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Attorney General Janet T. Mills Announces Major Settlements Against World's Largest Drug Manufacturer
September 2, 2009
FOR IMMEDIATE RELEASE
Contact: Kate Simmons Phone: (207) 626-8577
Attorney General Janet T. Mills Announces Major Settlements Against World’s Largest Drug Manufacturer
AUGUSTA- Attorney General Janet T. Mills announced that Maine has joined with the federal government and other states to reach two separate settlement agreements with Pfizer Inc., the world’s largest manufacturer of pharmaceuticals. Pfizer will pay the State of Maine nearly two million dollars in restitution and penalties in the two settlements.
The first agreement, which includes the federal government, settles allegations that Pfizer and its subsidiaries paid kickbacks and engaged in off-labeling marketing campaigns that improperly promoted certain Pfizer drugs. Pfizer will pay the federal government and the states a total of $2.3 billion in civil damages, penalties and criminal fines and forfeitures—the largest settlement ever in a health care fraud matter. Maine will receive $1,434,131.36 of this settlement.
In this multi-drug settlement, Pfizer will pay the states and the federal government a total of $1 billion in civil damages and penalties to compensate Medicaid, Medicare, and other federal healthcare programs for harm suffered as a result of its conduct. In addition, Pharmacia & Upjohn Company, Inc., a Pfizer subsidiary, has agreed to plead guilty to a felony violation of the Food, Drug, and Cosmetic Act (FDCA) and to pay a criminal fine and forfeiture of $1.3 billion. The criminal allegations center on illegal marketing and promotion of Bextra, an anti-inflammatory drug which Pfizer pulled from the market in 2005. Pharmacia & Upjohn Company, Inc. has agreed to plead guilty to a felony violation of the FDCA for misbranding the drug with the intent to defraud or mislead.
The government entities alleged that Pfizer engaged in a pattern of unlawful marketing activity to promote drugs for certain uses which the Food and Drug Administration (FDA) had not approved. While it is not illegal for a physician to prescribe a drug for an unapproved use, federal law prohibits a manufacturer from promoting a drug for uses not approved by the FDA. This promotional activity included:
Marketing Bextra for conditions and dosages other than those for which it was approved;
Promoting the use of the antipsychotic drug Geodon for a variety of off-label conditions such as attention deficit disorder, autism, dementia and depression for patients that included children and adolescents;
Selling the pain medication Lyrica for unapproved medical conditions;
Making false representations about the safety and efficacy of Zyvox, an antibiotic which had been approved only to treat certain drug-resistant infections.
In addition to improper off-label marketing of drugs, Pfizer is alleged to have illegally compensated health care professionals to induce them to promote and prescribe Bextra, Geodon, Lyrica, Zyvox, Aricept, Celebrex, Lipitor, Norvasc, Relpax, Viagra, Zithromax, Zoloft and Zyrtec. These payments allegedly took many forms that included entertainment, cash, travel and meals. Federal law prohibits payment of anything of value in exchange for the prescribing of a product paid for by a federal health care program.
As a condition of the settlement, Pfizer will enter into a Corporate Integrity Agreement with the United States Department of Health and Human Services, Office of the Inspector General, which will closely monitor the company’s future marketing and sales practices.
In a second and unrelated settlement, Maine and 42 other states have entered into a $33 million dollar multistate agreement with Pfizer Inc. for its alleged illegal promotion of Geodon to consumers. Pfizer has agreed to change its marketing of Geodon, including not promoting it for “off-label” uses that have not been approved by the U.S. Food and Drug Administration (FDA). The State of Maine will receive $476,304 from Pfizer from this settlement.
Geodon is the brand name for the prescription drug ziprasidone, which has been approved by the FDA for treatment of schizophrenia in adults and for manic or mixed episodes of bipolar disorder in adults. The State alleges that Pfizer illegally promoted Geodon for a number of off-label uses, which included its use in treating children, and at higher than FDA-approved dosages. Although a physician may prescribe drugs for off-label uses, federal law prohibits pharmaceutical manufacturers from marketing their products for off-label uses.
“The Office of the Attorney General will continue to be vigilant in monitoring the pharmaceutical industry to ensure that drugs are marketed in a fair and transparent manner,” said Attorney General Mills. “To follow the law, drug manufacturers must provide consumers with accurate information to enable them to make well-informed health care decisions.”
Under the multistate settlement, Pfizer has agreed to post on its website a list of physicians and other entities who received payments from Pfizer; to provide product samples of Geodon only to certain health care providers who customarily treat patients with certain kinds of conditions; to register and to post the results of certain clinical trials; to disclose information about grants on its website; and to require medical seminars to disclose Pfizer’s financial support of their programs and Pfizer’s financial relationship with faculty and speakers.
Attorney General Mills expressed great appreciation to Assistant Attorney General Michael Miller for her work on the federal settlement and Assistant Attorney General Carolyn Silsby for her work on the Geodon settlement.