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The Insufficient Inclusion of Pregnant Women in Biomedical Studies, and the Disproportionate Consequences for Low-Income Persons of Color.

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  • Law
  • Medicine


In the United States, women receive on average 1.3 prescriptions from each physician visit during pregnancy (Lee et al., 2006). Despite the considerable use of medications to manage and treat chronic and emergent conditions, the U.S. Food and Drug Administration (FDA) has approved only thirteen medications for use by pregnant women (Greenberg et al., 2011). This incongruity is largely a product of the complex problem of insufficient inclusion of pregnant women in biomedical research. This paper explores the consequences of exclusion, arguing that low-income populations of color are disproportionately burdened by both the insufficient inclusion of pregnant women in research and the resulting information gap on maternal-fetal drug safety and efficacy. To provide some context, the paper will begin by providing background on the history of women and biomedical research. In the following section, the scope of the problem will be outlined, followed by discussion of consequences for low-income persons of color. The final section will recognize both legal and non-legal challenges while presenting various recommendations for action.

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