Los Angeles Business Journal

Amgen to Pay $762 Million Settlement in Marketing Case

By Deborah Crowe Tuesday, December 18, 2012

Amgen Inc. has agreed to pay $762 million to resolve federal charges that the company improperly tried to market its troubled anemia drug Aranesp for uses for which it had not yet been approved.

The Thousand Oaks biotech giant on Tuesday pleaded guilty to a misdemeanor count in the case started by a whistleblower. The judge in the case is scheduled to review and approve the proposed settlement Wednesday, according to wire service reports.

Aranesp is primarily used to treat anemia in cancer patients that is a side-effect of chemotherapy treatments. It generated sales of $2.3 billion last year and was once Amgen’s biggest selling drug, but sales have declined in recent years over safety concerns.

Physicians often prescribe Food and Drug Administration-approved drugs for uses and at dosages beyond that which had been approved. Drug companies are forbidden from actively marketing these so-called “off-label” uses until they are approved.

The company was accused of stepping over the line in promoting the drug at higher dosages, which could be administered less frequently for greater patient convenience, and to treat anemia considered directly related to cancer, heart disease or other conditions.

The settlement money included a civil settlement, a criminal fine and a criminal forfeiture payment, according to the Associated Press. The company also will sign a five-year corporate integrity agreement with the Department of Health and Human Services, which makes corporate officers liable for any future compliance failures.

Amgen shares closed down 21 cents, or 1 percent, to $89.29 on the Nasdaq.