Abbott Labs to Pay $1.5 Billion for Unapproved Marketing
Posted on May 12, 2012
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
The Epoch Times:
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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