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Pfizer, Department of Justice finalize $2.3 billion fraud settlement
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WASHINGTON — Pfizer and a subsidiary agreed to pay $2.3 billion in the largest health care fraud settlement in U.S. history, the U.S. Department of Justice announced.
The settlement resolves criminal and civil liability stemming from the illegal promotion of four prescription drugs, including the anti-inflammatory Bextra (valdecoxib).
Pfizer subsidiary Pharmacia & Upjohn agreed to plead guilty to a felony violation of the Food, Drug and Cosmetic Act for improper off-label marketing of Bextra, which Pfizer voluntarily withdrew from the market in 2005. Pfizer will pay a criminal fine of $1.195 billion, the largest criminal fine ever levied in the United States. Pharmacia & Upjohn will pay $105 million. The criminal resolution totals $1.3 billion.
Additionally, Pfizer agreed to pay $1 billion to resolve allegations under the civil False Claims Act that it illegally promoted Bextra, the anti-psychotic drug Geodon (ziprasidone), the antibiotic Zyvox (linezolid) and the epilepsy medication Lyrica (pregabalin). The civil settlement also resolved allegations that Pfizer paid health care providers to prescribe those four drugs and several others, a DOJ press release said.
The federal government's share of the civil settlement totals about $669 million. The state Medicaid share is about $331 million.
The settlement also requires Pfizer to enter into a Corporate Integrity Agreement (CIA) with the Office of Inspector General of the U.S. Department of Health and Human Services. The agreement provides for procedures and reviews intended to prevent future improprieties.
"Pfizer expressly denies all of these civil allegations, with the exception that Pfizer acknowledges certain improper actions related to the promotion of Zyvox," the company said in a press release. "Pursuant to the CIA, Pfizer will engage an Independent Review Organization that will help the company assess and evaluate its promotional and product-related business function."
Under a previous CIA, Pfizer has "consistently and voluntarily strengthened its compliance program beyond those requirements, including enhancements to the company's comprehensive product risk assessment and mitigation process and compliance monitoring operations," the release said.