According to the Department of Justice, Pfizer will plead guilty to illegally promoting Bextra for uses not approved by the Food and Drug Administration and to illegally promoting Bextra and three other drugs for unapproved uses, which resulted in false claims to Medicaid and Medicare.
Government officials praised the settlement as a victory for their efforts to protect consumers.
“This resolution protects the FDA in its vital mission of ensuring that drugs are safe and effective. When manufacturers undermine the FDA’s rules, they interfere with a doctor’s judgment and can put patient health at risk,” said Michael L. Levy, U.S. Attorney for the Eastern District of Pennsylvania.
“The public trusts companies to market their drugs for uses that FDA has approved, and trusts that doctors are using independent judgment. Federal health dollars should only be spent on treatment decisions untainted by misinformation from manufacturers concerned with the bottom line,” he said.
Pfizer confirmed the payment to the Associated Press Wednesday. It told investors in January that it was going to settle the suit.
Pfizer removed Bextra from the market in 2005 after the FDA said it was concerned about the cardiovascular health of people taking the drug and reports of potentially life-threatening skin reactions in patients taking Bextra.
The charge involving Bextra and three other drugs – Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug – amounts for $1 billion of the total settlement. That money will be repaid to Medicaid and Medicare systems.
“This historic settlement will return nearly $1 billion to Medicare, Medicaid, and other government insurance programs, securing their future for the Americans who depend on these programs,” said Kathleen Sebelius, Secretary of Department of Health and Human Services.