Oregon Attorney General John Kroger today announced a global settlement that requires Allergan to pay $600 million to resolve allegations of illegal off-label marketing of Botox.
“We will vigorously prosecute corporations that engage in fraudulent marketing campaigns to protect the American taxpayer and the integrity of our health care programs,” said Deputy Attorney General Mary Williams.
Oregon was a leader of the federal-state investigation into allegations that Allergan promoted Botox for uses other than what was approved by the U.S. Food and Drug Administration.
Botox was initially approved for strabismus (crossed eyes) and blepharospasm (uncontrollable eye blinking), cervical dystonia (abnormal head and neck posture with involuntary contractions) and underarm sweating. The investigation revealed that Allergan engaged in a nation-wide off-label marketing campaign of Botox targeting patients suffering from headache, pain, overactive bladder and spasticity.
The marketing plan included providing physicians “free” reimbursement services and support that included coaching physicians to use a muscle spasm code in order to obtain reimbursement for this unapproved use. Allergan also funded continuing medical education programs, honoraria, and grants to health care professionals to promote unapproved uses for Botox.
Allergan will pay the states and the federal government $225 million dollars, including $33 million dollars for the Medicaid program. This settlement reimburses the federal government and participating states for excessive amounts paid by the Medicaid program as a result of Allergan’s marketing campaign of Botox for unapproved uses and other conduct. The Oregon Medicaid program will receive $171,041.76.
Allergan also entered into a Corporate Integrity Agreement (CIA) with the U.S. Department of Health and Human Services, Office of Inspector General, requiring strict scrutiny of its future marketing and practices.
Additionally, the Office of the United States Attorney for the Northern District of Georgia filed a one count information in the United States District Court alleging a misdemeanor violation of the Food, Drug and Cosmetic Act. Allergan has agreed to enter a guilty plea and pay an additional $350 million dollars in criminal fines and $25 million in forfeiture to resolve this Information.
This case was investigated by a group that included state attorneys general, the U.S. Attorney’s Office, the U.S. Department of Justice and the Office of Inspector General. The 50 states coordinated their efforts by appointing a team of 4 attorneys and 2 analysts to represent their interests.
Sheen Wu, Senior Assistant Attorney General of the Oregon Department of Justice, led the team for the states.
Attorney General John Kroger leads the Oregon Department of Justice. The Department’s mission is to fight crime and fraud, protect the environment, improve child welfare, promote a positive business climate and defend the rights of all Oregonians.
Tony Green, (503) 378-6002 firstname.lastname@example.org