Forest paying $313m to settle US DOJ investigation
Finalising the settlements resolves a US Department of Justice (DOJ) investigation. The investigation focused on allegations Forest distributed an unapproved new drug, as well as a misbranded drug, and obstructed a US Food and Drug Administration (FDA) inspection.
Howard Solomon, chairman and CEO of Forest, said: “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.
“We have continued to enhance our compliance program since the events at issue in this investigation which occurred a number of years ago.”
Deborah Autor, director of the Office of Compliance in the Center for Drug Evaluation and Research, said: "These charges should serve as a warning to industry that the FDA takes seriously its role to protect the public from unapproved drugs."
Criminal charges
Charges of obstructing an FDA inspection were brought after Forest employees were accused of making misleading statements during a 2003 inspection by the agency. Forest pleaded guilty to a single felony charge of obstructing an agency proceeding.
To resolve the criminal investigation Forest is paying a $150m fine and a forfeiture payment of $14m. These criminal penalties cover the obstructing of an agency proceeding and two strict liability, no-intent misdemeanour violations of the Food, Drug and Cosmetic Act.
The misdemeanours relate to: distribution of an unapproved new drug, Levothroid (levothyroxine), between August 2001 and August 2003; and off-label promotion of Celexa (citalopram) as a treatment for paediatric patients from 1998 to 2002. Forest pleaded guilty to both charges.
Civil charges
To settle civil claims asserted by the DOJ Forest is to make payments of approximately $149m plus interest to the federal government and state Medicaid programmes.
The civil claims allege Levothroid was distributed without a new drug application (NDA) between August 2001 and August 2003. They also allege off-label promotion of Celexa and Lexapro (escitalopram oxalate) for paediatric use between 1998 and 2005.
Forest expressly denies the allegations made in connection with the civil claims being settled.
