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Illegal Marketing of Drugs: Pfizer's Record Fine

U.S. drug maker settles charges for $2 billion for pushing unapproved uses of medicines. The company has now been fined four times since 2002. Transcript of radio broadcast:

This is the VOA Special English Economics Report.

The world's largest drug company has agreed to pay almost two and a half billion dollars for illegal marketing of medicines. The settlement between Pfizer and the United States Justice Department was announced last week.

The settlement is the nation's largest ever in a case of health care fraud. It also includes the largest criminal fine ever in any case in the United States, more than one billion dollars. Pfizer agreed to pay another billion for violations of a civil law, the False Claims Act. Pfizer, based in New York, had sales last year of forty-eight billion dollars.

A Pfizer division, Pharmacia & Upjohn, agreed to plead guilty to a criminal violation over the painkiller Bextra. Pfizer pushed sales of Bextra for several uses unapproved by the government because of safety concerns. It also pushed for use in unapproved amounts. Pfizer withdrew Bextra from the market in two thousand five because of links to heart attacks and other problems.

Pfizer also faced civil charges over Bextra as well as an anti-psychotic drug, Geodon; an antibiotic, Zyvox; and an anti-epilepsy drug, Lyrica. Officials said Pfizer paid health care providers to prescribe these medicines for conditions other than the ones for which they are approved. This is called "off-label" use of a drug.

Doctors are permitted to try off-label uses to treat their patients. The idea is that a doctor might find other ways that a drug is effective. But federal law bars drug companies from marketing their products for unapproved uses.

Kathleen Sebelius is the secretary of health and human services.

KATHLEEN SEBELIUS: "This settlement is historic not only because it's the most money taxpayers have ever recovered from a drug company, but also because it includes the most comprehensive corporate integrity agreement that a drug company has ever signed in the United States."

Under the agreement, doctors will have a way to report abuses by Pfizer sales representatives. And officials said Pfizer will have to make "detailed disclosures" on its Web site. Pfizer announced a plan in February to publicly disclose its financial relationships with doctors, medical organizations and patient groups.

Yet this is not the company's first corporate integrity agreement with the government. Pfizer has now been fined for illegal marketing four times since two thousand two.

Prescription drugs represent only about one-tenth of all health care spending in the United States. But fast-growing demand and prices have made them part of the debate over health reform.

And that's the VOA Special English Economics Report, written by Mario Ritter. I'm Bob Doughty.