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September 02, 2009

LITTLE ROCK- Attorney General Dustin McDaniel is pleased to announce the State of Arkansas's participation in two pivotal settlement agreements with Pfizer Inc. The first settlement was reached between over 40 states and the federal government and Pfizer. The agreement settles civil and criminal allegations that Pfizer and its subsidiaries paid kickbacks and engaged in off-labeling marketing campaigns that improperly promoted numerous drugs that Pfizer manufactures. The second settlement between 43 states and Pfizer settles consumer protection claims related to the alleged improper marketing of Pfizer's antipsychotic drug Geodon.

In the joint state/federal settlement, the largest settlement in history in a health care fraud matter, Pfizer will pay the states and the federal government a total of $1 billion in civil damages and penalties to compensate Medicaid, Medicare, and various federal healthcare programs for harm suffered as a result of its conduct. In addition, a Pfizer subsidiary, Pharmacia & Upjohn Company, Inc., 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 component of the resolution centers on the illegal marketing and promotion of Bextra, an anti-inflammatory drug that Pfizer pulled from the market in 2005. Because of the illegal promotion, 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, the largest pharmaceutical manufacturer in the world, engaged in a pattern of unlawful marketing activity to promote multiple drugs including Bextra, Geodon, Lyrica, Zyvox, Aricept, Celebrex, Lipitor, Norvasc, Relpax, Viagra, Zithromax, Zoloft and Zyrtec. 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 U.S. Food and Drug Administration (FDA). As part of the joint settlement, the State of Arkansas will receive $1,212,787.44 in restitution and other recovery.

A National Association of Medicaid Fraud Control Units team of representatives from 10 states participated in the investigation and conducted the settlement negotiations with Pfizer on behalf of the settling states. Mijanul Akbar, Chief Auditor, represented the State of Arkansas on that select panel. "I am proud that Arkansas was able to play such a prominent role in this investigation. I also want to commend Mijanul Akbar for his excellent work that contributed to this settlement ," said Attorney General Dustin McDaniel.

In the multistate consumer settlement, the States alleged that Pfizer engaged in unfair and deceptive practices when it marketed Geodon for off-label uses. Geodon has been approved by the FDA for treatment of schizophrenia in adults and for manic or mixed episodes of bipolar disorder in adults. However, Pfizer promoted Geodon for a number of off-label uses, including promoting Geodon for pediatric use and for use at higher than FDA-approved dosages.

In the related settlement between the states and Pfizer, Pfizer has agreed to change how it markets Geodon and to not promote Geodon for uses which are not approved by the FDA, called "off label" uses. The settlement mandates that Pfizer shall:

• Post on its website a list of physicians and related entities who received, or receive, payments from Pfizer until 2014;
• Not make any false, misleading or deceptive claims regarding Geodon or promote Geodon for off-label uses;
• Require its medical staff, rather than its marketing staff, to have ultimate responsibility for developing and approving the medical content for all medical letters regarding Geodon, including those that may describe off-label information, and
• Provide specific, accurate, objective and scientifically balanced responses to unsolicited requests for off-label information regarding Geodon.

For a six-year period, Pfizer must:

• Disclose on its web site information about grants it awards, including continued medical education grants, for at least two years following each grant and maintain the information for five years;
• Not use grants to promote Geodon, or condition continuing medical education (CME) funding on Pfizer's approval of speakers or program content; and
• Contractually require CME providers to disclose Pfizer's financial support of their programs and any financial relationship with faculty and speakers.

"The States, both independently and in conjunction with the federal government, actively monitor the marketing activities of pharmaceutical manufacturers. Today's settlements are evidence of these efforts, and will ensure that Pfizer's future drug marketing activities comply with all applicable laws," said Attorney General Dustin McDaniel.

The State of Arkansas will receive $573,853 in the multistate consumer settlement which will be held in trust and used to fund the Attorney General's ongoing consumer protection enforcement efforts.
The State of Arkansas will receive $573,853 in the multistate consumer settlement which will be held in trust and used to fund the Attorney General's ongoing consumer protection enforcement efforts.