TRENTON
-- Attorney General Anne Milgram announced
today that the State has issued a subpoena
to the pharmaceutical company AmGen, Inc.
concerning allegations that, in an effort
to increase the sale of its injectable drug
Enbrel, the company violated patient confidentiality
laws and marketed the drug for uses for
which it was not approved.
An
immunosuppressant drug, Enbrel was originally
approved by the federal Food and Drug Administration
for treatment of Rheumatoid Arthritis. It
was subsequently approved for treatment
of such ailments as juvenile rheumatoid
arthritis, psoriatic arthritis and, most
recently, moderate to severe psoriasis.
Past FDA warnings have cautioned that Enbrel
may lead to significant, and potentially
life-threatening, side-effects in some patients.
According
to Attorney General Milgram, the state-issued
subpoena calls for AmGen to deliver a comprehensive
array of documents and information concerning
the marketing, sale and prescription of
Enbrel between July 2002 and the present.
The
principal focus of the State’s inquiry
is whether AmGen, Inc. unlawfully engaged
in “off-label” marketing --
essentially promoting a drug for uses other
than those for which it was FDA-approved
– and whether the company violated
medical privacy laws for the purpose of
direct marketing.
Served
on January 14, the state subpoena calls
on AmGen to deliver the required materials
to the Division of Consumer Affairs offices
in Newark by February 4, 2008. The state’s
investigation is being conducted by the
Affirmative Litigation Unit within the Division
of Law.
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