FDA Underfunding, Understaffing Putting Consumers at Risk, Report SaysDec 4, 2007 | Parker Waichman LLP
A Food and Drug Administration (FDA) advisory panel report-"FDA Science and Mission at Risk"-being discussed today says that the agency is so underfunded and understaffed, it's putting US consumers at risk. The report, developed in the past year by experts from academia, industry, and other government agencies, delivers a scathing review of the FDA, an agency that regulates 80% of the nation's food, drugs, vaccines, and medical devices. The report echoes ongoing concerns from groups such as the Institute of Medicine; the Government Accountability Office, the investigative arm of Congress; and Congressional committees. Under these circumstances, the FDA cannot be expected to protect Americans from defective drugs and other products.
The report details numerous problems at the FDA. For instance, inadequate inspections of manufacturers. Foodmakers, for example, are inspected about once a decade and over the past 35 years, FDA inspections of the food supply have dropped 78% due to a rising number of products coupled with inadequate funding. There is also the issue of a depleted staff, about the same size as it was 15 years ago, despite huge growth in agency responsibilities. Short staffing does not enable the FDA to be proactive and a dearth of scientists due to high turnover rates in some scientific positions at the FDA leaves few who understand emerging technologies.
The FDA is also using an obsolete information technology (IT) system. Its IT systems are so lacking that product danger reports are not rapidly compared and analyzed; inspectors' reports are handwritten and slow to move through the system, and a lack of backup systems have resulted in lost files. Huge amounts of paper are warehoused with no backup and include clinical trial data.
Previous reports by the FDA advisory board, comprised of independent experts, echoed similar concerns, warning that crises would arise if funding wasn't addressed. Crises are realities and American consumers are at risk. Advisers traced problems to chronic underfunding and ongoing increases in FDA responsibilities: The FDA regulates 80% of America's food, yet receives about 30% of the nation's food-safety budget. The U.S. Department of Agriculture (USDA) receives the remainder of the funding.
Industry groups and lawmakers have pushed for increased funding and the Coalition for a Stronger FDA-co-chaired by the last three secretaries of Health and Human Services, which oversees the FDA-states the FDA needs an additional and yearly 15% boost over the next five years. The report states estimates are too low; American consumers pay less than two cents per day for the FDA and three cents per day in considered reasonable to ensure food and drug safety. As well as advocating for funding, the report recommends that the FDA invest in IT, centralize science programs, create new science directors, and hire more quality talent.
The FDA declined to comment on the report and said it won't make any immediate changes based on the report. Those working on the FDA study were reportedly horrified by what they found. Apparently, the subcommittee was supposed to look ahead to where the FDA needs to be, but came away agreeing that the FDA is unable to do its job now.