The Case Against Race-Based Quotas in Pharmaceutical Trials.

Abstract

This Article is the first to offer a comprehensive case against using racial quotas in pharmaceutical studies by providing a detailed examination of the arguments for and against the practice. It begins by discussing the current racial classification system, calls for racial quotas in pharmaceutical trials, and the troubling history of combining race and scientific investigation. It next examines the cautionary tale of BiDil, the first drug authorized by the U.S. Food and Drug Administration (FDA) for use in only Black people. The third part of the Article sets forth the arguments against racial quotas. The fourth part provides legal analysis of these arguments, concluding that racial quotas in pharmaceutical trials likely would not satisfy the strict scrutiny standard for two independent reasons. The fifth part evaluates the alleged benefits of racial quotas and demonstrates that when properly understood they are insignificant in comparison to the disadvantages. The final part weighs the evidence to arrive at a conclusion and considers future implications.Ultimately, this Article provides a valuable framework for assessing the legal and pragmatic implications not just for pharmaceutical trial quotas but also for other racial-classification issues in health care. For example, while it presents a cumulative case against the proposed practice of racial quotas in pharmaceutical trials, many of the same arguments presented are also applicable to the currently mandated practice of acquiring and reporting racial data of pharmaceutical trial participants. It will serve as a valuable resource not only for opponents of racial quotas but also for advocates. For example, this Article provides numerous race-neutral alternatives for consideration. And the strong case against racial quotas helps facilitate a refocus of efforts away from merely ameliorating the end results of health care disparities and instead targeting the root causes. Evidence suggests that this redirected focus on root causes is more effective at producing positive change. In this way, rejecting these quotas is not in conflict with addressing health disparities; rather, it is beneficial to it. This Article will hopefully serve as a catalyst for future research regarding best practices on how pragmatic; legal; and diversity, equity, and inclusion considerations can synergistically exist.