Actavis Agrees to Keep Digitek Manufacturing Plant Closed

Actavis, Inc. and the FDA agreed last week on a Consent Decree of Permanent Injunction, preventing the drug maker from distributing any products from their Actavis Totowa facility in New Jersey. This follows a series of manufacturing problems at the plant, including quality control problems which allowed oversized tablets of Digitek to be commercially released, resulting in hundreds of deaths and serious injuries.

In November 2008, the U.S. Justice Department and the FDA filed a lawsuit seeking a permanent injection against Actavis Totowa LLC, their parent company Actavis, Inc. and two of the company’s executives, barring them from manufacturing and distributing generic drugs until they can demonstrate their ability to comply with the Good Manufacturing Practice (GMP) requirements of the Federal Food, Drug and Cosmetic Act.

In agreeing to the Consent Decree on December 29, 2008, Actavis has indicated that they will not distribute any products from the manufacturing plant in New Jersey where Digitek was made until after they have passed follow-up FDA inspections and certify completion of certain requirements that demonstrate compliance with the federal manufacturing requirements.

Actavis issued a Digitek recall in April 2008 for all lots of their generic digoxin heart drug after it was discovered that they allowed some tablets to be sold that were thicker then they are supposed to be, containing up to twice the appropriate amount of the drug. These quality control problems have been linked at least 667 Digitek deaths reported to the FDA between April 1, 2008 and June 30, 2008.

In August 2008, another Actavis drug recall was issued for over 65 other generic medications manufactured at the New Jersey plant, including antidepressants, diet medications, painkillers and drugs for hypertension and blood pressure. The action was taken after an FDA investigation revealed that good manufacturing practices, including adequate quality controls, were not being followed at the Actavis Totowa plant.

The FDA has drawn criticism for their ability to oversee drug makers in recent months, and the U.S. House Committee on Energy and Commerce requested information from the FDA about the Digitek recall in October 2008, as part of a two year inquiry into the agency’s ability to protect Americans from unsafe foods and prescription drugs.

Critics have suggested that signs of manufacturing problems have been present at the New Jersey plant for years, with prior FDA inspections dating back to 2006 revealing failures to follow good manufacturing practices, failing to provide periodic safety reports.

According to an FDA warning letter sent to Actavis in 2007, inspections have revealed that at least one machine was strapped with duct tape to prevent powder from escaping and the company’s cleaning processes were cited as inadequate, without assurance that there was proper cleaning between the manufacture of different drugs.

Actavis currently faces a growing number of Digitek lawsuits that have been filed on behalf of users of the generic heart drug who suffered severe or fatal injuries caused by digoxin overdose. At least 66 federal cases have been centralized in an MDL in the U.S. District Court for the Southern District of West Virginia, and Digitek lawyers estimate that hundreds of additional claims will likely be filed in the coming months.