Abbott Reaches Settlement Agreement on Depakote

Abbott Laboratories will pay $1.6 billion to settle outstanding issues concerning past sales and marketing practices for its neurologic medication, Depakote. According to a Justice Department release, Abbott has pleaded guilty to a criminal misdemeanor for misbranding Depakote in violation of the Food, Drug, and Cosmetic Act. The settlement includes a criminal fine and forfeiture totaling $700 million and civil settlements with the federal government and the states totaling $800 million. An additional $100 million will be paid to the states to resolve consumer protection matters, according to an Abbott press release.

The Justice Department found that Abbott promoted Depakote to control agitation and aggression in elderly dementia patients, a use for which it was not approved. The company also used its sales force to promote the drug to healthcare providers and employees of nursing homes, and created programs and materials to train the pharmacy providers’ consultant pharmacists about the off-label use of Depakote to encourage them to recommend the drug for unapproved use. In addition, from 2001–2006, the company marketed Depakote in combination with atypical antipsychotic drugs to treat schizophrenia, another use for which it was not approved.

Abbott has also executed a Corporate Integrity Agreement with the Department of Health and Human Services, Office of Inspector General. The five-year CIA requires that Abbott's board of directors review the effectiveness of the company's compliance program, that high-level executives certify to compliance, that Abbott maintain standardized risk assessment and mitigation processes, and that the company post on its website information about payments to doctors. The CIA will transfer to AbbVie, the independent research-based company that Abbott expects to launch at the end of 2012.

"We are pleased to resolve this matter and are confident we have the programs in place to satisfy the requirements of this settlement," said Laura J. Schumacher, executive vice-president, General Counsel in the Abbott release. "The company takes its responsibility to patients and health care providers seriously and has established robust compliance programs to ensure its marketing programs meet the needs of health care providers and legal requirements."