PHARMACY

FDA “needs this money now” Specter says

BY Adam Kraemer

WASHINGTON Sen. Arlen Specter, R-Pa., in a letter sent Tuesday to Health and Human Services secretary Michael Leavitt, accused the administration of hindering the appropriation of funds to the Food and Drug Administration. Funds that Specter claimed were necessary to “save lives.”

Specter’s letter stated that, while the additional $275 million amendment to the federal budget for fiscal year 2009 submitted Monday by the White House Office of Management and Budget was an effort to be applauded, the timing of the request will “undermine” Congress’ attempts to provide more immediate funds to FDA. “While I applaud the effort to provide additional dollars for protecting the food supply, assuring safer drugs and modernizing FDA buildings,” the letter read, “I do not understand the timing of this request.”

While Specter has been working to get an additional $275 million in FDA funding included in a fiscal 2008 supplemental appropriations bill—a figure FDA commissioner Andrew von Eschenbach had suggested would provide FDA adequate resources needed to protect the country’s health—he acknowledged that current debate could lead to the elimination of the FDA emergency funding portion from the bill. “Currently, negotiations are underway to reduce the domestic portion of the supplemental bill,” Specter wrote in his June 10 letter. “The FDA funding is among the items being discussed for elimination.” 

“The submission of your budget amendment at this time undermines the work we have been doing to obtain these additional dollars on an expedited basis,” Specter continued, adding that by including the funds in next year’s budget instead of supporting the supplemental dollars in the fiscal 2008 budget means “no additional dollars will be available until March or April of 2009—at the earliest.”

The letter shows Specter’s frustration with what he views as a lack of urgency on the part of the administration to get the FDA additional funding this year. “The 81 deaths due to contaminated heparin and the one suspected death in the ongoing salmonella outbreak [linked to tomatoes] show that we cannot wait nine months to give FDA the resources needed to protect the public.”

To view the full text of the letter, click here.

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Florida e-prescribing organization releases registered vendor list

BY Alaric DeArment

JACKSONVILLE, Fla. ePrescribe Florida, an organization that assists pharmacies in adopting electronic prescription systems, released a list of registered vendor solutions Tuesday.

Registered vendors made the list by meeting a set of e-prescribing and patient-safety criteria, such as alerting customers about potential interactions between drugs and allergies, as well as meeting Medicare electronic prescription standards. The list of 13 vendors includes H2H Solutions, iScribe, MedPlus, Misys Healthcare Systems and NextGen Healthcare.

ePrescribe Florida comprises various pharmacies, physicians, insurers, health-care improvement organizations and other organizations and professionals.

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Cephalon sues Watson over Fentora patent

BY Alaric DeArment

NEW YORK Drug maker Cephalon alleges that Watson infringed on its patent by developing a generic equivalent to its drug, Fentora.

Fentora (fentanyl citrate) is used to treat pain in cancer patients and received approval from the Food and Drug Administration in September 2006.

Watson applied for FDA approval of its generic version in April. In response, Cephalon filed a lawsuit in the U.S. District Court for the District of Delaware on June 2, asserting that Watson had infringed on patents ‘604 and ‘590, both of which expire in 11 years.

Fentora recorded sales of $135 million in 2007.

The FDA has, however, granted approval for Watson’s application for a generic version of KV Pharmaceutical’s Micro-K Extencaps in 600 mg and 750 mg doses.

The company that is now Wyeth sold global rights and the trademark for Micro-K to KV for $36 million in 1999. Micro-K had sales of $80 between March 2007 and March 2008, according to IMS Health data.

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