Press Release: AG Jepsen: Connecticut Joins $71 Million Multistate Settlement with AMGEN Resolving Deceptive Marketing Allega...
19 August 2015 - 3:01AM
Dow Jones News
AG Jepsen: Connecticut Joins $71M Multistate Settlement with
AMGEN Resolving Deceptive Marketing Allegations
Attorney General George Jepsen today announced that Connecticut
has joined with 47 other states and the District of Columbia in a
$71 million settlement with biopharmaceutical company AMGEN, Inc.
to resolve allegations that the company unlawfully promoted two
biologic medications, Aranesp and Enbrel.
Aranesp is a biologic used to treat certain types of anemia by
stimulating bone marrow to produce red blood cells. The states
alleged that AMGEN marketed and promoted Aranesp for treating
anemia caused by cancer when it had never received approval from
the federal Food and Drug Administration (FDA) to use the drug for
that class of anemia.
The states further alleged that, in order to receive
reimbursement for insurance companies and federal programs for the
drug's prescription, the company lobbied aggressively for Aransep
to be listed in a drug compendium recognized by the Centers for
Medicare and Medicaid and that the company failed to timely
disclose to the compendium findings from drug trials showing an
increased risk of death and possible tumor stimulation in cancer
patients receiving the drug for anemia caused by cancer. AMGEN is
no longer marketing Aranesp.
Enbrel, also a biologic, is approved by the FDA for the
treatment of certain types of arthritis and chronic moderate to
severe plaque psoriasis in adults. The states alleged that AMGEN
overstated Enbrel's effectiveness and lacked competent and reliable
evidence to support the drug's use in the treatment of mild
psoriasis.
The states alleged that, despite a warning letter from the FDA
in 2005 about the company's advertisement of Enbrel, and despite
the issuance of FDA black box warnings about invasive infections
other risks observed in patients taking Enbrel - including lymphoma
and other malignancies observed in children and adolescent patients
- AMGEN promoted Enbrel off-label for patients with mild plaque
psoriasis from 2004 to 2011 and overstated its efficacy in
treatment of plaque psoriasis.
"Deceptive marketing in the pharmaceutical is particularly
concerning because, in addition to violating our unfair trade
practice laws, it could have potentially significant and dangerous
consequences on the health and well-being of those taking the
drug," said Attorney General Jepsen. "The settlement reached with
AMGEN will help to ensure that this company does not engage in
marketing practices for these biologic drugs that could be harmful
to patients in Connecticut and across the country."
Connecticut's share of the $71 million in settlement funds is
$1,026,663.83, which will be deposited in the state's General
Fund.
In addition to the settlement funds, the company has agreed to
significantly reform its marketing and promotional practices. Under
the settlement terms, the company will 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;
• 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 drug compendium listing or publication to promote Enbrel
or any drug in the same class as Aranesp to a proscriber or
healthcare professional for an off-label use;
• Allow its sales or marketing staff to develop or disseminate
medical content or determine the content of information submitted
to a drug compendium;
• Submit any written materials for which AMGEN has paid a
journal for placement or publication to a drug compendium to
support an off-label use of Enbrel or any drug in the same class as
Aranesp; and
• Use a third party to lobby a drug compendium on AMGEN's behalf
without notifying the drug compendium that it is acting at AMGEN's
request.
Assistant Attorneys General Jose Rene Martinez Onofre, Jeremy
Pearlman and Lorrie Adeyemi, head of the Consumer Protection
Department, assisted the Attorney General with this matter.
Please click here to view the complaint and settlement
documents.
###
Media Contact:
Jaclyn M. Falkowski
jaclyn.falkowski@ct.gov
860-808-5324 (office)
860-655-3903 (cell)
Consumer Inquiries:
860-808-5318
attorney.general@ct.gov
Facebook: Attorney General George Jepsen
Twitter: @AGJepsen
Subscribe to WSJ: http://online.wsj.com?mod=djnwires
(END) Dow Jones Newswires
August 18, 2015 12:46 ET (16:46 GMT)
Copyright (c) 2015 Dow Jones & Company, Inc.
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