Drugmaker Amgen Inc. is set to pay the federal government $762 million for marketing an anemia drug for off-label uses. Authorities say that the company marketed the drug Aranesp for off-label uses that the Food and Drug Administration specifically banned.
Off-label marketing is a problem throughout the prescription drug industry and spawns many pharmaceutical liability cases annually. This practice occurs when a drugmaker promotes a pharmaceutical for unapproved uses despite the potential harm to consumers. In this case, Amgen promoted its anemia drug to cancer patients who were not undergoing chemotherapy.
Although the drug was approved for cancer patients undergoing chemotherapy, studies have shown that the drug actually increases the risk of death in cancer patients who are not on chemotherapy.
The company’s inadequate safety data is one of the reasons why the FDA declined to approve Aranesp for cancer patients who didn’t receive chemotherapy. Amgen used the same inadequate set of data for its off-label marketing campaign. Federal prosecutors alleged that the company chased profits at the expense of patient safety and that its illegal marketing campaign was so pervasive that some employees had no idea they were helping the company break the law.
“In certain instances, Amgen employees were so thoroughly indoctrinated to sell the drug for off-label uses that they did not, in fact, know that the drug had not been approved for the use for which they were selling it,” one federal prosecutor said.
According to the National Institute of Health, side effects of Aranesp include seizures, serious allergic reactions, rashes, swelling and increases in blood pressure.