FDA Races in Wrong Direction

Considerable controversy exists about the use of race and ethnicity in scientific and medical research (1–4). Despite recent genetic evidence and the promise of individualized medicine, the use of restrictive self-identified categories of race and ethnicity as research variables continues. For example, recent draft guidance issued by the U.S. Food and Drug Administration (FDA) recommends a standardized approach for the collection of race and ethnicity data in clinical trials (5). We applaud efforts to ensure diversity in clinical trials and standardization of data, but we are concerned that applying antiquated labels to the analysis and interpretation of scientific data could result in misleading and biologically meaningless conclusions.