Press Release: Amgen to Pay $71 Million for Improper Drug Marketing, AG Cooper Says
August 18 2015 - 12:47PM
Dow Jones News
AMGEN TO PAY $71 MILLION FOR IMPROPER DRUG MARKETING, AG COOPER
SAYS
NC to get $2.1 million for faulty promotion of Aranesp,
Enbrel
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.
Arenesp
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
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.
Link: Amgen to pay $71 million for improper drug marketing, AG
Cooper says
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(END) Dow Jones Newswires
August 18, 2015 12:32 ET (16:32 GMT)
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