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期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2024.5737

摘要内容如下：

重要性

联邦贸易委员会（FTC）在药品市场中的监督作用对患者的健康和医疗保健系统至关重要。这项研究描述了联邦贸易委员会近几十年来对药品市场的政策，确定了它所支持的行动类型，它所面临的障碍，以及仍未得到检验的权威。

目的

审查2000-2022年联邦贸易委员会在药品市场的法律行动。

证据审查

法律行动是通过人工审查联邦贸易委员会在线法律图书馆的搜索结果以及2023年联邦贸易委员会关于药品行动的报告来确定的。指控的不当行为、采取的法律行动类型、时间和结果是从新闻稿、投诉、命令和其他法律文件中收集的。

调查结果

从2000年到2022年，联邦贸易委员会对62起并购提出了质疑，对涉嫌非法的商业行为采取了22项执法行动，并制定了1项与药品有关的规则。执法行动中被指控的不当行为涉及专利诉讼中的反竞争和解（n=11）、品牌制造商推迟仿制药竞争的单边行动（n=6）、竞业禁止协议（n=4）和垄断（n=3），其中10项结果涉及金钱支付，总计16亿美元。在受到联邦贸易委员会质疑的62起并购案中，有61起被允许继续进行，其中58起是在将某些药品转让给第三方竞争对手之后进行的。联邦贸易委员会对药品剥离的依赖从2000-2017年的每年18种药品减少到2017-2023年的每年4.3种药品。

结论和相关性

从2000年到2022年，联邦贸易委员会每年对制药商采取1次执法行动和3次合并行动，追究药品市场中估计的不当行为和合并的一小部分。尽管公平贸易委员会面临着巨大的法律和实践限制，但重要的工具仍未得到检验，包括一项界定“不公平竞争方法”的规则，该规则可能使其能够更有效地防止反竞争行为的重复模式。

英文原文如下：

Abstracts

Importance  The Federal Trade Commission's (FTC) oversight role in the pharmaceutical market is critical to the health of patients and the health care system. This study characterized the FTC's policy on the pharmaceutical market in recent decades, identifying the types of actions it has favored, barriers it has faced, and authorities that remain untested.

Objective  To review FTC legal actions in the pharmaceutical market from 2000-2022.

Evidence Review  Legal actions were determined through manual review of search results from the FTC's online Legal Library as well as a 2023 FTC report on pharmaceutical actions. The alleged misconduct, type of legal action taken, timing, and outcome were collected from press releases, complaints, orders, and other legal documents.

Findings  From 2000-2022, the FTC challenged 62 mergers, brought 22 enforcement actions against allegedly unlawful business practices, and made 1 rule related to pharmaceuticals. Alleged misconduct in enforcement actions involved anticompetitive settlements in patent litigation (n = 11), unilateral actions by brand manufacturers to delay generic competition (n = 6), noncompete agreements (n = 4), and monopolization (n = 3), with 10 outcomes involving monetary payment, totaling $1.6 billion. Of the 62 mergers the FTC challenged, 61 were allowed to continue, 58 after divesting certain drugs to third-party competitors. The FTC's reliance on drug divestitures decreased from 18 drugs per year from 2000-2017 to 4.3 per year from 2017-2023.

Conclusions and Relevance  The FTC brought about 1 enforcement action and 3 merger actions per year against pharmaceutical manufacturers from 2000-2022, pursuing a small fraction of the estimated misconduct and consolidation in the pharmaceutical marketplace. Although the FTC faces substantial legal and practical limitations, important tools remain untested, including a rule defining "unfair methods of competition," that may allow it to more effectively prevent repetitive patterns of anticompetitive behavior.

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