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Forest Pharmaceuticals Agrees to Guilty Plea for Violating FDA Laws
Date:9/15/2010

SILVER SPRING, Md., Sept. 15 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration (FDA), working in close coordination with the U.S. Department of Justice (USDOJ), today announced that Forest Pharmaceuticals, Inc. entered into a plea agreement in which the company accepted responsibility for criminal actions including distribution of an unapproved new drug, distribution of a misbranded drug, and obstruction of an FDA inspection.

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To resolve these charges and a related civil suit, Forest Pharmaceuticals, Inc. has agreed to pay more than $300 million, including $164 million in criminal penalties. This plea agreement is the culmination of a multiyear investigation conducted by FDA's Office of Criminal Investigations in cooperation with its law enforcement partners and the U.S. Attorney's Office for the District of Massachusetts.

Charges against Forest Pharmaceuticals, Inc. are primarily for its marketing of Levothroid (levothyroxine sodium tablets, USP), an unapproved drug used for the treatment of hypothyroidism. A 1997 Federal Register notice announced that these products are considered "new drugs" within the meaning of the Federal Food Drug and Cosmetic Act (FDCA) and that manufacturers who wished to continue marketing these products must obtain approved applications from the FDA by August 2000. 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 did not obtain drug approval, increased its distribution of Levothroid rather than scaling down, and ignored a subsequent Warning L
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SOURCE U.S. Food and Drug Administration
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