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FDA NEWS RELEASE
For Immediate Release: September 15, 2010
Media Inquiries: Elaine Gansz Bobo, 301-796-7567, [email protected]
Consumer Inquiries: 888-INFO-FDA
Forest Pharmaceuticals agrees to guilty plea for violating FDA laws
Company sold unapproved and misbranded drugs and obstructed agency investigation
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.
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 Letter to stop the manufacture and distribution of Levothroid.
“These charges should serve as a warning to industry that the FDA takes seriously its role to protect the public from unapproved drugs,” said
Deborah M. Autor, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research. “Any company that operates in violation
of the FDCA and ignores FDA’s warnings should be aware that a criminal action could follow.”
Forest Pharmaceuticals, Inc. also is charged with distribution of a misbranded drug for its off-label promotion of Celexa for pediatric use when it
was approved only for use in adults. Celexa is the brand name for the prescription drug citalopram, a selective serotonin reuptake inhibitor (SSRI)
drug for the treatment of adult depression. In addition, Forest Pharmaceuticals, Inc. also is charged with obstructing an agency proceeding because
of false statements made by its employees during a 2003 FDA inspection.
Under the terms of the plea agreement, Forest Pharmaceuticals, Inc. will plead guilty to all three counts brought against the company and will pay
criminal penalties totaling $164 million. The Department of Justice also announced that Forest Pharmaceuticals, Inc. and its parent company,
Forest Laboratories, Inc., have agreed to pay $149 million and to enter into a Corporate Integrity Agreement with the Office of Inspector General
of the U.S. Department of Health and Human Services in order to resolve a related civil complaint against the companies.
Consumers should be aware that the Levothroid product currently marketed by Forest Pharmaceuticals, Inc. is not the subject of today's actions.
Forest Pharmaceutical’s guilty plea and criminal penalties relate to the marketing of the previously unapproved Levothroid product. The current
Levothroid product now has an approved New Drug Application and is compliant with FDA regulations.
For more information:
• 1997 Federal Register Notice 1 • 2001 Federal Register Notice 2 • 2001 Guidance for Industry on Levothyroxine Sodium Products 3 • Warning Letter 4 Links on this page:
1. http://www.gpo.gov/fdsys/pkg/FR-1997-08-14/pdf/97-21575.pdf 2. http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2001_register&docid=01-17538-filed.pdf 3. /downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079807.pdf 4. /ICECI/EnforcementActions/WarningLetters/2003/ucm147641.htm http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm225890.htm

Source: http://www.kslaw.com/imageserver/KSPublic/library/publication/HH050211_FDA.pdf