October 25, 2010
Jefferson City, Mo. - Attorney General Chris Koster today announced that Allergan, Inc., and Allergan USA, Inc. will repay the Missouri Medicaid program $1.6 million as part of a national settlement stemming from allegations of improper off-label marketing of the drug Botox.
Koster said the settlement resolves allegations that Allergan promoted the drug Botox for unapproved uses, illegally targeting patients suffering from headache, pain, overactive bladder, and spasticity. Botox was initially approved only for treatment of certain eye disorders, head and neck spasms, and underarm sweating.
The investigation revealed that Allergan had engaged in a nationwide off-label marketing campaign of Botox. The marketing plan included providing physicians "free" reimbursement services and support, which included coaching physicians to use a muscle spasm code in order to obtain reimbursement for the off-label use. Allergan also funded continuing medical education programs, honoraria, and grants to health care professionals to promote off-label uses for Botox.
"Allergan's marketing of Botox operated outside the law to profit at the expense of Missouri taxpayers and those who need the state's Medicaid services," Koster said. "This settlement returns a significant amount of money to the taxpayers' coffers and will give other companies pause before using such methods."
Koster said Allergan will pay the states and the federal government a total of $225 million in damages and penalties to compensate Medicaid and various federal healthcare programs for harm suffered as a result of this conduct. The company also will pay the federal government $350 million in criminal fines and $25 million in forfeiture after pleading guilty to a misdemeanor violation of the Food, Drug and Cosmetic Act.
As part of the settlement, Allergan has entered into a Corporate Integrity Agreement with the United States Department of Health and Human Services, Office of the Inspector General, which will closely monitor the company's future marketing and sales practices.