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.

中文翻译：

---

反对药物试验中基于种族的配额的案例

本文首次通过详细审查支持和反对这种做法的论点，提供了反对在药物研究中使用种族配额的全面案例。它首先讨论了当前的种族分类制度、药物试验中种族配额的呼吁，以及种族与科学研究相结合的令人不安的历史。接下来，它探讨了 BiDil 的警示故事，这是美国食品和药物管理局 (FDA) 授权的第一种仅用于黑人的药物。该条的第三部分阐述了反对种族配额的论点。第四部分对这些论点进行了法律分析，得出的结论是，由于两个独立的原因，药物试验中的种族配额可能无法满足严格的审查标准。第五部分评估了种族配额所谓的好处，并表明，如果正确理解，与缺点相比，它们是微不足道的。最后一部分权衡证据以得出结论并考虑未来的影响。最终，本文提供了一个有价值的框架，用于评估法律和务实的影响，不仅适用于药物试验配额，还适用于医疗保健中的其他种族分类问题。例如，虽然它提出了反对药物试验中种族配额拟议做法的累积案例，但提出的许多相同论点也适用于当前强制获取和报告药物试验参与者种族数据的做法。它不仅对于种族配额的反对者而且对于种族配额的倡导者来说都将成为宝贵的资源。例如，本文提供了许多种族中立的替代方案供考虑。反对种族配额的有力理由有助于重新调整努力的重点，从仅仅改善医疗保健不平等的最终结果，转向针对根本原因。有证据表明，这种对根本原因的重新关注能够更有效地产生积极的变化。这样，拒绝这些配额与解决健康差距并不冲突；相反，这对它是有利的。本文有望成为未来有关如何务实的最佳实践的研究的催化剂；合法的; 多样性、公平性和包容性考虑因素可以协同存在。本文提供了许多种族中立的替代方案供考虑。反对种族配额的有力理由有助于重新调整努力的重点，从仅仅改善医疗保健不平等的最终结果，转向针对根本原因。有证据表明，这种对根本原因的重新关注能够更有效地产生积极的变化。这样，拒绝这些配额与解决健康差距并不冲突；相反，这对它是有利的。本文有望成为未来有关如何务实的最佳实践的研究的催化剂；合法的; 多样性、公平性和包容性考虑因素可以协同存在。本文提供了许多种族中立的替代方案供考虑。反对种族配额的有力理由有助于重新调整努力的重点，从仅仅改善医疗保健不平等的最终结果，转向针对根本原因。有证据表明，这种对根本原因的重新关注能够更有效地产生积极的变化。这样，拒绝这些配额与解决健康差距并不冲突；相反，这对它是有利的。本文有望成为未来有关如何务实的最佳实践的研究的催化剂；合法的; 多样性、公平性和包容性考虑因素可以协同存在。反对种族配额的有力理由有助于重新调整努力的重点，从仅仅改善医疗保健不平等的最终结果，转向针对根本原因。有证据表明，这种对根本原因的重新关注能够更有效地产生积极的变化。这样，拒绝这些配额与解决健康差距并不冲突；相反，这对它是有利的。本文有望成为未来有关如何务实的最佳实践的研究的催化剂；合法的; 多样性、公平性和包容性考虑因素可以协同存在。反对种族配额的有力理由有助于重新调整努力的重点，从仅仅改善医疗保健不平等的最终结果，转向针对根本原因。有证据表明，这种对根本原因的重新关注能够更有效地产生积极的变化。这样，拒绝这些配额与解决健康差距并不冲突；相反，这对它是有利的。本文有望成为未来有关如何务实的最佳实践的研究的催化剂；合法的; 多样性、公平性和包容性考虑因素可以协同存在。拒绝这些配额与解决健康差距并不冲突；相反，这对它是有利的。本文有望成为未来有关如何务实的最佳实践的研究的催化剂；合法的; 多样性、公平性和包容性考虑因素可以协同存在。拒绝这些配额与解决健康差距并不冲突；相反，这对它是有利的。本文有望成为未来有关如何务实的最佳实践的研究的催化剂；合法的; 多样性、公平性和包容性考虑因素可以协同存在。