Global health care giant Johnson & Johnson (J&J) and its subsidiaries have agreed to pay more than 2.2 billion U.S. dollars to resolve criminal and civil investigations for misbranding antipsychotic drugs and paying kickbacks to pharmacists, the U.S. Department of Justice (DOJ) said Monday.
The resolution, one of the largest health care fraud settlements in U.S. history, included criminal fines and forfeiture totaling 485 million dollars and civil settlements with U.S. federal and state authorities totaling 1.72 billion dollars, U.S. Attorney General Eric Holder said in a statement.
The settlement demonstrated the DOJ's firm commitment to preventing and combating all forms of health care fraud, Holder added.
The department charged that Janssen Pharmaceuticals, a subsidiary of J&J, promoted antipsychotic drug Risperdal for uses not approved by the U.S. Food and Drug Administration (FDA), including controlling anxiety and agitation for elderly dementia patients, from 1999 through 2005.
The company also provided incentives for off-label promotion and based sales representatives' bonuses on total sales of Risperdal in their sales areas, not just sales for FDA-approved uses, the DOJ said.
"J&J's promotion of Risperdal for unapproved uses threatened the most vulnerable populations of our society -- children, the elderly and those with developmental disabilities," said Zane Memeger, U.S. attorney for the Eastern District of Pennsylvania .
The FDA said in a statement that it had delivered repeated warnings to Janssen Pharmaceuticals about its "misleading marketing messages" targeted to physicians and later initiated a criminal investigation.
"We stand ready to take similar action in the future, if warranted, to protect public health," said John Roth, director of the FDA Office of Criminal Investigations.
The Justice Department also alleged that J&J paid millions of dollars in kickbacks to Omnicare, the nation's largest pharmacy specializing in dispensing drugs to nursing home patients, under various guises including "grants" and "educational funding."
These kickbacks were intended to induce Omnicare and its hundreds of consultant pharmacists to promote the use of Risperdal and other J&J drugs in nursing homes, the department said.
"Today we reached closure on complex legal matters spanning almost a decade," J&J vice president and general counsel Michael Ullmann said in a statement. "We remain committed to working with the U.S. Food and Drug Administration and others to ensure greater clarity around the guidance for pharmaceutical industry practices and standards."
As part of the deal, the global health care giant, based in New Jersey, has signed a five-year corporate integrity agreement with the U.S. Department of Health and Human Services to scrutinise future practices.
相关新闻：美国司法部4日发表声明说，美国强生公司将支付超过22亿美元罚金，了结对其违法销售药品和向医生及药商提供回扣的刑事及民事指控。这是美国医疗保健行业第三大罚款。
此次违法销售的药品包括抗精神病处方药维思通、芮达和抗心衰处方药奈西立肽。强生公司及其子公司杨森制药公司被指控未按照美国食品和药物管理局许可的用途，将维思通销售给老人、儿童和残疾人。同时，强生公司还被指控为全美最大的处方药分销商全护公司提供数百万美元回扣，用于推销自己的药品。此次罚款包括4.85亿美元刑事罚款和向联邦及州政府支付的17.2亿美元民事罚款。
强生公司发表声明称，已为应对诉讼结果做好了准备，此次罚款不会对公司的盈利状况造成影响。
美国司法部长埃里克?霍尔德在新闻发布会上指责强生等医药公司为“中饱私囊”，“毫无顾忌地拿社会上最弱势的群体――儿童、老人和残疾人的健康冒险。”
维思通曾是强生公司一款畅销药品，2003年和2010年全球销售额达到242亿美元。美国政府于2004年开始调查维思通的销售，并起诉强生公司以未经美国食品和药物管理局许可的用途推销该药物。
此前，因违法销售药品，英国葛兰素史克公司和美国辉瑞制药公司分别于2012年和2009年被罚款30亿美元和23亿美元。(新华网)
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