美国FDA：中国和印度，我拿什么爱你？

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% n* b, v  U! lFDA's Foreign Inspection Budget Lean
FDA缺乏进行海外审计的预算
3 U7 Y/ f) T* d2 g6 A5 _+ y8 d) SBy Marc Kaufman
Washington Post Staff Writer
Thursday, November 1, 2007; Page A02
* w, q0 H" P. l+ c0 b7 Q《华盛顿邮报》11月1日
Although the volume of prescription drugs and drug ingredients coming into the country from foreign manufacturers in developing nations such as India and China has exploded in recent years, the Food and Drug Administration's budget for foreign inspections has not kept pace and will be lower in 2008 than it was in 2002, according to congressional investigators.
根据国会调查人员的报告，虽然近几年美国从中国、印度等发展中国家进口的处方药和药物成分的数量在爆炸性地增长，但是FDA用于海外审计的预算却没有相应地增长，2008年的预算甚至比2002年的还要少。
As a result, foreign drug and drug ingredient makers are inspected on average once every eight to 12 years, while American-based manufacturers must be inspected at least once every two years
结果是，海外的药品和药物成分制造商平均8-12年才被审计一次，而美国本土的制造商每两年至少要被审计一次
6 D! R6 Z/ S. F8 H; D0 IIn addition, the investigators reported, FDA officials generally do not bring their own translators, and so in countries such as China they rely on company-supplied translators to conduct inspections. They also have to tell foreign manufacturers in advance that they are coming, while FDA inspectors can go into American plants at any time unannounced.
除此之外，调查人员还报告：FDA进行海外审计时一般自己不带翻译，所以到中国这样的国家他们就要依赖被审计的公司提供的翻译进行审计。而且他们必须在他们到达前先通知那些制造商，而FDA的检查官审计美国的工厂是从来不事先通知的。
"Given the high level of foreign imports, this lack of oversight puts American consumers at considerable risk," said Rep. John D. Dingell (D-Mich.), chairman of the House Energy and Commerce Committee, which has scheduled a hearing for today on the subject.
众议院能源和商务委员会的主席John D. Dingell先生（密歇根州的民主党议员）今天召集了一个这方面的听证会，他说：“面对大量的海外药品进口，监管的缺乏使美国消费者变得相当危险。”
1 _1 @3 u  C$ U+ t"China alone has more than 700 firms making drug products for the U.S., yet the FDA has resources to conduct only about 20 inspections a year in China," he said. "This is dangerously inadequate."
“仅中国就有700家企业在向美国出口药品，而F.D.A.的现有资源一年只能对中国企业进行大约20次审计。”
A bipartisan group of inspectors from the committee's oversight and investigations subcommittee accompanied FDA inspectors on an August trip to India and China -- two nations that have become major players in supplying the U.S. drug market. Neither country has a strong drug regulatory agency, and the committee inspectors concluded that setting up permanent FDA offices could solve many inspection problems. They reported that Indian officials supported the idea, while the Chinese officials' position was unclear.
众议院能源和商务委员会下属的监督与调查委员会派出两党联合调查组在FDA检查官的陪同下在今年8月份前往印度和中国调查（这两个国家正在成为美国药品市场的主要供应商）调查组认为鉴于这两个国家都缺乏强有力的监管机构，由FDA在这两个国家建立永久办公室是解决许多与审计有关的问题的根本办法。他们在报告中说：印度的官员支持这一建议，中国政府的立场还不清晰。
According to the committee investigators, the FDA spent $16.7 million on foreign inspections in 2002 and will have an estimated $16 million for 2008. FDA officials told the investigators that this occurred although the volume of FDA-regulated imports doubles every five years -- and that this is especially true for drugs and ingredients manufactured in India and China.
根据委员会调查人员的介绍，FDA在2002年用于海外审计的花费是1670万美元，，2008年的费用预计是1600万美元，FDA的官员告诉调查人员在这5年间，FDA要监管的进口药品的数量翻了1翻（这其中主要是来自中国和印度的药品和药物成分的增长）
9 l2 R0 q0 g: u# t/ e2 G0 PThe FDA has generally defended its oversight of foreign drug manufacturers, saying that it inspects plants when troubles become known. By law, foreign drugmakers must be inspected before their products can come into the United States, but there are no requirements to have continuing quality inspections every two years, as there is for firms manufacturing in the United States.
FDA Commissioner Andrew von Eschenbach is scheduled to testify on the subject today, along with critics and defenders of current foreign drug inspection policies.
FDA近期对关于其在海外监管中存在漏洞，等麻烦已经出来了再去审计工厂的观点进行反驳。因为法律虽然规定了外国药品生产者在将药品卖到美国前必须接受审计，但是却没有要求认证通过后每两年再审计一次。（美国的生产企业一般每两年要被审计一次）FDA的局长Andrew von Eschenbach准备今天参加讨论海外药品监管政策的听证会。
According to the committee report, the FDA database of foreign companies that supply U.S. markets is limited -- with some senior FDA officials reporting numbers as low as 2,100 companies and others saying there are 4,400. The Government Accountability Office reports that while 3,000 companies are registered to import drugs into the United States, nearly 7,000 foreign companies actually supplied the U.S. market in 2007.
4 z* H8 K7 q; X2 w$ A$ E2 @6 N4 b根据委员会的报告，FDA提供的关于供给美国市场的国外公司的资料非常有限，一些FDA的高级官员说总数可能只有2100家，另一些说是4400家。政府问责局的报告中说正式注册的有3000家，2007年实际出口药品到美国的可能有近7000家。

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