FDA Caving to Corps FDA的放顶煤，以兵团
The Food and Drug Administration is developing a proposal for how drug companies can inform doctors about drug uses that aren’t FDA approved, a contentious but important area of promotion for the industry.美国食品和药物管理局正在制定一项建议，如何制药公司可以告知医生对药物的使用不属于FDA批准，是一个有争议的，但重要领域，促进该行业的。
While it is legal for physicians to prescribe drugs or use medical devices in ways not specifically approved by the FDA, companies that make the products aren’t allowed to market such practices.虽然它是合法的医生处方药物或使用医疗器械的方式没有特别批准，由美国食品药品管理局，公司，使产品，均不得在市场的这种做法。 A number of drug makers have been prosecuted for allegedly pushing to increase “off-label” use.一些药品制造商被起诉据称推动，以增加“关闭标签”使用。
According to a draft of the proposal, the FDA is considering guidelines that would say manufacturers may give doctors articles from medical journals and materials drawn from scientific reference texts that discuss off-label uses of drugs and medical devices.根据草案的建议，美国食品药品管理局正在考虑的指引，会说，制造商可能给医生的文章，从医学期刊和材料得出的科学参考文本讨论小康标签使用药品和医疗设备。 The draft was released Friday by Rep. Henry Waxman (D., Calif.), who criticized it, saying it “would carve a large loophole in the law.” Supporters of allowing distribution of such materials say companies should be allowed to provide doctors with accurate and unbiased information.草案公布周五，由众议员亨利韦克斯曼（四，加州） ，谁批评它，说“会瓜分一个大的法律漏洞”的支持者，让分布这种材料说，公司应该获准提供医生准确和无偏见的信息。
Separately, the FDA Friday released a harsh report from a group of its own advisers that warned the agency isn’t equipped to deal with emerging scientific developments.另外，美国食品药品管理局发布了一个星期五苛刻的报告从一组其自身的顾问警告说，该机构是不具备应对新出现的科学发展。 The report said that “science at the FDA is in a precarious position: the agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.”报告说， “科学在FDA的是在一个岌岌可危的位置是：该机构有严重的缺陷和科学是没有位置，以满足目前或新出现的监管责任” 。
The report, from a subcommittee of the FDA’s outside Science Board that included members and advisers from industry as well as academe, echoed past critiques that have said the agency needs substantial new resources.报告中，从一个小组委员会， FDA的外科学委员会，成员包括顾问和来自业界以及学术界，呼应过去的批评有说，该机构需要大量新的资源。 But it was unusually blunt in pointing to specific areas of science where the agency was falling behind, including its information-technology resources, which the report termed “obsolete.” Today, “not only can the agency not lead, it cannot even keep up with the advances in science,” the report said.但它是不寻常钝在指向具体的科学领域的地方机构是落后的，包括其信息技术资源，该报告被称为“过时” ，今天“ ，不仅可以该机构不会导致，它甚至不能跟上随着科学的进步， “报告说。
An FDA spokeswoman declined to comment on the contents of the report, which will be discussed in a public meeting on Monday. 1 FDA的发言人拒绝评论该报告的内容，这将是讨论在一个公开会议上，周一。 The agency is expected to get some additional funding from increased industry user fees under a bill that recently passed Congress.该机构预计将得到一些额外拨款，从增加工业用户收费，根据一项法案，国会最近通过的。
On the matter of so-called off-label promotion of drugs and medical devices, there has long been debate, including court battles, about what falls over the legal line.就此事的所谓小康标签促进药品和医疗设备，有已久的辩论，包括法院的战斗，什么属于超过法律线。 The current legal situation is muddy.现行法律的情况是泥泞。 A 1997 law that laid out conditions under which companies could distribute certain information about off-label uses expired at the end of September. 1997年的法律规定在何种情况下公司可分配的某些资料约小康标签使用过期，截至今年九月底。
According to the draft, the agency would lay out details on what types of publications are appropriate, as well as certain other requirements, such as that the materials come with a copy of the drug or device’s FDA-approved label.根据该草案，该机构将铺陈细节，对哪些类型的刊物，是恰当的，以及其他一些要求，例如，该材料来一份副本药物或设备的FDA批准的标签。
Mr. Waxman said the proposal would allow companies to promote off-label uses.先生韦克斯曼说，这项建议将允许公司，以促进小康标签的用途。 In a letter to the company, he wrote that articles in medical journals may provide “a distorted picture of a drug’s safety or effectiveness,” because journal editors may not know the full story behind a study — such as whether its design was changed, or if negative results were left out of an article.在一封信中向本公司，他撰写的文章指出，在医学期刊上可能会提供“一个扭曲的图片一种药物的安全性或有效性” ，因为杂志编辑可能不知道，充分背后的故事研究-例如是否它的设计是改变，或者如果负面的结果，离开了一篇文章。
On the other side, courts have pressured the FDA to avoid restricting companies’ free-speech rights.在另一边，法院的压力， FDA的限制，以避免公司的免费语音的权利。 “Off-label prescribing is very often the standard of care,” and companies should be able to give doctors “truthful, non-misleading information” about such uses, said Daniel Troy, a former FDA chief counsel who previously helped argue against the agency in a major suit over restrictions on off-label promotion. “小康标签的处方是非常往往是标准的照顾， ”公司应该能够给医生“真，非误导性的资料”等用途，丹尼尔说，特洛伊，前FDA的首席律师谁以前帮助反对机构在一项重大诉讼的限制，场外的标签推广。 Mr. Troy now represents drug companies and others in private practice.特洛伊先生现在所代表的制药公司和其他私人执业。
An FDA spokeswoman declined to comment on the proposal and said the agency would respond directly to Mr. Waxman. 1 FDA的发言人拒绝评论有关建议，并表示该机构将直接回应先生韦克斯曼。
The FDA’s draft proposal seems to try to strike a middle ground, allowing companies to distribute information about off-label uses but setting limits on the practice. FDA的建议草案，似乎试图取得一个中间地带，允许公司派发资料约小康标签的用途，但设置的限制的做法。 Among other restrictions, the draft suggests that letters to the editor of a medical journal wouldn’t quality and that the scientific articles would have to be peer-reviewed.除其他的限制，该草案表明，读者来函一个医学杂志不会的质量和认为，科学的文章，便须同侪审查。 In addition, if the conclusions in a particular article have been disputed, it would have to be distributed along with another article showing the opposing view.此外，如果结论，在某一特定的文章已有争议的，它必须一起发行另一篇文章显示了反对意见。
Write to Anna Wilde Mathews at 写信给安娜王尔德在马修斯 anna.mathews@wsj.com anna.mathews @ wsj.com
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