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.