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Drug maker to plead guilty, pay fine

Associated Press / September 16, 2010

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WASHINGTON — Forest Pharmaceuticals Inc. has agreed to pay more than $313 million and to plead guilty to obstruction of justice, distribution of the then-unapproved drug Levothroid, and illegal promotion of Celexa for use in treating children and adolescents suffering from depression.

Forest Pharmaceuticals also will settle allegations that it caused false claims to be submitted to federal programs for the drug Lexapro as well as for Levothroid and Celexa, the Justice Department said yesterday.

Forest Pharmaceuticals is a subsidiary of Forest Laboratories Inc. Celexa and Lexapro are antidepressants; Levothroid treats thyroid deficiency.

Court papers in the case say that Forest Pharmaceuticals began distributing Levothroid in the early 1990s without first obtaining approval from federal regulators. Regarding Celexa, Forest Pharmaceuticals promoted the drug for pediatric use despite limited approval only for adult depression, the court papers state.

A civil complaint in the case says Forest Pharmaceuticals used illegal kickbacks including cash, free meals, and entertainment to induce physicians and others to prescribe Celexa and Lexapro.

Forest Pharmaceuticals agreed to plead guilty to obstructing justice, distributing an unapproved drug, and distributing a misbranded drug.

According to the Justice Department, Forest Pharmaceuticals distributed Levothroid in quantities exceeding amounts that regulators permitted and failed to advise the Centers for Medicare and Medicaid Services that Levothroid no longer qualified for coverage by government health care programs, causing false claims to be submitted.