SEATTLE -- A $430 million settlement with makers of a prescription epilepsy drug will return millions of dollars to Washington's Medicaid program and provide money to offset the company's improper efforts to market the drug Neurontin for other purposes, Attorney General Christine Gregoire announced today.
The joint federal and state investigation led by the Washington Attorney General's Medicaid Fraud Control Unit, with assistance from the Consumer Protection Division, concerned the "off-label marketing" of the epilepsy drug Neurontin by drug maker Warner-Lambert and its parent company, Pfizer.
Off-label marketing involves the promotion of prescription drugs for purposes that have not been approved by the U.S. Food and Drug Administration.
"Consumers deserve fair and accurate information about prescription drugs that is not tainted by illegal promotions by pharmaceutical manufacturers," Gregoire said.
While the prescription drug was approved for certain epilepsy patients, the company promoted Neurontin for other medical uses, such as bipolar disorder and pain management, which were not approved by the FDA. While it may be appropriate for physicians to prescribe drugs for off-label uses, it is illegal for pharmaceutical manufacturers to promote the off-label use of their drugs.
Payments made by Warner-Lambert to physicians for "research" were in effect inducements to prescribe Neurontin for off-label purposes. The marketing campaign resulted in inappropriate and unnecessary prescriptions paid by the state Medicaid program. Approximately 90 percent of Neurontin usage is for off-label purposes.
The $430 million settlement includes $152 million in restitution to various state Medicaid programs, including $4 million for the Washington Medicaid program operated by the state Department of Social and Health Services. A $38 million settlement portion for violating consumer protection laws includes $21 million for a consumer education fund to provide scientific information about Neurontin related to off-label uses. A total of $6 million will be used to help educate physicians on how to reverse the effects of the off-label promotion. The remaining $240 million is a federal fine for violations of the federal Food, Drug and Cosmetics Act.
Gregoire stated that this is the first of what may be many off-label marketing cases brought by state and federal governments and should send a strong message to the pharmaceutical industry that off-label marketing of pharmaceuticals is unacceptable.