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# Amerisource Bergen Settles Cancer Drug Charges for $625 Million
- URL: https://www.fdaweb.com/amerisource-bergen-settles-cancer-drug-charges-for-625-million/
- Published: 2018-10-02T12:00:00.000Z
- Updated: 2026-09-15T00:35:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142498

The Justice Department says that Amerisource Bergen Corp. (ABC), one of the nation’s largest wholesale drug companies, will pay $625 million to resolve allegations arising from its operation of a facility that improperly packaged oncology-supportive injectable drugs into pre-filled syringes and improperly distributed the syringes to doctors treating vulnerable cancer patients. A Justice Department [news release](https://www.justice.gov/opa/pr/amerisourcebergen-corporation-agrees-pay-625-million-resolve-allegations-it-illegally?ref=fdaweb.com) says the drugs involved in the scheme were Janssen’s Procrit (epoetin alfa), Helsinn’s Aloxi (palonosetron), Roche’s Kytril (granisetron), [Hoechst Marion Roussel](https://www.centerwatch.com/drug-information/fda-approved-drugs/drugs/company/Hoechst+Marion+Roussel?ref=fdaweb.com)’s Anzemet (dolasetron), and Amgen’s Neupogen (filgrastim).

The settlement resolves three whistleblower claims brought under the False Claims Act. The federal government contended that ABC sought to profit from the excess drug product or “overfill” contained within the original FDA-approved sterile vials for the cancer supportive injectable drugs by establishing a pre-filled syringe program through a subsidiary that it claimed was a pharmacy. The government says the “pharmacy” was actually a repackaging operation that created and shipped millions of pre-filled syringes to oncology practices for administration to cancer patients. As part of the operation, ABC reportedly purchased original vials from their respective manufacturers, broke their sterility, pooled the contents, and repackaged the drugs into pre-filled syringes.

The government says the company never submitted any safety, stability, or sterility data to FDA to show that its operation ensured the safety and efficacy of the repackaged drug products. It further alleged that at times, the pre-filled syringes were prepared in non-sterile conditions, contaminated with bacteria and other unknown particles, and lacked the required quality and purity.

By harvesting the overfill, the suit says, ABC was able to create more doses than it bought from the original vial manufacturers. The government says the scheme enabled ABC to bill federal healthcare programs for the same vial more than once. And it also enabled the company to increase its market share by offering various product discounts that it leveraged to obtain new customers and to keep existing customers buying its entire portfolio of oncology drugs.

The settlement also resolves allegations that ABC gave kickbacks to doctors to induce them to purchase Procrit through the pre-filled syringe program.