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美国联邦审计总署要求FDA明确对制药公司的审批权限

日期:2013年8月13日 09:50

  2013年8月12日讯 --美国FDA主任Margaret Hamburg一直强调希望国会能够区分清楚FDA在管理医药企业的具体职责。这一说法得到了美国审计总署(Government Accountability Office GAO)的认同,GAO出台的一份报告认为FDA在管理医药企业上的职责仍存在模糊之处,并建议立法明确FDA的合法职责范围。

  详细英文报道:

  FDA Commissioner Margaret Hamburg has insisted that Congress needs to explicitly spell out what kind of hammer the agency can wield when it comes to compounding pharmacies, like the one tied to last year's outbreak of fungal meningitis. Not everyone in Congress agrees, but the commissioner recently got some support from a Government Accountability Office (GAO) report that found the FDA's authority remains fuzzy.

  The GAO report said that two federal circuit court decisions have led to the FDA actually having different authority in different parts of the country. It also pointed to the fact that the FDA had to get warrants 11 times to inspect compounding pharmacies that resisted the agency taking a look at their production and sterility practices. The report recommends that Congress pass legislation that clears up the agency's authority.

  On Wednesday, Senate Democrat Tom Harkin, chairman of the committee which has approved a bill supported by the FDA, pointed to the report as proof that legislation he backs is sorely needed. He said there were two more deaths just this week from the meningitis outbreak tied to New England Compounding Center, bringing the total to 63. The letter says that the bill would give authority over the largest compounders, which operate like drug manufacturers, while leaving smaller, traditional compounders under state supervision.

  This year the FDA started a campaign to quickly inspect the largest compounding pharmacies, which often ship products nationwide. But Hamburg has said that inspectors often meet resistance to getting into the facilities. So far the FDA had done 56 inspections, and many have led to nationwide recalls of sterile products, including one this week. Hamburg has also appeared before Senate and House committees to defend the agency's oversight and to ask Congress to pass legislation.

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