OAG Consumer Protection Efforts Result in a $71 Million National Settlement, $718,000 to District of Columbia

District of Columbia and 48 States Reach Consumer Protection Settlement with Amgen over Unlawful Promotion of Aranesp® and Enbrel®

Washington, DC - District of Columbia Attorney General Karl A. Racine announced today that the District and 48 states have reached a $71 million consumer protection settlement with pharmaceutical manufacturer Amgen Inc. to resolve allegations that Amgen unlawfully promoted its drugs Aranesp and Enbrel. The settlement provides for a court injunction governing how Amgen markets drugs in the District.

Aranesp is used to treat certain types of anemia by stimulating bone marrow to produce red blood cells. Enbrel is used to treat a number of conditions, including plaque psoriasis.

In a complaint filed today in DC Superior Court, the District alleges that Amgen violated the District’s consumer-protection law by promoting Aranesp and Enbrel for uses that the FDA had not approved, including: (1) promoting Aranesp to treat anemia using higher dosing frequencies than were recommended by the drug’s FDA-approved label, (2) promoting Aranesp to treat anemia caused by cancer; and (3) promoting Enbrel to treat mild plaque psoriasis.

“We will continue to apply the District’s consumer-protection law aggressively against pharmaceutical companies whose unlawful off-label marketing results in patients being denied appropriate medical treatments.” Attorney General Racine said. “The Office of the Attorney General is devoted to ensuring the District’s residents are protected.

The agreed injunction, which must be approved by the DC Superior Court, prohibits Amgen from:

  • Making claims that are false, misleading, or deceptive in promoting Enbrel or any drug in the same class as Aranesp;
  • Representing that Enbrel or any drug in the same class as Aranesp has any sponsorship, approval, characteristics, ingredients, uses, benefits, quantities, or qualities that it does not have;
  • Using a drug compendium listing or publication to promote Enbrel or any drug in the same class as Aranesp to a health-care professional for an off-label use;
  • Allowing Amgen’s marketing or sales divisions to determine the content of Amgen’s submissions to a drug compendium relating to Enbrel or any drug in the same class as Aranesp;
  • Submitting special supplements to a drug compendium to support an off-label use of Enbrel or any drug in the same class as Aranesp;
  • And using a third party to lobby a drug compendium on Amgen’s behalf without notifying the compendium that the lobbying is at Amgen’s request.

The settlement concludes a multistate attorneys general investigation into Amgen’s marketing practices. The District’s share of the settlement will be $718,018.49.