WEDNESDAY, Sept. 2 (HealthDay News) -- In what it calls the largest health-care fraud settlement in U.S. history, the Justice Department said Wednesday that pharmaceutical giant Pfizer Inc. and a subsidiary have agreed to pay a $2.3 billion penalty for illegally promoting certain drugs.
Those drugs included Bextra, part of a group of painkillers called Cox-2 inhibitors, which Pfizer pulled from the market in 2005 after reports of potential heart risks to patients.
The other drugs were Geodon, an antipsychotic; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug, the Justice Department said in a news release.
In each case, the Justice Department accused Pfizer of marketing the drugs for uses other than those approved by the U.S. Food and Drug Administration, a practice called "off-label" use.
According to the news release, the Food, Drug and Cosmetic Act stipulates that a company must "specify the intended uses of a product in its new drug application to FDA. Once approved, the drug may not be marketed or promoted for so-called 'off-label' uses."
Pfizer promoted Bextra for several uses and dosages not sanctioned by the FDA due to safety concerns, the Justice Department said.
As part of the settlement, Pfizer also agreed to enter into a so-called "expansive corporate integrity agreement" with the Department of Health and Human Services' Office of Inspector General. That agreement calls for the establishment of "procedures and reviews" designed to prevent a similar occurrence, the agency said.
"Today's landmark settlement is an example of the Department of Justice's ongoing and intensive efforts to protect the American public and recover funds for the federal treasury and the public from those who seek to earn a profit through fraud," Associate Attorney General Tom Perrelli said in the news release.
Kathleen Sebelius, secretary of the Department of Health and Human Services, said: "The Department of Health and Human Services will continue to seek opportunities to work with its government partners to prosecute fraud wherever we can find it. But we will also look for new ways to prevent fraud before it happens. Health care is too important to let a single dollar go to waste."
In a statement, Pfizer general counsel Amy W. Schulman said the agreement ends all "material pending matters" with the Justice Department. "This gives us a very important opportunity to put final closure on the universe of material open items involving our U.S.-based operations," she said, Bloomberg News reported.
To learn more, visit the U.S. Department of Justice.
SOURCES: Sept. 2, 2009, U.S. Department of Justice, news release; Bloomberg News