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Bristol agrees to settle probes

September 29, 2007|From the Associated Press

BOSTON — Bristol-Myers Squibb Co. and a former subsidiary have agreed to pay more than $515 million to settle federal and state investigations into their drug marketing practices.

The civil settlement, which was announced Friday, resolves a broad array of allegations against Bristol-Myers Squibb that span from 1994 to 2005. Among them were allegations that the company illegally promoted the sale of antipsychotic drug Abilify for pediatric use and to treat dementia-related psychoses. Neither use is approved by the Food and Drug Administration.

In the second quarter, the New York-based pharmaceutical company reported $412 million in sales of Abilify, approved to treat bipolar disorder and schizophrenia, a 27% increase from a year earlier.

Although physicians are permitted to prescribe drugs for off-label uses, drug companies are prohibited from marketing them for uses that have not been approved by the FDA.

When companies market drugs for unapproved uses, there is a potential risk that patients could be harmed because the drugs have not been tested as rigorously as they would have been during the FDA approval process, U.S. Atty. Michael J. Sullivan said.

Prosecutors have no evidence that anyone was harmed by Bristol-Myers Squibb's actions in promoting Abilify for unapproved uses, he said.

The government also alleged that Bristol-Myers Squibb paid illegal inducements in the form of consulting fees and trips to luxury resorts to influence doctors and other healthcare providers to buy and prescribe the company's drugs.

Bristol-Myers Squibb's former generic drug subsidiary, Apothecon Inc., also was accused of giving illegal enticements to persuade retail pharmacy and wholesale customers to buy its products.

Bristol-Myers Squibb said in a statement that the settlement would not affect the company's ongoing business with any of its customers, including the government.

"Bristol-Myers Squibb is pleased to have resolved these matters from the past and is proud of its commitment to conduct business with the highest standards of integrity in its mission to extend and enhance human life," the company said in the statement.

Bristol-Myers Squibb shares fell 19 cents to $28.82.

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