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Lexapro Maker to Pay $313 Million to Settle Federal Charges

 |  By cclark@healthleadersmedia.com  
   September 16, 2010

Forest Pharmaceuticals will pay $313 million and plead guilty to federal charges related to distribution of an unapproved drug to treat hypothyroidism, the illegal promotion an anti-depressant drug for treating children and adolescents, and obstruction of justice.

The payment will resolve criminal and civil liability charges arising from these accusations, which involve Forest drugs Levothroid, a treatment for thyroid deficiency, and its antidepressants, Celexa and Lexapro.

The complaint regarding Celexa comes under the U.S. False Claims Act, and alleges that Forest promoted the drug for unapproved pediatric use, despite its limited approval for adult depression only. Instead, the company "promoted Celexa for use in treating children and adolescents suffering from depression."

Forest was also accused of publicizing and circulating the positive results of a double-blind, placebo-controlled Forest study on the use of Celexa in adolescents while at the same time, Forest "failed to discuss the negative results of a contemporaneous, double-blind, placebo-controlled European study on the use of Celexa in adolescents."

The complaint charges Forest with using "illegal kickbacks" to induce physicians and others to prescribe Celexa and Lexapro, "including expensive meals, lavish entertainment and cash payments disguised as grants or consulting fees."  Because of this, "Forest caused false claims to be submitted to federal healthcare programs.

Regarding Levothroid, federal agencies allege that Forest began distributing the drug in the early 1990s without first getting FDA approval. "Orally administered levothyroxine sodium drugs had been on the market to treat hypothyroidism since the 1950s, and manufacturers had introduced these drugs into the market without first obtaining FDA approval," the statement said.

But in 1997, the FDA said these drugs were "new drugs" and required the agency's approval, and gave the FDA four years, until Aug. 14, 2001, to conduct necessary studies and obtain approvals.  The agency also extended that if certain conditions were met, including the gradual two-year distribution phase-down until FDA approved its distribution.

The company also is entering into a five-year Corporate Integrity Agreement with the Office of Inspector General over the issues.

"Forest Pharmaceuticals deliberately chose to pursue corporate profits over its obligations to the FDA and the American public," said Carmen Ortiz, U.S. Attorney for the District of Massachusetts.

"We will not tolerate any company that obstructs justice and illegally promotes drugs that were not approved to treat children," said Tony West, Assistant Attorney General for the Civil Division of the Department of Justice. "Forest Pharmaceuticals has pled guilty to breaking the law. The Justice Department will continue to ensure that taxpayers do not foot the bill when such unlawful and improper conduct occurs."

Under the Food, Drug and Cosmetic Act (FDCA) a manufacturer is required to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration and obtain the agency's approval before distributing a new drug in interstate commerce, the United States Attorney's Office for the District of Massachusetts said in a statement Wednesday.

"In this NDA, the manufacturer is required to set forth information concerning the manufacturing processes and composition of the drug, and to provide sufficient data generated in adequate and well-controlled clinical investigations to demonstrate that the drug is safe and effective for its specified use," the statement said.

The FDA then approves the product as safe and effective for its use. Any promotion by the manufacturer for other uses, known as off-label, "renders the product misbranded," the statement said.

However, according to federal criminal charges, Forest "made a deliberate decision to continue distributing its unapproved Levothroid product in quantities far exceeding" permitted amounts, and was ordered to stop distribution in a warning letter.

"After receiving the warning letter, Forest Pharmaceuticals directed its employees at its St. Louis distribution center to work overtime until approximately 1 a.m. the following morning, and, during that time, to continue shipping as much of its unapproved Levothroid as possible."

The charges also allege that Forest submitted inaccurate information to the FDA and obstructed an FDA inspection.

"When FDA inspectors saw a portable humidifier in a testing room at a 2003 inspection of a manufacturing plant in Cincinnati, certain company management personnel falsely advised the investigators that the device was merely being stored" rather than used for humidity control, "which in fact it had been."

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