Beyond Best Practices: Strict Scrutiny as a Regulatory Model for Race-Specific Medicines

Abstract

A resounding debate has ensued over the utility of race in biomedical research, particularly as new drugs claiming to serve particular racial populations attempt to enter the marketplace. This creates a number of challenges for the Food and Drug Administration over how best to regulate new drugs seeking race specific indications. This article suggests that it may be beneficial for the FDA to turn to an area with experience negotiating such dilemmas--Constitutional Law--and its approach--strict scrutiny--to help guide when and under what circumstances Government should give effect to racial categories in biomedicine.