The FDA's risk/benefit calculus in the approvals of Qsymia and Belviq: treating an obesity epidemic while avoiding another fen-phen.

IF 0.3 4区 医学 Q4 FOOD SCIENCE & TECHNOLOGY
Food and drug law journal Pub Date : 2014-01-01
Lauren M Azebu
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引用次数: 0

Abstract

As obesity rates continue to rise in the United States, both physicians and patients have demanded more safe and effective drug treatment options. However, following the fen-phen/Redux and sibutramine failures, the FDA has been hesitant to approve any anti-obesity drugs, despite the magnitude of the epidemic. Some have argued that these public embarrassments have led the FDA to overestimate the risks and underestimate the benefits when deciding whether to approve new anti-obesity drugs. On June 27, 2012, the FDA approved Belviq for chronic weight management, making it the first anti-obesity drug approved by the FDA in thirteen years. Less than one month later, the FDA approved Qsymia for the treatment of obesity. Both drugs had been denied FDA approval less than two years earlier. In this paper, I will first review the obesity crisis and discuss the high-profile market withdrawals of fenfluramine, dexfenfluramine, and sibutramine. Second, I will explain the FDA's drug approval process with a focus on the FDA's risk/benefit calculus. Third, I will compare the FDA's risk/benefit analysis for Qsymia and Belviq in 2010 with the agency's risk/benefit analysis in 2012 to determine what caused the agency to grant approval in 2012 while denying it in 2010. Finally, I will analyze what these drug approvals may mean for the future of other anti-obesity drugs.

FDA批准Qsymia和Belviq的风险/收益计算:在治疗肥胖症流行的同时避免另一种芬-芬。
随着美国肥胖率的持续上升,医生和患者都要求更多安全有效的药物治疗选择。然而,在芬-芬/Redux和西布曲明失败之后,FDA一直在犹豫是否批准任何抗肥胖药物,尽管这种流行病的规模很大。一些人认为,这些公开的尴尬导致FDA在决定是否批准新的抗肥胖药物时高估了风险,低估了益处。2012年6月27日,FDA批准Belviq用于慢性体重管理,使其成为13年来FDA批准的第一种抗肥胖药物。不到一个月后,FDA批准Qsymia用于治疗肥胖症。不到两年前,这两种药物都被FDA拒绝批准。在本文中,我将首先回顾肥胖危机,并讨论芬氟拉明,右芬氟拉明和西布曲明的高调市场撤回。其次,我将解释FDA的药物批准过程,重点是FDA的风险/收益计算。第三,我将比较FDA 2010年对Qsymia和Belviq的风险/效益分析与该机构2012年的风险/效益分析,以确定导致该机构在2012年批准而在2010年拒绝批准的原因。最后,我将分析这些药物的批准对其他抗肥胖药物的未来意味着什么。
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
Food and drug law journal
Food and drug law journal 医学-食品科技
CiteScore
0.20
自引率
50.00%
发文量
0
审稿时长
>36 weeks
期刊介绍: The Food and Drug Law Journal is a peer-reviewed quarterly devoted to the analysis of legislation, regulations, court decisions, and public policies affecting industries regulated by the U.S. Food and Drug Administration (FDA) and related agencies and authorities, including the development, manufacture, marketing, and use of drugs, medical devices, biologics, food, dietary supplements, cosmetics, veterinary, tobacco, and cannabis-derived products. Building on more than 70 years of scholarly discourse, since 2015, the Journal is published in partnership with the Georgetown University Law Center and the O’Neill Institute for National & Global Health Law. All members can access the Journal online. Each member organization and most individual memberships (except for government, student, and Emeritus members) receive one subscription to the print Journal.
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