The U.S. Department of Justice recently announced that AmerisourceBergen Corp. (ABC) and several of its subsidiaries will pay $625 million to settle various allegations that it illegally repackaged and sold adulterated and unapproved new drugs, and that it double billed for such items and paid illegal kickbacks. The settlement resolves allegations that ABC violated the federal and state False Claims Act statutes.
As part of the settlement, ABC admitted that several of its subsidiaries operated a 13-year-long program that repackaged and distributed pre-filled syringes (PFS) that were not approved by the Food and Drug Administration (FDA). ABC further admitted that this program shipped millions of non-FDA approved PFS to oncology practices to be used in treating cancer patients. The fraudulent program created more doses than originally purchased by removing the drug product from a single glass vial packaged by the drug product’s manufacturer and then repackaging the drug product into multiple plastic containers. In addition to permitting ABC to bill multiple healthcare providers for the same vial of drug, the program also enabled ABC to unfairly offer the drug products at a discount, which enabled ABC to win new customers and increase its market share.
In addition to this civil settlement, one of ABC’s subsidiaries, AmerisourceBergen Specialty Group (ABSG), previously pled guilty in 2017 to criminal violations for introducing misbranded drug products into interstate commerce. The drug products were misbranded because they were repackaged at an unregulated facility not registered with the FDA. As part of the guilty plea, ABSG paid $260 million in criminal fines and forfeitures.
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