Amgen Settles Drug Marketing and Pricing Claims

December 19, 2012

AUGUSTA – Attorney General William J. Schneider announced today that Maine, various other states and the federal government reached an agreement with Amgen, Inc. (Amgen) to settle allegations that Amgen engaged in various illegal marketing practices to promote sales of the drugs Aranesp, Enbrel, Epogen, Neulasta, Neupogen and Sensipar and inaccurately reported and manipulated prices for these drugs causing the submission of false claims.

As part of this settlement, Maine will receive a total of $13,313 in restitution and other recovery.

“Improper marketing and pricing put enormous costs on Medicaid and taxpayers,” said Attorney General Schneider. “This settlement will bring some relief for the harm done and put in place measures to prevent these false claims from happening again.”

Amgen will pay the states and the federal government a total of $612 million in civil damages and penalties to compensate Medicaid, Medicare, and various federal healthcare programs for harm suffered as a result of its conduct.

In addition, Amgen has agreed to plead guilty to an information to be filed by the government in the United States District Court for the Eastern District of New York, that will allege a violation of Title 21, United States Code, Sections 331(a), and 333(a)(1) and Title 18, United States Code, Sections 2 and 3551 et seq., namely, the introduction into interstate commerce of a drug that was misbranded within the meaning of 21 U.S.C. 352(a), specifically, Aranesp, in violation of the Food, Drug and Cosmetic Act (“FDCA”).

The government entities alleged that Amgen engaged in several improper marketing and pricing practices that included the following:

  • Amgen illegally marketed the drugs Aranesp, Enbrel and Neulasta;

  • Amgen illegally offered, paid or caused to be paid kickbacks for the purpose of influencing health care providers’ selection and utilization of Aranesp, Enbrel, Epogen, Neulasta, Neupogen, and Sensipar for Medicaid recipients;

  • Amgen knowing reported inaccurate Average Sales Prices (“ASP”) for Aranesp, Epogen, Neulasta and Neupogen;

  • Amgen knowingly reported inaccurate Best Prices and AMPS for Aranesp, Enbrel, Epogen, Neulasta, Neupogen and Sensipar by failing to include remuneration that was paid to health care providers and that was conditioned on purchase of Amgen products in violation of the Medicaid Rebate Statute, 42 U.S.C. 1396r-8.

As a condition of the settlement, Amgen will enter into a Corporate Integrity Agreement with the United States Department of Health and Human Services, Office of the Inspector General, which will closely monitor the company’s future marketing and sales practices.

This settlement is based on ten qui tam cases that were filed in the United States District Court for the District of Massachusetts, the United States District Court for the Eastern District of New York and the United States District Court for the Western District of Washington by private individuals who filed actions under state and federal false claims statutes.

A National Association of Medicaid Fraud Control Units team participated in the investigation and conducted the settlement negotiations with Amgen on behalf of the settling states. Team members included representatives from the Offices of the Attorneys General for the states of California, Massachusetts, Indiana, Illinois, New York and North Carolina.

Maine was represented by Assistant Attorney General Michael Miller, Director of the Healthcare Crimes Unit.

The Healthcare Crimes Unit is the Medicaid Fraud Control Unit for the State of Maine charged with investigating and prosecuting financial fraud and other crimes committed by MaineCare providers or their employees, and investigating and prosecuting abuse, neglect or exploitation of elderly and dependent persons that occurs in health care facilities or by health care providers. To learn more about the Office of the Attorney General Healthcare Crimes Unit, go to:

http://www.maine.gov/ag/crime/crimesweprosecute/healthcare_crimes.shtml