Dec 5, 2007 (CIDRAP News) Safety inspectors still write their reports by hand, food processing plants are inspected once every 10 years at best, only two people work full-time on pet-food safety, and critical information is locked up in piles of warehoused paper documents.
Those are a few symptoms of the poor condition in which the US Food and Drug Administration (FDA) finds itself after decades of inadequate funding and growing responsibilities, according to a new report by a special FDA committee that was assigned to assess the agency's scientific and technological capabilities.
The bottom line is that "American lives are at risk," says the 60-page report, titled "FDA Science and Mission at Risk: Report of the Subcommittee on Science and Technology."
The report says the agency is losing its ability to keep up with scientific advances, its regular staff has stayed about the same size for 20 years, and its information technology (IT) systems are obsolete and unreliable.
"We found that FDA's resource shortfalls have resulted in a plethora of inadequacies that threaten our societyincluding, but not limited to, inadequate inspections of manufacturers, a dearth of scientists who understand emerging new technologies, inability to speed the development of new therapies, an import system that is badly broken, a food supply that grows riskier each year, and an information infrastructure that was identified as a source of risk in every Center and program reviewed by the Subcommittee," the report states.
The report suggests the agency may need as much as twice its current level of funding to equip it properly to fulfill its mission.
The document's release comes less than a month after the Bush administration released an import safety and food protection plan triggered by a series of tainted imports, including contaminated pet food and toys with lead paint, plus recent domestic food contamination episodes, such as instances of Salmonella in peanut butter and E coli in fresh produce.
The FDA' s mission includes regulating about 80% of food sold in the United States, plus all drugs, human vaccines, and medical devices, the report notes. The products the agency regulates account for about 25 cents of every consumer dollar spentabout $1 trillion per year.
A year ago, FDA Commissioner Andrew von Eschenbach asked his advisory board, called the FDA Science Board, to name a subcommittee to weigh whether the agency has the scientific and technologic capacity to support its regulatory mandate, the report says. The subcommittee that was subsequently appointed included three members of the Science Board and other experts representing industry, academia, and other government agencies.
Soaring demands, static funds
The subcommittee found two reasons for the "precarious" condition of science at the FDA:
- The demands on the agency have soared because of "the extraordinary advance of scientific discoveries, the complexity of the new products and claims submitted to FDA for pre-market review and approval, the emergence of challenging safety problems, and the globalization of the industries that FDA regulates."
- Funding has not kept pace with the scientific demands on the agency.
The funding shortage has forced the FDA to operate in a crisis-management or "firefighting" mode and kept it from building "a culture of proactive regulatory science," the report says. This is especially true of the agency's two food safety centers, the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM).
Crisis management at the two 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, provide effective routine surveillance, and conduct emergency outbreak investigation activities to protect the food supply," the document reads.
It says the FDA needs a group of scientists who have the ability, freedom, and support to apply the latest tools of biology, chemistry, and bioinformatics to food safety regulation. "These individuals must be isolated from acute regulatory crises."
Food inspections 'appallingly' rare
The subcommittee found the FDA has "an appallingly low inspection rate" for both domestic and imported foods. "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 rapidly increased. FDA estimates that, at most, it inspects food manufacturers once every 10 years," and it inspects no retail food stores or farms.
As an example of problems caused by scanty funding, the report cites the US experience with bovine spongiform encephalopathy (BSE), or mad cow disease. When BSE emerged in Europe, consumers and the cattle industry looked to the FDA to ensure that the disease would not spread to the United States via cattle feed, which the FDA regulates. "But Agency officials were denied the funds to bring the feed industry into rapid compliance with the new feed regulations, and the disease did appear in the US," the report says. (The first US case, found in December 2003, was in a Canadian-born cow; two more cases have been discovered since then, one in 2005 and one in 2006.)
The recent problems with imported pet food contaminated with the chemical melamine also point up the FDA's struggles, the panel reported. Pet food sales total $15 billion to $20 billion a year, and the CVM received more than 18,000 phone calls about the melamine contaminationbut the CVM "is able to devote only two people working full-time on pet food issues."
The authors recommend that the food safety centers collaborate more with other research programs, such as those of the Centers for Disease Control and Prevention, National Institutes of Health, and Department of Homeland Security. However, the centers still need their own scientific expertise, the report says.
Overall, the FDA doesn't have enough well-trained scientists, the report asserts. The number of "appropriated personnel" is about the same now as it was two decades ago, resulting in "major gaps of scientific expertise in key areas." The turnover rate for FDA scientists in key areas is twice that of other government agencies, and the agency spends too little on professional development to enable the staff to keep pace with scientific advances.
The agency should add several new positions to boost its scientific firepower and provide for a "coherent scientific structure and vision," the report says. First, the recently created position of deputy commissioner/chief medical officer should be broadened and renamed "deputy commissioner of scientific and medical affairs." This person should have authority to develop and oversee all science activities and ensure the adequacy of scientific expertise. Other recommended new jobs include chief scientific officer, a deputy director for science within each FDA center, and a director of extramural collaborations and training.
IT systems disturbingly poor
The report saves some of its strongest language for critiquing the FDA's IT infrastructure. The panel was "extremely disturbed" by the condition of the IT systems. The report continues, "The IT situation at FDA is problematic at bestand at worst it is dangerous. . . . Systems fail frequently, and even small systems are unstablemost recently during an E. coli food contamination investigation.
"More importantly, reports of product dangers are not rapidly compared and analyzed, inspectors' reports are still handwritten and slow to work their way through the compliance system, and the system for managing imported products cannot communicate with Customs and other government systems."
Because of inadequate backup systems, recent systems failures have erased FDA data, the report continues. Further, "Critical data reside in large warehouses sequestered in piles and piles of paper documents" for which there is no backup.
The report lists various estimates by others of the resources needed to restore the FDA's scientific capabilities. For example, the Coalition for a Stronger FDA has said that an increase of 15% a year for the next 5 years is needed. But the authors submit that this still would be inadequate. They suggest doubling the current fundingfrom about 1.5 cents to 3 cents per American per day. (Assuming a US population of 300 million, that would mean raising the budget from about $1.64 billion to $3.28 billion.)
Full text of "FDA Science and Mission at Risk" (appendices not included)
Nov 7 CIDRAP News story "Food safety plan taps others for inspection help"