AmerisourceBergen Specialty Group (ABSG), a subsidiary of pharmaceutical giant AmerisourceBergen Corp., has pleaded guilty in a Brooklyn federal court to violating federal rules on the packaging and distribution of drugs. The company agreed to pay $260 million in fines and forfeiture. The guilty plea was entered before U.S. District Judge Nina Gershon. ABSG will pay $208 million criminal fine and criminal forfeiture of $52 million. The company pleaded guilty to a single count of introducing misbranded drugs into interstate commerce.

Medical Initiatives Inc. (MII), an Alabama subsidiary of ABSG, opened sterile vials of oncology drugs, pooled the medicine and transferred the drugs into single-dose prefilled syringes. The syringes were often shipped out without a prescription signed by a physician, sometimes in doses far exceeding plausible or safe usage for an individual. Occasionally they were for dead people. Neither did ABSG register MII with the U.S. Food and Drug Administration (FDA) as required by the Federal Food, Drug and Cosmetic Act (FDCA). It was admitted to the court that ABSG and its parent company were aware of the misconduct and supported it.

The company also agreed to a three-year agreement “to maintain a compliance and ethics program designed to increase accountability of individuals and corporate board members, to increase transparency, and to strengthen ABSG’s compliance with the FDCA,” officials said. It was revealed that MII not only opened the sterile vials but stored the open vials in nonsterile conditions. So whatever overfill was in the vial could be harvested to make additional prefilled syringes at essentially no cost.

AmerisourceBergen Corp. said in a recent filing to the U.S. Securities and Exchange Commission that it may face a civil lawsuit from Brooklyn federal prosecutors for alleged violations of the False Claims Act.

The government is represented by Assistant U.S. Attorneys Alixandra E. Smith and Ameet B. Kabrawala. The case is U.S. v. AmerisourceBergen Specialty Group, LLC, (case number 1:17-cr-00507) in the U.S. District Court for the Eastern District of New York.

Source: Law360.com



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