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.
美國司法部2日表示，美國製藥巨頭輝瑞公司當天對其在營銷過程中故意誇大藥品適用範圍的刑事指控表示服罪，並同意支付創紀錄的23億美元罰款以了結因不當營銷13種藥品而引發的指控。 這筆罰款包括不當營銷鎮痛藥伐地考昔等藥物支付的13億美元刑事罰金以及10億美元民事賠償。美國司法部表示，輝瑞在誇大藥品適用範圍方麵已屬“慣犯”，此次的罰款數額也是美國有史以來針對不當營銷處方藥開出的最大罰單。 輝瑞公司2004年曾因營銷策略不當而服罪，此後該公司就被美國監管機構“盯”上了。輝瑞公司今年1月份曾表示，該公司2008年年底撥備了23億美元，以解決涉及伐地考昔等藥品的多起指控。不過輝瑞當時並沒有透露詳細信息。 美國司法部表示，輝瑞的市場推廣部門和銷售部門宣稱伐地考昔可以治療急性疼痛、手術疼痛等，這些功效都屬於美國食品和藥物管理局批準的藥物適用範圍之外的用途；此外，輝瑞還采取邀請度假、打高爾夫等行賄醫生的不當方式促銷伐地考昔，並發表有關伐地考昔安全性和有效性的錯誤及誤導性聲明。 美國司法部表示，打擊醫療保健行業的欺詐行為今後將是司法部門的重點之一。 輝瑞公司律師總顧問埃米·舒爾曼當天表示，輝瑞對該公司過去的一些行為“表示遺憾”。 伐地考昔(Bextra)原為美國法瑪西亞公司的產品，輝瑞公司2003年並購法瑪西亞公司後，伐地考昔成為輝瑞公司旗下的暢銷藥。2004年，伐地考昔的銷售額為13億美元。 由於醫學研究表明，伐地考昔不僅能誘發心肌梗塞和卒中，還引發了較多罕見、嚴重時甚至致命的皮膚病。輝瑞公司已於2005年4月終止在美國市場銷售伐地考昔。
