Abbott Labs to Pay $1.5 Billion for Unapproved Marketing
The pharmaceutical company will pay $1.5 billion to settle criminal and civil liability charges for promoting the drug Depakote for uses not approved by the Food and Drug Administration.
The pharmaceutical company will pay $1.5 billion to settle criminal and civil liability charges for promoting the drug Depakote for uses not approved by the Food and Drug Administration.
The drug is a neurological medicine labeled to treat mania, epilepsy and migraines, and can lead to life-threatening and deadly pancreatitis in children and adults.
The money will be distributed among 49 states and will go toward consumer protection, health care and other services. –ARK
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According to DOJ, Abbott Labs maintained a specialized sales force to market the drug for such purposes, targeting elderly dementia patients in nursing homes.
“Under the Food, Drug, and Cosmetic Act (FDCA), a company in its application to the FDA must specify each intended use of a drug. A company’s promotional activities must be limited to only the intended uses that FDA approved. In fact, promotion by the manufacturer for other uses — known as ‘off-label’ uses — renders the product misbranded,” states the press release.
The settlement is the second-largest payment ever made by a drug company. It includes a criminal fine and forfeiture totaling $700 million, as well as civil settlements with the federal government and 49 states, including the District of Columbia, totaling $800 million.
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