Tennessee Attorney General Bob Cooper today announced Tennessee has joined other states and the federal government, reaching the largest health care fraud settlement in history, with claims of civil and criminal illegal drug marketing allegations against Pfizer and its subsidiaries. The states and federal government allege Pfizer paid kickbacks and engaged in off-labeling marketing campaigns that improperly promoted numerous drugs that Pfizer manufactures.
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. Tennessee's share is $15.6 million.
Simultaneously, Attorney General Cooper and Director of Division of Consumer Affairs Mary Clement have announced a separate, multistate agreement with Pfizer regarding he antipsychotic drug Geodon or alleged unlawful improper marketing of the drug allegedly in violation of the Tennessee Consumer Protection Act. Tennessee will receive $768,804 in that case in addition to numerous stipulations to which the company has agreed to abide.
"My Office is proud to announce these agreements, which are an ongoing, cooperative effort to stop drug companies from using deceptive tactics to promote their products," Attorney General Cooper said.
TBI Director Mark Gwyn said of the agreement, "This historic settlement proves that kickbacks and improper marketing campaigns by pharmaceutical companies that defraud citizens and tax payers will be thoroughly investigated in Tennessee. The TBI is proud to be part of such a large monetary recovery for the State."
"We applaud the success of our partners in state and federal government in reaching this landmark health care fraud settlement," said TennCare Director Darin Gordon. "Cracking down on those who use illegal marketing to promote their products goes a long way to help ensure the health and safety of TennCare enrollees and all Tennesseans."
In addition, a Pfizer subsidiary, Pharmacia & Upjohn Company, Inc., has agreed to plead guilty to a federal 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 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 that 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 paid illegal remuneration to health care professional 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, 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.
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.
Tennessee's separate agreement with Geodon calls for the company (among other restrictions) to not make any misleading or false statements or claims regarding Geodon or any off-label uses. It must also post a list of physicians and related entities who received payments from Pfizer until 2014; register all clinical trials and submit results as required by federal law.
For a complete list of details of the agreement with Pfizer regarding its Geodon agreement, go to the Tennessee Attorney General's website at www.tn.gov/attorneygeneral/. Click on Office Information and then Cases of Interest. For more information on the complete Pfizer agreement with the sates and federal government, check the U.S. Department of Justice website at http://www.usdoj.gov/03press/03_1_1.html. If