|FDA attempts to keep Actavis shuttered under an injunction. Image Source: Actavis|
The FDA has filed a consent decree to bar Actavis Totowa, Actavis and their officers, Sigurdur Oli Olafsson and Douglas Boothe, from manufacturing and distributing drugs at the Actavis Totowa facilities.
The agency said the injunction will remain in effect until Actavis Totowa comes into compliance with U.S. current good manufacturing practice (cGMP) requirements, and obtains its approval to manufacture and distribute drugs in the U.S. The companies and their officers had also been manufacturing and distributing unapproved drugs in the U.S.
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 once an FDA inspection reveals compliance with the law, according to the agency. The consent decree also requires defendants to destroy any remaining drugs that they recalled in April through July 2008.
The safety and effectiveness of the drugs has not been established because the company has not submitted for FDA review and approval new drug applications for them.
As a result, the FDA has advised patients using these products to discuss alternative therapies with their healthcare provider. Pharmacists should discontinue dispensing all unapproved drugs manufactured by Actavis Totowa, the agency said.
“The FDA will not allow manufacturers to put the public's health at risk,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “These unapproved new drugs have not undergone FDA review for safety and efficacy and may pose potential health risks.”
The agency said that consent decree also authorizes it 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.
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.
Last week, Actavis agreed with the FDA to block production at its Totowa, N.J., manufacturing subsidiary until its facilities comply with cGMP.