Enhancing Prescription Drug Innovation and Adoption
Enhancing Prescription Drug Innovation and Adoption
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DOI：
10.7326/0003-4819-154-12-201106210-00012
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发表时间：
2011-06-21
影响因子：
39.2
通讯作者：
Stafford, Randall S.
中科院分区：
文献类型：
--
作者：
Alexander, G. Caleb;O'Connor, Alec B.;Stafford, Randall S.
理想情况下，新药的采用和使用应以其创新和成本效益为指导。然而，即使在进入市场后，有关药物相对功效和安全性的信息通常也是不完整的，并且各种其他力量创造了一个大多数新药比旧药好不了多少的市场。考虑了五种拟议的机制来促进创新并减少最终发现价值较低或具有不可接受风险的疗法的使用。这些变化包括增加美国食品和药物管理局批准所需的证据以及修改药品报销结构。尽管政策实施面临挑战，美国在成功提高处方药的社会价值和安全使用方面有着悠久的历史。
The adoption and use of a new drug would ideally be guided by its innovation and cost-effectiveness. However, information about the relative efficacy and safety of a drug is typically incomplete even well after market entry, and various other forces create a marketplace in which most new drugs are little better than their older counterparts. Five proposed mechanisms are considered for promoting innovation and reducing the use of therapies ultimately found to offer poor value or have unacceptable risks. These changes range from increasing the evidence required for U. S. Food and Drug Administration approval to modifying the structure of drug reimbursement. Despite the challenges of policy implementation, the United States has a long history of successfully improving the societal value and safe use of prescription medicines.