On September 27, 2017, a subsidiary of AmerisourceBergen – AmerisourceBergen Specialty Group (ABSG) – admitted to illegally distributing misbranded drugs. ABSG agreed to pay $260 million to resolve criminal liability for distribution of oncology supportive drugs from a facility that was not registered with the FDA. During the hearing, federal agents from various federal branches expressed the need for more enforcement and supervision of suppliers of injectable drugs, which must be pure, sterile, and produced in an FDA-compliant facility within the supply chain that the FDA oversees.
The court records state that two of ABSG’s subsidiaries Medical Initiatives Inc. (MII) and Oncology Supply Company (both are based in Alabama) prepared millions of syringes that had been pre-filled with oncology supportive care drugs – Aloxi, Anzemet, Kytril, Neupogen, Procrit. These syringes were shipped to oncology centers, medical practices, and physicians for administration. To prepare the syringes, the companies removed FDA-approved drug products from their original vials and repackaged them into plastic syringes allowing them to sell the left-overs. According to government documents, the repackaging was performed in unclean and unsterile conditions, as a result some syringes contained particles or foreign matters.
To avoid the FDA’s oversight, ABSG did not register MII as a re-packager or manufacturer with the FDA as required by the Federal Food, Drug and Cosmetic Act. Instead, ABSG represented MII as a state-regulated pharmacy.
In addition to substantial monetary penalties, ABSG has entered into a settlement with the federal government, which requires its board members to annually review the ongoing compliance program and to maintain a hotline that will receive and process complaints about any improper practices.
Press Release, Department of Justice