FDA commissioner asks Congress for additional $275 million
WASHINGTON Food and Drug Administration commissioner Andrew von Eschenbach has written to Congress, asking for an additional $275 million in funding immediately to help ensure that imported foods, drugs and medical devices are safe, according to The New York Times.
The request was made in a letter to Sen. Arlen Specter, R-Pa., that offers a detailed spending plan for such things as opening new foreign offices, increasing inspections and constructing new databases to track drug hazards.
Since the president announced the budget for the FDA in February, which was only an increase of $50.7 million from the prior year, the commissioner has been targeted by both Republicans and Democrats in the House and Senate asking how much it would take for the agency to operate in the coming year.
Matters got worse when reports kept popping up regarding tainted drugs and food entering the country.
Before the House Energy and Commerce Subcommittee on Investigations in April, von Eschenbach barely got a word in edgewise as Rep. John Dingell, D-Mich., who is the chairman of the commerce committee, asked him again and again to state a figure that would allow the FDA to inspect adequately imported food and drugs. Von Eschenbach never gave a figure.
In the Senate a week earlier, Sen. Robert Bennett, R-Utah, also tried to get von Eschenbach to specify how much more the agency needed. Von Eschenbach refused to give a number, but he did say that the agency could not efficiently absorb a $375 million increase in its budget next year.
In his letter to Specter, however, von Eschenbach said the agency could absorb an additional $275 million in just the next few months.
Last week, Sen. Herb Kohl, D-Wis., chairman of the Senate appropriations subcommittee with jurisdiction over the FDA, sponsored a measure that would provide the FDA an additional $275 million this year as part of an emergency supplemental appropriations bill largely intended to finance the war in Iraq, according to published reports.
The supplemental bill seems to be the only way to provide additional financing to the FDA, since appropriations bills for next year are likely to stall.
Kohl’s measure resembles von Eschenbach’s letter to Specter. Both call for $125 million to finance food safety activities; $100 million for medical product and drug safety activities; $40 million for modernizing FDA’s science and work force; and $10 million to upgrade agency facilities and laboratories. Nonetheless, all parties now seem to be happy about von Eschenbach’s move, the Times reported.
Sanofi-Aventis, Debiopharm sue W.C. Heraeus over Eloxatin patent
BRIDGEWATER, N.J. Sanofi-Aventis and Debiopharm have filed a lawsuit in the U.S. District Court for the District of New Jersey against W.C. Heraeus, in which they accuse the company of helping generic drug makers infringe a patent on their active ingredient for the colorectal cancer drug Eloxatin.
In the suit, the plaintiffs claim that Heraeus manufactured the active pharmaceutical ingredient in Eloxatin for Mayne Pharma, Sandoz and Ebewe Pharma. The three companies independently submitted applications to sell generic versions of the drug before the 2013 expiration of the ‘874 patent.
Sanofi and Debiopharm have asked the court to issue a permanent injunction restraining Heraeus and its officers from selling and importing generic oxaliplatin products claimed in the patent into the U.S.
Currently, there are no FDA-approved generic versions of the drug, which had worldwide sales of $2.35 billion in 2007, according to Sanofi.
FutureScripts launches new Web site
PHILADELPHIA FutureScripts, a pharmacy benefit manager in Philadelphia, has unveiled a new website, www.futurescripts.com. The website is a tool for plan participants, health care professionals and benefit managers to help find key information about the drugs on FutureScripts’ formulary, how safe prescribing procedures work and much more.
“The new website allows our customers to find vital information about their medications—whether a drug is available as a generic and what that drug costs compared to similar medications,” said Paul Urick, senior vice president of FutureScripts. “Our website also provides health care professionals and plan participants the latest updates on the drugs on our formulary.”
Through the site, plan participants can find a participating pharmacy within the FutureScripts’ national network of more than 60,000 retail and specialty locations by ZIP code search or by entering a pharmacy name benefit managers can read about the latest pharmacy trends through the online FutureScripts InSight newsletter. The frequently asked questions section features the most common inquiries received by FutureScripts, ranging from ‘What is a 96-hour temporary supply?’ to ‘How do I request an exception to an age, gender, or quantity limit?’
“Overall, our new site was designed to service the needs of our customers and was developed in response to their suggestions,” said Urick. “We expect to further enhance and customize our website to fit the evolving needs of plan participants, employers, health care providers, and pharmacists.”