A Forest Laboratories Inc. unit agreed to plead guilty to distributing its Levothroid thyroid drug before it was approved by the Food and Drug Administration and pay $313 million, the U.S. Department of Justice said.
The allegations also involved illegal promotion of Celexa for use in treating children and adolescents suffering from depression, the Justice Department said in a statement. The Forest Pharmaceuticals unit also agreed to settle allegations it caused false claims to be submitted to federal health care programs for Levothroid, Celexa and Lexapro.
The company will pay a $150 million criminal fine, will forfeit $14 million, and pay more than $149 million to settle the False Claims Act allegations, according to the statement.
“Forest Pharmaceuticals deliberately chose to pursue corporate profits over its obligations to the FDA and the American public,” U.S. Attorney Carmen Ortiz in Boston said in the statement. “The company knew that it did not have FDA approval to distribute Levothroid.”
Howard Solomon, chief executive officer of New York-based Forest Laboratories, said in a statement, “We are pleased to bring closure to this long-running investigation.”
“We remain dedicated to ensuring that we operate in full compliance with all laws and regulations, and that our employees uphold the highest principles of integrity, honesty and ethics,” he said.