On the Designation of Race in Clinical Pharmacology Reports

Abstract

Food and Drug Administration guidelines require that sponsors of new drugs in the United States prepare case report forms that identify the race of individual patients, and that clinical pharmacology and other summary reports compile such racial data as part of the demographic profile. Complying with these requirements is difficult, since the FDA offers neither a definition of race nor a model method for classifying subjects into racial categories. The resulting classification of Americans into so-called races, such as white, black, Hispanic, and Oriental, suffers from semantic, logical, and scientific flaws. While the analysis of demographic factors, including genetic factors, is of unquestioned importance for understanding the actions of drugs, the concept of race as a classification scheme warrants scrutiny. The gain from attempting to classify people based on this culturally determined concept may be outweighed by the harm.