New Jersey subpoenas Amgen's Enbrel marketing records

NEWARK, N.J. — New Jersey investigators today said they have subpoenaed records from Amgen following accusations from two former sales representatives that the biotech company pushed its sales force to market a top selling psoriasis drug for unapproved uses.

Amgen on Monday was ordered to deliver by Feb. 4 "a comprehensive array" of documents and information concerning the marketing, sale and prescription of Enbrel from July 2002 to the present, Attorney General Anne Milgram said.

She said the state is primarily focused on whether Amgen engaged in "off-label" marketing by promoting the arthritis and psoriasis treatment for uses that have not been approved by the Food and Drug Administration, and whether the company violated medical privacy laws for the purpose of direct marketing.

Amgen spokeswoman Mary Klem, in a statement, said the company would fully cooperate with the attorney general, but declined to discuss the matter in detail.

"The company does not comment on pending investigations or personnel maters. Our sales creed emphasizes that Amgen sales representatives follow compliance guidelines with absolute consistency," Klem said in the statement.

Amgen, of Thousand Oaks, Calif., co-markets Enbrel in the U.S. and Canada with Madison, N.J.-based Wyeth. Enbrel is a top seller, with sales of nearly $3 billion in 2006. Enbrel was developed for rheumatoid arthritis during the late 1990s in Seattle at Immunex, which Amgen acquired in 2002. Amgen has about 1,000 employees in the Seattle area.

The attorney general's office had no immediate comment on whether it has also subpoenaed Wyeth, and Wyeth had no immediate comment.

Lydia Cotz, a lawyer for two former Amgen sales representatives who are suing the biotech company, said, "I'm pleased that the state of New Jersey's Attorney General's Office will now be conducting a thorough investigation of Amgen's unethical marketing of Enbrel."

Those former workers charged that Amgen pushed its sales force to search doctor's confidential medical records for potential patients to boost Enbrel sales. They claim they objected to superiors and refused to participate in the effort, which legal experts say violates federal patient privacy law.

The veteran sales representatives also charged they were encouraged to get insurance companies to approve reimbursement for Enbrel for patients with mild psoriasis.

Enbrel, an injected, genetically engineered drug, is approved for use in patients with moderate to severe psoriasis; it has severe side effects in some patients, including occasionally fatal infections. The drug is also approved to treat rheumatoid arthritis.

One of the sales representatives, Elena Ferrante of Montvale, N.J., was fired in August 2005, while the other, Mark Engelman of Laguna Niguel, Calif., resigned last year after Cotz said he received a negative performance review.

The lawsuits are being handled through national arbitration services, because Amgen requires in its employment contracts that disputes be settled that way, Cotz said. Ferrante's case was filed in October in New York and Engelman's was filed in mid-December, she said.