U.S. District Judge Sterling Johnson, Jr., accepted a guilty plea by biotechnology giant Amgen for illegally introducing a misbranded drug into interstate commerce Dec. 19 in Brooklyn, N.Y. The plea is part of a settlement with the U.S., in which Amgen agreed to pay $762 million to resolve criminal and civil liability arising from its sale and promotion of certain drugs, according to the Department of Justice (DOJ).
The settlement represents the single largest criminal and civil False Claims Act settlement involving a biotechnology company in U.S. history.
As part of the plea agreement and criminal settlement, Thousand Oaks, Calif.-based Amgen entered a guilty plea Dec. 18 before Johnson of the Eastern District of New York to criminal information charging the firm with illegally introducing a misbranded drug, Aranesp, into interstate commerce.
Under the Food, Drug and Cosmetic Act, it is illegal for drug companies to introduce into the marketplace drugs that the company intends will be used “off-label,” i.e., for uses or at doses not approved by the FDA, according to the DOJ. Aranesp is an erythropoiesis-stimulating agent (ESA), which is approved by the FDA at calibrated doses for particular patient populations suffering from anemia. “[T]o increase sales of Aranesp and reap the resulting profits, Amgen illegally sold the drug with the intention that it be used at off-label doses that the FDA had specifically considered and rejected, and for an off-label treatment that the FDA had never approved,” the DOJ stated.
Under the terms of the criminal plea agreement, Amgen will pay a criminal fine of $136 million and criminal forfeiture in the amount of $14 million.
As part of the civil settlement, Amgen has agreed to pay $612 million ($587.2 million to the U.S. and $24.8 million to the states) to resolve claims that it caused false claims to be submitted to Medicare, Medicaid and other government insurance programs. The federal civil settlement agreement encompasses allegations that Amgen:
- Promoted Aranesp and two other drugs that it manufactured, Enbrel and Neulasta, for off-label uses and doses that were not approved by the FDA and not properly reimbursable by federal insurance programs;
- Offered illegal kickbacks to a wide range of entities in an effort to influence healthcare providers to select its products for use, regardless of whether they were reimbursable by federal healthcare programs or were medically necessary; and
- Engaged in false price reporting practices involving several of its drugs.
As part of the settlement, Amgen has also agreed to enter into a corporate integrity agreement with the U.S. Department of Health and Human Services and the Office of the Inspector General that will govern its conduct and oversee its branding and marketing practices.
“Instead of working to extend and enhance human lives, Amgen illegally pursued corporate profits while jeopardizing the safety of vulnerable consumers suffering from disease,” said Acting U.S. Attorney of the Eastern District of New York Marshall L. Miller, JD, in a release. “To all who might consider introducing misbranded drugs into the marketplace, you are on notice: we remain steadfastly committed to prosecuting such violations of law.”
Beginning at the launch of Aranesp in 2002 and extending until 2007, the DOJ reported that Amgen illegally introduced Aranesp for uses and at dosage levels that the FDA had specifically declined to approve due to insufficient clinical evidence to establish their safety and efficacy. In particular, Amgen illegally introduced Aranesp into the oncology and nephrology ESA markets, intending that it be used for patients suffering from anemia due to chronic kidney disease or chemotherapy at off-label, unapproved doses that were larger and less frequently administered than those approved by the FDA for these patient populations. Amgen also illegally introduced Aranesp into the oncology ESA market intending that it be used to treat anemia caused by cancer, irrespective of whether the patient had been prescribed chemotherapy—a use which the FDA had never approved and which the agency subsequently determined caused an increased risk of death.
In 2007, the FDA issued a black-box label for Aranesp’s label, warning that the drug “increased the risk of death . . . in patients with active malignant disease [cancer] receiving neither chemotherapy nor radiation.” At approximately the time that the FDA issued the black-box warning, the DOJ