CURRAN ANNOUNCES NATIONWIDE SETTLEMENTS RESOLVING INVESTIGATION OF ILLEGAL OFF-LABEL DRUG MARKETING BY WARNER-LAMBERT

Attorney General J. Joseph Curran, Jr. today announced two nationwide settlements with Warner-Lambert (a wholly owned subsidiary of Pfizer Inc. – the world’s largest pharmaceutical company) resolving allegations of deceptive “off-label” marketing of the epilepsy drug Neurontin. One settlement resolves an investigation by state consumer protection officials; Warner-Lambert will pay the 50 states and the District of Columbia a total of $38 million under this settlement. The other settlement resolves investigations by the National Association of Medicaid Fraud Control Units and the U.S. Attorney’s Office out of Boston; Warner-Lambert will pay the states $152 million in damages and penalties to the various states’ Medicaid programs.

The investigations focused on alleged violations of state consumer protection laws, and inappropriate use of Medicaid funds, that occurred when Warner-Lambert promoted Neurontin for various “off-label” indications – including various psychiatric disorders, back pain, and headache – even though the scientific evidence supporting the use of Neurontin for these indications was lacking. Neurontin is a prescription medication approved by the Food and Drug Administration (“FDA”) for adjunctive treatment of epilepsy and treatment of post-herpetic neuralgia. Approximately 90% of Neurontin prescriptions, however, are for off-label purposes. 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.

In addition to potential harm to consumers, the off-label marketing campaign resulted in inappropriate, unnecessary and/or ineffective prescriptions for Neurontin which were paid for by the states’ Medicaid programs.

The consumer protection settlement, by an Assurance of Voluntary Compliance, prohibits Warner-Lambert and its corporate parent Pfizer Inc. from the following activities:

• making false, misleading or deceptive oral or written claims about Neurontin and from
promoting off label uses in violation of the federal Food, Drug and Cosmetic Act;

• misrepresenting the nature of scientific evidence relating to Neurontin;

• failing to comply with the Pharmaceutical Research and Manufacturers of America Code with respect to payments, gifts and remuneration to health care providers (compliance with this Code has previously been voluntary);

• violating Federal anti-kickback laws; and,

The agreement also requires Warner-Lambert of Pfizer to have speakers at educational events disclose whether they have been paid to promote Neurontin.

As part of the Medicaid Fraud settlement, Warner-Lambert entered into a Corporate Integrity Agreement with the Department of Health and Human Services, Office of the Inspector General, requiring strict scrutiny of its future marketing and sales practices. The agreement will be available on the HHS/OIG website (www.oig.hhs.gov).

“These settlements will ensure that this drug will not be promoted to treat medical conditions unless the company has reliable scientific data that it is effective for such conditions,” said Attorney General Curran. “ Also, they send a strong message to the pharmaceutical industry that off-label marketing of pharmaceuticals is not only unacceptable but criminal and will be prosecuted aggressively by the government.”

Of the $152 million dollars in damages and penalties due to the states under the Medicaid Fraud settlement, the total Medicaid settlement for the State of Maryland (State/Federal) is $2,221,175.40. Of that, $1,152,804.65 will go directly to the State Medicaid program.

Of the $38 million dollars provided under the consumer protection settlement, $28 million dollars will be used in a remediation program and a total of $10 million dollars will be distributed to the participating Attorney General's offices. Maryland’s share of the payment 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. Finally, up to $1 million dollars of the fund will be utilized to evaluate the effectiveness of the remediation program.

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