March 31, 2005
Jefferson City, Mo. — Attorney General Jay Nixon today presented the Missouri Medicaid program with a check for $1,841,774 from a settlement with Pfizer Inc., the largest pharmaceutical manufacturer in the world. The nationwide settlement, announced last May, resolved concerns that a Pfizer subsidiary improperly marketed the epilepsy drug Neurontin for other uses.
Nixon, whose Medicaid Fraud Control Unit and Consumer Protection Division helped negotiate the settlement, said Missouri received a total of almost $4.4 million in the settlement, with $2,557,394 going to reimburse the federal government for its share of the state's Medicaid funding.
In addition to the settlement with all 50 state Attorneys General, Pfizer subsidiary Warner-Lambert pleaded guilty in federal court in Boston in May 2004 to violating the Food, Drug and Cosmetics Act and agreed to pay a fine of $240 million to the federal government.
"I am pleased that we recovered this money for the Missouri Medicaid program, and that cooperation between state and federal agencies brought Pfizer to the negotiating table," Nixon said. "We will continue our vigilance in going after those who are costing Medicaid millions through their actions."
The states and the federal government alleged that from 1994 to 2000, Parke-Davis illegally promoted the off-label use of Neurontin by physicians for uses other than to treat epilepsy. Neurontin was approved at the time by the Food and Drug Administration only as an adjunctive therapy epilepsy drug, a drug that should only be prescribed in combination with another drug to treat epilepsy. Parke-Davis was then a division of Warner-Lambert, which was purchased by Pfizer in 2000.
Physicians may prescribe Neurontin for off-label use, but it is illegal for pharmaceutical manufacturers to promote off-label use. Warner-Lambert subsidized the production and dissemination of anecdotal reports promoting Neurontin for off-label uses, including treatment of pain management, bipolar disorder, alcohol/drug withdrawal and migraines. The company also made payments to physicians that the government contended were kickbacks for off-label prescribing.
The government contended that this off-label marketing campaign resulted in inappropriate, unnecessary or ineffective prescriptions for Neurontin which were paid for by the Medicaid program. Approximately 90 percent of Neurontin usage is for off-label purposes.
In addition to the penalties, Warner-Lambert also will enter into an agreement with the Department of Health & Human Services, Office of Inspector General requiring strict scrutiny of its future marketing and sales practices.
The Medicaid Fraud Control Unit of the Attorney General's Office, formed by Nixon in 1994, has authority under state law to investigate and prosecute, both civilly and criminally, allegations of fraud against Missouri's Medicaid program.