Financial Conflicts of Interest at FDA Drug Advisory Committee Meetings
Financial Conflicts of Interest at FDA Drug Advisory Committee Meetings
复制标题
DOI：
10.1002/hast.833
复制
发表时间：
2018-03-01
影响因子：
3.3
通讯作者：
Prasad, Vinay
中科院分区：
文献类型：
--
作者：
Hayes, Michael J.;Prasad, Vinay
美国食品和药物管理局的药物咨询委员会为考虑批准的新疗法的安全性和有效性提供专家评估。一个委员会听取了来自六个团体的各种发言者的意见，包括委员会的投票成员、FDA工作人员、寻求批准一种疗法的制药公司的员工、患者和消费者代表、该公司邀请的专家发言者以及公众参与者。当新产品的风险和危害不能立即确定时，委员会应FDA的要求召开会议，他们的最终决定具有重大影响力，因为大多数获得咨询委员会批准的疗法随后都得到FDA的批准。近年来，通过一系列不同的出版物，调查了参加会议的每一类参与者的财务利益冲突。在这里，我们总结这些发现及其伦理影响，重点是FDA肿瘤药物咨询委员会，并建议如何走向更透明和公正的咨询委员会会议。
The U.S. Food and Drug Administration's drug advisory committees provide expert assessments of the safety and efficacy of new therapies considered for approval. A committee hears from a variety of speakers, from six groups, including voting members of the committee, FDA staff members, employees of the pharmaceutical company seeking approval of a therapy, patient and consumer representatives, expert speakers invited by the company, and public participants. The committees convene at the request of the FDA when the risks and harms of novel products are not immediately clear, and their final decisions carry significant weight, as most therapies that receive advisory committee approval are subsequently approved by the FDA. In recent years, across a series of diverse publications, the financial conflicts of interest of each category of participants in the meetings have been investigated. Here, we summarize these findings and their ethical implications, focusing on the FDA Oncologic Drugs Advisory Committee, and we suggest ways to move toward more transparent and impartial advisory committee meetings.