FDA Accused of Intentionally Creating Drug Monopolies FDA的指责，蓄意制造毒品垄断
By通过 David Gutierrez朱古铁雷斯
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.即将离任的首席执行干事制药业巨头惠氏指责FDA的“建立垄断” ，要求新的药物，以证明他们的工作总比产品目前市场上。
“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获得批准在某一地区和竞争对手无法在市场上，美国食品药品管理局现正建立的垄断。 And that’s certainly not their mandate,” Bob Essner said.这当然不是他们的任务， “鲍勃essner说。
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说， FDA的可能超越的界限，其法律的任务，这是唯一以确定是否药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质疑， ” essner说。 “Although that may not be a formal standard, it does appear to be a growing practice.” “虽然这可能不是一个正式的标准，但这似乎是一个日益增长的实践” 。
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的否认，这是迫使新的药物，以证明他们是更有效的比旧的，但承认，它是否作出这样的比较。 “[The FDA] does not have what is called a ‘comparable effectiveness’ standard for drugs,” the agency said. “ [林业局]没有什么是所谓的'可比效益'的标准药物， ”该机构说。 “We do consider other products already available as we make benefit/risk decisions for new products.” “我们考虑其他的产品已经可以作为我们的利益/风险的决定，为新产品” 。
Dan Vasella, chief executive officer of丹华塞拉，总行政主任 Novartis诺华公司 , agreed with Essner’s comments. ，同意essner的意见。 “The discussion on what this [drug] brings over and above what’s on the market is a question that’s being asked,” he said. “的讨论，这是什么[药物]带来超越什么的对市场是一个问题的要求， ”他说。 “The FDA doesn’t seem to trust the physicians any more.” “ FDA的似乎并不信任医师的任何更多” 。
Both两者 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.和诺华公司有药品批准通过FDA的评估，包括比较药物的有效性或地方在市场上相对已经批准的治疗方法。 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.三惠氏药物已被拒绝或已批准延迟在2007年：骨质疏松症的药物viviant ，抗抑郁药和更年期的治疗priztiq ，和精神分裂症的药物bifeprunox 。
Wyeth’s bifeprunox and Novartis’ Prexige, a painkiller, were the drugs subjected to market comparisons.惠氏的bifeprunox和诺华公司' prexige ，止痛药，药物受到市场的比较。
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