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一项有效卫生政策的典范:1983年《孤儿药法案》

A model of effective health policy: the 1983 Orphan Drug Act.

作者信息

Reaves Natalie D

机构信息

Department of Economics, Rowan University, Glassboro, NJ 08028, USA.

出版信息

J Health Soc Policy. 2003;17(4):61-71. doi: 10.1300/j045v17n04_04.

DOI:10.1300/j045v17n04_04
PMID:17824591
Abstract

There was a new pharmaceutical policy enacted in 1983 known as the Orphan Drug Act. It was designed to increase the availability of drugs used to treat rare diseases. In the decade prior to 1983, only ten orphan drugs had been marketed. Since 1983, over 200 orphan drugs have been marketed and over 800 have entered the regulatory pipeline. This paper examines a case of government regulation that industry, patients and politicians view as a resounding success. This policy should serve as a model of how to encourage innovation in other under-served areas.

摘要

1983年颁布了一项新的药品政策,即《孤儿药法案》。该法案旨在增加用于治疗罕见病的药物的可及性。在1983年之前的十年里,只有十种孤儿药上市。自1983年以来,已有200多种孤儿药上市,800多种进入了监管程序。本文研究了一个政府监管的案例,该案例被行业、患者和政治家视为巨大成功。这项政策应成为鼓励其他服务不足领域创新的典范。

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A model of effective health policy: the 1983 Orphan Drug Act.一项有效卫生政策的典范:1983年《孤儿药法案》
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Evolution and current status of the Orphan Drug Act.《孤儿药法案》的演变与现状
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Incentives for orphan drug research and development in the United States.美国孤儿药研发的激励措施。
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