Paxton Announces $71 Million Multi-State Settlement with Amgen

Texas Insider Report: AUSTIN Texas Texas Attorney General Ken Paxton today announced that Texas along with 48 other states has reached a $71 million settlement with Amgen relating to the promoting of its anemia and plaque biologic medications.  Texas share of the settlement is $4.3 million.    Arenesp is a treatment for anemia and Enbrel treats a variety of conditions including plaque psoriasis. The Petition and Agreed Final Judgment and Permanent Injunction filed today alleges that Amgen violated state consumer protection laws by:

1. promoting Aranesp for dosing frequencies longer than the FDA approved label without competent and reliable scientific evidence to substantiate the extended dosing frequencies;
2. promoting Aranesp for anemia caused by cancer without having FDA approval or competent and reliable scientific evidence to support it; and
3. promoting Enbrel for mild plaque psoriasis even though Enbrel is only approved by the FDA to treat chronic moderate to severe plaque psoriasis.

This settlement sends an important message to those who unsafely market medicines and treatments to people who are desperate to feel better" Attorney General Paxton said. Research and development has given us amazing new treatments for a variety of ailments but when companies skirt the law it costs the entire industry opportunity and the trust of the public."

The Consent Judgment also requires Amgen to reform its marketing and promotional practices. Under its terms Amgen shall not:

• Make or cause to be made any written or oral claim that is false misleading or deceptive in promoting Enbrel or any drug in the same class as Aranesp;
• represent 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;
• use a compendium listing or publication to promote Enbrel or any drug in the same class as Aranesp for an Off-Label use to a Health Care Professional;
• allow Amgen Marketing and Amgen Sales to initiate interactions with a compendium or determine the content of any materials for submissions to a compendium relating to Enbrel or any drug in the same class as Aranesp; or
• submit a special supplement to a compendium to support an off-label use of Enbrel or any drug in the same class as Aranesp or use a third party to lobby a compendium on Amgens behalf without notifying the compendium that it is acting at Amgens request.

The other states participating in the settlement are Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware District of Columbia Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Dakota Tennessee Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming. To view a copy of the petition please visit: https://www.texasattorneygeneral.gov/files/epress/images/2015/Petition_-_Amgen.PDF To view a copy of the judgement please visit: https://www.texasattorneygeneral.gov/files/epress/images/2015/Judgement_-_Amgen.pdf