摘要：这篇文章主要介绍了美国两家烟草公司起诉FDA委员会的结构不合法,需要的朋友可以参考下,如果你喜欢还可以浏览美国两家烟草公司起诉FDA委员会的结构不合法的最新相关推荐信息。
烟草在线据《烟业通讯》报道编译 罗瑞拉德于星期五（2月25日）表示，它提起了诉讼，要求美国食品与药品管理局停止接受或依赖其烟草产品科学顾问委员会提出的建议，包括在卷烟中使用薄荷醇的建议。
在诉讼中，罗瑞拉德要求地区法院命令FDA停止向顾问委员会提供由公司提交给FDA的任何交易秘密或机密的商业文件，直到顾问委员会依法设立为止。
“该诉讼是由罗瑞拉德和雷诺烟草公司在美国哥伦比亚区的地方法院提起的，”罗瑞拉德在其网站上公布的声明中表示。
到3月23日，顾问委员会将向FDA提交一项关于在卷烟中使用薄荷醇的不具有约束力的建议。
“诉讼声称烟草制品科学顾问委员会目前的构成不符合《联邦顾问委员会法》的合理平衡，以及不受任何特别利益不当影响的要求，”罗瑞拉德在其声明中表示。“相反地，该诉讼宣称，委员会中几个成员有利益冲突，致使委员会无法向FDA提供任何‘不受利益冲突集团影响’的报告或者建议。”(新商盟网xinshangmeng.org)
“诉讼明确指出该委员会的三名成员，Neil Benowitz博士、Jack E. Henningfield博士和Jonathan M. Samet博士，有利益冲突，因为他们担任起诉烟草产品制造商的专家证人并且由于他们同生产戒烟产品的医药公司持续的经济关系，赚取了成千上万美元。”
罗瑞拉德说，从去年年初开始，雷诺和其他公司呼吁FDA确保其小组成员没有利益冲突。然而，这些担心，要么被立即拒绝要么被完全忽略。
“在FDA没能依法设立委员会而且不能适当解决公平和公正的法律问题后，我们不得已提起了诉讼，”罗瑞拉德的资深副总裁兼总顾问罗纳德·S. Milstein说。
Tobacco companies sue over FDA committee make-up
Tobacco ReporterFeb 28, 2011(新商盟网xinshangmeng.org)
Lorillard said on Friday that it had filed suit to stop the US Food and Drug Administration from receiving or relying on recommendations from its Tobacco Products Scientific Advisory Committee, including recommendations regarding the use of menthol in cigarettes.
In the complaint, Lorillard asked a district court to enjoin the FDA from making available to the advisory committee any trade secret or confidential commercial documents submitted by the company to the FDA until the advisory committee was lawfully constituted.
"The lawsuit was filed jointly by Lorillard and R.J. Reynolds Tobacco Company in the United States District Court for the District of Columbia," Lorillard said in a note posted on its website.
The advisory committee is expected to submit a non-binding recommendation on the use of menthol in cigarettes to the FDA by March 23.
"The suit alleges that the Tobacco Products Scientific Advisory Committee as currently constituted fails to meet requirements of the Federal Advisory Committee Act to be fairly balanced and not to be inappropriately influenced by any special interest," Lorillard said in its note. "Instead, the suit alleges, conflicts of several members of the committee render the panel unable to deliver any report or recommendation to the FDA that is "free of the taint of conflicts of interest".(新商盟网xinshangmeng.org)
"The suit specifically alleges that three members of the committee, Drs. Neil Benowitz, Jack E. Henningfield and Jonathan M. Samet, are conflicted because they have made tens of thousands of dollars as paid expert witnesses in litigation against tobacco products manufacturers and due to their continuing financial relationships with pharmaceutical companies that make smoking-cessation products."
Lorillard said that, from the beginning of last year, it, Reynolds and others had urged the FDA to ensure that members of the panel were free of conflicts. Those concerns, however, were either summarily rejected or entirely ignored.
"We are taking this action reluctantly after the FDA failed to constitute the committee in accordance with the law and failed to properly address legitimate concerns regarding fairness and impartiality," said Ronald S. Milstein, senior vice president and general counsel of Lorillard.
美国两家烟草公司起诉FDA委员会的结构不合法
