WASHINGTON – The United States is seeking a permanent injunction to bar Actavis Totowa LLC, and Actavis Inc. and two of their officers, from the manufacturing and distribution of generic drug products until they demonstrate compliance with the Good Manufacturing Practice requirements of the Federal Food, Drug and Cosmetic Act (FDCA), the Justice Department announced today.
Actavis Totowa is a drug manufacturer located in New Jersey. Actavis Inc. is the United States manufacturing division of Actavis Group hf, an international generic pharmaceutical company located in Iceland, and the direct parent of Actavis Totowa. The two officers are Sigurdur Oli Olafsson, the Executive Chairman of Actavis Inc., and Douglas Boothe, the President and CEO of Actavis Totowa.
According to the complaint, The Food and Drug Administration (FDA) conducted five inspections of Actavis Totowa's facilities over the last three years. Despite written warnings to the company, during its last inspection this year, the FDA continued to find numerous and recurring violations of Good Manufacturing Practice requirements. FDA also found that the company continued to manufacturer and distribute unapproved new drug products.
Under the FDCA, drugs are adulterated if they were not manufactured in compliance with Good Manufacturing Practice requirements; and they are misbranded if they are unapproved by the FDA.
During its most recent inspection this year, FDA found that Actavis Totowa’s failure to comply with the Good Manufacturing Practice requirements resulted in, among other things, the company’s release of Digoxin tablets to the market after it had discovered that some tablets from the same production batch were double thick and, thus, double potent. Double dose Digoxin tablets can cause digitalis toxicity and result in cardiac instability, bradycardia and death among other things.
Recently, the defendants informed FDA that they would like to restart manufacturing drug products. However, Actavis has not demonstrated to FDA that it can do this in compliance with the Good Manufacturing Practice requirements.
"FDA and the Justice Department are committed to ensuring that drugs sold in the United States are safe and effective," said Gregory Katsas, Assistant Attorney General for the Justice Department’s Civil Division. "As part of this commitment, we have and will continue to file injunction actions to enforce strict compliance with Good Manufacturing Practice requirements."
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08-1012