AmerisourceBergen Specialty Group (ABSG), a wholly-owned subsidiary of AmerisourceBergen Corporation, one of the nation’s largest wholesale drug companies and number 11 on the Fortune 500 list, pled guilty to illegally distributing misbranded drugs.
ABSG will pay a total of $260 million to resolve criminal liability for its distribution of oncology supportive-care drugs from a facility that was not registered with the Food and Drug Administration (FDA).
The company was represented by Eric Sitarchuk, Kelly A. Moore, and John J. Pease of Morgan, Lewis & Bockius in Philadelphia.
Federal officials alleged that between 2001 and 2014, two of ABSG’s Alabama-based subsidiaries, Medical Initiatives Inc. (MII) and Oncology Supply Company (OSC), prepared millions of syringes that had been pre-filled with oncology supportive care drugs — specifically, Aloxi®, Anzemet®, generic versions of granisetron injection, Kytril®, Neupogen® and Procrit®.
Those syringes were shipped to oncology centers, medical practices and physicians for administration to immunocompromised cancer patients undergoing chemotherapy treatment in all 50 states.
To prepare pre-filled syringes (PFS), MII removed FDA-approved drug products from their original glass vials and repackaged them into plastic syringes through a process that allowed MII to access and sell excess drug product in the vials, known as “overfill,” that MII was able to extract from the vials.
Federal officials alleged that MII prepared PFS in an unclean, unsterile environment.
MII’s process for creating PFS resulted in some PFS that contained particles or foreign matter, which MII employees identified and termed “floaters.”
PFS were also at times not of the quality or purity that MII and OSC represented them to be to their customers.
MII’s business model was to combine the contents of multiple vials in a process known as “pooling.” However, as set forth in the information, many of the vials used by MII to prepare PFS were designated by the drug manufacturer as “single use” vials, meaning that the manufacturer could not guarantee the sterility of the drug product if the vials were breached.
However, in the pooling process, MII’s technicians frequently breached drug vials multiple times, thereby increasing the risk of contamination.
In order to avoid the FDA’s regulatory 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 inaccurately portrayed MII to its customers and to state agencies as a state-regulated pharmacy in the business of dispensing drugs pursuant valid prescriptions and claimed that MII was otherwise in compliance with state pharmacy laws.
By holding MII out as a pharmacy, ABSG unlawfully exploited an exemption to the FDA registration requirement that is reserved for legitimate pharmacies, not for manufacturers or re-packagers.
In connection with the guilty plea, ABSG filed a Statement of Facts setting forth those facts which it is admitting.
As part of its guilty plea, ABSG will pay a $208 million criminal fine, plus $52 million in criminal forfeiture, for a total financial penalty of $260 million.
ABSG has entered into an agreement with the Office and the Department of Justice’s Consumer Protection Branch 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.
The compliance and ethics program requires corporate board members to review annually the effectiveness of the company’s compliance program and for ABSG to maintain a hotline that will receive and process complaints about any improper practices.