Abbott Labs sentenced for misbranding drug; fined $500 million

US health care major Abbott Laboratories (NYSE: ABT) was sentenced by US District Court Judge Samuel Wilson of the Western District of Virginia in connection with its guilty plea related to its unlawful promotion of the prescription drug Depakote (divalproex)   for uses not approved as safe and effective by the Food and Drug Administration, the Justice Department announced yesterday.

Abbott, which was ordered to pay a criminal fine in the amount of $500 million, plus a forfeiture of $198.5 million, and $1.5 million to the Virginia Medicaid Fraud Control Unit, will also be subject to a five-year term of probation.

In May 2012, Abbott pleaded guilty to a criminal misdemeanor for misbranding Depakote in violation of the Federal Food, Drug and Cosmetic Act (FDCA). Abbott’s criminal plea related to the misbranding of Depakote by promoting the drug to control behavioral disturbances in dementia patients and to treat schizophrenia when neither of these uses was approved by the FDA (The Pharma Letter May 8).