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Inadequate staffing, poor retention, out-of-date technology and a lack of resources mar the FDA's ability, the report by a subcommittee of the agency's Science Board said.
"FDA's inability to keep up with scientific advances means that American lives are at risk," the report said.
The U.S. Congress passed more than 100 laws expanding the FDA's authority since 1988, but has not increased the funding appropriately, the report found.
The FDA lacks a coherent scientific structure and vision as a result of weak organizational infrastructure (Finding 3.1.4). Strong scientific leadership is needed at all levels to develop a new vision to build a strong science base within the Agency, and in parallel, this leadership must establish optimal mechanisms to access the best scientific knowledge and expertise from throughout the government, academia and industry. Consistent and rigorous peer reviews of programs and processes, which are currently lacking, are critical for wise utilization of resources and for rebuilding the Agency’s ability to implement its science-based regulatory responsibilities effectively.
The IT situation at FDA is problematic at best — and at worst it is dangerous. Many of the FDA systems reside on technology that has been in service beyond the usual life cycle. Systems fail frequently, and even email systems are unstable — most recently during an E.coli food contamination investigation.
Finding: FDA does not have the capacity to ensure the safety of food for the nation.
The Subcommittee found that FDA’s ability to provide its basic food system inspection, enforcement and rulemaking functions is severely eroded, as is its ability to respond to outbreaks in a timely manner and to develop and keep pace with the new regulatory science needed to prevent future problems arising from both novel (prion disease, genetically modified organism) and traditional (resistant microbes, chemical contamination) sources.
There is an appallingly low inspection rate: the FDA cannot sufficiently monitor either the tremendous volume of products manufactured domestically or the exponential growth of imported products.
During the past 35 years, the decrease in FDA funding for inspection of our food supply has forced FDA to impose a 78 percent reduction in food inspections, at a time when the food industry has been rapidly expanding and food importation has exponentially increased.
FDA estimates that, at most, it inspects food manufacturers once every 10 years, and cosmetic manufacturers even less frequently. The Agency conducts no inspections of retail food establishments or of food-producing farms.
Finding: The FDA lacks the information science capability and information infrastructure to fulfill its regulatory mandate.
Finding: The FDA cannot provide the information infrastructure support to regulate products based on new science.