FDA reaches agreement with firm that produced troubled heart drug

Introduction

The U.S. Food and Drug Administration last week announced a little-noticed tentative agreement setting conditions under which a troubled pharmaceutical company and its subsidiary could resume the production and distribution of certain drugs — among them a powerful heart drug that was the subject of a Center story in December.

The heart drug Digitek, which is produced by the pharmaceutical firm Actavis Inc., was recalled on April 25 by the firm’s subsidiary, Actavis Totowa; that action followed discovery that some of the Digitek tablets, manufactured in New Jersey, were twice as thick as intended, and thus could contain double the dose meant for a patient. The Center found that 667 deaths were reported between April 1 and June 30 to an FDA database by doctors, other health professionals, and consumers who cited Digitek as the “primary suspect” in the fatalities. Actavis maintained that none of the improperly manufactured Digitek ever reached the public.

In August, Actavis closed a plant in Little Falls, New Jersey, that manufactured Digitek to institute “remediation” efforts. Then in November, the Justice Department — representing the FDA — asked a federal judge to permanently enjoin Actavis and Actavis Totowa from manufacturing a variety of drugs until the firm could demonstrate compliance with FDA “Good Manufacturing Practice” requirements.

The FDA’s announcement states that it filed a proposed consent decree with a federal court in New Jersey on December 23, a day after the Center published its story. The proposed decree, signed by Actavis and Actavis Totowa and its officers, permits the firms to resume manufacture of certain drugs only after an expert certifies that the drugs comply with Good Manufacturing Practice requirements and have FDA approval. Commenting on the agreement, Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said, “The FDA will not allow manufacturers to put the public’s health at risk.”

Digitek is one of the drugs covered by a portion of the consent decree. Actavis told the Center that the company “has not yet decided if it will re-enter the Digitek market.”

According to a spokesperson for the Department of Justice, the “unopposed motion” requesting that the court enter the consent decree is set for a hearing on January 20.