This article examines the implications of U.S. federal and international regulatory mandates in the construction and circulation of racial categories in biomedical research and drug development. It will focus on the interface between two regulatory mandates in particular: the International Conference on Harmonization (ICH) Guideline Document E-5 on Ethnic Factors in the Acceptability of Foreign Clinical Data, and the U.S. Food and Drug Administration (FDA) Guidance for Industry: Collection of Race and Ethnicity Data in Clinical Trials. The ostensible purpose of both of these guidelines is to promote more efficient and economical development of new pharmaceutical interventions. Underlying both Guidances is a presumption that race and ethnicity are relevant variables in assessing the safety and efficacy of drugs in clinical trials.
Both Guidances also implicitly cast race and ethnicity as obstacles to be managed and overcome in the course of getting new drugs to global markets as quickly and cheaply as possible.
The ICH process is transforming global drug development and marketing, and, in particular, is opening up the large Japanese market to pharmaceuticals tested in the West. The FDA Guidance similarly promises to transform the production and organization of racial and ethnic data in clinical trials for the U.S. market. As pharmaceutical development goes global, however, the social classifications of the FDA Guidance also promise to collide with the mixture of social, physiological and genetic factors elaborated in the ICH guideline. These diverse classificatory schemes cannot be easily reconciled. This paper will explore how concepts of race and ethnicity are being produced and reproduced through this collision. It will further explore how these distinct attempts to regulate race in a bureaucratic context are shaping the development of global pharmaceutical markets.
Part II of the article will set forth the background to the ICH E5 regulatory mandate and its distinct concepts of race and ethnicity. Part III will explore how the ICH guidelines have already begun to affect global pharmaceutical development. Part IV will set forth the background to the FDA guidelines on the collection of racial and ethnic data for clinical trials. It will then go on to examine the debates that arose around the adoption of the FDA guidelines, specifically as they involved considerations of how the FDA guidelines might impact global pharmaceutical development under the ICH regulatory regime. Part V will conclude the article with an examination of the broader implications of this story for the production of social and regulatory understandings of the nature of race and ethnicity.
Harmonizing Race: Competing Regulatory Paradigms of Racial Categorization in International Drug Development,
5 Santa Clara J. Int'l L.
Available at: http://digitalcommons.law.scu.edu/scujil/vol5/iss1/3