How Drugs are Developed and Approved by the FDA: Current Process and Future Directions
How Drugs are Developed and Approved by the FDA: Current Process and Future Directions
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DOI：
10.1038/ajg.2013.407
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发表时间：
2014-05-01
影响因子：
9.8
通讯作者：
Kulkarni, Prasad
中科院分区：
文献类型：
--
作者：
Ciociola, Arthur A.;Cohen, Lawrence B.;Kulkarni, Prasad
目的：本文提供了一个概述FDA的药物开发和批准的监管程序，并与药物的开发相关的估计成本，并探讨了FDA在不久的将来面临的问题和挑战。方法：使用MEDLINE进行文献检索，总结目前FDA的药物审批程序和未来的方向。MEDLINE被进一步利用，以搜索所有的成本分析研究进行评估制药行业的R & D生产力和药物开发成本estimations.RESULTS：虽然药物审批过程仍然处于高风险，并跨越多年，FDA的药物审查和批准过程得到了改善，与新的分子药物的审批时间中位数从19个月减少到10个月。开发药物的总成本仍然相当高，估计在8.68亿美元至12.41亿美元之间。一些新的法律已经颁布，包括FDA的安全和创新法案（FDASIA）的2013年，这是为了改善药品审批过程，并提高获得新药。结论：FDA的改进过程中的药物审批和上市后监督已经实现了为患者提供及时获得有效的药物，同时最大限度地减少与药物相关的伤害的风险的目标。FDA的药物审批程序并非没有争议，因为在过去几年中，许多知名的胃肠病药物已从美国市场撤回。随着新FDASIA法的批准，FDA将继续改进其流程，并通过FDA相关事务委员会与ACG合作，继续为我们的患者开发安全有效的药物。
OBJECTIVES: This article provides an overview of FDA's regulatory processes for drug development and approval, and the estimated costs associated with the development of a drug, and also examines the issues and challenges facing the FDA in the near future.METHODS: A literature search was performed using MEDLINE to summarize the current FDA drug approval processes and future directions. MEDLINE was further utilized to search for all cost analysis studies performed to evaluate the pharmaceutical industry R & D productivity and drug development cost estimates.RESULTS: While the drug approval process remains at high risk and spans over multiple years, the FDA drug review and approval process has improved, with the median approval time for new molecular drugs been reduced from 19 months to 10 months. The overall cost to development of a drug remains quite high and has been estimated to range from $868M to $1,241M USD. Several new laws have been enacted, including the FDA Safety and Innovation Act (FDASIA) of 2013, which is designed to improve the drug approval process and enhance access to new medicines.CONCLUSIONS: The FDA's improved processes for drug approval and post-market surveillance have achieved the goal of providing patients with timely access to effective drugs while minimizing the risk of drugrelated harm. The FDA drug approval process is not without controversy, as a number of well-known gastroenterology drugs have been withdrawn from the US market over the past few years. With the approval of the new FDASIA law, the FDA will continue to improve their processes and, working together with the ACG through the FDA-Related Matters Committee, continue to develop safe and effective drugs for our patients.