Attorney general joins Warner-Lambert case

Attorney general joins Warner-Lambert case Attorney General Larry Long has announced that South Dakota is participating in a nationwide Consumer Protection/Medicaid settlement with Warner-Lambert, a wholly owned subsidiary of Pfizer Inc. This case marks the first time that representatives of state Attorneys General Consumer Protection Divisions and NAMFCU (National Association of Medicaid Fraud Control Units) jointly negotiated a case. The settlement resolves allegations of deceptive "off-label" marketing of the drug Neurontin©. In settling this consumer protection investigation, Warner-Lambert will pay the states a total of $38 million.

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 percent of Neurontin prescriptions, however, are for off-label purpose.

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 various psychiatric disorders, back pain, and headache, even though the scientific evidence supporting the use of Neurontin for these indications was lacking.

Of the $38 million provided under the consumer protection settlement, $28 million will be used in a remediation program and a total of $10 million will be distributed to the participating attorney general's offices to be used for attorney's fees and other costs of investigation.

South Dakota's share of the payment for attorney's fees and costs will be $25,000.

Warner-Lambert will also pay $152 million in damages and penalties to the various states' Medicaid programs. As part of that settlement, South Dakota will receive $88,155 in Medicaid restitution and penalties.

Under the remediation program, up to $6 million 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 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 sponsored by a participating attorney general that provide prescribers and/or consumers with fair and balanced information about drugs.

In addition, $1 million of the fund will be utilized to evaluate the effectiveness of the remediation program.

This 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 for Massachusetts. In total, Warner-Lambert will pay $430 million 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.

The settlement, by an Assurance of Voluntary Compliance or Discontinuance 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;


* Disseminating written materials that have not appeared in peer reviewed scientific journals in contravention of limitations set forth in the Assurance;


* Failing to make disclosures about funding of research and educational events related to Neurontin;


* Failing to require speakers at educational events related to Neurontin who have financial relationships with Warner Lambert or Pfizer from disclosing their relationship, including whether the speaker has been paid to promote 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);


* Failing to comply with Accreditation Council for Continuing Medical Education Guidelines (compliance with the Guidelines has previously been voluntary);


* Misrepresenting the credentials of sales, medical and technical personnel;


* Providing information that is misleading or lacking in fair balance to drug reference compendia; and,


* Violating Federal anti-kickback laws.

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