Statutory Thickets and Drug Shortages: Accumulating Legislation as an Underlying Cause.

IF 0.6 4区 社会学 Q3 LAW
American Journal of Law & Medicine Pub Date : 2025-07-01 Epub Date: 2025-09-16 DOI:10.1017/amj.2025.10065
Jonathan J Darrow, Erin R Fox, Timo Minssen
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引用次数: 0

Abstract

Over the past three decades, the U.S. health care system has experienced numerous shortages of commonly-used older medicines that are both off-patent and inexpensive. Commentators seeking to explain shortages have often pointed to manufacturing quality and low profit margins as principal causes. These proximate causes, however, do not explain why there was a sudden and dramatic increase in shortages between 2007 and 2012, when shortages almost tripled from 154 to 456, or why they have persisted at similar levels into the 2020s despite repeated efforts to address them. This Article posits that low prices and quality problems derive from underlying shifts in the market environment, and that these shifts in turn are largely the result of Congressional legislation. The role of such well-intentioned legislation over the past fifty years is evaluated, including the 1984 Hatch-Waxman Act, the 2003 Medicare Modernization Act, the 2012 Generic Drug User Fee Act, and the 2015 Bipartisan Budget Act. The analysis reveals these laws have inadvertently squeezed profitability out of the generic drug market and thereby served as a true root cause of many drug shortages. Also considered are the potential effects on drug shortages of more recent legislation, including the 2021 American Rescue Act Plan and the 2022 Inflation Reduction Act.

法定丛林与药物短缺:累积立法是根本原因。
在过去的三十年里,美国的医疗保健系统经历了许多常用的老药的短缺,这些药既不是专利,又便宜。试图解释短缺的评论人士常常指出,制造质量和低利润率是主要原因。然而,这些直接原因并不能解释为什么在2007年至2012年期间,短缺数量突然急剧增加,从154人增加到456人,短缺数量几乎增加了两倍,也不能解释为什么尽管一再努力解决这一问题,但短缺数量一直保持在本世纪20年代的类似水平。本文认为,低价格和质量问题源于市场环境的潜在变化,而这些变化又主要是国会立法的结果。这些善意的立法在过去五十年中的作用进行了评估,包括1984年的哈奇-韦克斯曼法案,2003年的医疗保险现代化法案,2012年的仿制药用户收费法案和2015年的两党预算法案。分析表明,这些法律无意中挤压了仿制药市场的盈利能力,从而成为许多药物短缺的真正根源。还考虑了最近立法对药品短缺的潜在影响,包括2021年美国救援法案计划和2022年通货膨胀减少法案。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
0.80
自引率
16.70%
发文量
8
期刊介绍: desde Enero 2004 Último Numero: Octubre 2008 AJLM will solicit blind comments from expert peer reviewers, including faculty members of our editorial board, as well as from other preeminent health law and public policy academics and professionals from across the country and around the world.
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