The Office of
Women's Health Scientific Research
Program
Summary
Office of Women's Health
U.S. Food and Drug Administration
OWH SCIENTIFIC PROGRAM
INTRAMURAL GRANT PROGRAM
1994-2000
Since its inception in 1994, OWH
has awarded funds for 95 intramural
research projects totaling over $8.5
million. An annual competitive peer
review process is utilized to select
the highest quality projects. Special
funding initiatives were also awarded
outside the competitive process for
projects that addressed immediate
regulatory needs.This report provides
summary statistics on the status
of the OWH funding program, highlights
several completed projects which
have made contributions to the protection
and promotion of women's health,
and descriptions of some projects
likely to provide important results
in the near future.
Summary Statistics
95 intramural projects have been
funded between FY 1994-FY 2000
at a cost of approximately $8.5
million
- 83 scientific/regulatory projects
funded through the competitive
grant program
- 12 projects funded through
noncompetitive, special funding
initiatives
Average cost per project - $88,858
(SD=$79,242)
Cost range - $11,000 to $530,000
Total projects funded per Center/Office
since 1994
- Center for Biologics Evaluation
and Research--15
- National Center for Toxicological
Research--13
- Center for Devices and Radiological
Health--24
- Center for Drug Evaluation
and Research--25
- Center for Food Safety and
Applied Nutrition--10
- Office of Regulatory Affairs--2
- Office of International and
Constituent Relations--3
- Center for Veterinary Medicine--2
- Office of Women's Health--1
Total dollar amount awarded per
Center/Office since 1994
- Center for Biologics Evaluation
and Research $1,921,000
- National Center for Toxicological
Research $1,765,000
- Center for Devices and Radiological
Health $1,851,000
- Center for Drug Evaluation
and Research $1,595,000
- Center for Food Safety and
Applied Nutrition $957,000
- Office of Regulatory Affairs $99,000
- Office of International and
Constituent Relations
$147,400
- Center for Veterinary Medicine $195,000
64% of funded projects have been
completed. The remaining projects
have scheduled completion dates
between May 1999 and November 2003.
- 92% of completed projects
were satisfactorily completed
- 5% of completed projects
were not satisfactorily completed
(3 projects)
- 3% of completed projects
were terminated prior to completion
(2 projects)
Outcomes measures
- 41 manuscripts have been
published in peer-reviewed
scientific journals. An additional
21 manuscripts have been submitted
for review.
- 24 projects have generated
results which have produced
scientific/regulatory outcomes
other than publications, such
as abstracts, scientific posters,
product labeling improvements,
databases, conferences, and
literature searches for regulatory
decision making.
Completed Project Highlights
- Breast Cancer
- Regional workshops for mammography
facility personnel regarding implementation
of the interim requirements mandated
by the Mammography Quality Standards
Act of 1992. Recipient of a Hammer
Award.
- Cardiovascular Disease
- A study which determined there
were no gender differences in outcomes
after thrombolytic treatment of acute
myocardial infarction.
- Determination of gender specific
effects of quinidine on prolongation
of QT intervals. A prolonged QT interval
is associated with a potentially
lethal syndrome of abnormal heart
arrhythmia (Torsades de pointes)
which is sometimes seen after administration
of quinidine. This study determined
that repolarization times are greater
in men than women after administration
of quinidine.
- Contraceptives
- A combined CDER and CDRH effort
resulted in a contraceptive efficacy
table designed to simplify product
comparisons for consumers. This table
is now used in the labeling of all
drug and device contraceptives.
- >Developmental/Reproductive
Toxicology
- Development of a pilot software
program designed to estimate the
reproductive toxicity of pharmaceuticals
for providing decision support information
for regulatory/research activities.
- Characterization of the ability
of tamoxifen to have a toxic effect
on the developing rat embryo. This
information was utilized to assess
the potential risk to the human fetus
of exposure to tamoxifen and other
antiestrogens.
- Estrogens
- Development of an estrogen knowledge
database for research, regulation,
and prediction of estrogenicity of
new compounds. This provides critical
information because estrogens are
developmental toxicants and tumor
promotors in animals and humans.
- Gender Effects
- Development of a pilot tracking
system for monitoring the participation
of women in clinical trials. This
system was designed to estimate the
impact of the 1993 Guideline for
the Study and Evaluation of Gender
Differences in the Clinical Evaluation
of Drugs. The data demonstrated that
while there was an overall increase
in the number of protocols which
permitted the participation of women
and women of childbearing potential,
a notable number of protocols continued
to exclude these important subgroups.
- Development of a software program
which applies exploratory statistics
and visualization tools to the FDA
Spontaneous Reporting System to aid
reviewers in determining if gender
specific effects exist.
- Pregnancy
- The Infant Feeding Practices Study
yielded databases of detailed longitudinal
information which will be used by
researchers from FDA, CDC and universities
to evaluate various aspects of infant
feeding practices. One evaluation
determined that breast feeding decreases
the incidence of infant ear infections.
- To address the lack of data on
risk to pregnancy from use of prescription
drugs, this study developed a profile
of drugs used during pregnancy from
an HMO database. This initial effort
determined the most commonly used
therapeutics according to pregnancy
outcome and estimated the proportion
of pregnancies that are potentially
exposed to these drugs. This system
has the potential for producing additional
postmarketing information related
to drug use in pregnant women.
Highlights - Ongoing
Projects
Near Completion
- Cardiovascular Disease
Women have slower cardiac repolarization
that is expressed as longer QT intervals
on the ECG. An evaluation of the
effect of the differing levels of
sex hormones experienced during the
menstrual cycle on the QT prolongation
seen after the administration of
an antiarrythmic drug will be conducted.
- Dietary Supplements
Based on the potential for botanical
products to become contaminated with
heavy metals, an evaluation of the
lead and cadmium levels in botanical
products marketed to women will be
conducted. If measured levels are
unacceptably high, specific regulatory
activities may be initiated in an
effort to limit future adverse events.
- Gender Effects
Development of datamining techniques
for detecting serious drug interactions
in women using the postmarketing
adverse event reports and commercially
available longitudinal databases.
- Pregnancy
Development and validation of an
assay to determine maternal risk
and progression of Down's syndrome
related to folic acid.
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