Lives are at risk because the U.S. Food and Drug Administration is woefully behind in the latest scientific advances and is underfunded for its vast responsibilities, an expert panel will tell the FDA on 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and Mission at Risk," which has been posted online, officials will hear that inadequate staffing and poor retention, out-of-date technology and a general lack of resources mar the agency's ability to do its job.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 U.S.
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 experts from government, industry and academia, the group will present its findings to top FDA officials, including Commissioner Andrew Von Eschenbach, at a public meeting on Monday in Maryland.
Heightened scrutiny of the FDA in recent years stems from high-profile recalls of pharmaceuticals — including Merck & Co Inc's Vioxx, belatedly tied to increased risk of heart attack — and from its handling of food scares such as one involving tainted bagged spinach.
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 warned.
System in crisis
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 charged.
Public health is at risk as "reports of product dangers are not rapidly compared and analyzed, inspectors' reports are still hand written," the report said.
Poor retention of critical staff 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."