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

Published online by Cambridge University Press:  01 January 2021

Osagie K. Obasogie
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Extract

Race is becoming an increasingly common lens through which biomedical researchers are studying the relevance of genes to group predispositions that may affect disease susceptibility and drug response. These investigations contravene decades of research in the natural and social sciences demonstrating that social categories of race have little genetic significance. Nevertheless, a resounding debate has ensued over the utility of race in biomedical research — particularly as new drugs claiming to serve particular racial populations enter the marketplace. Now that the Food and Drug Administration (FDA) has approved BiDil as the first race-specific treatment despite conflicting evidence and unsettled debates, is there a way for federal regulators to promote research that may address minority health concerns without giving undue credence to the dangerous idea that social understandings of race are genetically relevant? It may be useful 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 which circumstances government should give effect to racial categories in biomedicine.

Type
Symposium
Information
Journal of Law, Medicine & Ethics , Volume 36 , Issue 3 , Fall 2008 , pp. 491 - 497
Copyright
Copyright © American Society of Law, Medicine and Ethics 2008

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