48 States & Dist. of Columbia Reach Settlement with AmgenAug 25, 2015
In a settlement announced last week, Amgen Inc. has agreed to pay $71 million to 48 states and the District of Columbia to settle allegations that the drug maker unlawfully marketed the anemia drug Aranesp and the plaque psoriasis drug Enbrel for unapproved uses.
The drug maker, based in Thousand Oaks, California, agreed to a consent judgment last Tuesday, Law360 reports. New York Attorney General Eric Schneiderman and the 47 other attorneys general said Amgen marketed Aranesp (darbepoetin alfa) for cancer-related anemia without FDA approval and had promoted Enbrel (etarnecept) to treat mild plaque psoriasis — an auto-immune disorder that causes scaling and flaking of the skin— although the drug is approved only for moderate to severe plaque psoriasis, according to Schneiderman.
Aranesp is approved to treat certain types of anemia by stimulating the bone marrow to produce red blood cells. Enbrel is approved to treat conditions including certain types of plaque psoriasis. Schneiderman said "[c]onsumers need to have confidence in the accuracy of claims made by pharmaceutical companies." Pharmaceutical companies are prohibited from "making unapproved and unsubstantiated claims about prescription drugs," the statement said. In addition to promoting unapproved uses of the drugs, the attorneys general say Amgen promoted Aranesp for different dosage periods than what the FDA approved, and claimed that Enbrel's effects are longer-lasting than they actually are, Law360 reports.
Amgen is required to reform its marketing practices. The settlement prohibits the company from using drug compendiums—reference books that list a drug's strengths, qualities and ingredients—to promote Aranesp and similar blood stimulant medications, and Enbrel, the attorneys general said. Amgen is also forbidden from using outside lobbyists to facilitate the inclusion of such claims in compendiums without clarifying that they are representing Amgen's interests, according to Schneiderman's statement. New York's share of the settlement is over $3.16 million. Only South Carolina and Mississippi, did not participate in the settlement, Law360 reports.
Amgen, in a statement, said the settlement addresses some of the issues the company settled with the federal government in December 2012. Amgen spokeswoman Kelley Davenport said, "Separate state and federal resolutions of the same underlying issues is the normal practice in such legal matters." She added Amgen is pleased to have the matter resolved. Davenport said Amgen has a strong compliance program, and "is dedicated to fostering a culture of doing the right thing at Amgen in full compliance with the law," Law360 reports.
In 2012, Amgen pled guilty in federal court in New York to misbranding Aranesp. The company agreed to a combined $762 million civil and criminal payout to resolve allegations about its sales and marketing practices, according to Law360. Amgen paid $150 million in criminal forfeitures and penalties for marketing the drug to health care providers for unapproved uses. In addition, the company paid $612 million in civil settlement payments in related whistleblower lawsuits.