Congress Requests Information from FDA about Digitek Recall

The U.S. House Committee on Energy and Commerce has requested information from the FDA about a May 2008 Digitek recall issued by Actavis Totowa, as well as other regulatory issues involving the same generic drug maker in recent years.

The request expands a two-year Congressional inquiry into the ability of the U.S. Food and Drug Administration (FDA) to protect Americans from unsafe foods and prescription drugs.

In a letter sent to FDA Commissioner Andrew van Eschenback, M.D. on October 8, 2008, Rep. John Dingell (D-MI), the Chairman of the Committee on Energy and Commerce, and Rep. Bart Stupak (D-MI), the Chairman of the Oversight and Investigations Subcommittee, requested information and documents relating to all FDA regulated products that Actavis has received approval for since January 1, 2003.

Actavis is an international generic drug company that is headquartered in Iceland. Over the past year, Actavis and their subsidiaries have been cited for violations of the proper standards of manufacturing for drugs and poor quality controls that have led to at least three major drug recalls.

In February 2008, thousands of generic fentanyl pain patches were recalled by Actavis as a result of a manufacturing defect which could allow the fentanyl gel to leak directly onto the skin. This posed a severe risk of fentanyl overdose for users of the pain patch or caregivers who were opening the packaging.

In May 2008, Actavis Totowa, a United States manufacturing division of Actavis which operates a plant in New Jersey, issued a Digitek recall after it was discovered that generic digoxin tablets were commercially released that were twice as thick as they were supposed to be. This increased the risk that patients taking the drug could suffer potentially fatal reactions known as digitalis toxicity.

In August 2008, over 66 generic drugs made by Actavis Totowa at the same New Jersey plant were recalled after an FDA inspection uncovered a number of violations of the proper standards for manufacturing drugs and a lack of adequate quality controls.

“Recalls of this seriousness cause us to question whether FDA was deceived regarding the current good manufacturing practices of this company, or did the FDA simply fail to conduct adequate and timely inspections of these facilities,” wrote Reps. Dingle and Stupak in the letter.

 
Hundreds of Americans have suffered severe, and sometimes fatal injuries, as a result of the Actavis manufacturing problems that led to the Digitek recall earlier this year. The double strength tablets caused some users to experience a digoxin overdose, with symptoms like nausea, vomitting, dizziness, low blood pressure, cardiac instability and bradycardia.

Actavis currently faces a number of Digitek lawsuits filed by users throughout the United States. All of the federal Digitek cases have been consolidated in a multidistrict litigation, or MDL, in the U.S. District Court for the Southern District of West Virginia.