Tools for the FDA
TAINTED BATCHES of the blood-thinning drug heparin killed 81 people in the United States and exposed glaring weaknesses in the ability of the Food and Drug Administration to ensure that pharmaceuticals and other products entering the country are safe. In response, Congress was eager to give the agency funds to improve its overseas monitoring. But top officials repeatedly refused to ask for the needed funds.
That changed on May 5, when FDA Commissioner Andrew von Eschenbach responded to the latest entreaty -- this time a May 1 letter from Sen. Arlen Specter (R-Pa.) -- by requesting $275 million in additional funding. The money would go to increasing inspections, opening more offices abroad and devising new systems to track contaminants, share intelligence with other regulatory agencies and alert consumers, among other things, in the areas of food protection, safer drugs and devices, and agency modernization.
The FDA's cash crunch is well known. President Bush asked for a $50.7 million increase in the agency's budget over this year's, raising the total annual budget to $1.77 billion. But with unfunded costs of $34.3 million in fiscal 2009, the net increase is just $16.4 million.
What finally liberated Dr. von Eschenbach from his monetary muteness was a term of art used in Mr. Specter's letter. By asking the FDA commissioner for his "professional judgment," Mr. Specter freed Dr. von Eschenbach from having to worry about compromising the established budget process or competing with the priorities of the agency, the president or his advisers. The $275 million enumerated in the FDA letter to Mr. Specter became the foundation of a bill two days later from Sen. Herb Kohl (D-Wis.), chairman of the Senate Appropriations subcommittee with jurisdiction over the agency.
Janet Woodcock, director of the agency's Center for Drug Evaluation and Research, told a committee hearing last month that the FDA is an underfunded, 20th-century domestic agency struggling to protect American consumers in a globalized, 21st-century world. The Kohl measure would bring the agency closer to getting the tools it needs.