Forest Laboratories’ sales and distribution subsidiary, Forest Pharmaceuticals, will have to pay over $300 million in fines and criminal penalties to settle its guilty plea following a multiyear investigation by FDA’s Office of Criminal Investigation and the U.S. Attorney’s Office for the District of Massachusetts. The firm has admitted criminal actions including distribution of an unapproved levothyroxine sodium drug, distribution of a misbranded drug, and obstruction of the FDA inspection. $164 million of the $300 million total will settle the guilty plea relating to criminal penalties.
Forest Pharmaceutical and its parent company will have to pay an additional $149 million to resolve a related civil complaint, and establish a Corporate Integrity Agreement (CIA) with the Office of Inspector of the U.S. Department of Health and Human Services. The CIA requires Forest to maintain its current compliance program and to undertake a set of defined corporate integrity obligations for a period of five years.
The criminal charges relate primarily to Forest's marketing of the unapproved drug Levothroid® for the treatment of hypothyroidism between 2001 and 2003, despite an FDA ruling that the levothyroxine supplement drug class required NDA registration. The agency notes that rather than complying with federal rules and either gaining approval for the drug or scaling down and stopping its distribution by August 2003, the firm increased distribution without seeking marketing approval. Forest also ignored a subsequent Warning Letter from FDA to stop its activities, the agency adds. The firm has, in addition, admitted to the off-label promotion of the SSRI Celexa® as a treatment for pediatric patients, for which Celexa had not been approved, between 1998 and 2002.
Forest has separately agreed to resolve civil claims relating to allegations concerning the distribution of Levothroid without an NDA between August 2001 and August 2003, and to off-label promotion of Celexa and Lexapro for pediatric use between 1998 and 2005, prior to the FDA approval of Lexapro for the treatment of major depressive disorder in adolescents in March 2009. However, Forest says it “expressly denies the allegations made in connection with the civil claims being settled.”
The firm nevertheless appears relieved to draw a line under the 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,” remarks Howard Solomon, chairman and CEO. “We have continued to enhance our compliance program since the events at issue in this investigation, which occurred a number of years ago.”
FDA has stressed that the Levothroid product currently marketed by Forest has been approved by the agency and is compliant with all relevant regulations.