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Food and Drug Administration and Compliance Issues
Wednesday, June 15, 2022
Department of Justice
Office of Public Affairs
FOR IMMEDIATE RELEASE
Monday, June 13, 2022
District Court Enjoins Vermont Pharmacy from Distributing Drugs Not Made in Compliance with FDCA
A federal court permanently enjoined a Colchester, Vermont, compounding pharmacy from distributing drugs unless they are manufactured in compliance with the Federal Food, Drug and Cosmetic Act (FDCA), the Justice Department announced.
In a complaint filed May 20, the United States alleged that Edge Pharm Inc., and its owners and operators Marc Chatoff and Kurt Radke, violated the FDCA by manufacturing and distributing adulterated and misbranded drugs, by causing drugs to become adulterated and misbranded while held for sale, and by introducing new unapproved drugs into interstate commerce. According to the complaint, the defendants manufactured injectable drugs intended to be sterile under conditions that fell short of the minimum requirements to ensure sterility. The complaint further alleged that U.S. Food and Drug Administration (FDA) inspections of the Edge facility between 2014 and 2021 revealed record-keeping violations, labelling inadequacies, improper airflow, structural disrepair and the presence in cleanroom suites of mold species that can cause diseases in humans which may be deadly to immunocompromised patients.
“Compounding pharmacies must ensure that their products are safe,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The department will continue to work closely with the FDA to ensure that drugs are compounded in compliance with the law.”
“Edge Pharma LLC has put patients’ lives at risk by repeatedly producing drugs under insanitary conditions and failing to follow good manufacturing practice requirements,” said Director Donald Ashley of the Center for Drug Evaluation and Research (CDER) Office of Compliance. “While compounded drugs are not FDA-approved, all drug firms must prioritize patient safety, which Edge Pharma has been unable to do. This consent decree ensures that Edge Pharma will be held accountable, and FDA will continue to take all necessary steps within our regulatory authority to protect the health of the American public.”
The defendants did not admit or deny the allegations in the government’s complaint, but agreed to settle the suit and be bound by a consent decree of permanent injunction. The consent decree requires, among other things, that the defendants stop manufacturing and distributing drugs until they take specific remedial measures and demonstrate to the FDA that they will comply with federal law. Judge Chief Judge Geoffrey W. Crawford of the U.S. District Court for the District of Vermont entered the order against the defendants.
The government was represented by Trial Attorney David G. Crockett of the Civil Division’s Consumer Protection Branch, with the assistance of Claudia Zuckerman of the FDA’s Office of Chief Counsel. The U.S. Attorney’s Office for the District of Vermont provided valuable assistance.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch.