Drug Company Fined After Using Dirty Packaging For Its Drugs, Prosecutors Say

DOWNTOWN BROOKLYN — One of the nation’s largest drug companies packed syringes filled with medicine meant for cancer patients in unsanitary packaging to cut costs, prosecutors announced Wednesday.

AmerisourceBergen Specialty Group pleaded guilty and will pay $260 million for using a non-sterile facility and pack the drugs, according to Acting U.S. Attorney Bridget M. Rohde.

ABSG — a subsidiary of the AmerisourceBergen Corporation, a company that ranks eleventh on the Fortune 500 list — distributed millions of the syringes filled with prescription anti-nausea medications between 2001 and 2014, prosecutors said.

The company removed drugs from FDA-approved packaging so it could syphon off "overfill" – surplus medicine that was in the vials. It then repackaged them in unsanitary vials that that contained “floaters,” or foreign substances, prosecutors said.

The drugs — Aloxi, Anzemet, granisetron, Kytril, Neupogen and Procrit — treat chemotherapy-related nausea and blood disorders.

The drugs were prepared by two Alabama-based ABSG subsidiaries — Medical Initiatives Inc. and Oncology Supply Company — then shipped to treatment centers in all 50 states, including 37 in Brooklyn, Queens, Staten Island and Long Island, said prosecutors.

ABSG did not register Medical Initiatives Inc. as a re-packager with the FDA to avoid federal oversight, prosecutors said.

ABSG pleaded guilty to distributing misbranded drugs in Brooklyn federal court on Wednesday and agreed to pay a $208 million criminal fine and $52 million in criminal forfeiture, prosecutors said.

The company also promised to maintain a hotline for consumers with complaints about any improper practices, prosecutors said.

"We believe this settlement is the right approach to resolving the matter with our formerly operating subsidiary, Medical Initiatives, Inc.," ABSG spokesman Gabe Weissman said in a statement,

"AmerisourceBergen takes this matter very seriously and has robust controls in place across all of our businesses to ensure that its handling of products fully complies with all requirements."

Weissman added that government investigators found no evidence of patients being harmed by medicine repackaged in the Medical Initiatives Inc. facility.

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