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Amgen agrees to $71m settlement over false advertising

pharmafile | August 19, 2015 | News story | Sales and Marketing Amgen, Aranesp, Enbrel 

Amgen has reached a $71 million settlement with 48 US states and the District of Columbia, to resolve allegations that the company illegally promoted the biologic medications Aranesp and Enbrel for off-label uses.

Amgen’s home state of California will receive the largest share of the settlement at $4.6 million, while $3.16 million goes to New York, and Ohio will receive 1.8 million.

Amgen was accused by multiple state attorney generals of having violated consumer protection laws by promoting Aranesp (darbepoetin alfa) for dosing frequencies longer than the FDA-approved label, as well as advertising it for cancer-related anaemia without FDA approval.

In the case of Enbrel (etanercept), Amgen advertised it as a treatment for mild plaque psoriasis between 2004 and 2011, and additionally overstated the duration of its effectiveness. However the drug is only approved by the FDA for treatment of chronic moderate to severe plaque psoriasis,

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In a press release, New York State Attorney General Eric Schneiderman, who served on the investigative committee, says: “Pharmaceutical companies are prohibited from making unapproved and unsubstantiated claims about prescription drugs. Consumers need to have confidence in the accuracy of claims made by pharmaceutical companies.”

As a condition of the settlement, Amgen will be required to reform its marketing practices, and is forbidden from continuing in its current false claims.

Joel Levy

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