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Today, the U.S. Food and Drug Administration announced that it had filed a Consent Decree on December 23, 2008, and currently awaits the court's entry of a permanent injunction that bars Actavis Totowa, LLC, Actavis, Inc., and their officers, Sigurdur Oli Olafsson and Douglas Boothe, from manufacturing and distributing drugs at the Actavis Totowa facilities. The injunction will remain in effect until Actavis Totowa comes into compliance with U.S. current Good Manufacturing Practice (cGMP) requirements, and obtains FDA's approval to manufacture and distribute drugs in the United States. The companies and their officers had also been manufacturing and distributing unapproved drugs in the United States.
The defendants signed a consent decree that permits them to resume operations with respect to three categories of drugs only after an expert certifies that the drugs comply with the CGMP requirements and have FDA approval, and FDA inspects to confirm compliance with the law. The consent decree also requires defendants to destroy any remaining drugs that they recalled in April-July 2008, that are currently in their possession.
To view the complete list of unapproved drugs made by Actavis Totowa see List. The safety and effectiveness of these drugs has not been established because the company has not submitted for FDA review and approval new drug applications for them. FDA advises patients who have been using these products to discuss alternative therapies with their health care provider. Pharmacists should discontinue dispensing all unapproved drugs manufactured by Actavis Totowa.
"The FDA will not allow manufacturers to put the public's health at risk," said Janet Woodcock, M.D., director, Center for Drug Evaluation and Research, FDA. "These unapproved new drugs have not undergone FDA review for safety and efficacy and may pose potential health risks."
The consent decree also authorizes FDA to order the defendants to cease operations in the event of future violations. It further subjects the defendants to liquidated damages of $15,000 per day if they fail to comply with any of the provisions of the decree, and to the payment of an additional $15,000 for each violation, up to $7 million per year.
Actavis Totowa manufactures, processes, packages, labels, holds, and distributes drugs from two sites in Totowa, N.J., and one in Little Falls, N.J. FDA inspected Actavis Totowa's Riverview Drive facility in Totowa from March-May 2008, and found that the company had significant cGMP violations and continued to manufacture unapproved drugs. As a result of this inspection, which led to this action, Actavis Totowa recalled all products manufactured and distributed from its three facilities. Actavis Totowa is a wholly owned subsidiary of Actavis, Inc., the manufacturing and marketing arm of Actavis Group hf, a generic pharmaceutical company based in Reykjavik, Iceland.
"The FDA will carefully monitor the provisions of this injunction to ensure compliance, said Michael Chappell, FDA acting associate commissioner, Office of Regulatory Affairs. "Companies should know that FDA will investigate and take action against other marketers of unapproved drugs."
The government's complaint, filed Nov. 14, 2008, by the U.S. Department of Justice in the District Court for the District of New Jersey, alleged that the defendants violated the Federal Food, Drug, and Cosmetic Act by not complying with cGMP requirements and failing to obtain FDA's approval of some of its drugs, two requirements designed to ensure the safety, effectiveness, and quality of pharmaceutical products.
FDA's
ongoing efforts against marketed unapproved drugs
FDA/CDER Web page on Compliance
with Current Good Manufacturing Practices
FDA Press Release on Actavis Recall:
http://www.fda.gov/oc/po/firmrecalls/actavis08_08.html
FDA Warning Letters to Actavis Totowa:
http://www.fda.gov/foi/warning_letters/archive/g6007d.htm
http://www.fda.gov/foi/warning_letters/archive/g6235d.htm
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