Johnson Candon, Wolff Carolyn, Xu Jing
Food and Drug Administration, Office of the Commissioner, Silver Spring, MD, USA.
Federal Trade Commission, Bureau of Economics, Washington, DC, USA.
J Racial Ethn Health Disparities. 2024 Jul 22. doi: 10.1007/s40615-024-02094-x.
Understanding and evaluating equity in access to care is a critical component to ensuring health equity for all individuals. During the COVID-19 pandemic, the U.S. Food and Drug Administration made unprecedented use of its regulatory authority by authorizing the use of unapproved products through Emergency Use Authorizations (EUAs). We use data from the U.S. National COVID Cohort Collaborative (N3C) to understand how access to therapeutic products authorized under EUAs has varied across COVID-19 patients and over time. We find that Black patients were more likely to receive early EUA drugs while White patients were more likely to receive monoclonal antibodies. Male patients were more likely to receive any EUA drug than Female patients. Patients in Metropolitan areas were more likely to receive EUA drugs than patients in other regions. Additionally, differences in the rates of exposure to EUA drugs by gender, rural-urban classification, and length of stay decreased over time while differences by race and ethnicity have generally persisted. Our project identifies inequities in the rate of access to EUA drugs across patient groups that can inform policy makers in future planning and decision making.
理解和评估医疗服务可及性方面的公平性是确保所有人实现健康公平的关键组成部分。在新冠疫情期间，美国食品药品监督管理局史无前例地动用其监管权力，通过紧急使用授权（EUA）批准使用未经批准的产品。我们利用美国国家新冠队列协作组（N3C）的数据，来了解在新冠患者中以及随着时间推移，通过紧急使用授权获批的治疗产品的可及性情况如何变化。我们发现，黑人患者更有可能接受早期紧急使用授权药物，而白人患者更有可能接受单克隆抗体。男性患者比女性患者更有可能接受任何紧急使用授权药物。大都市地区的患者比其他地区的患者更有可能接受紧急使用授权药物。此外，按性别、城乡分类和住院时间划分的紧急使用授权药物暴露率差异随着时间推移而减小，而按种族和族裔划分的差异总体上持续存在。我们的项目确定了不同患者群体在紧急使用授权药物可及率方面的不公平现象，可为政策制定者未来的规划和决策提供参考。
