Source: United States Department of Justice News
A federal court today ordered an Illinois company to stop manufacturing and distributing drugs alleged to be adulterated in violation of the Federal Food, Drug, and Cosmetic Act (FDCA).
In a civil complaint filed on Aug. 17, the United States alleged that Morton Grove Pharmaceuticals Inc., violated the FDCA at the company’s facility in Morton Grove, Illinois, by manufacturing and distributing adulterated drugs. Morton Grove Pharmaceuticals makes and distributes prescription and over-the-counter drugs, such as cough syrups and nasal sprays. The Department of Justice alleged that the company violated the FDCA by failing to have adequate procedures to prevent cross-contamination of equipment, failing to reject drug lots using a contaminated ingredient, and failing to fully investigate the root cause of such contamination. The department also alleged the Food and Drug Administration (FDA) inspected the company’s facility five times, in 2011, 2014, 2016, 2019, and 2021, and that many of the violations were repeat violations the FDA had identified in earlier inspections.
The current good manufacturing practice regulations mandate that manufacturers control the processes and procedures by which drugs are manufactured, processed, packed, and held, to ensure that drugs have the identity, strength, quality, purity, and other attributes necessary for their safe and effective use. Drugs not made in conformance with current good manufacturing practice regulations are adulterated and in violation of the law. According to the Justice Department’s complaint, the FDA issued Morton Grove Pharmaceuticals several warnings, including a warning letter to the company in 2017, regarding alleged deficiencies at its facility.
“Drug manufacturers have an important responsibility to ensure drug quality and safety,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the Justice Department’s Civil Division. “The Department of Justice will continue to work closely with the FDA and take action against manufacturers who fail to abide by laws designed to protect public health.”
“Pharmaceutical companies must manufacture and distribute prescription and over-the-counter drugs in compliance with federal law,” said U.S. Attorney John R. Lausch, Jr., for the Northern District of Illinois. “The U.S. Attorney’s Office is committed to working with our colleagues at the Department of Justice’s Consumer Protection Branch to ensure public health is not jeopardized.”
“Current good manufacturing practice requirements are the foundation of a safe and effective national drug supply,” said Director Donald Ashley of the FDA’s Center for Drug Evaluation and Research, Office of Compliance. “These manufacturing fundamentals are necessary to ensure the public is not put at risk from adulterated drug products. Today is a culmination of the dogged oversight needed to hold drug manufacturers accountable for the safety, efficacy, and quality of the drug products they produce as we work to best protect public health.”
The defendants agreed to settle the suit and be bound by a consent decree of permanent injunction. The negotiated consent decree entered by the court permanently enjoins the defendants from violating the FDCA, and requires, among other things, that the defendants stop manufacturing, processing, labeling, holding, or distributing adulterated drugs. Further, the defendants must destroy all drugs in the facility, except for those that are medically necessary.
Senior Litigation Counsels Donald Lorenzen and Christina Parascandola of the Civil Division’s Consumer Protection Branch prosecuted the case.
The U.S. Attorney’s Office for the Northern District of Illinois, along with Senior Counsel Michele Svonkin and Joshua A. Davenport of the FDA’s Office of Chief Counsel, 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.
The claims resolved by the resolution announced today are allegations only and there has been no determination of liability.