Thyroid Drug Manufacturer Forest Pharmaceutical Fined Millions After Pleading Guilty to Multiple Charges

The Justice Department has announced that Forest Pharmaceuticals, the maker of a number of drugs -- including thyroid drugs Armour Thyroid, Thyrolar and Levothroid -- has been sentenced to pay $150 million in fines, after pleading guilty last fall to a number of charges. The company is also forfeiting assets of $14 million. The sentence is a result of Forest's guilty plea last November to a variety of charges, including:

felony obstruction of justice
misdemeanor distribution of an unapproved new drug in interstate commerce
misdemeanor distribution of a misbranded drug in interstate commerce Forest has also signed a Corporate Integrity Agreement with the Department of Health and Human Services, Office of Inspector General. (You can read Forest's Corporate Integrity Agreement here (PDF). Last fall, Forest also settled a civil suit involving their drugs Levothroid, Celexa and Lexapro, agreeing to pay more $149 million to the federal government and states. The specific criminal charges against Forest Pharmaceuticals were based on the company's efforts to obstruct an FDA regulatory inspection of their production facility, illegal distribution of Levothroid (when it was still an unapproved new drug), and illegal promotion of Celexa, an anti-depressant, for use in children and teens. Regarding Levothroid, the FDA determined that during the new drug approval application period for levothyroxine, which took place between 1997 and 2001, Forest deliberately did not reduce its production level, according to FDA requirements, and instead, continued a high level of production. After receiving a warning letter by the FDA saying that Forest could no longer distribute Levothroid until it received approval, the company apparently put workers on overtime well into the night, so as to ship as much Levothroid as possible. According to court documents, Forest also blocked the FDA efforts to inspect one of Forest's plants producing Levothroid, and misled investigators regarding mechanical malfunctions that affected production quality. According to Tony West, Assistant Attorney General for the Justice Department's Civil Division: "Forest Pharmaceuticals pleaded guilty to obstructing justice and marketing drugs for unapproved uses, including improperly promoting an anti-depressant to children and adolescents. As the court's stiff sentence demonstrates, not only is such conduct unacceptable, taxpayers should not foot the bill for practices that violate the law."