The Attorney General’s office reports Aranesp is used to treat certain types of anemia by stimulating bone marrow to produce red blood cells.
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The second drug, Enbrel, is approved by the FDA for treatment of certain types of arthritis and chronic moderate to severe plaque psoriasis in adults; but the states alleged Amgen overstated its effectiveness and lacked evidence to support its use for mild psoriasis.
The agreement requires Amgen to reform its marketing practices and prevents it from promoting off-label uses of Enbrel and Aranesp.
“Pharmaceutical companies are prohibited from making unapproved and unsubstantiated claims about prescription drugs”, said New York Attorney General Eric Schneiderman.
Amgen did not admit to any wrongdoing Tuesday in the settlement with the states, though it pleaded guilty to a criminal charge of illegally introducing a misbranded drug, Aranesp, into interstate commerce in 2012.
The settlement with 48 states involves allegations that Amgen unlawfully promoted biologic medications Aranesp and Enbrel.
In that case, in U.S. District Court in Brooklyn, Amgen was recommending higher doses and frequency of use than the drug was labeled for by the FDA.
Arizona will receive $2.2 million as a result of the national settlement.
Although doctors can prescribe medications for off-label uses, drug companies are banned from promoting uses that aren’t approved by the FDA.
Despite these growing concerns, Amgen promoted Aranesp to treat anemia caused by cancer.
Aside from the financial settlement, Amgen is also required to modify its current advertising approach in such a way that the misleading claims are removed and discontinued. “Amgen is pleased to have this matter resolved, and remains committed to fulfilling its mission to serve patients”, a company spokeswoman said in an email.
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The case was handled by Attorney General Herring’s Consumer Protection Section, which helps educate Virginians about fraud and accepts consumer complaints regarding a variety of issues.
