Forest Laboratories Settles Claims Regarding Celexa , Lexapro and Levothroid

As part of a crackdown by the Justice Department on off-label marketing, a unit of Forest Laboratories, maker of Celexa, an antidepressant, will pay more than $313 million to settle various criminal and civil complaints. This includes a claim that it illegally promoted the drug for use in children and adolescents, though it was only approved for adult depression. In addition, the government claimed that Forest publicized positive results in a study on Celexa in adolescents, but failed to report on a similar study with negative results.

Federal prosecutors also accused Forest of giving doctors cash and other incentives to encourage them to prescribe both Celexa and another antidepressant, Lexapro. Some of the items included tickets to St. Louis Cardinal and Boston Red Sox games, a $1,000 gift certificate to a gourmet French restaurant, a deep-sea fishing trip, and Broadway theater tickets.

Forest Pharmaceuticals will also plead guilty to one felony count of obstructing justice because its employees allegedly lied to F.D.A. officials during a 2003 plant inspection.

In addition, Forest was charged with the illegal distribution from 2001-2003 of the F.D.A. unapproved drug, Levothroid, to treat thyroid hormone deficiency.

The company will pay $150 million fine and forfeits $14 million in assets. They will pay $88 million to the Federal government and more than $60 to the states to resolve false claims submissions to health care programmers. Two whistleblowers will split $14 million from the federal portion of the settlement.

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