While alarms were being sounded on Capitol Hill about thedire state of the FDA after a recent Science Board report said American livesare at risk, and a Government Accountability Office (GAO) investigationconfirmed 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 theCongress, was immediately assailed by critics, including highly regarded formerFDA associate commissioner for policy William Hubbard. Speaking for theAlliance for a Stronger FDA, he said: “The amount in the administration’sproposed budget is not only inadequate, it is barely half of what FDA needsjust to keep pace with inflation.”
The unreality straddling the political divide on SuperTuesday Eve had commissioner Andrew von Eschenbach, a Bush family friend,loyally declaring that the budget request “enables us to continue developmentof the staff and programs necessary to safeguard the food we eat and improvethe safety and development of drugs, vaccines, devices, and other medicalproducts.” Characteristically, the agency offered no details to substantiatethis 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 theGAO seeking a top-to-bottom resource review of the FDA, including anexamination of its thinning staff and other resources necessary for it tooversee foods, drugs, biologics and devices.
The FDA is in crisis. But, given the highly chargedpolitical climate through November and this commissioner’s partisanship, expectthe agency’s woes to deepen, along with the public’s unhappiness with it.
Dickinson is editor of Dickinson’s FDA Webview (fdaweb.com)
From the March 01, 2008 Issue of MM+M - Medical Marketing and Media
