Amgen to Pay $71 Million to States for Promoting Off-Label Drug Uses

LOS ANGELES (Los Angeles Times/TNS) -

Biotech company Amgen Inc. has agreed to pay $71 million to settle allegations by 48 state attorneys general that it improperly marketed two of its drugs.

The states alleged that Amgen violated consumer-protection laws by promoting the use of its anemia drug Aranesp for longer periods than the Food and Drug Administration had approved and by encouraging its use to treat anemia caused by cancer without FDA approval.

Additionally, Amgen was accused of promoting its drug Enbrel as a treatment for mild plaque psoriasis even though it was only approved for severe plaque psoriasis, and for overstating the length of time that Enbrel effectively treats the disease.

In 2012, Amgen, based outside Los Angeles in Thousand Oaks, Calif., pleaded guilty to a criminal charge in federal court in New York for improperly marketing Aranesp and agreed to pay $762 million in criminal fines and civil settlements.

Federal prosecutors had accused Amgen of “pursuing profits at the risk of patient safety” by encouraging doctors to prescribe Enbrel for unapproved uses to boost sales and take market share away from a rival drug maker.

Although doctors can prescribe medications for off-label uses, drug companies are banned from promoting uses that aren’t approved by the FDA.

The settlement reached Tuesday involved the same allegations addressed in the federal settlement.

Amgen issued a statement that said it was “pleased to have this matter resolved.”

“Amgen has a strong compliance program, and our management is dedicated to fostering a culture of doing the right thing at Amgen in full compliance with the law,” the company said.

New York Attorney General Eric T. Schneiderman said in a statement that the settlement was important: “Consumers need to have confidence in the accuracy of claims made by pharmaceutical companies.”

The 2012 federal settlement followed 11 whistleblower complaints. One of the key complaints was filed by former Amgen employee Kassie Westmoreland, who worked as an Aranesp product manager from 2002 to 2005.

She filed suit against Amgen in 2006 under seal, alleging that the company overfilled vials of Aranesp and then encouraged doctors to bill Medicare and private insurance for the surplus amount.

In trading Tuesday, Amgen shares dropped $2.07, or 1.2 percent, to $167.72.