FDA Awaiting Court's Entry of Actavis Permanent Injunction

Rockville, MD (Jan. 9)-The US Food and Drug Administration announced that it had filed a Consent Decree on Dec. 23, 2008 and was awaiting the court’s entry of a permanent injunction that bars Actavis (Hafnarfjordur, Iceland), its officers Sigurdur Oli Olafsson and Douglas Boothe, and its subsidiary Actavis Totowa (Totowa, NJ) from manufacturing and distributing drugs at the Actavis Totowa facilities.

FDA asserted that the companies and their officers had been manufacturing and distributing unapproved drugs in the United States. Actavis has not submitted new drug applications for the products, and their safety and effectiveness has not been established, according to the agency. FDA advises patients who have been using these products to discuss alternative therapies with their healthcare provider. The agency recommends that pharmacists stop 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, director of FDA’s Center for Drug Evaluation and Research, in an agency press release. “These unapproved new drugs have not undergone FDA review for safety and efficacy and may pose potential health risks.”

Actavis signed the consent decree on Dec. 29, 2008, effectively settling the issues identified by the US Department of Justice in its complaint. After an expert certifies that the company’s drugs comply with current good manufacturing practice (CGMP) requirements and have FDA approval, and after the agency performs inspections to confirm compliance, Actavis will gain permission to resume operations with respect to three categories of drugs. The company anticipates that commercial production in the Actavis Totowa facilities will resume shortly.

“We have been working with the FDA to address compliance issues at the Totowa facilities,” said John LaRocca, Actavis’s chief legal officer, in a company statement. “We have an entirely new management team in place at Little Falls, [New Jersey], and have invested significantly to reinforce systems and procedures intended to better ensure robust, sustainable compliance. This agreement with the agency is a positive step and is one we have looked forward to reaching. We will continue to work with the FDA to show that we have addressed all of the agency’s compliance and manufacturing issues.”

The consent decree authorizes FDA to order the defendants to halt operations if future violations are discovered. If Actavis fails to comply with any of the provisions of the decree, it will be subject to liquidated damages of $15,000 per day and the payment of an additional $15,000 for each violation.

Actavis Totowa manufactures, processes, packages, labels, holds, and distributes drugs at two sites in Totowa, New Jersey, and one in Little Falls, New Jersey. An FDA inspection of Actavis Totowa’s Riverview Drive facility in March–May 2008 led to the consent decree. FDA found significant CGMP violations and observed that Actavis was continuing to manufacture unapproved drugs. In April–July 2008, Actavis Totowa recalled all products manufactured and distributed from its three facilities. The consent decree requires Actavis to destroy the remaining drugs in its possession after the recall.