Pfizer paying record $2.3B settlement for illegal promotions of 4 prescription drugs (Wednesday September 2, 2009, 12:18 pm EDT)
Pfizer Inc., the world's largest drug maker, will pay a record $2.3 billion civil and criminal penalty over unlawful prescription drug promotions. Announcing the settlement Wednesday, the Justice Department said that it included the largest criminal fine in U.S. history -- $1.2 billion. The agreement also included a criminal forfeiture of $105 million. Authorities called Pfizer a repeat offender, noting it is the fourth such settlement of government charges in the last decade. They said the government will monitor the company's conduct for the next five years to rein in the abuses.
To promote the drugs, authorities said Pfizer invited doctors to consultant meetings at resort locations, paying their expenses and providing perks. "They were entertained with golf, massages, and other activities," said Mike Loucks, the U.S. attorney in Massachusetts. Loucks said that even as Pfizer was negotiating deals on past misconduct, they were continuing to violate the very same laws with other drugs. Six corporate whisteblowers who first brought the misconduct to light will share $102 million of the settlement money. FBI Assistant Director Kevin Perkins praised the whistleblowers who decided to "speak out against a corporate giant that was blatantly violating the law and misleading the public through false marketing claims." Associate Attorney General Thomas Perelli said the settlement illustrates ways the department "can help the American public at a time when budgets are tight and health care costs are rising." The overall settlement is the largest ever paid by a drug company for alleged violations of federal drug rules.
The government said the company promoted four prescription drugs, including the pain killer Bextra, as treatments for medical conditions different than those the drugs had been approved for by federal regulators. Use of drugs for so-called "off-label" medical conditions is not uncommon, but drug manufacturers are prohibited from marketing drugs for uses that have not been approved by the Food and Drug Administration. Bextra, one of a class of painkillers known as Cox-2 inhibitors, was pulled from the U.S. market in 2005 amid mounting evidence it raised the risk of heart attack, stroke and death. A Pfizer subsidiary, Pharmacia and Upjohn Inc., which was acquired in 2003, has entered an agreement to plead guilty to one count of felony misbranding. The criminal case applied only to Bextra. The $1 billion in civil penalties was related to Bextra and a number of other medicines. A portion of the civil penalty will be distributed to 49 states and the District of Columbia, according to agreements with each state's Medicaid program. "These agreements bring final closure to significant legal matters and help to enhance our focus on what we do best -- discovering, developing and delivering innovative medicines to treat patients dealing with some of the world's most debilitating diseases," said Amy W. Schulman, senior vice president and general counsel of Pfizer. Justice officials discussed details of the deal at a news conference with FBI, federal prosecutors, and Health and Human Services Department officials. In financial filings in January, the company had indicated that it would pay $2.3 billion over allegations it had marketed the pain reliever Bextra and possibly other drugs for medical conditions different than their approved use. The civil settlement announced Wednesday also covered Pfizer's promotions of three other drugs: blockbuster nerve pain and epilepsy treatment Lyrica, schizophrenia medicine Geodon, antibiotic Zyvox and nine other medicines. Pfizer said the agreement with the Justice Department resolves the investigation into promotion of all those drugs, plus several related whistleblower lawsuits. Under terms of the settlement, Pfizer must pay $1 billion to compensate Medicaid, Medicare, and other federal health care programs. Some of that money will be shared among the states: New York, for example, will receive $66 million, according to the state's attorney general, Andrew Cuomo. "Pfizer ripped off New Yorkers and taxpayers across the country to pad its bottom line," Cuomo said. "Pfizer's corrupt practices went so far as sending physicians on exotic junkets as well as wining and dining health care professionals to persuade them to prescribe the company's drugs for patients in taxpayer-funded programs."
Pfizer spokesman Chris Loder confirmed Wednesday that the $2.3 billion charge to the company's earnings had been taken in the fourth quarter of 2008. "No additional charge to the company's earnings will be recorded in connection with this settlement," he said. In her statement, Schulman said: "We regret certain actions taken in the past, but are proud of the action we've taken to strengthen our internal controls and pioneer new procedures so that we not only comply with state and federal laws, but also meet the high standards that patients, physicians and the public expect from a leading worldwide company dedicated to healing and better health." "Corporate integrity is an absolute priority for Pfizer," she said, "and we will continue to take appropriate actions to further enhance our compliance practices and strengthen public trust in our company." When Pfizer originally disclosed the settlement figure, it also announced plans to acquire rival Wyeth for $68 billion. That deal, which would bolster Pfizer's position as the world's top drug maker by revenue, is expected to close before year's end.
美国司法部2日表示，美国制药巨头辉瑞公司当天对其在营销过程中故意夸大药品适用范围的刑事指控表示服罪，并同意支付创纪录的23亿美元罚款以了结因不当营销13种药品而引发的指控。 这笔罚款包括不当营销镇痛药伐地考昔等药物支付的13亿美元刑事罚金以及10亿美元民事赔偿。美国司法部表示，辉瑞在夸大药品适用范围方面已属“惯犯”，此次的罚款数额也是美国有史以来针对不当营销处方药开出的最大罚单。 辉瑞公司2004年曾因营销策略不当而服罪，此后该公司就被美国监管机构“盯”上了。辉瑞公司今年1月份曾表示，该公司2008年年底拨备了23亿美元，以解决涉及伐地考昔等药品的多起指控。不过辉瑞当时并没有透露详细信息。 美国司法部表示，辉瑞的市场推广部门和销售部门宣称伐地考昔可以治疗急性疼痛、手术疼痛等，这些功效都属于美国食品和药物管理局批准的药物适用范围之外的用途；此外，辉瑞还采取邀请度假、打高尔夫等行贿医生的不当方式促销伐地考昔，并发表有关伐地考昔安全性和有效性的错误及误导性声明。 美国司法部表示，打击医疗保健行业的欺诈行为今后将是司法部门的重点之一。 辉瑞公司律师总顾问埃米·舒尔曼当天表示，辉瑞对该公司过去的一些行为“表示遗憾”。 伐地考昔(Bextra)原为美国法玛西亚公司的产品，辉瑞公司2003年并购法玛西亚公司后，伐地考昔成为辉瑞公司旗下的畅销药。2004年，伐地考昔的销售额为13亿美元。 由于医学研究表明，伐地考昔不仅能诱发心肌梗塞和卒中，还引发了较多罕见、严重时甚至致命的皮肤病。辉瑞公司已于2005年4月终止在美国市场销售伐地考昔。
