The Food and Drug Administration is so underfunded and understaffed that it's putting U.S. consumers at risk in terms of food and drug safety, an advisory panel to the FDA says in a report to be discussed Monday.
The report — developed in the past year by experts from academia, industry and other government agencies — delivers a scathing review of the state of the FDA, which regulates 80% of the nation's food, its drugs, vaccines and medical devices.
The report details a "plethora of inadequacies" in the agency, including:
•Inadequate inspections of manufacturers, noting that foodmakers, for example, are inspected about once every 10 years.
•A "badly broken" food-import system and food supply "that grows riskier each year." In the past 35 years, FDA inspections of the food supply have dropped 78% due to soaring numbers of products and inadequate FDA funding.
•A depleted FDA staff, which is about the same size as it was 15 years ago despite huge growth in agency responsibilities. Instead of being proactive, the agency is often in "fire-fighting" mode.
•A workforce with a "dearth" of scientists who understand emerging technologies. Turnover rates in some scientific positions at the FDA run twice that of other government agencies.
•An "obsolete" information-technology system.
The report says that the FDA's IT systems are so lacking that reports of product dangers are not rapidly compared and analyzed, and that inspectors' reports are handwritten and slow to move through the system. The IT systems have resulted in lost FDA data and lack backup systems. "Piles and piles" of paper documents are in warehouses with no backup, including clinical trial data.
The report echoes concerns put forth before by others, including the Institute of Medicine; the Government Accountability Office, the investigative arm of Congress; and congressional committees.
Previous reports by FDA advisory boards — which are made up of independent experts — have voiced similar concerns, the report said. But those boards warned that crises would arise if funding issues weren't addressed, the report said. "Some of those crises are now realities, and American lives are at risk," the report said.
The advisers traced the long list of ailments to chronic underfunding and a continual expansion of FDA duties. While the FDA regulates 80% of America's food, it receives about one-third of the nation's food-safety budget; the U.S. Department of Agriculture gets the rest.
Many, including industry groups and some lawmakers, have pushed for greater FDA funding. The Coalition for a Stronger FDA is co-chaired by the last three secretaries of Health and Human Services, which oversees the FDA. The coalition says the FDA needs a 15% boost in funding per year for the next five years.
The report, "FDA Science and Mission at Risk," says all estimates so far are too low. It says U.S. consumers pay about 1.5 cents per day for the FDA and that 3 cents per day would not be "a great price to pay" to ensure food and drug safety.
The FDA declined to comment on the report, which will be discussed today at a meeting of the full science advisory board, of which the subcommittee that wrote the report is part. The FDA has said it won't make any immediate changes based on the report. In addition to advocating for increased funding, the report recommends that the FDA, among other things, invest in IT, centralize science programs, create new science directors and hire more high-quality talent.
The subcommittee included: Allen Roses of Duke University, an expert in neurology; Gail Cassell, a vice president of Eli Lilly; and Barbara McNeil, a public health policy expert at Harvard Medical School.
William Hubbard, a former FDA associate commissioner who supports the Coalition for a Stronger FDA, says the report stands out because of the "intensity of the feelings" expressed by the subcommittee.
"These people were horrified by what they found," he says. While the subcommittee was supposed to look ahead to where the FDA needs to be, Hubbard says it came away concluding that "it cannot even do its job now."