Major drug distributor AmerisourceBergen Corporation will pay the Justice Department $625 million to resolve allegations it improperly repackaged cancer drugs and exposed cancer patients to potentially unsafe products.
The settlement announced Monday concerned the company's treatment of the excess fluid that is often included in injectable drugs to treat cancer. Usually, manufacturers fill vials of liquid drugs beyond the intended dose to account for any loss of liquid in storage or when the drugs are delivered via syringes.
But AmerisourceBergen took that excess amount, called "overfill," and put it into syringes. It then sold those syringes to oncology practices to give to cancer-stricken patients, the Justice Department said.
“As part of this operation, ABC purchased original vials from their respective manufacturers, broke their sterility, pooled the contents, and repackaged the drugs into pre-filled syringes,” the Justice Department said in a release. “The United States alleged that ABC never submitted any safety, stability, or sterility data to the FDA to show that its operation ensured the safety and efficacy of the repackaged drug products.”
The settlement also covers allegations that the company gave kickbacks to doctors to get them to purchase their syringes instead of the FDA-approved drug.
This is the latest settlement against one of the biggest drug distributors in the country.
Last year, Amerisource paid $260 million to settle allegations that it distributed drugs that weren’t registered with the FDA.
“The $885 million combined civil and criminal resolution with ABC underscores our determination to utilize all tools at our disposal to pursue illicit schemes that seek to profit from circumvention of important safeguards designed to protect the nation’s drug supply,” said Assistant Attorney General Joseph H. Hunt of the Department of Justice’s Civil Division.
The distributor told the Washington Examiner that the medical initiatives that were the subject of the settlement were voluntarily closed in 2014. "ABC is not aware of, and did not admit to any conduct pertaining to, evidence that any patient was harmed," the company added.
AmerisourceBergen is also being sued by several states for its role in the opioid crisis. Several states like Kentucky allege the distributor neglected to identify large, suspicious packages of opioids sent to small and rural communities.