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Forest Pharmaceuticals Agrees to Pay $300M in Criminal Penalties

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Washington, DCThe U.S. Food and Drug Administration (FDA), working in close coordination with the U.S. Department of Justice (USDOJ), has announced that Forest Pharmaceuticals Inc, has 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 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 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 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, the company 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 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 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.

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READER COMMENTS

Posted by

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I too, have had a problem with being awakened in the middle of the night with severe pain mostly in my upper arms and upper torso. The pain is incredible and I am forced to get up and try to exercise some of the pain away, but it takes several hours before the pain subsides. Narcotic pain relievers are the only thing that helps.

Posted by

on
I've been taking Levothyroxine for two years now. I began having frightening daily episodes of being short of breath,and nearly fell down the stairs several times.I didn't associate it with the med.,because I'm 5,and really thought it was my heart. Then,I noticed that when my prescription ran out,i felt better & better. When I started taking it again..the same light headedness,dizziness and I absolutely thought i was going to die from not being able to breathe. I completely stopped,and will never take it again.I'm looking into buying Iodine supplemental drops,because I've read great things about it as a natural alternative. If there is a class action against this drug-count me in,as I realize that I could have died many times due to this 'medication',and have children & grandchildren that I shouldn't be taken from so soon. It makes me very upset that not enough research has been done on this-as well as too many other drugs. Thank you for letting me rant, and certainly hope it helps the next victim.

Posted by

on
I HAVE BEEN TAKEN THIS MED FOR TWO MONTH AND IT CAUSE PAIN IN MY ARMS AND CHEST AND PLUS IT MAKE MY ARM NUMB IT NOT SAFE TO TAKE THIS MED .....

Posted by

on
I have been taking Levothyroxine 88mcg for approximately one year. It has caused me to have palpitations and issues with my heart. I also have joint pains terribly and can't lose any of this weight. Something needs to be done about this medications.
Sincerely
Teresa

Posted by

on
i took the med levothyroxine 200 mg it cause me to have liver damage and i lost 30 pounds, energy,and cant seem to gain any waight back,my breathing got shorter,i stoped taking this drug bout 4 months ago,do i have a law suit on this drug its bad and can cause damage to you i no cause it did it to me,it almost killled me,

sincerly
elizabeth

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