In what the Justice Department has declared to be one of the largest payments by a drug company in U.S. history, Abbott Laboratories was ordered on Monday to pay a combination of criminal fines and civil settlements totaling more than $1.5 billion. The company previously pleaded guilty to marketing its drug Depakote for uses which the Food and Drug Administration had not approved, according to CNN.
Depakote is only approved by the FDA for use as a treatment for bipolar disorder, migraines, and epileptic seizures. In the guilty plea it entered with the court, Abbott Laboratories admitted that between the years 1998 and 2006, the company actively promoted the drug to nursing homes as an effective treatment for the aggression and agitation that can be a side effect of elderly dementia. Additionally, the company admitted that in 2001 it began promoting Depakote as an effective treatment for schizophrenia. Depakote has not been tested or approved for either of those uses.
The Justice Department held a press conference on Monday afternoon where U.S. Attorney Timothy Heaphy discussed the specifics of what Abbott Laboratories had been found guilty of doing. He emphasized that the misbranding and misrepresentation of the uses for Depakote was a company-wide design and a determined effort to commit fraud by the whole corporation, not just a few sales agents, according to the Associated Press.
Perhaps just as disturbing as Abbott Laboratories’ fraudulent claims is the fact that there were no studies to back them up. This was not merely a case of a company having a drug that was useful in the treatment of other issues and failing to go through the correct channels to be properly approved. Abbott Laboratories did not have any evidence whatsoever that the drug could be used in the ways that it chose to market it, and had in fact halted clinical trials that had been undertaken to determine if Depakote was useful in treating other issues because it found that the drug caused some concerning side effects.
The payment that was ordered by the court includes some $700 million in criminal fines, and another $800 million in civil settlements to be paid out to 45 different states and the District of Columbia. For its part, Abbott Laboratories tried to reassure the public on Monday as to its intentions and practices, telling the media that it “takes its responsibility to patients and health care providers seriously,” as quoted by the Associated Press.
The Wall Street Journal reported that under the terms of its plea deal, which saw the company plead guilty to a criminal misdemeanor violation regarding the marketing of a drug for “off-label” uses, Abbott Laboratories will now be on probation for the next five years. In addition, it will have to adhere to certain compliance measures as set forth by the federal government.