Prescription drug lawyers at Pintas & Mullins Law Firm are warning anemia patients about improper marketing by a major biotech drug company. The company recently agreed to pay hundreds of millions of dollars to resolve deceptive marketing complaints.
As the Los Angeles Times is reporting, Amgen Inc. pleaded guilty to falsely marketing its anemia medication Aranesp. The biotech company also agreed to pay a hefty $762 million in fines to resolve related complaints.
At trial, prosecutors revealed that Amgen endorsed the use of the drug to treat anemia in cancer patients who were not receiving chemotherapy, even though the drug was approved only for cancer patients undergoing chemotherapy. A later study sponsored by Amgen revealed that the use of the drug by non-chemotherapy cancer patients actually raised the risk of death, and lessened the off-label use.
Amgen’s general counsel pleaded guilty to one misdemeanor count of falsely branding the drug or selling it for uses that were not FDA approved. The drug manufacturer agreed to forfeit $14 million and pay criminal fines of $136 million, with approximately $612 million going to settle civil litigation.
The federal charges also reveal that Amgen encouraged using a greater but less frequent injection of the drug than the label instructed in order to make it more appealing to doctors and patients instead of a competitor anemia drug from Johnson & Johnson called Procrit.
Amgen tried to get approval for the less frequent dose but the FDA refused its requests, stating that the company’s studies were insufficient. Nevertheless, the drug manufacturer continued to endorse the off-label dosing, based on the very same studies that the FDA deemed inadequate.
A federal prosecutor revealed to the judge that on certain occasions, the employees of the company were so thoroughly instructed to sell the drug for off-label uses that they were not even aware that the drug was not approved for the very use they were selling it for.
The company was also able to list the unaccepted uses in a compendium. If off-label uses of cancer medication are listed in an approved compendium, Medicare must pay for them. Though the compendium system is meant to make drugs more conveniently available to cancer patients, critics are of the view that compendiums do not properly assess the evidence.
While doctors are permitted to use drugs for non-FDA approved uses, companies do not have the right to encourage such use. The government was able to amass billions of dollars from pharmaceutical businesses in recent years for off-label endorsement.
More recently, another New York Times article revealed that the outcome of the undercover work of a longtime sales representative at Amgen, in addition to the information given by other whistle-blowers, resulted in Amgen’s consenting to pay the $762 million.
The lawsuits include more than just the off-label marketing of the anemia drug. They also include allegations of off-label marketing of Neulasta, which increases the white blood cell count, and Enbrel for psoriasis.
Amgen is also accused of offering kickbacks to clinics and doctors to encourage
them to use its drugs. The kickbacks were supposedly research and educational
grants, rebates, dinners and travel, free samples, cash and other inducements.
In related news, drug company GlaxoSmithKline agreed to a $3 million payment earlier this year, partly for endorsing anti-depressants and other drugs for non-FDA approved uses. Critics still claim that fines are insufficient to dissuade such actions because executives are not held personally accountable.
If you suspect off-label drug marketing, contact a whistleblower attorney and you may be eligible for a portion of the government’s profits.