Office of the Attorney General
Attorney General Conway Announces Settlement with Botox Manufacturer Allergan USA
Attorney General Jack Conway today announced that Kentucky will participate in a settlement with Botox manufacturer Allergan USA over allegations of deceptive and illegal marketing of Botox. Under the terms of the settlement, Allergan has agreed to pay $225 million to resolve civil and criminal claims brought by the federal government, Kentucky and other participating states that Allergan caused false claims to be submitted to the Medicaid program and paid illegal kickbacks to physicians to induce them to prescribe Botox for off-label uses.
The settlement resolves claims that Allergan illegally disseminated unsubstantiated and misleading information to physicians that Botox was a safe and effective means for treating conditions such as headache, pain, spasticity, and overactive bladder that had not been approved by the FDA. Allergan also paid illegal kickbacks to physicians to induce them to prescribe Botox for off-label uses and further instructed physicians how to falsify Medicaid claims by using inapplicable diagnosis and billing codes to ensure payment by the Medicaid Program.
In addition to its familiar cosmetic use, the Food and Drug Administration (FDA) has approved Botox for the treatment of several rare diseases and conditions such as crossed eyes, uncontrollable eye blinking, abnormal head and neck posture, with involuntary contractions, underarm sweating and spasticity in the flexor muscles of the elbow, wrist and fingers.
"Drug companies that engage in deceptive and illegal marketing of their products will be held accountable," General Conway said. "I remain committed to recovering taxpayer money that is lost to health care fraud and to ensuring that the public health is not at risk from this illegal activity."
As a result of the settlement, the Kentucky Medicaid program will receive $472,249, which represents double the amount that Kentucky Medicaid expended for prescriptions written as a result of the company's off- label marketing. After reimbursing the federal government for its contribution, the Kentucky Medicaid program will retain $132,108 of the settlement proceeds.
Additionally, Allergan pled guilty to one criminal misdemeanor count of violating the Federal Food, Drug, and Cosmetic Act was required to execute a Corporate Integrity Agreement with the United States Department for Health and Human Services to insure that these illegal marketing activities do not occur again in the future.
Attorney General Conway recently announced settlements with Schwarz Pharma and Novartis Pharmaceuticals Corp. to resolve allegations of improper and illegal marketing of their products. As a result of those settlements, Kentucky's Medicaid program will receive more than $4.2 million.
Since Attorney General Conway took office in January 2008, his Office of Medicaid Fraud and Abuse Control has recovered or been awarded more than $141 million dollars for the state and federal Medicaid programs. These cases range from lawsuits and settlements against pharmaceutical companies to cases against individual providers.
The Attorney General's Tip Line for reporting allegations of Medicaid fraud is 1-877-228-7384.