PHARMACY

Senate passes Defense bill, maintains TRICARE

BY Adam Kraemer

WASHINGTON The Senate voted 91-3 on Tuesday to approve a new version of the National Defense Authorization Act, revised following a pocket veto by President Bush in December.

The House of Representatives last week passed its version, H.R. 4986, a bill similar to the Defense Authorization Act that was vetoed by President Bush, who objected to a provision related to funding for the Iraqi government. As such, it retains important provisions related to the TRICARE pharmacy program.

The National Association of Chain Drug Stores applauded the bill’s passage, especially the two “critical” provisions it had long championed: “1) extending the current freeze on increases to retail pharmacy co-payments; and 2) language clarifying that the Department of Defense may negotiate with drug manufacturers for federal pricing discounts for TRICARE prescriptions filled at retail pharmacies, in the same manner as they do today for TRICARE prescriptions filled at military bases or by mail order.” The NACDS claimed in a statement Wednesday that this last would save the DOD $1.8 billion through the year 2012.

The White House is expected to sign the revised $696 billion bill into law. The portion of the original bill to which the President objected, a provision relating to funds for lawsuits brought against states that sponsor terrorism, has been removed. The bill also includes a 3.5 percent pay raise for military personnel. Both houses of Congress are hoping to avoid another veto. “The administration’s people need to work more closely with both parties,” said Senate Armed Services member Ben Nelson, D-Neb.

“NACDS applauds the Senate for taking the earliest opportunity to pass a revised version of this bill,” stated NACDS president and chief executive officer Steve Anderson. “Our nation’s soldiers, military retirees and their families should have the freedom to choose where they obtain prescription medications, and this legislation will help preserve access to retail pharmacies in the TRICARE program. The bill will not only maintain choice for TRICARE beneficiaries—it also provides substantial savings to the Department of Defense.”

“We commend the House and Senate Armed Services Committees for their leadership and commitment on these important provisions,” Anderson continued. “The Senate’s action yesterday has brought us one step closer to achieving good public policy that is pro-soldier and pro-savings. We urge President Bush to sign this legislation promptly so that it can be enacted into law.”

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Ranbaxy, GSK settle over Imitrex litigation

BY Drew Buono

HARYANA, India Ranbaxy Laboratories has settled litigation with GlaxoSmithKline related to sumatriptan succinate tablets, the generic of GlaxoSmithKline’s drug Imitrex, according to published reports.

The settlement will allow Ranbaxy to exclusively sell the generic for 180 days starting December this year. Under the terms of the settlement, Ranbaxy can distribute a generic version of sumatriptan in 25 mg, 50 mg and 100 mg doses.

Analysts expect the company to make around $100 million in sumatriptan sales in the U.S. during the exclusivity period. Sumatriptan sales in the U.S. are worth $985 million, according to IMS data.

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FDA delays Kynapid decision pending final review

BY Drew Buono

VANCOUVER, Canada The Food and Drug Administration has delayed its decision on an application for the heart treatment drug Kynapid, according to published reports. The drug manufacturer Cardiome Pharma and its co-development partner Astellas Pharma US said yesterday that the FDA did not provide an action letter by the expected date of Jan. 19.

The application for Kynapid (vernakalant hydrochloride), based on a five-year clinical development program, was submitted in December 2006. In December 2007, the FDA’s cardiovascular and renal drugs advisory committee voted 6-2 in favor of recommending to the FDA that Kynapid be approved for the rapid conversion of acute atrial fibrillation to sinus rhythm.

“While we look forward to the FDA reaching a decision, we respect their need for additional time to review the Kynapid’s application,” said William Fitzsimmons, senior vice-president for research and development at Astellas.

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