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Amgen to pay $71M Nationwide for Improper Drug Marketing, Attorney General Roy Cooper Says
NC to get $2.1 million for faulty promotion of Aranesp, Enbrel
NC Dept of Justice Press Release
Aug. 18, 2015
Raleigh: Drug manufacturer Amgen will pay North Carolina and 48 other states $71 million to resolve allegations that the company unlawfully promoted two medications, Attorney General Roy Cooper said Wednesday.
“Drug companies have a duty to put safety before profits, and that means marketing medicines for approved uses only,” Cooper said.
Cooper’s Consumer Protection Division filed a complaint and consent judgment in Wake County Superior Court against Amgen this morning. North Carolina will receive more than $2.1 million as its share of the judgment.
The settlement resolves allegations that Amgen illegally used a practice called off-label marketing to promote two biologic medications, Arenesp and Enbrel, for purposes that had not been approved by the Food and Drug Administration (FDA) or for which there was not competent and reliable scientific evidence. Once the FDA has approved a particular use of a drug as safe and effective, drug companies are prohibited from marketing it for any unapproved use.
The FDA has approved Arenesp to treat certain types of anemia by stimulating bone marrow to produce red blood cells. In the complaint and consent judgment filed today, North Carolina and the other states allege that Amgen illegally promoted Aranesp for dosing frequencies longer than the FDA approved label without competent and reliable scientific evidence to substantiate the extended dosing frequencies. The states also contend that Amgen unlawfully marketed Aranesp for anemia caused by cancer without credible scientific evidence or the required FDA approval.
Enbrel is approved by the FDA to treat a number of conditions, including certain types of arthritis and plaque psoriasis. The states allege that Amgen promoted Enbrel for mild plaque psoriasis even though Enbrel is only approved by the FDA to treat chronic moderate to severe plaque psoriasis.
Consent judgment requires reforms
In addition to paying $71 million, including $2,142,922.31 to North Carolina, Amgen is required to change its marketing practices to avoid false, misleading, or deceptive promotion of Enbrel or any medication in the same class as Aranesp.
The consent judgment bans Amgen marketing and sales professionals from preparing materials for or submitting supplementary information to drug reference books used by medical professionals. Amgen is also prohibited from misrepresenting the sponsorship, approval, characteristics, ingredients, uses, benefits or qualities of Enbrel or any medication in the same class as Aranesp.
“Patients and doctors deserve accurate information about medications based on sound science, and that’s what this agreement requires,” Cooper said.