The Attorney General’s office announced today that the State of Delaware, along
with other states and the federal government, has reached agreement with Pfizer Inc to settle civil and
criminal allegations that the company and its subsidiaries paid kickbacks and engaged in improper
marketing of numerous drugs that it manufactures. The largest settlement in history in a health care
fraud matter, Pfizer will pay the states and the federal government $1 billion in civil damages and
penalties to compensate Medicare, Medicaid, and other federal healthcare programs. It will also 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. Delaware’s Medicaid program will receive $537,266.

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 fine and forfeit $1.3
billion for misbranding with the intent to defraud or mislead the anti-inflammatory drug Bextra. Pfizer
pulled Bextra from the market in 2005.

“Deceptive and fraudulent practices by pharmaceutical companies endanger the public health
by compromising effective medical decision-making,” stated Timothy Mullaney, Director of the
Attorney General’s Fraud and Consumer Protection Division. “This agreement demonstrates that the
Government will not tolerate this profit-driven abuse of the public welfare.”
This announcement follows the September 2, 2009 announcement that Delaware reached a
settlement with Pfizer following an investigation into its alleged improper marketing of the
antipsychotic drug Geodon for off-label uses. As a result, Pfizer agreed to change how it markets
Geodon, will not promote its off-label use, and will pay $33 million to the states. The Delaware
Consumer Protection Fund will receive $448,200 in that agreement.

The states and federal government allege that Pfizer, the world’s largest pharmaceutical
manufacturer, engaged in a pattern of unlawful marketing activity to promote multiple drugs for
certain “off-label” uses which the Food and Drug Administration (FDA) had not approved. Although a
physician is allowed to prescribe drugs for off-label uses, federal law prohibits pharmaceutical
manufacturers from marketing their products for such uses. 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 conditions Making false representations about the safety and efficacy of Zyvox, an antibiotic only approved to treat certain drug resistant infections
In addition to the improper off-label marketing of these drugs, Pfizer is alleged to have made illegal payments to health care professionals to induce them to promote and prescribe the drugs Bextra, Geodon, Lyrica, Zyvox, Aricept, Celebrex, Lipitor, Norvasc, Relpax, Viagra, Zithromax, Zoloft, and Zyrtec. These payments allegedly took many forms, including 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.
This settlement is based on nine qui tam, or “whistleblower” cases that were filed by private individuals under state and federal false claims statutes in the United States District Courts for the District of Massachusetts, the Eastern District of Pennsylvania, and the Eastern District of Kentucky. A National Association of Medicaid Fraud Control Units team participated in the investigation and conducted the settlement negotiations with Pfizer on behalf of the settling states.
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The Delaware Attorney General’s office announced today that it has reached a
nationwide settlement with Pfizer Inc. following a 4 month investigation into the drug company’s
alleged improper marketing of the antipsychotic drug Geodon. In a complaint soon to be filed in
Superior Court along with the settlement agreement, Delaware alleges that Pfizer engaged in unfair
and deceptive practices when it marketed Geodon for off-label uses. As a result of the investigation,
Pfizer has agreed to change how it markets Geodon and will not promote off-label uses. Pfizer will
also pay $33 million to the 43 states that participated in the investigation. The Delaware Consumer
Protection Fund will receive $448,200.

Delaware and Maryland led the states’ negotiation of the settlement of Pfizer’s marketing and
promotional practices. Deputy Attorney General Ian McConnel, Director of the Consumer Protection
Unit, handled the case for Delaware.

“This case demonstrates that we are actively monitoring the pharmaceutical industry for
inappropriate and illegal sales and marketing practices and are holding it accountable,” stated Timothy
Mullaney, Director of the Attorney General’s Fraud and Consumer Protection Division. “Delaware’s
Consumer Protection Unit took a leading role in this nationwide investigation and we’ll continue to be
out front in protecting Delaware consumers and enforcing fair business practices.”
Geodon is the brand name for the prescription drug ziprasidone, which is approved by the U.S.
Food and Drug Administration (FDA) for treatment of schizophrenia and for certain symptoms of
bipolar disorder in adults. The states’ complaint alleges that Pfizer promoted Geodon for off-label
uses, which are uses that have not been approved by the FDA, including pediatric use and use at higher
than FDA-approved dosages. Although a physician is allowed to prescribe drugs for off-label uses,
federal law prohibits pharmaceutical manufacturers from marketing their products for off-label uses.
Under terms of the settlement, Pfizer will:

• Not make false, misleading or deceptive claims regarding Geodon or promote it for off-label uses
• Not promote Geodon using selected symptoms of the FDA-approved diagnoses unless certain
disclosures are made regarding the approved diagnoses
• Post on its website a list of physicians and related entities who received payments from Pfizer until
2014
• Provide product samples of Geodon only to health care providers who have specialties that
customarily treat patients who have diseases for which treatment with Geodon would be consistent
with its current labeling
• Register and post on a publicly accessible website certain Pfizer-sponsored clinical trials
• Require its medical staff to be responsible for the identification, selection, approval and
dissemination of scientific article reprints containing off-label information regarding Geodon, and
that such information not be referred to or used in a promotional manner.
The settlement also requires that for a nine-year period (which extends beyond the patent term
for Geodon), Pfizer will require its medical staff, rather than its marketing staff, to be responsible for
developing and approving the medical content for all medical letters regarding Geodon.
In addition, for a six-year period, Pfizer must:
• Disclose on its website information about grants it makes to health care providers, including
continued medical education (CME) grants
• Not use grants to promote Geodon, or condition CME funding on Pfizer’s approval of speakers or
program content
• Contractually require continuing medical education providers to disclose Pfizer’s financial support
of their programs and any financial relationship with faculty and speakers
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