Healthy Skepticism Library item: 12020

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

González A.
Feds issue subpoenas for Amgen records
Seattle Times 2007 Nov 13
http://seattletimes.nwsource.com/html/businesstechnology/2004010210_amgen13.html

Full text:

U.S. attorneys in Seattle and New York issued subpoenas to Amgen seeking “documents relating to its products,” the company said Friday in a regulatory filing.

The Thousand Oaks, Calif.-based company, which is the biggest local biotech employer, didn’t disclose what products were involved. Amgen said it will cooperate fully with the subpoenas.

Amgen’s filing with the Securities and Exchange Commission said it received a subpoena Oct. 25 from the U.S. attorney for New York’s Eastern District, and another Nov. 1 from the U.S. attorney in Seattle.

The U.S. Attorney’s Office for the Western District of Washington didn’t return a call for comment.

The world’s largest biotech company, Amgen has faced severe financial and regulatory fallout in recent months from safety concerns related to two of its best-selling anemia treatments.

It’s unclear whether the documents requested by federal authorities are related to those anemia drugs, Aranesp and Epogen.

Congress and the federal Centers for Medicare and Medicaid (CMS) Services are looking closely at the drugs after researchers showed increased risk from using the therapies at doses higher than approved by the Food and Drug Administration.

In July, CMS tightened restrictions on the dosages of Aranesp and Epogen it would pay for.

Last week, Amgen asked CMS to reconsider the restrictions and said it would present new evidence to support that request.

Thursday, the FDA further strengthened boxed warnings for the products, after already stiffening the warnings in March.

The issue has been a blow to Amgen’s finances. The company announced it would eliminate about 2,600 jobs out of its 20,000-strong global work force. Some 50 people were laid off in Seattle, and others have left voluntarily.

In Friday’s filing, Amgen disclosed that a union health-insurance fund sued the company Nov. 2, alleging both federal and state antitrust violations, as well as violations of California’s Unfair Competition Law.

The Sheet Metal Workers National Health Fund sued in federal court in New Jersey, claiming Amgen “engaged in an ‘anticompetitive tying arrangement and pricing scheme’ involving the sale of three of our marketed products, Neupogen, Neulasta and Aranesp,” Amgen reported.

The company said it has not yet been served in that suit.

Amgen also said it would close one of its Enbrel manufacturing facilities to bring costs down. The facility is in Rhode Island, spokeswoman Carol Pawlak said.