WASHINGTON (Legal Newsline) — The U.S. Department of Justice announced July 5 that a consent decree has been entered that features a permanent injunction against a group of defendants to prevent distribution of allegedly adulterated and misbranded drugs and unapproved new drugs.
“Doctors and patients must be able to rely on the quality of drug products that are purported to be sterile,” said acting assistant attorney general Chad A. Readler of the Justice Department’s Civil Division. “When insanitary conditions are identified in areas where sterile drugs are made, such conditions need to be corrected. The Department of Justice will continue to work actively with FDA to ensure that compounding pharmacies comply with the law and provide safe products to patients.”
The parties entered the consent decree in the U.S. District Court for the Southern District of Alabama. The defendants are Medistat RX LLC (Medistat); Mark D. Acker, who served as its chief executive officer; Timothy L. Fickling, who served as its production manager; and V. Elaine Waller, who served as its pharmacist-in-charge and quality manager.
These defendants allegedly ran a processing facility that was contaminated. Upon identifying the contamination, the defendants allegedly failed to take sufficient action.
“We commend the outstanding work of the FDA and the Justice Department’s Consumer Protection Branch in bringing to light these harmful conditions at Medistat,” said acting U.S. attorney Steve Butler for the Southern District of Alabama. “It was shocking to learn that pharmacists in our own district would produce medicines in a contaminated environment, jeopardizing the health and safety of our citizens.”