Op-Ed

Cover of the article issue

Numerous articles and commentaries in the health literature recently have questioned the emergence of race as an increasingly powerful organizing principle in clinical medicine and pharmaceutical development [1,2]. Yet proposals for regulatory reform remain thin. Debate over racebased medicine crystallized around the FDA's June 2005 approval of BiDil, a drug approved to treat African-Americans with heart failure. Some saw BiDil as a dangerous example of marketing trumping science [3], whereas others heralded BiDil as a step towards eliminating racial disparities in health care [4]. One thing is clear: the BiDil debate has left major questions about how clinical trial design and drug regulation should engage this trend [5].

The need for new regulatory approaches to medicines with race-specific indications is growing more acute. A new trend towards designing and conducting clinical trials for race-specific medicines [6] carries serious implications for equitable access to pharmaceutical innovations. Under current policies FDA-approved racial indications might prevent certain groups from accessing certain drugs, even when there is little evidence to warrant such exclusion. Given the stakes of such exclusions for public health, new regulatory...