Forest Pharmaceuticals To Plead Guilty For Food, Drug, And Cosmetic Act Violations

Sep 16, 2010   

On September 15, 2010, the Food and Drug Administration (“FDA”) announced that Forest Pharmaceuticals (“Forest”) has agreed to plead guilty to two violations of the Food, Drug, and Cosmetic Act (“FDCA”). Forest has agreed to plead guilty to one count of distributing an unapproved drug in interstate commerce and one count of distributing a misbranded drug in interstate commerce. Additionally, Forest has agreed to plead guilty to one count of obstruction of justice. Charges stem from Forests marketing of two drugs, Levothroid and Celexa.

In 1997, the FDA announced that Levothroid, though already on the market, would be considered a new drug within the meaning of the FDCA. At that time, the FDA advised drug manufacturers that in order to continue to market Levothroid they would have seek new drug approval by the FDA. However, Forest failed to obtain drug approval, continued to market unapproved Levothroid, and disregarded an FDA warning letter ordering Forest to stop production and distribution. As a result of these actions, Forest was charged with distribution of an unapproved drug in violation of the FDCA.

U.S. authorities also charged Forest with distributing a misbranded drug based on its off-label marketing of Celexa to treat depression in children though the drug was only approved for use in adults. Prosecutors allege that Forest paid doctors to prescribe Celexa and failed to inform prescribing doctors of negative studies regarding the effects of Celexa on adolescents. Forest was also charged with obstruction of justice because of false statements made by employees during the FDA investigation.

As part of the plea agreement, Forest has agreed to plead guilty to all three counts and pay $164 million in criminal penalties. Additionally, Forest has agreed to resolve a civil complaint against it by paying $149 million in civil fines and entering into a Corporate Integrity Agreement with the Office of Inspector General of the Department of Health and Human Services.

For more information on FDA regulation and labeling guidelines, please contact us at contact@fidjlaw.com.