Fda On The Brink

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The chief culprit, says this study and others, is a lack of funding for an agency that oversees 80 percent of what 300 million Americans eat and drink, as well as 100 percent of drugs, vaccines, and medical devices for people, pets, and livestock.

These products account for 25 cents of every dollar spent by Americans, $1 trillion total, yet the F.D.A.'s budget in real terms has declined by $300 million since 1988.

This year, the budget is $1.6 billion—$5.50 a year per American. That is less than the cost of a movie or a couple of bags of spinach at Safeway.

In short, the demands placed on the agency far exceed its ability to meet them, a shortfall that places "American lives at risk," the subcommittee concludes.

"This report is like a warning that says a bridge is about to collapse; the question is, will people listen to it?" says Nancy Myers, a former senior strategic adviser to the F.D.A. commissioner. She's also on the board of the F.D.A. Alliance, a group that includes six ex-commissioners and 121 patient-advocacy groups, nonprofits, companies, and trade associations.

The alliance has pointed out that the F.D.A.'s budget is about the same as what is spent on public schools in Montgomery County, Maryland, where the agency is based. The F.D.A.'s budget is the equivalent of three days of U.S. expenditures on the Iraq war.

Compare this with the nearly $100 billion spent on public and private research and development in medicine, just one of the F.D.A.'s purviews. Private R&D spending has nearly tripled in 20 years, while the agency's annual allotment has remained flat.

"We found that F.D.A.'s resource shortfalls have resulted in a plethora of inadequacies that threaten our society," the report concludes, "including, but not limited to, inadequate inspections of manufacturers, a dearth of scientists who understand emerging new technologies, inability to speed the development of new therapies, an import system that is badly broken, a food supply that grows riskier each year, and an information infrastructure that was identified as a source of risk in every center and program reviewed by the subcommittee."

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