© 2003 by Oxford University Press
Journal of the National Cancer Institute, Vol. 95, No. 6, 425-426,
March 19, 2003
© 2003 Oxford University Press
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FDA Guidelines on Race and Ethnicity: Obstacle or Remedy?
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In an effort to increase the efficacy of drug treatments and reduce potential unintended drug interactions among different racial and ethnic groups, the U.S. Food and Drug Administration has issued new guidelines calling for establishment of more detailed race and ethnicity categories in the collection of effectiveness and safety data during clinical trials of promising pharmaceuticals that the agency regulates.
Current FDA regulations require drug sponsors to present an analysis of data according to age, gender, and race. But the agency cited an increasing body of evidence that points to substantial differences in response to medications among racially and ethnically distinct subgroups of the U.S. population.
In its draft guidance, the FDA conceded that such dissimilarities
Drug Responses
Category Standardization
Exceptions
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