Welcome to the Department of Justice, Iowa Attorney General Tom Miller

For immediate release - Thursday, May 13, 2004.

Contact Bob Brammer - 515-281-6699.

Warner-Lambert to Remedy Allegations of "Off-Label" Marketing of "Neurontin"

States and U.S. alleged deceptive and unlawful promotion of the prescription drug for "off-label" indications, even though scientific evidence was lacking to support use of "Neurontin" for some indications.

Warner-Lambert Company is taking major steps to resolve allegations by state and federal officials of deceptive "off-label" marketing of the prescription drug "Neurontin."

"We alleged that Warner-Lambert promoted Neurontin in various ways that dramatically increased doctors prescribing Neurontin for off-label indications for which there was little or no scientific evidence of efficacy," said Iowa Attorney General Tom Miller. "It is illegal for prescription-drug makers to promote use of their drugs for 'off-label' indications that are not included in the FDA-approved label, although doctors may prescribe for other uses. Doctors must have fair and accurate information about drugs in order to make effective prescriptions for patients."

Warner-Lambert is a wholly-owned subsidiary of Pfizer Inc., the world's largest pharmaceutical company. Its U.S. revenues last year for Neurontin were over $2.2 billion.

The states alleged their consumer protection laws were violated when Warner-Lambert promoted Neurontin for various off-label indications, including bipolar and other psychiatric disorders, back pain and other pain disorders, Lou Gehrig's Disease, attention-deficit disorder, migraine, and monotherapy treatment for epilepsy, even though scientific evidence was lacking to support use of the drug for the indications. Neurontin has been approved by the FDA as an adjunctive or add-on treatment for epilepsy, and treatment of post-herpetic neuralgia (pain after shingles.) The States said that about 90% of Neurontin prescriptions are for off-label purposes.

One study of Medicaid patients in Oregon who were prescribed Neurontin has shown that 95% of the patients were prescribed the drug for off-label purposes, and for many their condition did not improve after taking the drug.

The "global settlement" today with Warner-Lambert resolves investigations by the states, the U.S. Attorney's Office out of Boston, and the Association of Medicaid Fraud Control Units. The states said there was extraordinary cooperation among the officials. For the states, the consumer protection investigation was led by Vermont, Oregon, Florida, New York, Ohio, and Texas.

In total, Warner-Lambert will pay $430 million under the settlements, including $38 million to the states. Most of the states' payment, $28 million, will go for a nationwide "remediation" program consisting of advertising and education programs aimed at prescribers and consumers to provide fair and balanced information about drugs. The programs will aim to remedy the "glide effect" of Warner-Lambert promotions in the past (the fact that prescribing patterns might continue to reflect alleged misinformation the company disseminated in the marketplace.) The states will receive $10 million for costs, consumer education, and litigation. Iowa's share is $25,000.

The states alleged Warner-Lambert used various methods to deceptively promote Neurontin for off-label indications, including continuing medical education classes that lacked fair balance and misrepresented the nature of the classes, and provided expensive "perks" to attending physicians; a "publication strategy" that subsidized the production and dissemination of anecdotal reports favorable to off-label use of Neurontin and were of no scientific value; and payments to prescribers for "research" that was, in effect, a kickback for off-label prescribing.

The 50-state settlement, by an Assurance of Voluntary Compliance or Discontinuance, prohibits Warner-Lambert and its corporate parent, Pfizer Inc., from many activities, including: making false, misleading or deceptive oral or written claims about Neurontin and promoting off-label uses in violation of the federal Food, Drug and Cosmetic Act; misrepresenting the nature of scientific evidence relating to Neurontin; violating Federal anti-kickback laws; and several other prohibitions.

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