WASHINGTON (AP) – Forest Pharmaceuticals Inc. has agreed to pay more than $313 million and 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 health care programs for the drug Lexapro as well as for Levothroid and Celexa, the Justice Department said Wednesday.
Forest Pharmaceuticals, headquartered near St. Louis, is a wholly owned subsidiary of New York-based Forest Laboratories Inc. Celexa and Lexapro are anti-depressants; Levothroid is used to treat 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.
The government says Forest Pharmaceuticals’s off-label promotion for Celexa involved directions to its sales representatives to promote pediatric use of the drug in sales calls to physicians. The company hired speakers to talk to pediatric specialists about the benefits of Celexa for children and teens, filings in the case state.
Forest engaged in similar marketing conduct for Lexapro, which at the time lacked approval for pediatric use.
A civil complaint in the case says Forest Pharmaceuticals used illegal kickbacks including cash, free meals and lavish entertainment to induce physicians and others to prescribe Celexa and Lexapro.
Forest Pharmaceuticals agreed to plead guilty to obstructing justice and distributing an unapproved drug regarding Levothroid, and distributing a misbranded drug with regard to Celexa.
According to documents filed in the case, Forest Pharmaceuticals:
-Concealed information from federal drug regulators about its testing of Levothroid.
-Distributed Levothroid in quantities far exceeding amounts that federal drug regulators permitted.
-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 to those programs.
Date: September 15, 2010
Source: Associated Press
Filed Under: Drug Discovery