AmerisourceBergen Wednesday pled guilty to a federal misdemeanor charge and agreed to pay $260 million to lay to rest one piece of a five-year-old Justice Department probe into its sales of millions of prefilled cancer med syringes that came from a facility that was never registered with the FDA.
The federal misdemeanor charge said that between 2001 and 2014, two of the wholesaler’s Alabama-based subsidiaries, Oncology Supply Co. and the now-defunct Medical Initiatives, prepared millions of syringes of cancer medicines, including Aloxi and Anzemet and generics of Neupogen and Procrit, in the unapproved facility.
“Injectable drugs prescribed for patients—especially vulnerable cancer patients—must be pure, sterile and produced in an FDA-compliant facility that is within the supply chain that FDA oversees,” FDA Special Agent-in-Charge Mark McCormack said in a statement.
The company in August acknowledged the deal with the Justice Department when it set aside $260 million to pay the penalty. AmerisourceBergen said at the time, however, that there were still ongoing discussions in another phase of the case in which the DOJ intended to pursue civil claims under the False Claims Act. The wholesaler said there were significant disagreements in that action and that it was unclear that it would be resolved without litigation.
In an emailed statement today, the company said that while the former Medical Initiatives facility was not registered with the FDA, it had passed inspections by the Alabama Board of Pharmacy. It pointed out that the complaint did not indicate any patients were harmed by the drugs and that FDA testing of syringes that were seized in the case had not found any “quality concerns.”
The probe dates to 2012, when the U.S. Attorney in the Eastern District of New York began looking into how the drug wholesaler was handling intercompany transfers involving its prefilled syringe program overseen by the now-defunct Medical Initiatives, the company’s oncology distribution center and its group purchasing organization for oncologists.
This is the company's second time in less than two months to resolve a federal probe that indicated it had violated federal laws or standards. In August it agreed to pay more than $13 million to settle federal allegations that its specialty pharmacy unit had pushed patients to get refills of Exjade in return for more patient referrals and higher rebates from the Novartis, which makes the iron toxicity treatment. AmerisourceBergen did not admit any wrongdoing in that case.
Novartis, which was the alleged mastermind of the deals, settled with the Justice Department and states two years ago for $390 million shortly before the matter went to trial.