Settlement offered by Bristol-Myers Squibb

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 and pricing practices.

The civil settlement announced Friday resolves a broad array of allegations against Bristol-Myers Squibb, dating from 1994 through 2005.

Among them were a charge the New York-based pharmaceutical company illegally promoted the sale of Abilify, an anti-psychotic drug, for pediatric use and to treat dementia-related psychoses. Neither use is approved by the U.S. Food and Drug Administration.

In the second quarter, the company reported $412 million in sales of Abilify, approved to treat bipolar disorder and schizophrenia, a 27 percent 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.

U.S. Attorney Michael Sullivan said when pharmaceutical 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 are during the FDA approval process.

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

"People depend on this industry, thus the industry has an obligation to ensure that all rules, regulations and laws are complied with," Sullivan said.