FDA Accused of Intentionally Creating Drug Monopolies FDA的指責，蓄意製造毒品壟斷
By通過 David Gutierrez朱古鐵雷斯
The outgoing chief executive officer of pharmaceutical giant Wyeth has accused the FDA of “establishing monopolies” by requiring new drugs to prove that they work better than products currently on the market.即將離任的首席執行幹事製藥業巨頭惠氏指責FDA的“建立壟斷” ，要求新的藥物，以證明他們的工作總比產品目前市場上。
“If you’re the first company to get approved in a certain area and competitors can’t get on the market, the FDA is now establishing monopolies. “如果您的第一家公司獲得批准在某一地區和競爭對手無法在市場上，美國食品藥品管理局現正建立的壟斷。 And that’s certainly not their mandate,” Bob Essner said.這當然不是他們的任務， “鮑勃essner說。
Essner said that the FDA might have overstepped the bounds of its legal mandate, which is only to determine if drugs are safe and effective. essner說， FDA的可能超越的界限，其法律的任務，這是唯一以確定是否藥物是安全的和有效的。 “It could well be legally challenged,” Essner said. “它很可能在法律上受到質疑， ” essner說。 “Although that may not be a formal standard, it does appear to be a growing practice.” “雖然這可能不是一個正式的標準，但這似乎是一個日益增長的實踐” 。
The FDA denies that it is forcing new drugs to prove that they are more effective than old ones, but acknowledges that it does make such comparisons. FDA的否認，這是迫使新的藥物，以證明他們是更有效的比舊的，但承認，它是否作出這樣的比較。 “[The FDA] does not have what is called a ‘comparable effectiveness’ standard for drugs,” the agency said. “ [林業局]沒有什麼是所謂的'可比效益'的標準藥物， ”該機構說。 “We do consider other products already available as we make benefit/risk decisions for new products.” “我們考慮其他的產品已經可以作為我們的利益/風險的決定，為新產品” 。
Dan Vasella, chief executive officer of丹華塞拉，總行政主任 Novartis諾華公司 , agreed with Essner’s comments. ，同意essner的意見。 “The discussion on what this [drug] brings over and above what’s on the market is a question that’s being asked,” he said. “的討論，這是什麼[藥物]帶來超越什麼的對市場是一個問題的要求， ”他說。 “The FDA doesn’t seem to trust the physicians any more.” “ FDA的似乎並不信任醫師的任何更多” 。
Both兩者 Wyeth惠氏 and Novartis have had drugs approved through FDA assessments that included a comparison of the drug’s effectiveness or place in the market relative to already-approved treatments.和諾華公司有藥品批准通過FDA的評估，包括比較藥物的有效性或地方在市場上相對已經批准的治療方法。 Three Wyeth drugs have been rejected or had their approval delayed in 2007: the osteoporosis drug Viviant, the antidepressant and menopause treatment Priztiq, and the schizophrenia medication bifeprunox.三惠氏藥物已被拒絕或已批准延遲在2007年：骨質疏鬆症的藥物viviant ，抗抑鬱藥和更年期的治療priztiq ，和精神分裂症的藥物bifeprunox 。
Wyeth’s bifeprunox and Novartis’ Prexige, a painkiller, were the drugs subjected to market comparisons.惠氏的bifeprunox和諾華公司' prexige ，止痛藥，藥物受到市場的比較。
See More: 看到更多的： Health News 健康新聞 USA News 美國新聞Have Your Say: FDA Accused of Intentionally Creating Drug Monopolies 你說： FDA的指責，蓄意製造毒品壟斷
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