FDA Caving to Corps FDA的放頂煤，以兵團
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.美國食品和藥物管理局正在制定一項建議，如何製藥公司可以告知醫生對藥物的使用不屬於FDA批准，是一個有爭議的，但重要領域，促進該行業的。
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.雖然它是合法的醫生處方藥物或使用醫療器械的方式沒有特別批准，由美國食品藥品管理局，公司，使產品，均不得在市場的這種做法。 A number of drug makers have been prosecuted for allegedly pushing to increase “off-label” use.一些藥品製造商被起訴據稱推動，以增加“關閉標籤”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.根據草案的建議，美國食品藥品管理局正在考慮的指引，會說，製造商可能給醫生的文章，從醫學期刊和材料得出的科學參考文本討論小康標籤使用藥品和醫療設備。 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.草案公佈週五，由眾議員亨利韋克斯曼（四，加州） ，誰批評它，說“會瓜分一個大的法律漏洞”的支持者，讓分佈這種材料說，公司應該獲准提供醫生準確和無偏見的信息。
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，美國食品藥品管理局發布了一個星期五苛刻的報告從一組其自身的顧問警告說，該機構是不具備應對新出現的科學發展。 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.”報告說， “科學在FDA的是在一個岌岌可危的位置是：該機構有嚴重的缺陷和科學是沒有位置，以滿足目前或新出現的監管責任” 。
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.報告中，從一個小組委員會， FDA的外科學委員會，成員包括顧問和來自業界以及學術界，呼應過去的批評有說，該機構需要大量新的資源。 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.但它是不尋常鈍在指向具體的科學領域的地方機構是落後的，包括其信息技術資源，該報告被稱為“過時” ，今天“ ，不僅可以該機構不會導致，它甚至不能跟上隨著科學的進步， “報告說。
An FDA spokeswoman declined to comment on the contents of the report, which will be discussed in a public meeting on Monday. 1 FDA的發言人拒絕評論該報告的內容，這將是討論在一個公開會議上，週一。 The agency is expected to get some additional funding from increased industry user fees under a bill that recently passed Congress.該機構預計將得到一些額外撥款，從增加工業用戶收費，根據一項法案，國會最近通過的。
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.就此事的所謂小康標籤促進藥品和醫療設備，有已久的辯論，包括法院的戰鬥，什麼屬於超過法律線。 The current legal situation is muddy.現行法律的情況是泥濘。 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年的法律規定在何種情況下公司可分配的某些資料約小康標籤使用過期，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.根據該草案，該機構將鋪陳細節，對哪些類型的刊物，是恰當的，以及其他一些要求，例如，該材料來一份副本藥物或設備的FDA批准的標籤。
Mr. Waxman said the proposal would allow companies to promote off-label uses.先生韋克斯曼說，這項建議將允許公司，以促進小康標籤的用途。 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，他撰寫的文章指出，在醫學期刊上可能會提供“一個扭曲的圖片一種藥物的安全性或有效性” ，因為雜誌編輯可能不知道，充分背後的故事研究-例如是否它的設計是改變，或者如果負面的結果，離開了一篇文章。
On the other side, courts have pressured the FDA to avoid restricting companies’ free-speech rights.在另一邊，法院的壓力， FDA的限制，以避免公司的免費語音的權利。 “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. “小康標籤的處方是非常往往是標準的照顧， ”公司應該能夠給醫生“真，非誤導性的資料”等用途，丹尼爾說，特洛伊，前FDA的首席律師誰以前幫助反對機構在一項重大訴訟的限制，場外的標籤推廣。 Mr. Troy now represents drug companies and others in private practice.特洛伊先生現在所代表的製藥公司和其他私人執業。
An FDA spokeswoman declined to comment on the proposal and said the agency would respond directly to Mr. Waxman. 1 FDA的發言人拒絕評論有關建議，並表示該機構將直接回應先生韋克斯曼。
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的建議草案，似乎試圖取得一個中間地帶，允許公司派發資料約小康標籤的用途，但設置的限制的做法。 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，該草案表明，讀者來函一個醫學雜誌不會的質量和認為，科學的文章，便須同儕審查。 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，如果結論，在某一特定的文章已有爭議的，它必須一起發行另一篇文章顯示了反對意見。
Write to Anna Wilde Mathews at 寫信給安娜王爾德在馬修斯 anna.mathews@wsj.com anna.mathews @ wsj.com
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