[Opinion]Are We Sure Our Drugs Are Safe?

StephenW

http://pharmalive.com/news/index.cfm?articleID=824037&categoryid=9&newsletter=1
                            Are We Sure Our Drugs Are Safe?
       
                        
   
   
                                        
Are We Sure Our Drugs Are Safe? [St. Joseph News-Press (MO)]
From St. Joseph News-Press (MO) (February 1, 2012)
(CNN) -- When Americans pick up their prescriptions from the pharmacy or reach for a prescription bottle from their medicine cabinet, they probably don't think much about where the drugs were made or whether they are safe.
What most Americans don't realize is the staggering fact that the number of drug products manufactured outside the United States has doubled between 2001 and 2008. Nearly 40% of all drugs taken by Americans come from overseas, and nearly 80% of the active pharmaceutical ingredients used to make these drugs also come from overseas -- mainly China and India.
I support the global marketplace, but we must be aware that without the proper enforcement of quality standards, the trust that we put into the prescriptions that we take can be broken at any time by a supplier in China, a counterfeiter in India or an importer from Thailand.
Too many people believe incorrectly that the U.S. Food and Drug Administration has the authority to properly monitor our drug supply system for safety. Under current law, the FDA does not have the authority to require a manufacturer to notify the agency if a drug has been corrupted, to recall pharmaceuticals that the FDA believes are unsafe, to refuse imported pharmaceuticals that are counterfeited at the border or to ensure that drug manufacturers are responsible for quality controls throughout their supply chain. These are authorities we must give to FDA if we are to truly oversee the safety of our drug supply.
Even more worrisome is the inability of the FDA to conduct comparable inspections of domestic and foreign pharmaceutical manufacturers. It lacks the necessary funding and personnel.
Domestic pharmaceutical facilities are inspected, on average, every two years by the FDA, whereas foreign drug facilities are inspected only every nine years. According to the Government Accountability Office, some of the 3,765 foreign drug establishments in the FDA's database may never have been inspected. An increasing demand, coupled with an expanding globalized drug market, blatantly calls for a more globalized and fully equipped FDA.
A globalized FDA not only would ensure safety; it would also level the playing field for our manufacturers.
FDA approval is the gold standard in the world marketplace: domestic pharmaceutical and ingredient manufacturers in the United States are held to that high standard. Their foreign counterparts should be, too. These competitors are from countries like India and China, nations that are home to 70% of the world's drug manufacturing sites, up from just 49% in 2004.
Now, more than ever, U.S. manufacturing facilities should be rewarded, not penalized, for retaining jobs in the United States. It is not only fair and the right thing to do to protect American competitiveness, it's critically important for the health of American consumers.
Although improved drug safety authorities for the FDA are important, they will be ineffective without a reliable funding stream, free from political whims, to implement them. A chronically underfunded agency, like the FDA, cannot successfully oversee our drug supply's safety without a stable funding source that will allow the agency to hire the staff it needs to conduct inspections overseas or to monitor pharmaceuticals that are entering our country. The re-authorization of the Prescription Drug User Fee Act, which expires in October, offers an opportunity to remedy these problems.
As we begin debate and negotiations around the Prescription Drug User Fee Act, we have a responsibility to ensure that we are equipping the FDA with the resources, personnel and authorities to assure the pharmaceuticals Americans take every day are neither contaminated, counterfeited, corrupted nor mislabeled.
It is hard to believe that it already has been three years since the contaminated blood thinner heparin, which authorities believe originated in China, killed several people and caused multiple cases of serious illness. Although fears generated by this crisis may have subsided, the reality that it can happen again should be fresh in the minds of those of us on the Hill as we reauthorize the Prescription Drug User Fee Act, and give the FDA more authority in the process.
This is not and should not be a partisan issue. We must focus not only on making, and ensuring timely access to, the latest innovative drug treatments, but on establishing one quality standard for every drug sold in the United States. American consumers, and their families, deserve no less.
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The opinions in this commentary are solely those of John Dingell.
       

StephenW

我们确信我们的药物是安全的吗？


我们确信我们的药物是安全的吗？ [圣约瑟夫新闻出版社（MO）]

从圣约瑟夫新闻出版社（MO）（2012年2月1日）

（CNN） - 当美国人拿起他们的处方从药店或达到从他们的药柜处方瓶，他们可能没有多想有关药物或它们是否安全。

大多数美国人不知道什么是惊人的事实，即在美国境外生产的药品产品的数量已经在2001年和2008年之间翻了一番。来自海外近40％的美国人所采取的所有药物，使用，使这些药物的活性药物成分的近80％也来自海外 - 主要是中国和印度。

我支持全球市场，但我们必须意识到，如果没有适当的执法质量标准，处方，我们采取的信任，我们可以在任何时候打破在中国的供应商，在印度的伪造或进口商来自泰国。

太多的人错误地认为，美国食品和药物管理局有权妥善监管安全的药品供应保障体系。根据现行法律，FDA并不有权要求制造商通知该机构，如果一种药物已损坏，召回药品，FDA认为是不安全的，拒绝假冒进口药品，在边境或确保药品生产企业，负责整个供应链的质量控制。这些都是当局如果我们要真正监督我们的药品供应的安全，我们必须向FDA。

更令人担忧的是，FDA无法进行国内外药品生产企业相媲美的检查。它缺乏必要的资金和人员。

国内制药设施进行检查，平均每隔两年，由美国FDA，而外资药设施进行检查只有每9年。根据政府问责办公室，一些药物在FDA的数据库中的3765外国机构可能永远也不会被检查。一个日益增​​加的需求，再加上全球化的毒品市场扩大，公然呼吁一个更加全球化和设备齐全的FDA。

全球化的美国食品药品管理局（FDA）不仅将确保安全，我们的制造商，它也将级别比赛场。

FDA的批准是在世界市场上的黄金标准：国内制药和配料制造商在美国举行的高标准。他们的外国同行，也应该是。这些竞争对手是来自中国和印度这样的国家，是世界毒品生产基地的70％的国家，从2004年只有49％。

现在，比以往任何时候都更，美国制造业的设施，应予以奖励，不受惩罚，保留在美国的工作。它不仅是公平和正确的事情做，以保护美国的竞争力，这是美国消费者的健康极为重要。

虽然改进FDA的药物安全管理机构是重要的，他们将是无效的，没有一个可靠的资金流，从政治率性，以实现它们。长期资金不足的机构，如美国FDA，不能成功地监督我们的药品供应的安全，没有一个稳定的资金来源，将允许该机构聘请的工作人员需要到海外进行检查或监测药品进入我国。重新授权的处方药用户收费法，在10月到期，提供了一个机会来解决这些问题。

当我们开始周围的处方药用户收费法的辩论和谈判，我们有责任确保我们配备的资源，人员和机关的FDA，以确保药品美国人每天既不污染，伪造，损坏，也没有贴错标签。

这是很难相信它已经受污染的血液稀释剂肝素，当局认为起源于中国的三年以来，几个人丧生，并造成严重的疾病多例。虽然这场危机所产生的恐惧，可能已经消退，它可能再次发生的现实应该是新鲜上的山，我们授权的处方药用户收费法，给FDA的权力的过程中，我们这些头脑。

这是不是不应该是一个党派的问题。我们必须集中精力，不仅决策，并确保及时获得，最新的创新药物治疗，但建立一个在美国销售的每一种药物质量标准。美国的消费者和他们的家庭，应该不会少。

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咬牙硬挺

安不安全都得吃啊