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Attorney
General Mike DeWine
49 AGs Reach
$71 Million Settlement with Amgen over Drug Marketing
(COLUMBUS, Ohio)—Ohio Attorney General Mike DeWine, along with 48 other
attorneys general, today announced a $71 million settlement with the
pharmaceutical company Amgen over allegations that it unlawfully
promoted two of its drugs, Aranesp and Enbrel.
Ohio will receive $1,856,585 as part of the settlement.
Aranesp 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.
The attorneys general alleged that Amgen violated state consumer
protection laws by:
Promoting Aranesp for dosing frequencies longer than the U.S. Food and
Drug Administration (FDA) approved label without competent and reliable
scientific evidence to substantiate the extended dosing frequencies;
Promoting Aranesp for anemia caused by cancer without having FDA
approval or competent and reliable scientific evidence to support it;
and
Promoting Enbrel for mild plaque psoriasis even though Enbrel is only
approved by the FDA to treat chronic moderate to severe plaque
psoriasis.
“Unlawful promotion of pharmaceutical drugs is a problem we take
seriously,” Attorney General DeWine said. “Under this settlement, Amgen
has agreed not only to pay millions of dollars to the states but also
to make significant changes to the way it promotes these drugs.”
Under the settlement, Amgen agrees to reform its marketing and
promotional practices. Specifically, Amgen shall:
Not make any written or oral claim that is false, misleading, or
deceptive in promoting Enbrel or any drug in the same class as Aranesp;
Not 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;
Not use a listing in a publication or compendium (a non-profit
reference book listing drug strengths, quality, and ingredients) to
promote Enbrel or any drug in the same class as Aranesp for an
off-label use to a healthcare professional;
Not allow Amgen’s marketing and sales teams to initiate interactions
with a compendium or 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
Not 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 Amgen’s behalf without notifying the
compendium that it is acting at Amgen’s request.
Participating in the settlement are the attorneys general of: 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, Texas, Utah, Vermont, Virginia,
Washington, West Virginia, Wisconsin, and Wyoming.
The proposed settlement (a consent judgment) and a complaint outlining
the allegations against Amgen were submitted to the Franklin County
Common Pleas Court.
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