US pharmaceutical company Abbott Laboratories has been fined a total of $1.6 billion for the marketing of Depakote, an anti-seizure medication.
The company pleaded guilty to a violation of the Food, Drug and Cosmetic Act for misbranding Depakote, which is also a mood-stabiliser.
The drug has been approved for the treatment of epilepsy, migraines and bipolar, but according to the US Justice Department, Abbott Laboratories encouraged its sales team to market the drug as being a suitable treatment for dementia and autism.
It is thought to be the biggest settlement ever involving just one single drug.
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Abbott Laboratories will now pay $800 million to federal and state governments, $700 million as a criminal penalty and $100 million to states to resolve consumer protection matters.
The company reportedly had a team of sales representatives that specifically sold the drug to nursing homes.
There have also been allegations made claiming Abbott Laboratories used financial bribes to persuade healthcare professionals to prescribe the drug to their patients.
Although doctors themselves can prescribe medication to a patient in the way that they see fit, pharmaceutical manufacturers are only permitted to market products as they have been approved by the FDA (US Food and Drug Administration).
Following today’s ruling, Abbott Laboratories has agreed to undergo a probationary period of five years, during which its operations will be overseen by the US government to ensure no other misdemeanours take place.
Commenting on the settlement, Laura J. Schumacher, Executive Vice President of the Abbott General Counsel, said: “We are pleased to resolve this matter and are confident we have the programs in place to satisfy the requirements of this settlement.
“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.”
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