Report paints bleak picture of FDA IT, resources, science

The Food and Drug Administration is so underfunded that it does not have the science foundation, staff or information technology to meet mounting demands to oversee the country’s drugs, medical devices and food safety, FDA’s Science Board said in a report released Nov. 29. The Science Board, an advisory group of academics, industry and government experts to FDA Commissioner Andrew von Eschenbach, painted a picture of an agency that lacks resources. The country’s food supply and the regulatory systems that oversee the drug and device supplies are at risk, a board subcommittee said in a report it expected to present today to FDA. The situation is the result of soaring demands on FDA and resources that have not increased proportionately, the panel said. “This imbalance is imposing a significant risk to the integrity of the food, drug, cosmetic and device regulatory system, and hence the safety of the public,” the report states. The report is the product of a yearlong review by the board’s Science and Technology Subcommittee. FDA, an agency of the Health and Human Services Department, also plays a central role in protecting the country from the potential effects of terrorist attacks. The subcommittee urged funding to support the agency's scientific base, hiring  a broadly capable scientific workforce and building a sophisticated, modern information technology infrastructure. Past reviews also pointed to FDA’s underfunding. The subcommittee found substantial weaknesses across the agency. “In contrast to previous reviews that warned crises would arise if funding issues were not addressed, recent events and our findings indicate that some of those crises are now realities and American lives are at risk,” the panel stated in the report. The deficiencies’ effect is profound because science is at the heart of what FDA does, the subcommittee stated, adding that the agency will fail without a strong scientific foundation. “FDA cannot fulfill its mission because its scientific base has eroded and its scientific organizational structure is weak,” the subcommittee found. Crisis management in FDA’s two food safety centers, the Center for Food Safety and Applied Nutrition and the Center for Veterinary Medicine, has drawn attention and resources away from the agency’s ability to develop the science base and infrastructure needed to support innovation in the food industry, provide effective routine surveillance and conduct emergency outbreak investigation activities, the subcommittee said. “Due to constrained resources and lack of adequate staff, FDA is engaged in reactive regulatory priority setting or a fire-fighting regulatory posture instead of pursuing a culture of proactive regulatory science,” the subcommittee said. This is particularly true for the two centers, which are in a state of crisis. FDA cannot adequately monitor development of food and medical products because it can’t keep up with scientific advances, it added. The subcommittee said it was “extremely disturbed” at the state of FDA’s IT infrastructure. Although progress is being made to improve information sciences and technology, the subcommittee found that FDA lacks the IT infrastructure necessary to meet its mandate. It also found that the agency has insufficient access to data and cannot effectively regulate products based on new science due to lack of a supportive IT infrastructure. “The FDA IT infrastructure is obsolete, unstable and lacks controls to execute effective disaster recovery protocols that ensure continuity of operations when systems are compromised,” the report states. “The IT situation at FDA is problematic at best — and at worst it is dangerous.” The panel also found that many of FDA’s systems reside on technology that has been in service b eyond the usual life cycle  and that systems fail frequently and even e-mail systems are unstable — most recently during an E.coli food contamination investigation. Other findings include reports of product dangers are not rapidly compared and analyzed, inspectors’ reports are handwritten and slow to move through the compliance system and the system for managing imported products cannot communicate with customs and other government systems. The panel also stated that there are inadequate emergency backup systems in place and recent system failures have resulted in loss of FDA data. Critical data reside in large warehouses sequestered in piles of paper documents. There is no backup of these records, which include valuable clinical trial data. The subcommittee found that despite the significant increase in workload during the past two decades, in 2007 the number of appropriated personnel remained essentially the same, resulting in major gaps of scientific expertise in key areas. And despite the critical need for a highly trained workforce, FDA faces substantial recruitment and retention challenges. The turnover rate in FDA science staff in key scientific areas is twice that of other government agencies. There is insufficient investment in professional development, which means that the workforce does not keep up with scientific advances FDA said it appreciated the insights from the subcommittee and recognized the effort that went into the research and drafting of the report. “The Science Board agreed to provide further review of high-priority scientific programs needed by the agency, the role of the National Center for Toxicological Research, and the scientific capacity and processes of the FDA’s Office of Regulatory Affairs,” said FDA spokeswoman Karen Riley. The Science Board also will seek comments on the report from FDA leaders and the public.