Post by jeffolie on May 7, 2012 15:16:51 GMT -6
drugs seniors Abbott $1.6B penalty The drug is associated with certain safety risks including liver disease.
bart posted this graphic
Misplaced Trust in Big Pharma, Medical Systems, HMOs
The above chart should not be so favorable to these that heavily rely on medications which Big Pharma has a proven record of abusing patients through over reaching the approved use so as to sell tons more for unapproved use.
$1.6 Billion penalty
Real big penalty...real big abuse: Abbott $1.6B drugs seniors The drug is associated with certain safety risks including liver disease.
===========================
May 7, 2012
.
2nd UPDATE: Abbott To Pay $1.6B To Settle Depakote Marketing Probes
--Abbott to plead guilty to misdemeanor charge that it promoted Depakote for "off-label" uses
--Justice Department says settlement amount is second-largest by a drug maker
--Abbott also agrees to compliance measures and five-year probationary period
(Adds comments from prosecutors, additional details of settlement beginning in 6th paragraph.)
By Peter Loftus and Brent Kendall
Of DOW JONES NEWSWIRES
Abbott Laboratories (ABT) agreed to pay $1.6 billion and plead guilty to violating a federal drug law to resolve allegations that the company improperly promoted antiseizure drug Depakote for unauthorized uses.
The Justice Department said it was the second-largest payment by a drug company to settle an investigation, after Pfizer Inc.'s (PFE) $2.3 billion settlement in 2009. It is the latest in a series of settlements by major drug makers--including GlaxoSmithKline PLC (GSK), Eli Lilly & Co. (LLY) and Merck & Co. (MRK)--whose marketing practices have been investigated by the government in recent years.
As part of its agreement with federal and state officials, Abbott admitted that from 1998 through 2006, it had a specialized sales force trained to market Depakote in nursing homes for the treatment of aggression and agitation in elderly dementia patients, despite the absence of credible scientific evidence that the drug was safe and effective for that use, according to the Justice Department.
The company also admitted that from 2001 through 2006 it 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 Justice Department said.
Neither of those so-called off-label uses were approved by the Food and Drug Administration. The drug is approved to treat epilepsy and bipolar disorder and to prevent migraines. Drug makers are generally barred from actively promoting such off-label uses of their drugs, though doctors have discretion to prescribe off-label.
"Abbott's misconduct exposed elderly nursing home residents and schizophrenia patients to serious side effects from a drug that was not proven effective, at a cost of hundreds of millions of dollars to government health care programs," U.S. Attorney Timothy Heaphy of the Western District of Virginia said at a press conference in Washington.
"This is an elder abuse case," he said.
The drug is associated with certain safety risks including liver disease.
Abbott General Counsel Laura Schumacher said in a statement: "The company takes its responsibility to patients and health care providers seriously and has established robust compliance programs to ensure its marketing programs meet the needs of health care providers and legal requirements." She said the company is confident it has programs in place to satisfy the requirements of the settlement.
Abbott agreed to plead guilty to one misdemeanor violation of the Food, Drug and Cosmetic Act for "misbranding" Depakote, in connection with the promotion of the drug for use in the elderly and in schizophrenia patients.
The drug maker will pay $800 million to resolve civil allegations split among federal and state governments, a $700 million criminal fine and forfeiture, and $100 million to states to resolve consumer-protection matters. The settlement resolves investigations by the federal government, 49 states and the District of Columbia.
The civil aspect of the settlement stems from allegations that Abbott's marketing practices caused false claims to be submitted to government health programs for prescription reimbursements. The civil settlement doesn't include a determination of liability.
Abbott previously reserved the amounts in anticipation of the settlement, including a $1.5 billion charge in the third quarter of 2011.
Depakote was once one of Abbott's best-selling drugs, racking up $1.6 billion in sales for 2007, before patent expirations cleared the way for cheaper generic copies.
In addition to monetary penalties, Justice Department officials said the Abbott agreement included novel provisions that haven't been used in past similar settlements with drug companies.
Among them, Abbott will be subject to court-supervised probation for five years, and its chief executive and board of directors must make certain certifications to the probation office about the company's marketing and sales practices.
Abbott also agreed not to compensate sales reps for off-label sales and take other steps during the probationary period.
These compliance measures and certification requirements will transfer to a stand-alone pharmaceutical company that is being split off from Abbott Labs, to be called AbbVie. Abbott has tapped Richard A. Gonzalez, currently head of Abbott's pharmaceutical unit, to become CEO of AbbVie.
Abbott Chief Executive Miles White will remain CEO of Abbott Labs after the split. In 2010, a federal judge in Virginia ordered Abbott to turn over to federal prosecutors some of White's email messages that prosecutors wanted as part of their investigation.
The split is expected to be completed by the end of 2012.
Justice Department officials said the agency wanted to increase penalties each time it resolves an off-label marketing case with a drug company. They said they hoped the Abbott agreement would provide new incentives for drug makers to comply with the law.
The government investigations were based partly on lawsuits filed in federal court by former Abbott sales reps who made allegations about Depakote marketing.
One of the lawsuits was filed in 2007 by Meredith McCoyd, who worked as an Abbott Labs sales rep from 1998 until 2007 in Atlanta and surrounding areas. She alleged Abbott promoted Depakote for treating dementia in nursing-home patients and other uses.
She also alleged Abbott paid kickbacks to doctors and long-term care pharmacists to induce use of Depakote, and misrepresented its safety and efficacy profile.
"We're obviously pleased this matter has come to a resolution," said McCoyd's lawyer, Reuben Guttman. Abbott "was marketing to populations without the ability on their own to be cognizant of the impact of the drugs on them."
McCoyd and the others who filed lawsuits stand to split $84 million of the federal share of the settlement under a U.S. law designed to encourage people to report allegations of false-claims fraud. They stand to receive additional money from the states.
Guttman said it was a "reasonable reward for coming forward and revealing information that's going to have a very positive impact on the way patient populations are treated in the days ahead."
Abbott's guilty plea and sentence won't be final until accepted by the U.S. District Court for the Western District of Virginia.
online.wsj.com/article/BT-CO-20120507-714070.html
bart posted this graphic
Misplaced Trust in Big Pharma, Medical Systems, HMOs
The above chart should not be so favorable to these that heavily rely on medications which Big Pharma has a proven record of abusing patients through over reaching the approved use so as to sell tons more for unapproved use.
$1.6 Billion penalty
Real big penalty...real big abuse: Abbott $1.6B drugs seniors The drug is associated with certain safety risks including liver disease.
===========================
May 7, 2012
.
2nd UPDATE: Abbott To Pay $1.6B To Settle Depakote Marketing Probes
--Abbott to plead guilty to misdemeanor charge that it promoted Depakote for "off-label" uses
--Justice Department says settlement amount is second-largest by a drug maker
--Abbott also agrees to compliance measures and five-year probationary period
(Adds comments from prosecutors, additional details of settlement beginning in 6th paragraph.)
By Peter Loftus and Brent Kendall
Of DOW JONES NEWSWIRES
Abbott Laboratories (ABT) agreed to pay $1.6 billion and plead guilty to violating a federal drug law to resolve allegations that the company improperly promoted antiseizure drug Depakote for unauthorized uses.
The Justice Department said it was the second-largest payment by a drug company to settle an investigation, after Pfizer Inc.'s (PFE) $2.3 billion settlement in 2009. It is the latest in a series of settlements by major drug makers--including GlaxoSmithKline PLC (GSK), Eli Lilly & Co. (LLY) and Merck & Co. (MRK)--whose marketing practices have been investigated by the government in recent years.
As part of its agreement with federal and state officials, Abbott admitted that from 1998 through 2006, it had a specialized sales force trained to market Depakote in nursing homes for the treatment of aggression and agitation in elderly dementia patients, despite the absence of credible scientific evidence that the drug was safe and effective for that use, according to the Justice Department.
The company also admitted that from 2001 through 2006 it 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 Justice Department said.
Neither of those so-called off-label uses were approved by the Food and Drug Administration. The drug is approved to treat epilepsy and bipolar disorder and to prevent migraines. Drug makers are generally barred from actively promoting such off-label uses of their drugs, though doctors have discretion to prescribe off-label.
"Abbott's misconduct exposed elderly nursing home residents and schizophrenia patients to serious side effects from a drug that was not proven effective, at a cost of hundreds of millions of dollars to government health care programs," U.S. Attorney Timothy Heaphy of the Western District of Virginia said at a press conference in Washington.
"This is an elder abuse case," he said.
The drug is associated with certain safety risks including liver disease.
Abbott General Counsel Laura Schumacher said in a statement: "The company takes its responsibility to patients and health care providers seriously and has established robust compliance programs to ensure its marketing programs meet the needs of health care providers and legal requirements." She said the company is confident it has programs in place to satisfy the requirements of the settlement.
Abbott agreed to plead guilty to one misdemeanor violation of the Food, Drug and Cosmetic Act for "misbranding" Depakote, in connection with the promotion of the drug for use in the elderly and in schizophrenia patients.
The drug maker will pay $800 million to resolve civil allegations split among federal and state governments, a $700 million criminal fine and forfeiture, and $100 million to states to resolve consumer-protection matters. The settlement resolves investigations by the federal government, 49 states and the District of Columbia.
The civil aspect of the settlement stems from allegations that Abbott's marketing practices caused false claims to be submitted to government health programs for prescription reimbursements. The civil settlement doesn't include a determination of liability.
Abbott previously reserved the amounts in anticipation of the settlement, including a $1.5 billion charge in the third quarter of 2011.
Depakote was once one of Abbott's best-selling drugs, racking up $1.6 billion in sales for 2007, before patent expirations cleared the way for cheaper generic copies.
In addition to monetary penalties, Justice Department officials said the Abbott agreement included novel provisions that haven't been used in past similar settlements with drug companies.
Among them, Abbott will be subject to court-supervised probation for five years, and its chief executive and board of directors must make certain certifications to the probation office about the company's marketing and sales practices.
Abbott also agreed not to compensate sales reps for off-label sales and take other steps during the probationary period.
These compliance measures and certification requirements will transfer to a stand-alone pharmaceutical company that is being split off from Abbott Labs, to be called AbbVie. Abbott has tapped Richard A. Gonzalez, currently head of Abbott's pharmaceutical unit, to become CEO of AbbVie.
Abbott Chief Executive Miles White will remain CEO of Abbott Labs after the split. In 2010, a federal judge in Virginia ordered Abbott to turn over to federal prosecutors some of White's email messages that prosecutors wanted as part of their investigation.
The split is expected to be completed by the end of 2012.
Justice Department officials said the agency wanted to increase penalties each time it resolves an off-label marketing case with a drug company. They said they hoped the Abbott agreement would provide new incentives for drug makers to comply with the law.
The government investigations were based partly on lawsuits filed in federal court by former Abbott sales reps who made allegations about Depakote marketing.
One of the lawsuits was filed in 2007 by Meredith McCoyd, who worked as an Abbott Labs sales rep from 1998 until 2007 in Atlanta and surrounding areas. She alleged Abbott promoted Depakote for treating dementia in nursing-home patients and other uses.
She also alleged Abbott paid kickbacks to doctors and long-term care pharmacists to induce use of Depakote, and misrepresented its safety and efficacy profile.
"We're obviously pleased this matter has come to a resolution," said McCoyd's lawyer, Reuben Guttman. Abbott "was marketing to populations without the ability on their own to be cognizant of the impact of the drugs on them."
McCoyd and the others who filed lawsuits stand to split $84 million of the federal share of the settlement under a U.S. law designed to encourage people to report allegations of false-claims fraud. They stand to receive additional money from the states.
Guttman said it was a "reasonable reward for coming forward and revealing information that's going to have a very positive impact on the way patient populations are treated in the days ahead."
Abbott's guilty plea and sentence won't be final until accepted by the U.S. District Court for the Western District of Virginia.
online.wsj.com/article/BT-CO-20120507-714070.html