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Their Lawyer Says Corporate Integrity is Their No. 1 Goal.

September 3, 2009

Medical News: Pfizer Settles Fraud Charges for $2.3 Billion

Pfizer will pay the government $2.3 billion to settle criminal and civil charges that it promoted off-label uses for the disgraced painkiller valdecoxib (Bextra) and three other drugs.

The Justice Department said it was the largest healthcare fraud settlement in history.

More than half the settlement — $1.3 billion — involves Pfizer’s efforts to promote valdecoxib, a COX-2 inhibitor withdrawn from the market in 2005 because of cardiovascular and other risks.

Pfizer’s sales staff had urged doctors to prescribe the drug for surgical pain and to prevent deep vein thrombosis, according to court records from a criminal trial of a Pfizer manager earlier this year.

The other $1 billion covered charges that Pfizer improperly promoted the antipsychotic drug ziprasidone (Geodon), the antibiotic linezolid (Zyvox), and pregabalin (Lyrica), approved for epilepsy, fibromyalgia, and neuropathic pain.

The settlement will be shared between the federal government, state Medicaid programs, and whistleblowers. The latter include a Pennsylvania psychiatrist and at least one former Pfizer employee whose allegations helped launch the investigation.

Their complaints, which had been sealed until the settlement was reached, provided details on Pfizer’s alleged transgressions.

For example, according to one complaint, Pfizer pushed linezolid for several types of infections not named on its FDA-approved labeling, and also claimed it was superior to vancomycin without FDA approval.

Similarly, Pfizer was said to have promoted ziprasidone — approved only for schizophrenia or acute manic or mixed episodes associated with bipolar disorder — for depression, obsessive-compulsive disorder, autism, and a host of other conditions.

In addition to promoting the off-label uses, Pfizer was also accused of paying kickbacks to doctors who prescribed the drugs.

Sales of ziprasidone, pregabalin, and linezolid in 2008 totaled about $2.5 billion, according to the consulting firm SDI Health.

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