In May 2017, the US Food and Drug Administration (FDA) announced a Drug Competition Action Plan, designed to address competition and pricing in the generic market and improve access to prescription drugs.1 One of FDA’s stated goals is to reexamine “places where its rules—including standards and procedures related to generic drug approvals—are being used in ways that may create obstacles to generic access,”1 instead of ensuring the vigorous competition Congress intended. In this Viewpoint, we examine FDA’s 2006 Unapproved Drugs Initiative (UDI), designed to strengthen the agency’s regulatory oversight related to unapproved marketed drugs. Using an illustrative example, we discuss this initiative’s unintended consequences, as it appears to have created obstacles to generic drug access, likely increasing prescription drug costs. The FDA estimates that in the United States, as many as several thousand drug products are marketed without FDA approval, many of which entered the market prior to the 1938 Federal Food, Drug and Cosmetic Act.2 Examples of unapproved prescription drugs include nitroglycerin sublingual tablets, phenobarbital, prenatal vitamins, calcium gluconate injection, and sodium phosphate injection. The goal of the UDI was to remove unapproved drugs from the market, “without

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FDA 批准以前未经批准的上市药物的高成本

2017 年 5 月，美国食品和药物管理局 (FDA) 宣布了一项药品竞争行动计划，旨在解决仿制药市场的竞争和定价问题，并改善处方药的获取。1 FDA 的既定目标之一是重新审查“其所在的地方”。规则——包括与仿制药批准相关的标准和程序——的使用方式可能会对仿制药的获取造成障碍，”1 而不是确保国会预期的激烈竞争。在这个观点中，我们研究了 FDA 的 2006 年未批准药物倡议 (UDI)，该倡议旨在加强该机构对未批准上市药物的监管。使用一个说明性示例，我们讨论了该计划的意外后果，因为它似乎对仿制药的获取造成了障碍，可能会增加处方药成本。FDA 估计，在美国，多达数千种药品未经 FDA 批准就上市销售，其中许多产品在 1938 年联邦食品、药物和化妆品法案之前就已进入市场。 2 未经批准的处方药例子包括硝酸甘油舌下含片、苯巴比妥、产前维生素、葡萄糖酸钙注射液、磷酸钠注射液。UDI 的目标是将未经批准的药物从市场上移除，“没有