Amgen to Pay $71 Million to State AG Charges

Amgen Inc. will pay $71 to resolve allegations that it unlawfully promoted biologic medications Aranesp and Enbrel for uses not approved by the U.S. Food and Drug Administration (FDA).

amgenAranesp 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.

Amgen was represented by Brien O’Connor of Ropes & Gray in Boston and David Rosenbloom of McDermott Will & Emery in Chicago.

“Corporations must be held accountable for promoting uses of their pharmaceutical products that have not been established by the FDA to be safe and effective,” Massachusetts Attorney General Maura Healey said. “We are proud to have worked with our state partners to achieve this settlement and bring more than one million dollars back to Massachusetts.”

The complaint, filed and joined by AG Healey along with 48 attorneys general, alleges that Amgen violated state consumer protection laws by promoting Aranesp for anemia caused by cancer without having FDA approval, and promoting Enbrel for mild plaque psoriasis even though Enbrel is only approved by the FDA to treat chronic moderate to severe plaque psoriasis.

Under the consent decree, “Amgen does not admit any violation of the State Consumer Protection Law, and does not admit any wrongdoing that was or could have been alleged by any Signatory Attorney General before the date of the Consent Judgment under those laws.”

“No part of this Consent Judgment, including its statements and commitments, shall constitute evidence of any liability, fault, or wrongdoing by Amgen.  This document and its contents are not intended for use by any third party for any purpose, including submission to any court for any purpose.”

Under the terms of the consent judgment, Amgen is required to reform its marketing and promotional practices and is prohibited from making any written or oral claim that is 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 compendium listing – or reference book listing drug strengths, quality, and ingredients – or publication to promote Enbrel or any drug in the same class as Aranesp for an off-label use to a health care professional, allowing Amgen’s marketing and sales personnel to determine the content of any materials for submissions to a compendium relating to Enbrel or any drug in the same class as Aranesp, and submitting a supplement to a compendium to support an off-label use of Enbrel or any drug in the same class as Aranesp or using a third party to lobby a compendium on Amgen’s behalf without disclosing that it is acting at Amgen’s request.


Copyright © Corporate Crime Reporter
In Print 48 Weeks A Year

Built on Notes Blog Core
Powered by WordPress