Forest Pharmaceuticals has agreed to pay $313 million to settle criminal and civil complaints brought by the federal government accusing the company of illegally marketing the antidepressant drug Celexa to children. The U.S. Food and Drug Administration approved Celexa for treatment of adult depression only.
“Forest Pharmaceuticals deliberately chose to pursue corporate profits over its obligations to the FDA and the American public,” said Carmen Ortiz, the U.S. attorney for the District of Massachusetts, in a statement published in The New York Times.
The government said Wednesday that New York-based Forest Pharmaceuticals, a unit of Forest Laboratories, also broke the law by publicizing the positive results of a study on Celexa in adolescents while failing to tell doctors about a second study that produced negative results.
Federal prosecutors, in addition, accused the company of bribing doctors with cash payments and gifts intended to sway them to prescribe Celexa and another antidepressant, Lexapro. According to the Times, the gifts included tickets to St. Louis Cardinals and Red Sox games, and a deep-sea fishing trip.
Civil claims against Forest involved the illegal distribution of the drug Levothroid, used to treat thyroid hormone deficiency, along with with promoting Celexa and Lexapro for unapproved purposes. According to an agency news release, Forest, among other things, scaled up distribution of the Levothroid when it was told to scale down, and ignored an FDA warning letter to stop manufacturing and distributing the drug,
As part of the settlement, Forest agreed to plead guilty to a felony charge of obstructing an agency proceeding and to two misdemeanor charges related to improper drug distribution and promotion. The company, in a statement, denied the civil claims brought by the federal government but added that it remains “dedicated to ensuring that we operate in full compliance with all laws and regulations.”


