Patel Anjur N
Fordham Law Rev. 2009 Nov;78(2):1075-115.
Prescription drug costs can be astronomical. The advent of generic drugs, which sell at substantially lower prices than their brand-name counterparts, can save consumers billions of dollars per year. The Hatch-Waxman Act, which governs the introduction of generic pharmaceuticals into the marketplace, produces an undesired side effect-the "approval bottleneck." This Comment examines the "approval bottleneck"-a potential roadblock to the generic drug approval process, and comments on attempts to alleviate the problem.This Comment suggests that developments in statutes and case law have made leaps in attempting to alleviate the "approval bottleneck" problem.The Comment evaluates these developments, which include (1) the ability of a subsequent Abbreviated New Drug Application (ANDA) filer to trigger the generic exclusivity period of the first ANDA filer; (2) the forfeiture provisions; (3) declaratory judgments and the relaxed declaratory judgment test; and (4) the rulings on covenants not to sue. Despite these attempts, however, the potential harm to consumers resulting from delayed access to generic medicines remains.
处方药的成本可能高得惊人。仿制药的出现，其售价远低于同类品牌药，每年可为消费者节省数十亿美元。《哈奇-沃克斯曼法案》（Hatch-Waxman Act）规定了仿制药进入市场的相关事宜，但却产生了一个意想不到的副作用——“审批瓶颈”。本评论文章探讨了“审批瓶颈”——仿制药审批过程中的一个潜在障碍，并对缓解该问题的尝试进行了评论。本评论文章指出，法规和判例法的发展在缓解“审批瓶颈”问题方面取得了显著进展。该评论文章评估了这些进展，包括：（1）后续简略新药申请（ANDA）提交者触发首个ANDA提交者的仿制药独占期的能力；（2）没收条款；（3）宣告性判决及宽松的宣告性判决测试；以及（4）不起诉契约的裁决。然而，尽管有这些尝试，因延迟获得仿制药而给消费者带来的潜在危害依然存在。
