A federal judge in Virginia fined Abbott Laboratories $500 million after the pharmaceutical giant pled guilty to unlawfully promoting the prescription drug Depakote for uses not approved as safe and effective by the Food and Drug Administration (FDA).
In addition to the fine, Abbott was ordered to forfeit $198.5 million, and $1.5 million to the Virginia Medicaid Fraud Control Unit, and will also be subject to a five-year term of probation.
In May 2012, Abbott pled 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.
Under the provisions of the FDCA, a company is required to specify the intended uses of a product in its new drug application to FDA.
Once approved, the drug may not be marketed or promoted for “off-label” uses – unless the company applies to the FDA for approval of the additional use.
In an agreed statement of facts, Abbott admitted that from January 1998 to December 2006 it marketed Depakote off-label to treat behavioral disturbances in dementia patients, and from January 2002 to December 2006, Abbott marketed Depakote off-label to treat schizophrenia.
Under the terms of the plea agreement, Abbott agreed to pay the second-largest criminal fine for a single drug, executed a fulsome statement of facts revealing the extent of its unlawful conduct, admitted that it engaged in misleading statements, and submitted to a five-year term of probation.
Under the terms of its probation, on an annual basis, Abbott’s CEO and board of directors will need to personally certify that the company is complying with the law.
Abbott’s guilty plea was part of a global resolution involving its illegal promotional activity.
Abbott also entered into a civil settlement agreement under which it agreed to pay $800 million to the federal government and the states to resolve claims that its unlawful marketing and illegal remuneration practices caused false claims to be submitted to government healthcare programs.
The parallel civil settlement covered a broader range of conduct by Abbott.
The settlement resolved allegations that in addition to off-label marketing for dementia and schizophrenia, Abbott also marketed Depakote for other psychiatric conditions in adults, including depression, anxiety, obsessive-compulsive disorder, post-traumatic stress disorder, alcohol and drug withdrawal and psychiatric conditions in children, including conduct disorders, attention deficit disorder and autism.