Company sold unapproved and misbranded drugs and obstructed agency investigation
Forest Pharmaceuticals has agreed to pay US$313m and plead guilty to the distribution of Levothroid, which at the time was an unapproved drug, and illegal distribution of Celexa and Lexapro. The St Louis-based firm, a division of Forest Laboratories, has also pleaded guilty to obstructing an FDA inspection.
The agreement is the culmination of an investigation begun in 2004 by the FDA’s Office of Criminal Investigations in cooperation with its law enforcement partners and the US Attorney’s Office for the District of Massachusetts.
Forest Pharmaceuticals began marketing Levothroid (levothyroxine sodium tablets, USP) in the 1990s without FDA Approval.
Because levothyroxine was considered a medically necessary product, the FDA permitted a gradual phase-out with all distribution of unapproved levothyroxine sodium drug products to cease no later than August 2003. Forest Pharmaceuticals increased its distribution of Levothroid rather than scaling it down, and ignored a subsequent Warning Letter to stop the manufacture and distribution of the drug, which is used to treat hypothyroidism.
In addition, Forest Pharmaceuticals promoted Celexa and Lexapro for paediatric use when they were approved only for treating depression in adults.
The company has been charged with obstructing a 2003 FDA investigation because of false statements made by its employees during a plant inspection in 2003.
‘These charges should serve as a warning to industry that the FDA takes seriously its role to protect the public from unapproved drugs,’ said Deborah Autor, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research.
Under the terms of the agreement, Forest Pharmaceuticals pleaded guilty to all three counts brought against it and will also pay criminal penalties totalling US$164m.
In addition the firm will pay US$149m and enter into a Corporate Integrity Agreement with the Office of Inspector General of the US Department of Health and Human Services to resolve a related civil complaint against it.
‘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,’ said Howard Solomon, chairman and chief executive of Forest.
The Levothroid product currently marketed by Forest Pharmaceuticals has an approved NDA and is compliant with FDA regulations.