Saturday, Dec. 8, 2007 | 7:26 a.m.
A report presented this week by a U.S. Food and Drug Administration subcommittee says that a combination of factors - the agency's poor funding, lack of modern computer technology and inadequate scientific staff - seriously imperils the health of the American public.
The report released Monday was created at the direction of FDA Commissioner Andrew Von Eschenbach, who had instructed the agency's Science Board to evaluate failings that have included the recent recalls of tainted foods and prescription drugs.
The report, "FDA Science and Mission at Risk," says Congress has greatly expanded the FDA's authority and the products under its review over the past 20 years but has not increased funding accordingly.
What's more, the report says, the FDA's record-keeping and computer systems practically operate in a technological stone age. The agency's aging computer system lacks adequate backup applications, resulting in the loss of some FDA data.
In addition, the report says, the public is placed at serious health risk because "reports of product dangers are not rapidly compared and analyzed, and inspectors' reports are still handwritten." The report cites "piles and piles" of documents - including clinical trial data - that remain stored in warehouses.
The FDA also lacks adequate staffing in both numbers and level of scientific expertise.
The committee recommends increasing funding to improve the agency's technology and to hire - and retain - more scientists. The FDA's scientists leave the agency at a rate twice that of other federal agencies, the committee said. The $2.1 billion the FDA has requested in 2008 - a 5 percent increase over 2007 funding - is not enough to make these needed changes, the committee says.
In an age when even preschoolers own computers, it is hard to fathom that the agency responsible for ensuring the safety of 80 percent of the nation's food supply and 100 percent of its drugs and medical devices continues to file scientific reports by hand. Still, simply throwing more money at the FDA's problems isn't going to solve them.
Congress must demand that the agency refocus its energies on science by naming a director to oversee such work and finding ways to hire, and keep, good scientists on staff. The FDA's job is too important and its failings could have consequences that are too detrimental to accept anything less.
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