New Jersey Attorney General Announces Subpoena of Pharmaceutical Firm Over Marketing of Injectable Drug Enbrel
TRENTON, Jan. 17, 2008 -- New Jersey 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. Â
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.