Perpetual debate regarding the delicate balance between access and innovation and the protection of the public health and safety dominate discussions of the United States Food and Drug Administration (“FDA”). Established chiefly as a command and control federal administrative agency, iterative changes in legislation have shaped the FDA's activity in drug, biologic, and medical device regulation over the course of the last one hundred plus years. The most recent fundamental reframing of the agency's authority and directive presented itself in the 21st Century Cures Act, reflecting an important role for patient perspectives in the regulatory process. This Article explores recent developments in patient-focused product development efforts at the FDA and offers modest insights on the increasing role of patients, and patient advocacy groups, in agency decision-making. The Article terms this era “21st century citizen pharma.”

中文翻译：

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21st Century Citizen Pharma：FDA 和以患者为中心的产品开发

美国食品和药物管理局 (“FDA”) 的讨论一直围绕着获取和创新以及保护公众健康和安全之间的微妙平衡展开辩论。主要作为一个指挥和控制联邦行政机构建立，立法的迭代变化在过去一百多年的过程中塑造了 FDA 在药物、生物和医疗器械监管方面的活动。该机构的权威和指令最近的根本性重构出现在 21英石世纪治愈法案，反映了患者观点在监管过程中的重要作用。本文探讨了 FDA 以患者为中心的产品开发工作的最新进展，并就患者和患者倡导团体在机构决策中日益重要的作用提供了适度的见解。文章称这个时代为“21英石世纪公民制药公司。”