USA Today published two articles about food safety for this weekend’s USA Today. In the first article, titled, "Report: FDA so underfunded, consumers are put at risk," Julie Schmidt reports on a report that was released by an advisory panel to the FDA which concludes:
The Subcommittee concluded that science at the FDA is in a precarious position: the Agency suffers from serious scientific deficiencies and is not positioned to meet current or emerging regulatory responsibilities.
The Subcommittee found that the deficiency has two sources:
- The demands on the FDA have soared due to 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.
- The resources have not increased in proportion to the demands. The result is that the scientific demands on the Agency far exceed its capacity to respond. 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 Subcommittee further noted that the impact of the deficiency is profound precisely because science is at the heart of everything FDA does. The Agency will flounder and ultimately fail without a strong scientific foundation. That foundation rests on three pillars. The first pillar is strong selective scientific research programs that are appropriately mission-supportive, in all areas of FDA responsibility. This research is critical because it is not conducted by other public or private entities, but is fundamental to the discharge of FDA’s statutory responsibilities to protect and promote the public health. The second pillar is excellent staff with cutting-edge scientific expertise appropriate to the mission. This expertise includes the ability to access, understand and evaluate science; effectively apply this science to the regulatory process; and communicate the implications of its findings for product safety and efficacy to the public. The third pillar is an information infrastructure and processing capability that ensures the FDA has access to the best data and information necessary to support the regulatory science required to fulfill FDA’s mission.
The USA Today article provides more background on the report, and highlights deficiencies identified by the advisory committee:
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.
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•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.
As Bill Marler stated on his blog post titled, "Government Puts Consumers At Risk":
The report says Congress has given the FDA more responsibilities over the past two decades, but no funds to cover the extra work. Meanwhile, the agency hasn’t been able to recruit the sophisticated scientific expertise needed to oversee complex medicines and food. The report says the FDA needs at least an extra 350 million dollars to address drug safety, and 450 million more dollars to improve food safety. Actually, the same holds true for the USDA. Just in the last two months we have seen the USDA move slowly on the Topps recall, putting people at risk, and then we see them announce one day that the USDA is getting tough on Canadian E. coli imports, only to turn around quietly and stop testing a week later.
His comments are along the lines of another USA Today article’s topic – the USDA. Julie Schmidt partnered with Barbara Hansen to write, "Most recalled meat is never recovered, likely is eaten," an article about meat recalls conducted by the United States Department of Agriculture. In the article, Schmidt and Hansen describe the current recall process and point out inefficiencies that result in ineffective recalls.
A particularly alarming statistic pointed out in the article is that ,"for five recalls that followed reports of consumer illness, recovery rates per recall averaged just 20%," which means that most of the meat recalled had already been eaten or was in consumers’ freezers but never made it back to the manufacturer. Improvements in the recall process are expected to come, but what is most promising in the short-term is, as reported:
To get more consumers to check homes for recalled meats, the USDA next year plans to publicize names of retailers selling meat that was later recalled. "We think it would be helpful for people to know, ‘Gee, that is my store,’ " says Petersen.
Recall notices now posted on the USDA’s website typically name states where a product was sent but not retailers, unless their names are on the product. Retailer names have been considered confidential business information, as with any customer lists.
While much more must be done to improve our food safety system, the FDA report and USDA’s proposed improvements to the recall process are baby steps in the right direction.