Drug distributor AmerisourceBergen has set aside $575 million to settle civil charges for distributing oncology support drugs from a facility not registered with the Food and Drug Administration.
The Valley Forge pharmaceutical wholesaler said in an SEC filing Nov. 2 that it was in "advanced settlement" talks with the Justice Department to resolve claims that it illegally distributed injectable drugs from a facility that was not FDA compliant.
AmerisourceBergen pleaded guilty in September to a criminal charge in the same case and agreed to pay $260 million. The additional $575 million will bring the company's total liability to $835 million.
Between 2001 and 2014, two AmerisourceBergen subsidiaries based in Alabama prepared millions of syringes that had been prefilled with oncology support care drugs. The syringes were shipped to medical centers, physicians, and oncology centers for cancer patients undergoing chemotherapy treatment. The U.S. Attorney's Office for the Eastern District of New York said that the vials were prepared in an unclean, unsterile environment and that some contained particles that did not meet quality or purity standards.
"Medical Initiatives Inc. was licensed and passed all inspections by the Alabama Board of Pharmacy, but the case brought by the U.S. Attorney's office primarily stems from a lack of registration with the U.S. FDA," said AmerisourceBergen spokesman Gabe Weissman. "The filings in this case do not include any specific allegations of patient harm, and during the government's investigation they did not issue warning letters, corrective action plans, and/or stop Medical Initiatives operations."