Abbott will pay $1.6 billion in a settlement with U.S. federal and 49 state authorities, plus the District of Columbia, to resolve all outstanding allegations regarding past sales and marketing practices for its neurologic drug Depakote. The settlement follows a four-year investigation into past Depakote sales activities that began in 1998.
Abbott will pay $800 million to resolve civil allegations, federal and state governments, $700 million for a criminal penalty, and $100 million to states to resolve consumer protection matters. These amounts were previously reserved in anticipation of the settlement.
As part of the resolution, Abbott has agreed to plead guilty to one misdemeanor violation of the Food, Drug and Cosmetic Act for misbranding. The settlement also includes a five-year probationary period for the maintenance of specified compliance measures and annual certification by Abbott’s chief executive officer and board of directors.
The compliance measures and certification requirements will transfer to Abbott’s soon-to-be-spun-off research-based pharma company, AbbVie. Abbott will also enter into a Corporate Integrity Agreement (CIA) with the Office of Inspector General of the U.S. Department of Health and Human Services. The CIA will govern the compliance program for a period of five years.
"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. "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."