| The Office of Women's
Health established its Science Program in 1994 with three specific
goals in mind:
- To address gaps in current scientific knowledge
- To encourage new directions in research
- To set new standards of excellence in women's health
This site has complete information about:
- Funding available to researchers
-- Learn about the intramural, extramural and special funding
opportunities
- Pregnancy initiatives
-- Discover what OWH is doing to promote healthy pregnancies,
including new counter terrorism activities
- Outcomes of Science Program
efforts -- See how OWH research has improved the health
of women
For general science information, you can also check out Firstgov
for Science. However, following this link will take
you off the FDA Web site.
For more information about funding and research, contact Margaret
Miller, Ph.D., R.N., D.A.B.T., director of the OWH Health Sciences
Program: margaret.miller@fda.hhs.gov.
Funding Opportunities and Initiatives
The OWH funds research to provide a foundation for the development
of sound policies and regulations to enhance women's health.
To date, OWH has provided approximately $12 million for over
100 women's health research studies on topics ranging from cancer,
HIV and osteoporosis to dietary supplements, dioxins and statistical
approaches to gender analysis.
While the topics are diverse, all funded Science Program studies:
- Display rigorous thought
- Are well focused
- Can accomplish meaningful results in the allotted time
- Have scientific and regulatory significance
Greatest emphasis is given to research studies that fill the
gap between basic research and regulatory decision-making. The
results of these studies appear in scientific journals, provide
information for the development of regulations and guidances,
and contribute to OWH educational and outreach programs.
Research Funding Mechanisms
The Office of Women's Health (OWH) utilizes a variety of funding
programs to support research both inside and outside the agency:
The Intramural Research Program supports researchers
within the FDA to develop the agency's infrastructure for performing
research that enhances women's health. The OWH partners with
FDA research scientists to develop projects that address gaps
in current knowledge or set new directions for research in gender
studies and other women's health issues. See
Current and Previous Intramural Research Science Program Awards.
The
Extramural Research Program helps FDA scientists answer
regulatory research questions that require technology, expertise
or resources outside the agency. The OWH partners with FDA scientists
to develop the research questions, contract with outside institutions
and oversee the study.
To facilitate FDA's ability to conduct extramural women's health
research, FDA has partnered with the Department of Health and
Human Services' (DHHS) National Centers of Excellence in Women's
Health (COE). The COEs were established by the DHHS Office on
Women's Health in 1996. Their mandate was to create and evaluate
a new model health care system uniting women's health research,
medical training, clinical care, public health education, community
outreach and the promotion of women in academic medicine around
a common mission: to improve the health status of diverse women
across the life span.
The COEs provide OWH with access to highly developed research
centers and leading scientists representing diverse scientific
disciplines specializing in women's health. Find out more about
specific OWH/COE extramural research projects:
Special Funding Initiatives provide the OWH with the
capability to rapidly respond to immediate or recurring women's
health issues. The program is designed to be flexible. Funded
projects are diverse in nature to reflect the variety of methods
by which information is gathered and shared to benefit women's
health. OWH has used the Special Funding Initiatives mechanism
to co-fund topical workshops, conduct analytical surveys and
host similar events targeting vital women's health issues.
Pregnancy Initiatives -- Enhancing
Health for Mother and Child
Many pregnant women need medicine
In the United States (U.S.), there are 60 million women of
reproductive age. Over 9 million of these women have chronic
asthma, hypertension or epilepsy and require ongoing or episodic
treatment with prescription medication. Approximately 10% of
women between the ages of 15 and 44 become pregnant annually.
Thus, many women who become pregnant require medication. Also,
new medical problems may develop or old ones may become more
severe during pregnancy. These medical problems often require
treatment with prescription medication.
Many babies are exposed to medicine unintentionally
About half of all pregnancies in the U.S. are unintended. For
prescription medicines used in women of childbearing age, it
is common for medication exposure to occur during the critical
period of fetal development, before the woman is aware of her
pregnancy.
Information on fetal safety
During clinical development of most medicines, pregnant women
are actively excluded from trials, and, if pregnancy does occur
during the trial, the usual procedure is to discontinue treatment
and drop the woman from the study. Consequently, at the time
of a medicine's initial marketing, except for products developed
to treat conditions unique to pregnancy, there are seldom meaningful
human data on the effects of that medicine during pregnancy.
Even after years of marketing, information on fetal safety of
medicine in human pregnancy is usually not available. To address
this problem, the Food and Drug Administration (FDA) has recently
issued guidance on how to conduct a pregnancy exposure registry
for the collection of fetal safety data.
Promoting healthy pregnancies
Under FDA's Pregnancy Labeling Initiative, the Agency is taking
a two-pronged approach for improving fetal safety and maternal
dosing information. First, the FDA is drafting new regulations
on the format and content of the pregnancy and lactation section
of the label for prescription medicines. Second, the agency
is working to improve the quality and quantity of information
that is available to be put into the label.
Helping practitioners prescribe for pregnant women
The new proposed label will provide clinically relevant information
useful for 1) treating women during pregnancy and lactation,
and 2) counseling pregnant or lactating women regarding the
effects of medicine on herself, her developing baby, or her
breastfed child. The revised regulations will significantly
improve the way the agency communicates risk information and
provide for efficient risk management during pregnancy.
Information on dosing the mother
When deciding on the right dose of medicine for a pregnant
woman, healthcare practitioners usually rely on information
from studies on non-pregnant individuals. Since pregnancy influences
the action of many medicines, these practices risk exposing
the fetus to medicine with little or no benefit to the mother.
Knowledge about correct dosing in pregnant women can only be
obtained by studying the activity of the medicine throughout
the pregnancy.
Research on medications used in pregnancy
OWH has funded research on two prescription medicines commonly
used to treat high blood pressure during pregnancy. The studies
will determine the dose of medicine that provides the greatest
benefit and least risk for the mother and her baby. The studies,
which are being conducted at two National Centers of Excellence
in Women's Health, will demonstrate that this type of study
can and should be done for medicines widely used during pregnancy.
Research in this area will continue with studies to determine
if dosing adjustments are needed for antidepressants used during
pregnancy.
Counter-terrorism activities
As part of FDA's counter-terrorism activities, OWH and the
Center for Drug Evaluation and Research have funded studies
on prescription medicine that may be used to treat conditions
that could occur after a terrorist attack in special populations;
pregnant and lactating women and the elderly. One type of study
will determine the appropriate dose of medicines used in these
populations. The other study type will evaluate the fetal outcomes
of pregnant women exposed to these medicines using a Medicaid
claims database.
Pregnancy Registry Website
A Pregnancy Registry is the most effective technique for collecting
information on the fetal safety for prescription medicines.
In May 2002, OWH launched a new website listing registries in
the United States and Canada that are currently enrolling pregnant
women. The website helps women learn more about pregnancy registries
and how to participate in them. The website also provides links
to other sources of information regarding the fetal safety of
medicines used during pregnancy. For
more information, visit the website.
Outcomes
OWH tracks objective measures to determine the success of the
research program, including the completion rate, the number
of papers published, and if the project has lead to additional
research or other outcomes. To date, the results of OWH funded
research have been published in over 40 papers in peer-review
journals. Animal models developed with OWH funds have been used
for other research and regulatory projects. OWH also monitors
the impact of its funded projects on regulatory decision-making,
including guidance documents issued, label changes and standard
development. OWH provides information about its scientific program
to external stakeholders by reporting on program activities
and outcomes in the quarterly newsletter, The OWH Update, and
on the Internet.
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