FDA'S OFFICE OF WOMEN'S HEALTH
ANNOUNCES 2002 RESEARCH CONTRACTS

Five Contracts Awarded; Four for Counter Terrorism Studies

The Food and Drug Administration's (FDA's) Office of Women's Health today announced contracts for five research studies including four focusing on drugs used to counteract the effects of biological and chemical warfare that would particularly affect elderly, pregnant and lactating women. Three of these studies are being funded in partnership with the agency's parent organization, the Department of Health and Human Services (DHHS) through its Office on Women's Health and its National Centers of Excellence in Women's Health (CoE). The other counter terrorism-related study is funded by FDA's Center for Drug Evaluation and Research through FDA's Office on Women's Health and will investigate infant outcomes when mothers are exposed to drugs needed to prevent medical problems following a terrorist attack.

"In light of the nation's recent experience with bioterrorism, these contracts provide for extremely important research on the safe use of medicines in vulnerable populations," said Secretary of Health and Human Services, Tommy G. Thompson. A fifth contract was awarded for a study to evaluate methods for controlling diabetes. This study is also being conducted at one of the National Centers of Excellence in Women's Health.

"Through these women's health contracts we are promoting research at some of the world's leading academic institutions on matters which will provide valuable insight into critical public health issues," said Dr. Lester M. Crawford, FDA Deputy Commissioner.

The contracts awarded in partnership with the DHHS Office on Women's Health include:

• Indiana School of Medicine, CoE (Center of Excellence) $448,455. "Ciprofloxacin and Doxycycline Disposition in Lactating Women and in the Elderly"--a study to determine the doses of these antibiotics needed to prevent anthrax in lactating women and the elderly.
• University of Washington, Seattle, CoE, $272,100. "The Pharmacokinetics of Amoxicillin during Pregnancy and Postpartum"--a study of how pregnancy changes the doses of antibiotics needed to prevent or treat illness.
• University of Wisconsin, Madison, CoE, $832,192. "Pharmacokinetics and Pharmacodynamics of Gentamicin, Azithromycin and Ciprofloxicin During Pregnancy" --a study to determine the doses of these antibiotics needed to prevent illness in pregnant and lactating women.

The final counter-terrorism contract awarded by FDA focuses on safety for the baby rather than the health of the mother:

• Vanderbilt University, Nashville $750,000. "Research on the Fetal Safety of Prescription Medications used to Prevent Illness following a Bioterrorist Attack" --a study to examine outcomes for babies born to women who were exposed to ciprofloxacin, doxycycline, amoxicillin, gentamicin and azithromycin compared to babies born to a group of pregnant women not exposed to these drugs.

The fifth women's health contract awarded in partnership with the DHHS Office on Women's Health is a study related to factors that affect the control of blood sugar levels in patients with diabetes. The burden of diabetes falls disproportionately on women, who are at greater risk for blindness and serious cardiovascular disease than men with diabetes.

• Boston University, CoE $150,000. "Self Monitoring of Blood Glucose with Finger Tip Sampling vs. Alternative Site Sampling; Source of Variability and Effect on Long Term Glycemic Control" --a study to evaluate the difference in diabetes control with blood glucose monitoring via fingerstick versus drawing blood samples from other locations on the body.

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