Compared with the proportions of children from racial and ethnic minority groups in the U.S. population, smaller proportions of children from minority groups were included in the pediatric clinical drug studies requested by FDA before the enactment of BPCA that GAO reviewed. However, FDA required, and drug sponsors included, larger proportions of African American children in clinical studies for hypertension drugs because there is evidence that hypertension is more prevalent and more severe

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... g African Americans. Furthermore, FDA has requested that forthcoming studies for certain drugs include larger proportions of minority children.