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While alarms were being sounded on Capitol Hill about the dire state of the FDA after a recent Science Board report said American lives are at risk, and a Government Accountability Office (GAO) investigation confirmed the agency's incapacity to intercept contaminated medical imports, the Bush administration in February proposed a 5.7% budget increase. Last year, the FDA got an 11% increase.

The new budget request, sure to be dismembered in the Congress, was immediately assailed by critics, including highly regarded former FDA associate commissioner for policy William Hubbard. Speaking for the Alliance for a Stronger FDA, he said: “The amount in the administration's proposed budget is not only inadequate, it is barely half of what FDA needs just to keep pace with inflation.”

The unreality straddling the political divide on Super Tuesday Eve had commissioner Andrew von Eschenbach, a Bush family friend, loyally declaring that the budget request “enables us to continue development of the staff and programs necessary to safeguard the food we eat and improve the safety and development of drugs, vaccines, devices, and other medical products.” Characteristically, the agency offered no details to substantiate this Alice in Wonderland assessment.

Presumably motivated by the Science Board and GAO findings, Rep. Henry Waxman (D-CA) and Sen. Edward Kennedy (D-MA) had earlier written the GAO seeking a top-to-bottom resource review of the FDA, including an examination of its thinning staff and other resources necessary for it to oversee foods, drugs, biologics and devices.

The FDA is in crisis. But, given the highly charged political climate through November and this commissioner's partisanship, expect the agency's woes to deepen, along with the public's unhappiness with it.

Dickinson is editor of Dickinson's FDA Webview (fdaweb.com)

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