Actavis Agrees to Consent Decree with FDA

January 8, 2009

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The generic-drug manufacturer Actavis reached an agreement on a consent decree of permanent injunction with the US Food and Drug Administration regarding the company?s US subsidiary Actavis Totowa LLC.

Hafnarfjordur, Iceland (Dec. 29)-The generic-drug manufacturer Actavis reached an agreement on a consent decree of permanent injunction with the US Food and Drug Administration regarding the company’s US subsidiary Actavis Totowa LLC. This agreement, in effect, settles the issues identified by the US Department of Justice in its previously filed complaint against Actavis Inc., Actavis Totowa, and officers Sigurdur Oli Olafsson and Douglas Boothe.

In August 2008, Actavis Totowa issued a voluntary recall to the retail level of all drug products manufactured at its Little Falls, New Jersey, facility following an earlier inspection by FDA that revealed deviations in current good manufacturing practices (CGMPs).

The consent decree only affects operations at Actavis Totowa in New Jersey, which include two oral-dose manufacturing sites and a packaging facility. Under the consent decree, Actavis has agreed to not distribute any products from the Actavis Totowa facilities until it has certified completion of certain enumerated requirements that demonstrate compliance with CGMPs and has passed follow-up FDA inspections of the facilities. 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 press release “We have an entirely new management team in place at Little Falls 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.”

Prior to reaching this agreement, Actavis engaged Parexel (Lowell, MA), a contract services provider and consulting firm, to assess Actavis Totowa facilities. Actavis says Parexel will continue to work with Actavis Totowa to facilitate ongoing compliance with the consent decree.