Actavis, FDA agree to keep Digitek manufacturing plant shuttered
Actavis has entered into a consent decree with the FDA to block production at its Totowa, N.J., manufacturing subsidiary until its facilities comply with current good manufacturing practices (cGMP). The decision follows a series of manufacturing problems at the plant, including quality control problems, which allowed oversized tablets of heart failure drug Digitek to be sold publicly, resulting in many deaths and serious injuries.
In agreeing to the consent decree on Dec. 29, 2008, Actavis indicated that it will not distribute any products from the manufacturing plant in New Jersey, where Digitek was made until after it has passed follow-up FDA inspections and certify completion of certain requirements that demonstrate compliance with the federal manufacturing requirements.
The consent decree covers all drugs produced at the Totowa facilities in New Jersey, but does not affect other locations. As part of the agreement, Actavis must retain an outside expert to ensure compliance with cGMP, according to the agency.
In November 2008, the U.S. Justice Department and the FDA filed a lawsuit seeking a permanent injection against Actavis Totowa, its parent company Actavis and two of its executives, barring them from manufacturing and distributing generic drugs until they can demonstrate their ability to comply with the cGMP requirements of the Federal Food, Drug and Cosmetic Act.
The FDA has drawn criticism for its ability to oversee drug makers in recent months, and in October 2008, as part of a two year inquiry, the U.S. House Committee on Energy and Commerce requested information from the FDA about a Digitek recall in April 2008.
The Hafnarfjörour, Iceland-based Actavis issued a Digitek recall in April 2008 for all lots of its generic digoxin heart drug after it was discovered that some tablets sold contained twice the appropriate amount of the drug. The quality control problems have been linked at least 667 Digitek deaths reported to the FDA from April thru June of 2008.
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 a multi-district litigation in the U.S. District Court for the Southern District of West Virginia.
In agreeing to the consent decree on Dec. 29, 2008, Actavis indicated that it will not distribute any products from the manufacturing plant in New Jersey, where Digitek was made until after it has passed follow-up FDA inspections and certify completion of certain requirements that demonstrate compliance with the federal manufacturing requirements.
The consent decree covers all drugs produced at the Totowa facilities in New Jersey, but does not affect other locations. As part of the agreement, Actavis must retain an outside expert to ensure compliance with cGMP, according to the agency.
In November 2008, the U.S. Justice Department and the FDA filed a lawsuit seeking a permanent injection against Actavis Totowa, its parent company Actavis and two of its executives, barring them from manufacturing and distributing generic drugs until they can demonstrate their ability to comply with the cGMP requirements of the Federal Food, Drug and Cosmetic Act.
The FDA has drawn criticism for its ability to oversee drug makers in recent months, and in October 2008, as part of a two year inquiry, the U.S. House Committee on Energy and Commerce requested information from the FDA about a Digitek recall in April 2008.
The Hafnarfjörour, Iceland-based Actavis issued a Digitek recall in April 2008 for all lots of its generic digoxin heart drug after it was discovered that some tablets sold contained twice the appropriate amount of the drug. The quality control problems have been linked at least 667 Digitek deaths reported to the FDA from April thru June of 2008.
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 a multi-district litigation in the U.S. District Court for the Southern District of West Virginia.