AmerisourceBergen (ABSG), one of the largest wholesale drug companies in the U.S., agreed to pay $260 million for selling misbranded cancer drugs. The company pled guilty to illegally distributing misbranded drugs, as well as failing to register with the FDA. U.S. Attorney for the Eastern District of New York Bridget M. Rohde prosecuted the company.
How Did ABSG Mislabel the Drugs?
Court documents reveal that the Alabama-based drug company had two subsidiaries that prepared syringes with mislabeled cancer drugs. They then shipped the drugs to oncology centers across the country, to be used by patients undergoing chemotherapy.
To do this, the subsidiaries removed FDA-approved drugs from their original vials and repacked them into smaller plastic syringes. They then sold the excess drugs. Prosecutors also accused the companies of performing this illegal conduct in unsterile environments, which resulted in foreign contamination of the drugs.
Why Didn’t ABSG Register with the FDA?
In a scheme to avoid federal oversight, ABSG claimed that it was a state-regulated pharmacy in compliance with state regulations. But according to prosecutors, this loophole around registering with the FDA is intended for pharmacies, not drug manufacturers and distributors.
ABSG will pay a criminal fine of $208 million, plus $52 million in criminal forfeiture. The company will also maintain a compliance and ethics program to keep board members accountable in the future.
“This case sends a strong message to drug companies that we will not stand for unsafe practices that endanger patients,” said Attorney Walter Clark, founder of Walter Clark Legal Group.
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