Forest Laboratories, the New York-based maker of Levothroid, Celexa and Lexapro, will pay $313 million in criminal and civil penalties related to its illegal distribution and off-label marketing of the drugs in defiance of federal law and Food and Drug Administration mandates.
Forest Labs to pay $313 million in penalties
The company has agreed to plead guilty to a felony obstruction charge and two misdemeanor violations of the Federal Food, Drug and Cosmetics Act, as well as settling related but separate civil allegations of billing Medicare for drugs not approved for use by the FDA. Forest will pay $164 million in criminal fines and forfeitures, and $149 million to settle the civil claims—money that was already set aside in reserves and disclosed in earnings reports, the company said.
Investigators say Forest deliberately disobeyed an order to stop distributing its drug Levothroid in 2003 following and FDA determination that the drug class needed new certification. The company also misled inspectors about manufacturing of the drug that year. The disputed formulary has since been abandoned, although Forest continues to distribute a similar drug under the same name, which is not involved in the allegations.
Regulators also say Forest marketed its adult depression drugs Celexa and Lexapro for pediatric and adolescent use, even though the drugs at the time were only approved for adult use.
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