To what lengths will a company go to in order to profit on the misery of others? It is a fair question that calls into question the ethical framework of a corporation or any type of association. AmerisourceBergen settled for $625 Million fine, read on for details.
The AmerisourceBergen Corporation (ABC)
AmerisourceBergen is one of America’s largest wholesale drug companies with several subsidiaries. It has just settled with the government for $625 million under what is called the False Claims Act.
The company was found guilty of repackaging chemotherapy and other “cancer support drugs,” in packaging materials not approved for sale by the U.S. Food and Drug Administration (FDA). The packaging materials may not have been sterile. The methods they used, even to the layperson, would cause us all to worry about the safety of drugs.
AmerisourceBergen admitted to the courts that from January 2001 to January 2014, they shipped millions of units of oncology drugs to practices throughout the country. The company admitted that the drugs were removed from their original glass packaging (it comes in vials), then it was “pooled” in plastic containers that had not undergone safety testing. Then the drug repackaged into single-dosage syringes.
We can well imagine that cancer patients undergoing chemotherapy have low resistance to disease. If the drugs they are administered were transferred to unapproved plastic containers before being re-packaged, the result could be catastrophic for patients.
Why would they do this?
A logical question is why would AmerisourceBergen break open one package, pool the oncology drugs and then re-package them? Simply put, to make more money. The vials they broke open were a larger dose. They then created smaller doses in smaller containers (pre-filled syringes) from the overfill of the smaller containers. If they received a larger than needed batch of the oncology drugs in the larger containers, they distributed and sold the larger containers through another one of their subsidiaries.
Over the 13 years, AmerisourceBergen manufactured tens of millions of doses of re-packaged chemotherapy 
drugs. It has been estimated the re-packaged drugs turned an annual profit of anywhere from $2 million to more than $14 million annually. It was a scheme where they could offer the drugs in different sized containers (to create a larger product line). What the customers were not aware of is that some of the products in that line may not have been absolutely sterile.
However, those irregularities were not accidental mistakes in filling and refilling. They knew they were being unethical. They “seemed” to have excluded the breaking, pooling, and refilling program from their required compliance programs.
Even more troubling, was that the majority of patients were in government healthcare assistance programs such as the Veteran’s Administration. There is, to my find, a highly biased component to these unethical programs, certainly toward income levels of the patients (and worse) as well as an attempt to defraud the government.
$885 million in penalties
The $625 million settlement is added to previous penalties, bringing the total amount leveled against the company to $885 million. The previous lawsuit was in September 2017, where the company pleaded guilty to introducing misbranded drugs into interstate commerce. These drugs were “manufactured” and re-packaged in a facility never registered with the FDA. Apparently, the packaging did reflect an FDA approved the package.
The Special Agent-in-Charge of the investigation said:
“Drug companies such as ABC that seek to boost profits at the expense of cancer patients unnecessarily put the health and safety of this vulnerable population at risk. Greed must never be a part of medical decision making.
More than just AmerisourceBergen
Unfortunately, it wasn’t just the pharmaceutical distribution company that was at fault here. There were also allegations that physicians were given kickbacks through pharmacy “credits” supposedly given to customers. The kickbacks were never specifically identified as being the cheaper refilled chemo drugs, but “magically” the only drugs that received such gifts.
In other words, the physicians and pharmacies who were quietly participating in the fraud had enabled AmerisourceBergen and its subsidiaries to perpetuate its unethical behavior.
The company, of course, settled with the government without an admission of wrong-doing, as though the huge settlement would wash away their culpability. The company is still very much in business and though the fines were immense, they will make back all that was lost in this environment of high-priced pharmaceuticals.
We cannot know if any lives were lost during their deception. Given the size of this fraud over 13 years, I cannot help but believe that they really didn’t care. AmerisourceBergen Settled For $625 Million Fine
