When applying to sell a new drug in the US, companies must specify the intended use of the drug and at which dosages they will be sold. Pfizer ran afoul of drug law here by marketing the anti-inflammatory drug Bextra for off-label uses and at dosages the FDA refused to approve out of safety concerns.
Pfizer pulled Bextra from the market in 2005.
For this offense alone, Pfizer will pay a $1.195 billion fine, the single largest criminal fine ever served in the US for any matter, and forfeit another $105 million in revenue gathered from sales. “The size and seriousness of this resolution, including the huge criminal fine of $1.3 billion, reflect the seriousness and scope of Pfizer’s crimes” said Mike Loucks, acting U.S. Attorney for the District of Massachusetts.
Pfizer will also pay a $1 billion civil penalty under the False Claims Act to the government for alleged kickbacks to health care providers in exchange for increased prescriptions for several drugs including Bextra, Geodon, Zyvox, and Lyrica. This civil penalty is the largest fraud settlement against a pharmaceutical company ever.
A large portion of the settlement will pay directly back into health care systems, important at a time when Medicare is underfunded and health care reform are in the news every day.‚ “This historic settlement will return nearly $1 billion to Medicare, Medicaid, and other government insurance programs” said Kathleen Sebelius, Secretary of Department of Health and Human Services, “securing their future for the Americans who depend on these programs.”Pfizer