The company will pay $800 million to resolve civil allegations split among federal and state governments, plus $700 million for a criminal penalty, the Justice Department said. Abbott marketed the drug, approved for epilepsy, bipolar mania and migraine prevention, for unapproved uses including dementia, the U.S. said.
The settlement results from a four-year-old investigation into Abbott sales practices that began in 1998, the Abbott Park, Ill., company said Monday. Abbott said it is also paying $100 million to the states to resolve consumer protection matters.
|Comsumer protection settlement with states tops $100 million|
|Maryland, Virginia, the District of Columbia and 43 other states announced a $100 million consumer protection settlement with Abbott Laboratories on Monday over allegations of illegal marketing of its drug, Depakote.|
|Virginia's share of the settlement tops $2 million, and Maryland will receive more than $1.8 million from Abbott. The District's share will be just over $1 million, plus about $255,000 from a related settlement of Medicaid fraud claims from Abbott's marketing of Depakote. - Liz Farmer|
"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," Acting Associate Attorney General Tony West said. "As this criminal and civil resolution demonstrates, those who put profits ahead of patients will pay a hefty price."
Under U.S. law, a doctor can prescribe a medicine for any condition as long as it's licensed by the U.S. Food and Drug Administration and is proven to be safe and effective. Drug companies aren't allowed to promote a drug for uses other than those approved.
"Abbott admits that from 1998 through 2006, the company 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.
Abbott also marketed the drug to be used with certain 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.
Federal regulators only approved Depakote for prevention of migraines, treating acute manic episodes in bipolar patients and halting seizures in adults and children.