Actavis Agrees to Close Digitek PlantDec 30, 2008 | Parker Waichman LLP Actavis Totowa announced today that it has agreed to temporarily close its Little Falls, New Jersey manufacturing facility, as well as another in Riverview and a packaging plant in Taft as part of a Consent Decree it has reached with federal regulators. The Little Falls Actavis plant made several generic drugs, including Digitek, that were subject to recalls this year.
Actavis said in a press release that the Consent Decree reached with the Food & Drug Administration settles the issues identified by the Department of Justice in its previously filed lawsuit against Actavis Inc., Actavis Totowa, and officers Sigurdur Oli Olafsson and Douglas Boothe. Under the Consent Decree, Actavis has agreed to not distribute any products from the closed facilities until it has certified completion of certain enumerated requirements that demonstrate compliance with FDA’s current good manufacturing practice and has passed follow-up FDA inspections of the facilities. The company said it anticipates that commercial production in the Actavis Totowa facilities will resume shortly.
As we’ve previously reported, the FDA issued a warning letter to Actavis back in August 2006 for failing to provide periodic safety reports at one of its oral dose manufacturing plants in New Jersey. Another FDA inspection in early 2006 revealed six potentially serious and unexpected adverse drug events dating back to 1999 for products that included generic Digitek, that weren’t reported to the agency.
In April, Actavis recalled Digitek tablets, some of which were made in Little Falls. Actavis said at the time that some Digitek tablets might have been oversized, and could expose patients to a dangerously high level of the drug’s active ingredient. The FDA deemed the Digitek recall a Class I recall, meaning that the defective Digitek tablets could cause serious health problems or death. A double-strength Digitek tablet poses a serious risk of digitalis toxicity in those patients suffering from renal failure.
Finally in August, Actavis issued another recall of all generic drugs made at the Little Falls facility. That recall was prompted by an inspection at the facility which revealed that operations did not meet the FDA’s standards for good manufacturing practices.
After the August recall, Actavis finally closed the New Jersey plants to institute “remediation” efforts. But the company sought to reopen the facilities, prompting the Justice Department lawsuit in November.
Just last week, a the Center for Public Integrity published a report that found that the number of fatalities associated with Digitek spiked around the time of the recall. According to the report, there were 667 deaths reported to the FDA Adverse Events Reporting System that involved Digitek between April 1 and June 30. The group also found that FDA had received just one reported death attributed to Digitek in the previous three-month reporting period. The Center says the FDA has confirmed the findings of its analysis.