Switching omeprazole in Sweden and the United States.
Switching omeprazole in Sweden and the United States.
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DOI：
10.1097/00045391-200309000-00010
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发表时间：
2003-09-01
影响因子：
4.2
通讯作者：
Cohen, Joshua
中科院分区：
文献类型：
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作者：
Cohen, Joshua
本文对瑞典医疗产品管理局 (MPA) 将奥美拉唑从处方 (Rx) 改为非处方 (OTC) 状态的决定与美国食品和药物管理局 (FDA) 顾问小组不授权转换的决定进行了比较。各机构对功效、安全性、标签和临床试验要求的不同观点是针对一般处方药到非处方药的转换过程，特别是奥美拉唑的情况进行评估的。 FDA 和 MPA 关于交换机的监管政策存在很大差异。 FDA 拥有一套比 MPA 更严格的转换指南和要求。由此可以推断，FDA 比 MPA 更厌恶风险。尽管如此，瑞典的奥美拉唑转换似乎是一个例外，因为它与 MPA 历来不愿转换药物 Rx 状态形成鲜明对比。成本考虑似乎引发了奥美拉唑的转变，使其成为一个特例。从这个案例研究中汲取的教训既是具体的，也是一般的。在具体层面上，本案例研究表明 MPA 决定更换奥美拉唑是出于经济考虑，而 FDA 的授权不允许成本影响其对奥美拉唑的决定。总体而言，本案例研究表明 FDA 和 MPA 在开关监管政策及其授权方面的差异不仅适用于奥美拉唑，也适用于各自监管机构目前正在考虑的数十种开关。
This article compares the Swedish Medical Products Agency's (MPA) decision to switch omeprazole from prescription (Rx) to over-the-counter (OTC) status with the US Food and Drug Administration (FDA) advisory panel's decision not to authorize the switch. The agencies' differing perspectives on efficacy, safety, labeling, and clinical trial requirements are evaluated with regard to the Rx-to-OTC switch process in general and omeprazole's case in particular. The FDA and MPA regulatory policies on switches are substantially divergent. The FDA maintains a stricter set of switch guidelines and requirements than the MPA. One could infer from this that the FDA is more risk-averse than the MPA. Nevertheless, the omeprazole switch in Sweden appears to be an exception in that it contrasts with the MPA's historical reluctance to switch the Rx status of medications. Cost considerations appear to have triggered the omeprazole switch, making it a special case. The lessons to be drawn from this case study are both specific and general. At the specific level, this case study suggests the MPA's decision to switch omeprazole was prompted by economic considerations, whereas the FDA's mandate did not allow cost to affect its decision on omeprazole. At a general level, this case study indicates that the differences between the FDA and MPA with respect to their regulatory policies on switches and their mandates apply not only to omeprazole but also to the dozens of switches currently under consideration by the respective regulatory agencies.