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In 1994, the Food and Drug Administration Office of Women's Health (FDA-OWH) was created to provide leadership and policy direction for the Agency regarding issues of women's health. Within its first year, the FDA-OWH established a science program for women's health research, promoting the development of sound policy and regulation. In a little over a decade, the program has provided approximately 14 million dollars to fund more than 100 women's health research studies covering a broad range of health topics affecting women across their lifespan. Some studies, such as those elucidating drug effects on QT prolongation in women and drug-dietary supplement interaction, have had significant influence on regulatory decisions. Other studies have provided sound scientific data on sex and gender differences supporting FDA guidelines to protect women's health. This paper describes the science program at the FDA-OWH, providing examples of how funded research impacts regulatory policy.

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The U.S. Food and Drug Administration Office of Women's Health (FDA OWH) has supported women's health research for ∼20 years, funding more than 300 studies on women's health issues, including research on diseases/conditions that disproportionately affect women in addition to the evaluation of sex differences in the performance of and response to medical products. These important women's health issues are studied from a regulatory perspective, with a focus on improving and optimizing medical product development and the evaluation of product safety and efficacy in women. These findings have influenced industry direction, labeling, product discontinuation, safety notices, and clinical practice. In addition, OWH-funded research has addressed gaps in the knowledge about diseases and medical conditions that impact women across the life span such as cardiovascular disease, pregnancy, menopause, osteoporosis, and the safe use of numerous medical products.

The initial challenge in primary prevention of sudden cardiac death (SCD) lies in identifying those at greatest risk, before the index event. Ventricular fibrillation is the leading cause of SCD; however, many clinical conditions predispose fatal ventricular dysrhythmias. In patients with structural heart disease, left ventricular dysfunction is the strongest predictor of SCD. Noninvasive markers such as nonsustained ventricular tachycardia, delayed potentials, decreased heart rate variability and baroreflex sensitivity, and repolarization alternans are further observed to assess risk in ischemic cardiomyopathy; however, most of these markers have poor positive predictive value and lack specificity. The electrophysiologic study has strong positive predictive value, but remains a costly and invasive method for risk stratification. In patients with normal hearts, genetic predisposition may identify patients at risk but clinical markers are not readily recognized. The implantable loop recorder is a useful tool in detecting dysrhythmic causes of syncope and identifying patients at risk for SCD.