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【社会人文】FDA宣布Purdue Frederick 公司非法促销
FDA Announces Results of Investigation Into Illegal Promotion of OxyContin by The Purdue Frederick Company, Inc.
Company Misrepresented Prescription Pain Reliever to Health Care Professionals
The U.S. Food and Drug Administration's (FDA) Office of Criminal Investigations (OCI) announced today that The Purdue Frederick Company, Inc. has agreed to pay more than $600 million to resolve criminal charges and civil liabilities in connection with a long-term illegal scheme to promote, market and sell OxyContin, a powerful prescription pain reliever that the company produces.
An investigation by OCI uncovered an extensive, long-term scheme by The Purdue Frederick Company, Inc. to generate the maximum amount of revenues possible from the sale of OxyContin. To further this goal, Purdue trained its sales representatives to make false representations to health care providers about the difficulty of extracting oxycodone, the active ingredient, from the OxyContin tablet; trained its sales force to represent to health care providers that OxyContin did not cause euphoria and was less addictive than immediate-release opiates; and allowed health care providers to entertain the erroneous belief that OxyContin was less addictive than morphine. In addition, Purdue falsely labeled OxyContin as providing "fewer peaks and valleys than with immediate-release oxycodone," and falsely represented that patients taking lower dosages of the drug can always be discontinued abruptly without suffering withdrawal symptoms or tolerance.
"FDA will not tolerate practices that falsely promote drug products and place consumers at health risk," said Margaret O.K. Glavin, Associate Commissioner for Regulatory Affairs. "We will continue to do all we can to protect the public against drug companies and their representatives who are not truthful and bilk consumers of precious health care dollars."
To resolve the criminal charges, Purdue pled guilty to a felony count of misbranding a drug with intent to defraud and mislead. As part of the plea, Purdue will pay a $600 million settlement. That amount includes a criminal fine, restitution to government agencies, over $276 million in forfeiture, and a related civil settlement under which Purdue will pay $100.6 million to the United States.
In addition, Purdue's current and former executive employees, Michael Friedman, Howard Udell and Dr. Paul Goldenheim, pled guilty to a misdemeanor violation of misbranding OxyContin as being the responsible corporate officers during the long-term illegal promotion of the drug.
This case was prosecuted by the U. S. Attorney's Office for the Western District of Virginia and investigated by FDA's Office of Criminal Investigations; the Internal Revenue Service's Criminal Investigations Division; the U.S. Department of Health and Human Services' Office of Inspector General; and the State Police Departments of Virginia and West Virginia. This case serves as an excellent example of federal and state law enforcement cooperation. 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 FDA Announces Results of Investigation Into Illegal Promotion of OxyContin by The Purdue Frederick Company, Inc.
Company Misrepresented Prescription Pain Reliever to Health Care Professionals
FDA宣布Purdue Frederick 公司非法促销OxyContin（盐酸羟考酮控释片）调查结果
该公司向医疗专业人员提供止痛处方药的虚假信息
The U.S. Food and Drug Administration's (FDA) Office of Criminal Investigations (OCI) announced today that The Purdue Frederick Company, Inc. has agreed to pay more than $600 million to resolve criminal charges and civil liabilities in connection with a long-term illegal scheme to promote, market and sell OxyContin, a powerful prescription pain reliever that the company produces.
美国食品药品监督管理局（FDA）犯罪调查办公室（OCI）今天宣布，Purdue Frederick公司同意支付6亿多美元用以解决其长期非法推广、上市和销售OxyContin的罪行指控和民事责任，OxyContin是该公司生产的一种高效止痛处方药。
An investigation by OCI uncovered an extensive, long-term scheme by The Purdue Frederick Company, Inc. to generate the maximum amount of revenues possible from the sale of OxyContin. OCI的调查揭露了Purdue Frederick公司旨在通过OxyContin销售以达到最大收入的详细的、长期计划。 To further this goal, Purdue trained its sales representatives to make false representations to health care providers about the difficulty of extracting oxycodone, the active ingredient, from the OxyContin tablet; trained its sales force to represent to health care providers that OxyContin did not cause euphoria and was less addictive than immediate-release opiates; and allowed health care providers to entertain the erroneous belief that OxyContin was less addictive than morphine. 为到达此目的，Purdue Frederick公司培训其销售人员向医疗机构提供有关OxyContin的活性成分羟二氢可待因酮从制剂中释放难度的虚假宣传，向医疗机构强力宣传OxyContin不产生欣快感、比速释鸦片制剂成瘾性小，并使医疗人员接受这样错误的理念，即OxyContin比吗啡的成瘾性小。 In addition, Purdue falsely labeled OxyContin as providing "fewer peaks and valleys than with immediate-release oxycodone," and falsely represented that patients taking lower dosages of the drug can always be discontinued abruptly without suffering withdrawal symptoms or tolerance. 此外，Purdue公司在OxyContin标签上错误地提供“较速释羟二氢可待因酮具有少的药物峰谷效应，”，并错误地声称患者服用低剂量的药物可立即停药而不出现戒断症状或耐受现象。
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作者:admin@医学,生命科学 2011-03-05 17:15
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