Wednesday, May 09, 2012
Miles White, CEO of Abbott Labs
Pharmaceutical company Abbott Laboratories has agreed to pay $1.6 billion to settle accusations that it illegally marketed the anti-seizure medication Depakote for uses not approved by the Food and Drug Administration (FDA).
About $800 million will go to resolve civil cases brought by federal and state governments, while $700 million will cover criminal penalties. State governments will receive another $100 million to resolve consumer protection cases.
As part of the settlement, Abbott will plead guilty to one misdemeanor violation of federal law for misbranding Depakote. The company will be on probation for five years, but, as usual, no individuals will be charged. Miles W. White has been CEO and chairman of the board of Abbott since 1999.
The U.S. Department of Justice accused Abbott of illegally marketing Depakote for uses including for treatment of schizophrenia, agitated dementia and autism. According to the FDA, in 1999, Abbott was forced to halt testing of Depakote for dementia “due to an increased incidence of adverse events, including somnolence, dehydration and anorexia experienced by the elderly study participants.”
The company also allegedly gave doctors and pharmacists illegal kickbacks in exchange for promoting non-FDA approved uses of the drug.
On the market since 1983, Depakote was first approved as an anti-seizure and mood-stabilizing drug for adults and children age 11 and older. Since then, the drug has been authorized by federal regulators to treat other types of seizures, manic episodes of bipolar disorder and migraine headaches.
The settlement with Abbott brings the amount recovered by the government for health care fraud to $10.2 billion since Barack Obama became president of the United States.
-Noel Brinkerhoff, David Wallechinsky
To Learn More:
Abbott To Pay $1.6B To Settle Depakote Claims (by Peter Frost, Chicago Tribune)
Abbott Labs to Pay $1.5 Billion to Resolve Criminal & Civil Investigations of Off-label Promotion of Depakote (U.S. Department of Justice)
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