Pfizer pays DOJ $2.3 billion in off-label marketing suit

9/2/2009

NEW YORK The world’s largest drug maker will pay the largest criminal fine in U.S. history.

Pfizer will pay the Department of Justice $2.3 billion to settle allegations of off-label marketing of the painkiller Bextra (valdecoxib), which the company pulled from the market in 2005, while subsidiary Pharmacia and Upjohn Co. will plead guilty to one criminal count of violating the U.S. Food, Drug and Cosmetic Act in its marketing of the drug, the pharmaceutical company announced Wednesday.

The settlement also resolves allegations of off-label promotions of the antibiotic Zyvox (linezolid), the schizophrenia and bipolar disorder drug Geodon (ziprasidone hydrochloride) and the epilepsy drug Lyrica (pregabalin). The DOJ alleged that Pfizer illegally promoted the drugs, causing government healthcare programs to receive false claims for them for off-label uses, and gave kickbacks to healthcare professionals to encourage them to prescribe them and other drugs.

In addition, Pfizer agreed to pay $33 million to attorneys general in 42 states and the District of Columbia to settle allegations of off-label marketing of Geodon.

The $2.3 billion includes a criminal fine of $1.2 billion – the largest ever imposed in the United States for any matter, according to the DOJ – and $1 billion to resolve civil allegations of off-label marketing of the drugs, though the company denied the allegations, except for “certain improper actions” in the promotion of Zyvox.

“We regret certain actions taken in the past, but are proud of the action we’ve taken to strengthen our internal controls and pioneer new procedures so that we not only comply with state and federal laws, but also meet the high standards that patients, physicians and the public expect from a leading worldwide company dedicated to healing and better health,” Pfizer SVP and general counsel Amy Schulman said in a statement. “Corporate integrity is an absolute priority for Pfizer, and we will continue to take appropriate actions to further enhance our compliance practices and strengthen public trust in our company.”

The DOJ heralded the settlement.

“Illegal conduct and fraud by pharmaceutical companies puts the public health at risk, corrupts medical decisions by healthcare providers and costs the government billions of dollars,” DOJ Civil Division assistant attorney general Tony West said in a statement. “This civil settlement and plea agreement by Pfizer represent yet another example of what penalties will be faced when a pharmaceutical company puts profits ahead of patient welfare.”

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