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【技术产业】FDA驻外办公室：首站设中国
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根据FDA分管国际和特殊项目的副局长莫瑞•兰普金（Murray M. Lumpkin）在上个月的美国药品食品法律事务所举行的一次内部会议上表示，“FDA考虑在海外设立办公室进行监管，并将负责与所在国/地区政府及医药产业之间的沟通。”尽管这位副局长一直强调美国进口食品药品安全问题不都是由中国造成的，并将会在许多国家都设立类似的驻外办公室，但是业内人士普遍预计中国将成为FDA的首家试验地。
目前，FDA负责监察美国300个进口口岸的近2000万件进口商品检查（其中有40%来自中国），却只有450名进口检察员，监管压力巨大。在去年国会通过FDA改革方案之后，卫生和人类服务部部长麦克•列维特（Mike Leavitt）和FDA局长安德鲁•冯•艾森巴哈（Andrew von Eschenbach）均在公众场合表示过要在华设立专门的办事处来加强FDA监管。兰普金认为：“在美国境外设立办事处将能确保FDA的监管更实用、更有效，并且能和所在国的药品食品管理部门加强合作和交流，推动双方持续合作的愿景。”那些海外办公室的“全职”人员们除了要和当地政府、产业人士建立良好沟通之外，也可能担任更多实质性的监管任务，缓解美国本土FDA的监管压力。他还透露已经就此事接洽中国有关方面，具体的商谈也已进入启动阶段。
另外，进口安全机构间工作组日前向美国总统布什提交了一份确保进口安全的行动计划，其中的一条备忘录显示“美国将与中国一起加强食品药品、医疗器械和动物饲料方面的监管合作”(1"The Gray Sheet" Dec. 17, 2007, In Brief)，比如在医疗设备领域，在中国注册的血糖试条和避孕套生产企业必须制定一个方案以确保符合FDA的安全标准。不过，包括参议员Richard Durbin在内的美国国会成员批评该协议“没有覆盖足够的货品种类，无法重建对于中国产品的信心”。兰普金对此解释到：“该协议只在为FDA评估项目正常运作的可行性，一旦奏效将会立即想其他同样存在安全风险的领域进行推广。”
January 14, 2008
FDA Aims To Establish Overseas Staff Posts, Starting In China
This article is reprinted from "The Gray Sheet" – January 14, 2008
FDA is considering posting staff overseas to perform inspections and foster relationships with foreign government counterparts and industry.
"There is a very real interest in pursuing this and obviously the spotlight has been on China ... but this is not just a China issue," FDA Deputy Commissioner for International and Special Programs Murray Lumpkin said during a Dec. 13 panel discussion on FDA's international issues hosted by the Food and Drug Law Institute.
"The products that we are responsible for within the United States are no longer domestic commodities," Lumpkin said.
"For the most part, whether it's on the food side of the house or the medical products side of the house, they are global commodities. They are discovered, developed, marketed, and most importantly they are used by consumers, practitioners and patients around the world."
By establishing FDA posts in foreign countries, the agency will actually be in a better position to do its job domestically, Lumpkin said. And it will position itself to get more help from abroad.
"This is a broader issue of how do we best position our resources to help us do our job in the 21 century that we need to do around the world," he said.
"Having a presence outside the United States is simply necessary to help make our interactions with [our] counterparts more useful, more productive and more fruitful, and to meet the goals we have with this country and with the areas being served."
The overseas staff positions would be "full-time day jobs" focused on creating relationships with foreign governments and businesses, Lumpkin said. Performing foreign inspections with greater ease would be another important benefit of the posts, he added.
Though Lumpkin stressed that FDA is interested in establishing such posts in several countries, China is likely to be the first place it happens.
"It's estimated perhaps 40% of all consumer products are coming from China, and so there are significant issues there," said William Hubbard, head of the Coalition for a Stronger FDA, whose members include health care manufacturers and nonprofit public health organizations.
The old paradigm of placing most of the burden on FDA to catch a problem at the border is no longer working, he said.
"The fact that the level of import shipments is now approaching 20 million FDA regulated products, and FDA only has 450 import inspectors to cover more than 300 ports clearly indicates a mismatch," Hubbard noted.
Public comments from Health and Human Services Secretary Mike Leavitt and FDA Commissioner Andrew von Eschenbach indicate strong U.S. support for establishing FDA posts in China, Lumpkin said.
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作者:admin@医学,生命科学 2011-04-25 05:14
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