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Race in a BottleThe Story of BiDil and Racialized Medicine in a Post-Genomic Age$
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Jonathan Kahn

Print publication date: 2014

Print ISBN-13: 9780231162999

Published to Columbia Scholarship Online: November 2015

DOI: 10.7312/columbia/9780231162999.001.0001

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Capitalizing [on] Race in Drug Development

Capitalizing [on] Race in Drug Development

Chapter:
(p.87) 4 Capitalizing [on] Race in Drug Development
Source:
Race in a Bottle
Author(s):

Sheldon Krimsky

Publisher:
Columbia University Press
DOI:10.7312/columbia/9780231162999.003.0004

This chapter provides a close reading of the FDA hearing that approved the race-specific indication for BiDil, in which the racial frame played a critical role in shaping how the committee reviewed the data. The story of BiDil had presented a new model for development of targeted therapeutics that exploited race to cast the drug as an advance toward individualized pharmacogenomics. Specifically, BiDil's proponents used race to first resurrect the fortunes of an apparently failed drug; then to gain faster and cheaper FDA approval; and finally, to expand its potential market by informally promoting off-label use of the product to the general population. BiDil is situated at the forefront of a drive to bring the long-established corporate practice of “ethnic niche marketing” into the world of pharmaceuticals.

Keywords:   FDA hearing, BiDil, targeted therapeutics, FDA approval, ethnic niche marketing, pharmacogenomics, pharmaceuticals

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