Forest Pharmaceuticals has agreed to pay more than $300 million, including $164 million in criminal penalties, for charges involving distribution of an unapproved new drug, distribution of a misbranded drug and obstruction of an FDA inspection.
The plea agreement stems from a multiyear investigation conducted by the Food and Drug Administration’s Office of Criminal Investigations in cooperation with law enforcement partners and the United States Attorney’s Office for the District of Massachusetts.
Charges against New York-based Forest Pharmaceuticals are focused on its marketing of Levothroid, an unapproved drug used for the treatment of hypothyroidism. A 1997 Federal Register notice indicated these products are considered “new drugs” within the meaning of the Federal Food Drug and Cosmetic Act and that manufacturers must obtain approved applications from the FDA by August 2000.
Because levothyroxine is 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.
Federal investigators said Forest Pharmaceuticals didn't 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 the drug.
“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 the 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 was charged with distribution of a misbranded drug for its off-label promotion of Celexa for pediatric use whenthe drug was approved only for use in adults. Additionally, the company was charged with obstructing an agency proceeding because of false statements made by employees during a 2003 FDA inspection.
Under the terms of the plea agreement, Forest Pharmaceuticals will plead guilty to all three counts and pay criminal penalties totaling $164 million.
The Department of Justice also announced that the pharmaceutical company and its parent company, Forest Laboratories, have agreed to pay $149 million and enter into a Corporate Integrity Agreement with the Office of Inspector General of the Department of Health and Human Services to resolve a related civil complaint against the companies.