[Federal Register: October 4, 2000 (Volume 65, Number 193)]
[Notices]
[Page 59192-59193]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04oc00-65]
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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.
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets. Register on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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:
kennedyd@cder.fda.gov.
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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