美国多家公共卫生管理机构对原料药厂家进行调查

joke

2013年8月27日讯 /自从去年一起全国范围的脑膜炎疫情出现后，负有监管责任的FDA开始对美国一些大型原料药厂家进行审查。而采取行动的并不只是FDA一个机构。马萨诸塞州的医药行业注册委员会同样开始对本州的两家原料药生产商家Medi-Son Solutions 公司和CarePro公司开始检查。来自该州卫生部门的Anne Roach表示，自从去年的安全事件出现后，他们检查了37种原料药样品，仅有4种符合要求。
　　目前FDA希望被赋予更加明确的管理原料药企业的权利。最近正在讨论的一项法案将规定原料药企业将需要在FDA注册，并按规定向其报告关于产品的负面信息。虽然美国国会有人并不赞同扩大FDA的监管范围，但是的确有原料药企业以此为理由对FDA的监管提出异议。如上周FDA提醒不要使用来自NuVision Pharmacy公司生产的无菌设备，NuVision Pharmacy就立刻在其官网上回应对FDA的管理权限提出质疑。
　　详细英文报道：
　　The FDA this year has done an inspection sweep through the largest compounding pharmacies after being caught off guard last year when a nationwide fatal meningitis outbreak was tied to a compounder in Massachusetts. But the federal agency is not alone in trying to get on top of the issues. Authorities in Massachusetts, which have stepped up their own oversight, recently halted production at two drug compounders there.
　　The Massachusetts Board of Registration in Pharmacy sent cease-and-desist notices to Medi-Son Solutions in Norwood and sister compounder CarePro in Quincy after an inspection found problems at Medi-Son, according to the Boston Globe. Hearings for the two facilities are in progress. Anne Roach, a spokeswoman for the Massachusetts Department of Public Health said the state stepped up enforcement after last year's outbreak of fungal meningitis that infected hundreds of people and killed dozens who were injected with pain drugs from New England Compounding Center (NECC) of Framingham. She said the state got an extra $1 million to pump up its efforts. It has inspected 37 compounders since the NECC deal, and only four passed, Roach said.
　　Neither of the closed compounders are among the more than 50 that the FDA has inspected since the NECC situation blew up. The federal agency is looking at large compounders that operate more like small drug manufacturers and often ship nationally. The FDA is supporting a bill that would establish clear authority of its oversight powers when it comes to compounders. The proposed law would establish a new category of large compounding pharmacies that would have to register with the FDA and report any adverse reactions tied to their drugs. They would not have to meet all of the strict regulations that drug manufacturers do, but the law would prevent them from continuing to make the most complex biologic drugs that are more easily contaminated. They also would have to kick in fees for the privilege of having FDA supervision.
　　Some members of Congress oppose extending the agency's authority, saying it just needs to use the powers it has to do a better job. But a situation that recently played out between the FDA and a compounding pharmacy in Texas is sure to feed the debate. The FDA last week updated a notice to healthcare providers to remind them not to use products produced by NuVision Pharmacy of Dallas. The FDA said questions of sterility were raised during an inspection of the facility. But the compounder is contesting the FDA's authority and findings. In a notice on its own website, NuVision says the FDA is judging compounders using manufacturing standards and that is not a manufacturer. It claims all of its products are sterile, tested by an outside lab and will provide oversight and that clients with concerns can have the results of those tests sent them as proof.
　　That fight is playing out even as the FDA last week said that another Texas compounder, Specialty Compounding of Cedar Park, TX, is yanking all of its sterile products after 15 patients at two Texas hospitals contracted bacterial bloodstream infections. Two of those patients have reportedly died