Abbott Laboratories has admitted to promoting its anti-seizure drug Depakote for uses that were not approved by the Food and Drug Administration (FDA), and has agreed to pay $1.5 billion in criminal fines and civil settlement fees. Deputy Attorney General James Cole said the settlement shows the government’s determination to “hold accountable those who commit fraud.”
Depakote is approved by the FDA to treat seizures as well as bipolar disorder. However, the company was found guilty of marketing the drug for unapproved uses including as a treatment for schizophrenia, agitated dementia, and autism.
Abbott admitted that it trained its sales staff to push Depakote as a dementia treatment because the drug was not subject to federal regulations designed to prevent the use of unnecessary medications in nursing homes. The company also said it marketed the drug as a treatment for schizophrenia despite clinical trials that showed the drug was no more effective than antipsychotic drugs in treating the condition.
Doctors are allowed to prescribe medications for conditions that are not indicated by the drug’s safety label. However, drug companies cannot market these unapproved uses to doctors.
The settlement involves a $700 million criminal fine and forfeiture, and a total of $800 million in civil settlements with the federal government and states. Separately, Abbott has agreed to pay $100 million for consumer claims in 45 states and the District of Columbia over the pharmaceutical company’s promotion of Depakote for unapproved uses.
Abbott also received a five-year probation designed to ensure that there is no repeat of the company’s misconduct.