of the meeting is the Holiday Inn, Capitol 
room, 550 C St. SW., Washington, DC 20024, 202-479-4000. Transcripts of 
the meeting will be available from the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852, and on the Internet at http://www.fda.gov/ohrms/dockets. Register on the Internet at http://www.fda.gov/cder/audiences/women/pharmpreg2000.htm.

FOR FURTHER INFORMATION CONTACT: Dianne L. Kennedy, Center for Drug 
Evaluation and Research (HFD-104), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857 301-827-2185, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Most women and physicians seek to avoid the use of medications 
during pregnancy to protect the developing fetus from any potential 
adverse effects. However, medication use by pregnant women is common. A 
study conducted in 1994 by FDA, using several managed care data bases, 
found that the average number of prescriptions per patient during 
pregnancy (excluding prenatal vitamins, iron preparations, and 
medications at the time of delivery) was three. The number of 
prescriptions increased with maternal age. For pregnant women over the 
age of 35, the average number of prescriptions was five (unpublished 
data, FDA).
    In considering the needs for clinical pharmacology data to guide 
drug dosing among special populations, the pregnant woman is rarely 
addressed. Yet, the physiology of pregnancy is dynamic and capable of 
influencing the pharmacokinetic profiles of many drugs. It is commonly 
appreciated that hormonal changes, particularly elevated estrogens and 
progesterone, accompany normal pregnancy, but their effects are often 
unappreciated.
    Many women enter pregnancy with health conditions that require 
medications, such as neurologic and psychiatric conditions. Some health 
conditions tend to worsen during pregnancy, including hypertension, 
asthma, endocrinopathies, rheumatologic diseases, and cardiac 
conditions. Previously healthy women often develop illnesses during 
pregnancy, such as infections, diabetes, thyroid disease, 
thromboembolism, or cancers. Often, not using medications poses far 
greater risk to fetal well being and survival than the risk of a 
particular drug.
    Most physicians seek to prescribe the lowest effective dose of any 
given drug to treat a pregnant woman. Their goal is to provide the best 
effect for the least exposure possible to the fetus. However, when 
deciding what the appropriate dose is for a given patient, health care 
practitioners usually rely on information (typically from product 
circulars) from studies of individuals who are not pregnant. 
Particularly for drugs with a narrow therapeutic window, or with 
marginal efficacy at the lower end of the therapeutic spectrum, this 
practice risks exposing the fetus to a dose of medication with little 
or no benefit to the mother. The result may be that the mother's 
condition worsens. She may require a second course of the same 
treatment or a switch to a second or third drug, exposing her 
developing infant to multiple courses of treatment over a much longer 
period of time.
    Pregnant women are usually excluded from clinical trials and even 
in situations where pregnant women require therapeutics, 
pharmacokinetic studies are rarely done. There are many reasons for 
this. Pregnancy is a temporary condition and easily forgotten in ``wish 
lists'' for data, by subspecialists who treat pregnant women with 
serious medical problems. Also, interested investigators may be 
reluctant to pursue pharmacokinetic studies in pregnant women because 
of their lack of knowledge related to pregnancy or fetal development. 
Finally, where information does exist in the medical literature about 
pharmacokinetics of individual drugs in pregnancy, the data have rarely 
appeared in product labels, creating further disincentives for 
conducting such clinical research. This latter reality has its own set 
of probable causes, but may change as FDA enhances requirements for 
product safety updates based on scientific literature and human 
experience data. Regardless of the root causes for the current paucity 
of information, rational prescribing for the pregnant patient must 
attempt to ensure that she will have the greatest likelihood of 
clinical benefit from a medication in exchange for the safest or least 
exposure of her developing baby. This can only be achieved when 
adequate pharmacokinetic dosing data are available.
    The agency hopes this meeting will help summarize the state of 
knowledge on clinical pharmacology in pregnancy, raise awareness among 
clinician researchers and leaders about the need for clinical research 
and collaboration in this area, and garner support for such research 
from health advocacy groups and others.

[[Page 59193]]

II. Registration

    There is no registration fee, however preregistration is required. 
Register early, as space is limited. The meeting room will hold 
approximately 250 people. Registration will begin with the publication 
of this notice. If you will need special accommodations due to a 
disability to attend the meeting, please inform the contact person 
listed above. You may obtain information and register on the Internet 
at http://www.fda.gov/cder/audiences/women/pharmpreg2000.htm.

    Dated: September 25, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-25386 Filed 10-3-00; 8:45 am]
BILLING CODE 4160-01-F