US v. Forest Pharmaceuticals, Inc.

Food & Drug Administration (FDA)

Most Recent Update: 10/1/10 (See end of document)

United States v. Forest Pharmaceuticals, Inc., Cr. No. 10-10294-NG (D. Mass.)

10/1/10 Update:

On September 15, 2010, the Assistant Attorney General for the Civil Division and the United States Attorney for the District of Massachusetts announced that Forest Pharmaceuticals, Inc., agreed to plead guilty to three counts of a criminal information and pay $164 million in criminal penalties. The plea agreement requires Forest to plead guilty to a felony obstruction charge relating to an FDA administrative inspection, and two Food, Drug, and Cosmetic Act charges. Forest will pay a criminal fine of $150 million and forfeit an additional $14 million in assets. Forest Pharmaceuticals’ guilty plea and sentence is not final until accepted by the U.S. District Court.

Forest also will pay over $149 million to resolve allegations under the False Claims Act, including a civil complaint filed by the United States in February 2009. The global resolution concerns three drugs distributed by Forest: Levothroid, Celexa, and Lexapro. Levothroid was an orally administered levothyroxine sodium drug used to treat hypothyroidism, a condition in which an individual has a thyroid deficiency. Celexa and Lexapro are anti-depressant drugs that, at the time period at issue, were approved only for use in treatment of adult depression. Regarding Celexa, the criminal information alleges that despite a limited approval only for adult depression, Forest Pharmaceuticals promoted Celexa for use in treating children and adolescents suffering from depression. The government alleges, in part, that Forest Pharmaceuticals publicized and circulated the positive results of a double-blind, placebo-controlled Forest study on the use of Celexa in adolescents while, at the same time, Forest Pharmaceuticals failed to discuss the negative results of a contemporaneous double-blind, placebo-controlled European study on the use of Celexa in adolescents. The government further alleges that Forest Pharmaceuticals’ off-label promotion consisted of various sales techniques, including directing its sales representatives to promote pediatric use of Celexa in sales calls to physicians who treated children and adolescents, and hiring outside speakers to talk to pediatric specialists about the benefits of prescribing Celexa to children and teens.

The announcement was issued in a DOJ Press Release (9/15/10).

The following documents are attached:

Information

Plea Agreement

Letter Agreement

Corporate Integrity Agreement

Civil Settlement