For Immediate Release
Media Contact: Bob Cooper
Date: May 13, 2004
Attorney General Wasden Joins Warner-Lambert Settlement
Attorney General Lawrence Wasden today announced that Idaho is participating in a nationwide settlement with Warner-Lambert, a wholly owned subsidiary of Pfizer, Inc. The settlement resolves allegations of deceptive "off-label" marketing of the drug Neurontin©. Warner-Lambert will pay a total of $38 million dollars to all 50 states.
Neurontin is a prescription medication approved by the Food and Drug Administration ("FDA") for adjunctive treatment of epilepsy and post-herpetic neuralgia. Approximately 90% of Neurontin prescriptions, however, are for off-label purposes. The consumer protection investigation focused on alleged violations of state consumer protection laws that occurred when Warner-Lambert promoted Neurontin for various "off-label" indications, including certain psychiatric disorders, back pain, and headache, even though the scientific evidence supporting the use of Neurontin for these indications was lacking.
$28 million dollars will be used in a remediation program and a total of $10 million dollars will be distributed to the participating states for attorney fees and other costs of investigation. Idaho's share of the payment for attorney fees and costs will be $278,000.
Under the remediation program, up to $6 million dollars of the fund will go toward a national advertising program to provide physicians and other prescribers with fair and balanced information about Neurontin and other drugs in its therapeutic class. At least $21 million dollars will be used to fund a Prescriber and Consumer Education Program, which will make grant monies available to governmental entities, academic institutions, and not-for-profit organizations that provide prescribers and/or consumers with fair and balanced information about drugs. Up to $1 million dollars of the fund will be utilized to evaluate the effectiveness of the remediation program.
The settlement of state consumer protection claims is part of an unprecedented global 50-state settlement that also resolves investigations by the National Association of Medicaid Fraud Control Units and the U.S. Attorney's Office out of Boston. In total, Warner-Lambert will pay $430 million dollars under these settlements.
It is illegal for pharmaceutical manufacturers to promote the off-label use of their drugs, although doctors are permitted to prescribe for such uses. Warner-Lambert engaged in off-label promotion of Neurontin in a variety of ways, dramatically increasing the prescribing of Neurontin for off-label indications for which there is little or no scientific evidence of efficacy.
Among the methods used by Warner Lambert to deceptively promote Neurontin for off-label indications were:
The settlement prohibits Warner-Lambert and its corporate parent Pfizer, Inc. from the following activities:
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