WASHINGTON - Lives are at risk because the US Food and Drug Administration is woefully behind in the latest scientific advances and is under funded for its vast responsibilities, a specialist panel will tell the FDA next Monday.
In a 56-page report titled "FDA Science and Mission at Risk," which has been posted online, officials will hear that inadequate staffing and poor retention, out-of-date technology, and a general lack of resources mar the agency's ability to do its job.
The FDA regulates products ranging from pharmaceuticals and medical devices to food and cosmetics, representing about $1 trillion, or a quarter of every dollar spent in the United States.
The FDA's chief commissioned the report to assess whether its scientific expertise can support its regulatory mission.
"FDA's inability to keep up with scientific advances means that American lives are at risk," said the report, written by a subcommittee to the Science Board, an expert advisory group.
Made up of specialists from government, industry, and academia, the group will present its findings to top FDA officials, including Commissioner Andrew Von Eschenbach, at a public meeting Monday in Maryland.
Heightened scrutiny of the FDA in recent years stems from high-profile recalls of pharmaceuticals - including
The FDA's ever-expanding responsibilities have not been matched by adequate resources, the report said, a frequent criticism of the agency's effectiveness.
The agency is requesting $2.1 billion in its fiscal year 2008 budget, a 5.3 percent increase over the current budget.
"Without a significant increase in resources," the "recommendations will be superfluous," the report said.
The report calls out the FDA's poor track record in regulating the safety of the food supply, noting a systems failure during a recent e. coli food contamination inquiry.
"Crisis management in FDA's two food safety centers . . . has drawn attention and resources away from FDA's ability to develop the science base and infrastructure needed to efficiently support innovation in the food industry," it said.
The FDA's regulatory priorities are "reactive," especially in the food safety units, the report said.
Public health is at risk as "reports of product dangers are not rapidly compared and analyzed, inspectors' reports are still hand written," it stated.
Poor retention of critical employees was faulted. The report noted the turnover rate of the science staff is twice that of other government agencies.
The agency lacks a good system of talking to scientists outside the agency, "thus limiting infusion of new knowledge and missing opportunities to leverage resources," it said.
The panel "was extremely disturbed" at the state of the agency's information technology infrastructure, calling it the "weakest but most critical link."
