slimvictor
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Abbott Laboratories has pleaded guilty and agreed to pay $1.6 billion to resolve its criminal and civil liability arising from the company's unlawful promotion of the prescription drug Depakote, the U.S. Justice Department said Monday.
Acting Associate Attorney General Tony West said it was case of Abbott putting "profits ahead of patients."
The total includes a criminal fine of $700 million and civil settlements with the states and federal government totaling $800 million. Abbott pleaded guilty to a criminal misdemeanor for misbranding Depakote.
(...)
That makes this the second-largest fraud settlement involving a drug company, behind only the $2.3 billion Pfizer settlement in 2010. It is the third-largest fraud settlement against the government in any field.
(...)
Abbott pleaded guilty to misbranding Depakote by promoting the drug to control agitation and aggression in patients with elderly dementia and to treat schizophrenia when neither use was approved by the Food and Drug Administration, the Justice Department said.
Abbott will be subject to court-supervised probation and reporting obligations for Abbott's CEO and board of directors.
(...)
"This is an elder abuse case," U.S. Attorney Timothy Heaphy of the Western District of Virginia told reporters.
Top Justice Department officials led by Deputy Attorney General James Cole were joined by Virginia state officials who began the investigation after they were approached by whistle-blowers.
Officials said the federal government will receive about $560 million from the civil settlement. The total expected to be divided among all 50 states is about $240 million. The whistle-blowers will receive a total of $84 million.
(...)
Heaphy said Abbott earned about $13 billion from Depakote sales during the period investigated, but he said it was difficult to determine how much of that was the result of sales for illegal purposes. He expressed confidence that, once the fines are factored in, Abbott will not have profited from the improper practices.
(...)
The company admitted that from 1998 through 2006, it "maintained a specialized sales force trained to market Depakote in nursing homes for the control of agitation and aggression in elderly dementia patients, despite the absence of credible scientific evidence that Depakote was safe and effective for that use," the Justice Department said in a news release.
"In addition, from 2001 through 2006, the company marketed Depakote in combination with atypical antipsychotic drugs to treat schizophrenia, even after its clinical trials failed to demonstrate that adding Depakote was any more effective than an atypical antipsychotic alone for that use."
The FDA approved Depakote only for epileptic seizures, bipolar mania and the prevention of migraines.
In 1999, Abbott discontinued a trial of Depakote in the treatment of dementia due to adverse events that included drowsiness, dehydration and anorexia.
Abbott trained its sales force to promote the drug to health care providers and employees of nursing homes as better than antipsychotic drugs for controlling agitation and aggression in elderly dementia patients, the release said.
(...)
"Not only did Abbott engage in off-label promotion, but it targeted elderly dementia patients and downplayed the risks apparent from its own clinical studies," said West, the acting associate attorney general. "As this criminal and civil resolution demonstrates, those who put profits ahead of patients will pay a hefty price."
cont at
http://edition.cnn.com/2012/05/07/justice/abbott-fine-drug/index.html
Acting Associate Attorney General Tony West said it was case of Abbott putting "profits ahead of patients."
The total includes a criminal fine of $700 million and civil settlements with the states and federal government totaling $800 million. Abbott pleaded guilty to a criminal misdemeanor for misbranding Depakote.
(...)
That makes this the second-largest fraud settlement involving a drug company, behind only the $2.3 billion Pfizer settlement in 2010. It is the third-largest fraud settlement against the government in any field.
(...)
Abbott pleaded guilty to misbranding Depakote by promoting the drug to control agitation and aggression in patients with elderly dementia and to treat schizophrenia when neither use was approved by the Food and Drug Administration, the Justice Department said.
Abbott will be subject to court-supervised probation and reporting obligations for Abbott's CEO and board of directors.
(...)
"This is an elder abuse case," U.S. Attorney Timothy Heaphy of the Western District of Virginia told reporters.
Top Justice Department officials led by Deputy Attorney General James Cole were joined by Virginia state officials who began the investigation after they were approached by whistle-blowers.
Officials said the federal government will receive about $560 million from the civil settlement. The total expected to be divided among all 50 states is about $240 million. The whistle-blowers will receive a total of $84 million.
(...)
Heaphy said Abbott earned about $13 billion from Depakote sales during the period investigated, but he said it was difficult to determine how much of that was the result of sales for illegal purposes. He expressed confidence that, once the fines are factored in, Abbott will not have profited from the improper practices.
(...)
The company admitted that from 1998 through 2006, it "maintained a specialized sales force trained to market Depakote in nursing homes for the control of agitation and aggression in elderly dementia patients, despite the absence of credible scientific evidence that Depakote was safe and effective for that use," the Justice Department said in a news release.
"In addition, from 2001 through 2006, the company marketed Depakote in combination with atypical antipsychotic drugs to treat schizophrenia, even after its clinical trials failed to demonstrate that adding Depakote was any more effective than an atypical antipsychotic alone for that use."
The FDA approved Depakote only for epileptic seizures, bipolar mania and the prevention of migraines.
In 1999, Abbott discontinued a trial of Depakote in the treatment of dementia due to adverse events that included drowsiness, dehydration and anorexia.
Abbott trained its sales force to promote the drug to health care providers and employees of nursing homes as better than antipsychotic drugs for controlling agitation and aggression in elderly dementia patients, the release said.
(...)
"Not only did Abbott engage in off-label promotion, but it targeted elderly dementia patients and downplayed the risks apparent from its own clinical studies," said West, the acting associate attorney general. "As this criminal and civil resolution demonstrates, those who put profits ahead of patients will pay a hefty price."
cont at
http://edition.cnn.com/2012/05/07/justice/abbott-fine-drug/index.html
