PHARMACY

Amgen hit with subpoenas from U.S. attorneys seeking documents

BY Drew Buono

NEW YORK and SEATTLE Attorneys in the Western District of Washington and the Eastern District of New York have filed federal subpoenas against biotech company Amgen, seeking documents relating to the companys’ products, according to The New York Times.

The company released the requests during a filing to the Securities and Exchange Commission. They were received on Oct. 25 from New York and on Nov. 1 from Seattle. It has not yet been released as to whether the products stated in the subpoenas are the company’s anemia drugs, which have been part of a major issue recently with the Centers for Medicaid and Medicare.

CMS recently suggested that patients on anemia drugs should have a hemoglobin level less than 10 g/dL. Amgen, a manufacturer of erythropoieses-stimulating agents Aranesp and Epogen were looking for the levels to be between 10 and 12 g/dLs.

The company, as a result, stated that it would eliminate 2,600 jobs.

The company also announced that it had been sued in federal court in New Jersey by the Sheet Metal Workers National Health Fund for allegedly, “engaging in an ‘anticompetitive tying arrangement and pricing scheme’ involving the sale of three of its marketed products, Neupogen, Neulasta and Aranesp,” according to Amgen.

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Cephalon submits application to FDA for supplemental uses of Fentora

BY Drew Buono

FRAZER, Pa. Cephalon has submitted a supplemental application to the Food and Drug Administration to market its cancer drug Fentora as a “breakthrough pain” drug that would treat chronic pain conditions that could include lower back and neuropathic pain, according to the Philadelphia Business Journal.

Breakthrough pain is characterized as pain that is rapid on its onset and moderate-to-severe in intensity and relatively short in duration. If the application is approved, Fentora would also be indicated for breakthrough pain in chronic pain conditions experienced by opiod-tolerant patients.

In September, the FDA and Cephalon issued warnings to patients and doctors alerting them of the potential fatal risk factors associated with improper use of Fentora in such cases as patients using them to treat migraines or other types of short-term pain. Cephalon is also working with the FDA to update the package insert of the drug to include revised patient selection criteria and dosing instructions.

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Reverse-payment bill held up in Congress by pharmaceutical lobbying

BY Drew Buono

WASHINGTON Legislation aimed at speeding up the availability of cheaper generic drugs has stalled in Congress due to major lobbying by the drug industry, according to the Associated Press.

The Senate bill would ban most reverse payments, which occur when a brand-name company pays a generic manufacturer to delay the introduction of a drug.

An Associated Press review of lobbying reports, from July 1, 2006, through June 30, 2007, found that $38.8 million was spent by at least a dozen generic and brand-name companies and their trade associations on issues including the Senate legislation.

More than half of those expenses were piled up by the Pharmaceutical Research & Manufacturers of America, which represents brand-name drug companies. PhRMA spent $19.5 million in the 12-month period ended June 30 on in-house lobbying expenses, an increase of about $3 million over the previous 12-month period.

And the Generic Pharmaceutical Association reported lobbying expenses of around $420,000 for the first six months of this year. The remaining $19 million was spent by a variety of drug companies, including Bayer, Schering-Plough, Pfizer and Teva Pharmaceuticals.

“Lobbyists have a lot of influence in Washington,” said the bill’s sponsor, Sen. Herb Kohl, D-Wis., who chairs the Senate Judiciary subcommittee on antitrust, competition policy and consumer rights. “If we can just get this to a vote, it will be pretty hard for people to vote against it. A vote against this is a vote against consumers.”

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