Amgen paying $71M in off-label drug marketing case
NEW YORK (AP) — Biotech drugmaker Amgen will pay $71 million to settle an investigation into illegal marketing of its drugs Aranesp and Enbrel, ending an investigation by 48 states and Washington DC.
Less than three years ago, Amgen agreed to pay $762 million to settle a federal government inquiry into “off-label” marketing of the drugs and plead guilty to one criminal charge. Tuesday’s settlement resolves state-level investigations into the same actions, which occurred from 2002 to 2011 according to Amgen.
The 2012 settlement resolved allegations Amgen marketed Aranesp for unapproved uses. Prosecutors said the company tried to convince doctors and patients to administer the drug in bigger doses just once a month, saying they would save time. The promotion was intended to help Aranesp compete with another drug, and the government said there was insufficient evidence Aranesp works when it’s given so infrequently.
The company was also accused of unauthorized promotion of Enbrel and its anti-infection drug Neulasta, and of offering kickbacks.
Tuesday’s state-level settlement, like the previous agreement, covers the dosing schedule of Aranesp, promotion of the drug as a treatment for anemia caused by cancer, and marketing of Enbrel as a treatment for mild plaque psoriasis even though it’s only approved for chronic moderate to severe plaque psoriasis.
Aranesp was once one of Amgen’s best-selling products, but studies showed that Aranesp and similar medications sped up tumor growth and increased the risk of death when they were given to patients with some types of cancer. A New York legal complaint against Amgen says the company continued promoting Aranesp as a treatment for anemia caused by cancer even as the Food and Drug Administration studied those dangers.
In 2007 the FDA strengthened the warning label on the drugs and their sales fell.
Amgen Inc. reported $1.28 billion in U.S. sales of Enbrel, a treatment for rheumatoid arthritis and other inflammatory disorders, and $223 million in U.S. Aranesp sales in the second quarter. Aranesp is approved to treat anemia caused by chronic kidney disease or by chemotherapy.
The Thousand Oaks, California-based company said it is pleased to have resolved the matters and that it has a strong legal compliance program. Amgen shares fell $2.07 to $167.72.